Alprazolam is a short-acting drug in the benzodiazepine class used to treat anxiety disorders and as an adjunctive treatment for depression. Alprazolam was invented by Pfizer and is marketed under the trade name Xanax. Its patent expired in September 1993. Pharmacology Alprazolam is a triazolobenzodiazepine, that is, a benzodiazepine with a triazolo-ring attached to its structure. Alprazolam binds to the GABAA subtype of the GABA receptor, increasing inhibitory effects of GABA within the central nervous system. The binding site for benzodiazepines is distinct from the binding site for barbiturates and GABA on the GABA receptor. Unlike other benzodiazepines, alprazolam may also have some antidepressant activity, although clinical evidence of this is lacking. Pharmacokinetics The mechanism of action is not fully understood; However, Alprazolam is readily absorbed from the gastrointestinal tract. The peak plasma concentration is achieved in 1-2 hours. Most of the drug is bound to plasma protein, mainly albumin. Alprazolam is hydroxylated in the liver to ?-hydroxyalprazolam, which is also pharmacologically active. This and other metabolites are later excreted in urine as glucuronides. Some of the drug is also excreted in unchanged form. Indications alprazolam 2mg tablet bottleThe main medical uses for alprazolam include: Treatment of panic disorder, with or without agoraphobia. Alprazolam is very effective in preventing panic attacks. However, despite its efficacy, many psychiatrists are reluctant to use alprazolam for this condition because of the possibility of dependence and interdose ("breakthrough") anxiety due to its short-acting nature. An extended-release formulation of alprazolam known as Xanax XR® was introduced in 2001 and is often preferred. Treatment of panic attacks. Alprazolam is taken as needed (PRN); 4 to 6 doses per day are the acceptable limit. If dependence seems to develop and/or the limit is exceeded, therapy may be reconsidered and/or discontinued. Long-term treatment of severe generalized anxiety disorders. Alprazolam may be used for long-term treatment of anxiety if other therapies either do not work or are contraindicated. Duration of therapy in this case is often four months or longer. The decision to use alprazolam for this purpose must be carefully made by a specialized psychiatrist, taking into account the individual's suffering, quality of life, loss of social performance and risk of dependence. Adjunctive treatment of depression. SSRIs (e.g. sertraline or fluoxetine) are often co-administered with alprazolam at the outset of long-term SSRI anxiety treatment in order to counteract the initial anxiogenic (anxiety-producing) effects of SSRI treatment. Tricyclic antidepressants and buspirone are also used with alprazolam in refractory (resistant) cases of generalized anxiety disorder. Other uses. Alprazolam may be used by specialists to treat severe cases of Borderline Personality Disorder. Some studies have shown positive results. [edit] Availability Alprazolam is generally sold in generic form in the United States. It is also sold under many other brand names, depending on the country: Xanax® - United States, Australia, United Kingdom, Turkey, Portugal, Ireland, Greece, Hungary, Belgium, Croatia, Switzerland, Netherlands, Italy, New Zealand, Pakistan Xanax XR® - (an extended release formulation) United States, Israel[1] Frontal® - Brazil Frontal XR® - (an extended release formulation) Brazil Apraz® - Brazil Aceprax® - Uruguay Sedipral® - Paraguay Helex® - Slovenia, Croatia Niravam® - (formulary that dissolves on the tongue) United States Apo-Alpraz® - Canada (also made by other companies under different names) Xanor® - Finland, Philippines, South Africa, Sweden, Norway, Austria Kalma® - Australia Ralozam® - Australia Zamhexal® - Australia Alplax® - Argentina Alviz® - Indonesia Alzolam® - India, Malaysia Alprax® - India Tranax® - India Alpralid® - Israel Restyl® - Bahrain, Cyprus, Egypt, India, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Republic of Yemen, Saudi Arabia, Syria, United Arab Emirates Tranquinal® - Ecuador, Peru Trankimazin® - Spain Tafil® - Costa Rica, Denmark, El Salvador, Germany, Guatemala, Honduras, Mexico, Nicaragua, Panama, Venezuela Tafil AP® - (an extended release formulation) Mexico Constan® - Japan Solanax® - Japan Zolarem® - Bahrain, Benin, Burkina-Faso, Cyprus, Egypt, Ethiopia, Gambia, Ghana, Guinea, Iran, Iraq, Israel, Ivory Coast, Jordan, Kenya, Kuwait, Lebanon, Liberia, Libya, Malawi, Mali, Mauritania, Mauritius, Morocco, Niger, Nigeria, Oman, Qatar, Republic of Yemen, Saudi Arabia, Senegal, Seychelles, Sierra-Leone, South Africa, Sudan, Syria, Tanzania, Tunia, Uganda, United Arab Emirates, Zambia, Zimbabwe Zoldac® - Benin, Burkina-Faso, Ethiopia, Gambia, Ghana, Guinea, India, Ivory Coast, Kenya, Liberia, Malawi, Mali, Mauritania, Mauritius, Morocco, Niger, Nigeria, Senegal, Seychelles, Sierra-Leone, South Africa, Sudan, Tanzania, Tunia, Uganda, Zambia, Zimbabwe Calmax® - Ireland Frontin® - Slovakia and possibly other European countries Prazolex® - Romania Kinax® (???) - Taiwan Manorest® - Sri Lanka Ksalol® - Serbia [edit] Packaging Appearance is generally as follows in the United States. Alprazolam Inscriptions on tablet vary depending on manufacturer. .25 mg White oval tablet scored .5 mg Peach oval tablet scored (.5 mg Alprazolam may also be found in White round tablet scored) 1 mg Blue oval tablet scored 2 mg White rectangle multi-scored tablet. May also be called a Xanax XR® .5 mg White pentagonal tablet Imprinted "X /0.5" 1 mg Yellow square tablet Imprinted "X / 1" 2 mg Blue round tablet Imprinted "X / 2" 3 mg Green triangular tablet Imprinted "X / 3" Side effects Common side effects of alprazolam can include: Somnolence (drowsiness) Euphoria Confusion Less common side effects can include: Fatigue Headache Rare side effects can include: Sleep apnea Hypoventilation (Respiratory depression) Blurred vision Difficulty in depth perception Slurred speech or dysarthria Changes in personality Confusion Disorientation Amnesia (memory impairment) Vivid dreams and/or nightmares Jaundice Tachycardia Bradycardia Changes in plasma cortisol and ACTH levels Blood dyscrasias Decreased salivation Increased salivation Diarrhea Constipation Nausea Elevated hepatic (liver) enzymes Incontinence Rare paradoxical side effects can include: Nervousness Anxiety Agitation Rage Insomnia Muscle spasms and rigidity Paradoxical side effects are usually a result of too high a dose (sometimes deliberate) and/or combination with alcohol. Adjusting the dosage usually causes them to cease. Long-term treatment with alprazolam may lead to physical and/or psychological dependence. Users often develop a tolerance to the drug's sedative effects, though tolerance to its anxiolytic efficacy rarely develops when used at theraputic dosage levels. There is now a general consensus among many psychiatrists that alprazolam (a so-called 'high-potency' benzodiazepine) poses a particularly high risk for misuse, abuse and dependence. Withdrawal after long-term treatment should be done slowly over a period of weeks (or even months) to avoid serious withdrawal symptoms such as agitation, panic attacks, rebound anxiety, muscle cramps and seizures. Some patients may benefit from a substitution with diazepam or clonazepam as these drugs remain in the bloodstream longer and have a somewhat lower risk of dependency. Contraindications Use of alprazolam should be avoided in individuals with the following conditions: Myasthenia gravis Acute intoxication with alcohol, narcotics, or other psychoactive substances Ataxia Severe hypoventilation Acute narrow-angle glaucoma Severe liver deficiencies (e.g. hepatitis and cirrhosis) Severe sleep apnea Hypersensitivity or allergy to any drug in the benzodiazepine class Patients at a High Risk for Abuse and Dependence At a particularly high risk for misuse, abuse, and dependence are: Patients with a history of alcohol or drug abuse and/or dependence Emotionally unstable patients Patients with severe personality disorders Patients with chronic pain or other physical disorders Patients from the aforementioned group should be monitored very closely during therapy for signs of abuse and development of dependence. Discontinue therapy if any of these signs are noted. Long-term therapy in these patients is not recommended. alprazolam 2mg tabletsAlprazolam, like all benzodiazepines, has the potential for abuse, especially in individuals prone to addiction. Although it is not manufactured illegally, it is often diverted to the black market. The state of relaxation, anxiolysis, disinhibition and euphoria induced by benzodiazepines is the main reason for their illicit use. Injecting alprazolam is highly dangerous. When crushed in water, it will not dissolve, potentially causing severe damage to arteries. While it is somewhat soluble in alcohol, the combination of the two, particularly when injected, can easily cause a serious (and potentially fatal) overdose. Alprazolam is sometimes used with other recreational drugs to relieve the panic or distress of dysphoric reactions to psychedelics such as LSD and also to promote sleep in the "come-down" period following use of recreational drugs with stimulant or insomniac properties (such as LSD, cocaine, amphetamines, DXM, and MDMA). It is also often used in conjunction with marijuana or heroin to potentiate the relaxing effect. Alprazolam is often combined with the drug Methadone to produce a unique, Heroin-like "high". It is also sometimes used by heroin addicts to suppress withdrawal symptoms. Insufflating alprazolam is another popular recreational method of administration. This method is short-acting, lasting anywhere from 30 minutes to 1 hour. Because of fillers, snorting the drug causes moderate nasal inflammation. Users should be very careful when snorting Alprazolam, as when up to 4mg has been insufflated, rare side-effects are more likely to become present. The three dominant ones being 'memory loss', 'loss of motor-function', and 'slurred speech'. [citation needed] Legal status In the United States, alprazolam is a prescription drug and is assigned to Schedule IV of the Controlled Substances Act by the Drug Enforcement Administration. Internationally, alprazolam is included under the United Nations Convention on Psychotropic Substances[3]. Alprazolam is a short-acting drug in the benzodiazepine class used to treat anxiety disorders and as an adjunctive treatment for depression. Alprazolam was invented by Pfizer and is marketed under the trade name Xanax. Its patent expired in September 1993. Pharmacology Alprazolam is a triazolobenzodiazepine, that is, a benzodiazepine with a triazolo-ring attached to its structure. Alprazolam binds to the GABAA subtype of the GABA receptor, increasing inhibitory effects of GABA within the central nervous system. The binding site for benzodiazepines is distinct from the binding site for barbiturates and GABA on the GABA receptor. Unlike other benzodiazepines, alprazolam may also have some antidepressant activity, although clinical evidence of this is lacking. Pharmacokinetics The mechanism of action is not fully understood; However, Alprazolam is readily absorbed from the gastrointestinal tract. The peak plasma concentration is achieved in 1-2 hours. Most of the drug is bound to plasma protein, mainly albumin. Alprazolam is hydroxylated in the liver to ?-hydroxyalprazolam, which is also pharmacologically active. This and other metabolites are later excreted in urine as glucuronides. Some of the drug is also excreted in unchanged form. alprazolam 2mg tablet bottleThe main medical uses for alprazolam include: Treatment of panic disorder, with or without agoraphobia. Alprazolam is very effective in preventing panic attacks. However, despite its efficacy, many psychiatrists are reluctant to use alprazolam for this condition because of the possibility of dependence and interdose ("breakthrough") anxiety due to its short-acting nature. An extended-release formulation of alprazolam known as Xanax XR® was introduced in 2001 and is often preferred. Treatment of panic attacks. Alprazolam is taken as needed (PRN); 4 to 6 doses per day are the acceptable limit. If dependence seems to develop and/or the limit is exceeded, therapy may be reconsidered and/or discontinued. Long-term treatment of severe generalized anxiety disorders. Alprazolam may be used for long-term treatment of anxiety if other therapies either do not work or are contraindicated. Duration of therapy in this case is often four months or longer. The decision to use alprazolam for this purpose must be carefully made by a specialized psychiatrist, taking into account the individual's suffering, quality of life, loss of social performance and risk of dependence. Adjunctive treatment of depression. SSRIs (e.g. sertraline or fluoxetine) are often co-administered with alprazolam at the outset of long-term SSRI anxiety treatment in order to counteract the initial anxiogenic (anxiety-producing) effects of SSRI treatment. Tricyclic antidepressants and buspirone are also used with alprazolam in refractory (resistant) cases of generalized anxiety disorder. Other uses. Alprazolam may be used by specialists to treat severe cases of Borderline Personality Disorder. Some studies have shown positive results. Availability Alprazolam is generally sold in generic form in the United States. It is also sold under many other brand names, depending on the country: Xanax® - United States, Australia, United Kingdom, Turkey, Portugal, Ireland, Greece, Hungary, Belgium, Croatia, Switzerland, Netherlands, Italy, New Zealand, Pakistan Xanax XR® - (an extended release formulation) United States, Israel[1] Frontal® - Brazil Frontal XR® - (an extended release formulation) Brazil Apraz® - Brazil Aceprax® - Uruguay Sedipral® - Paraguay Helex® - Slovenia, Croatia Niravam® - (formulary that dissolves on the tongue) United States Apo-Alpraz® - Canada (also made by other companies under different names) Xanor® - Finland, Philippines, South Africa, Sweden, Norway, Austria Kalma® - Australia Ralozam® - Australia Zamhexal® - Australia Alplax® - Argentina Alviz® - Indonesia Alzolam® - India, Malaysia Alprax® - India Tranax® - India Alpralid® - Israel Restyl® - Bahrain, Cyprus, Egypt, India, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar, Republic of Yemen, Saudi Arabia, Syria, United Arab Emirates Tranquinal® - Ecuador, Peru Trankimazin® - Spain Tafil® - Costa Rica, Denmark, El Salvador, Germany, Guatemala, Honduras, Mexico, Nicaragua, Panama, Venezuela Tafil AP® - (an extended release formulation) Mexico Constan® - Japan Solanax® - Japan Zolarem® - Bahrain, Benin, Burkina-Faso, Cyprus, Egypt, Ethiopia, Gambia, Ghana, Guinea, Iran, Iraq, Israel, Ivory Coast, Jordan, Kenya, Kuwait, Lebanon, Liberia, Libya, Malawi, Mali, Mauritania, Mauritius, Morocco, Niger, Nigeria, Oman, Qatar, Republic of Yemen, Saudi Arabia, Senegal, Seychelles, Sierra-Leone, South Africa, Sudan, Syria, Tanzania, Tunia, Uganda, United Arab Emirates, Zambia, Zimbabwe Zoldac® - Benin, Burkina-Faso, Ethiopia, Gambia, Ghana, Guinea, India, Ivory Coast, Kenya, Liberia, Malawi, Mali, Mauritania, Mauritius, Morocco, Niger, Nigeria, Senegal, Seychelles, Sierra-Leone, South Africa, Sudan, Tanzania, Tunia, Uganda, Zambia, Zimbabwe Calmax® - Ireland Frontin® - Slovakia and possibly other European countries Prazolex® - Romania Kinax® (???) - Taiwan Manorest® - Sri Lanka Ksalol® - Serbia Packaging Appearance is generally as follows in the United States. Alprazolam Inscriptions on tablet vary depending on manufacturer. .25 mg White oval tablet scored .5 mg Peach oval tablet scored (.5 mg Alprazolam may also be found in White round tablet scored) 1 mg Blue oval tablet scored 2 mg White rectangle multi-scored tablet. May also be called a "bar". Xanax XR® .5 mg White pentagonal tablet Imprinted "X /0.5" 1 mg Yellow square tablet Imprinted "X / 1" 2 mg Blue round tablet Imprinted "X / 2" 3 mg Green triangular tablet Imprinted "X / 3" Side effects Sleep apnea Hypoventilation (Respiratory depression) Blurred vision Difficulty in depth perception Slurred speech or dysarthria Changes in personality Confusion Disorientation Amnesia (memory impairment) Vivid dreams and/or nightmares Jaundice Tachycardia Bradycardia Changes in plasma cortisol and ACTH levels Blood dyscrasias Decreased salivation Increased salivation Diarrhea Constipation Nausea Elevated hepatic (liver) enzymes Incontinence Rare paradoxical side effects can include: Nervousness Anxiety Agitation Rage Insomnia Muscle spasms and rigidity Paradoxical side effects are usually a result of too high a dose (sometimes deliberate) and/or combination with alcohol. Adjusting the dosage usually causes them to cease. Long-term treatment with alprazolam may lead to physical and/or psychological dependence. Users often develop a tolerance to the drug's sedative effects, though tolerance to its anxiolytic efficacy rarely develops when used at theraputic dosage levels. There is now a general consensus among many psychiatrists that alprazolam (a so-called 'high-potency' benzodiazepine) poses a particularly high risk for misuse, abuse and dependence. Withdrawal after long-term treatment should be done slowly over a period of weeks (or even months) to avoid serious withdrawal symptoms such as agitation, panic attacks, rebound anxiety, muscle cramps and seizures. Some patients may benefit from a substitution with diazepam or clonazepam as these drugs remain in the bloodstream longer and have a somewhat lower risk of dependency. Contraindications Use of alprazolam should be avoided in individuals with the following conditions: Myasthenia gravis Acute intoxication with alcohol, narcotics, or other psychoactive substances Ataxia Severe hypoventilation Acute narrow-angle glaucoma Severe liver deficiencies (e.g. hepatitis and cirrhosis) Severe sleep apnea Hypersensitivity or allergy to any drug in the benzodiazepine class [edit] Patients at a High Risk for Abuse and Dependence At a particularly high risk for misuse, abuse, and dependence are: Patients with a history of alcohol or drug abuse and/or dependence Emotionally unstable patients Patients with severe personality disorders Patients with chronic pain or other physical disorders Patients from the aforementioned group should be monitored very closely during therapy for signs of abuse and development of dependence. Discontinue therapy if any of these signs are noted. Long-term therapy in these patients is not recommended. alprazolam 2mg tabletsAlprazolam, like all benzodiazepines, has the potential for abuse, especially in individuals prone to addiction. Although it is not manufactured illegally, it is often diverted to the black market. The state of relaxation, anxiolysis, disinhibition and euphoria induced by benzodiazepines is the main reason for their illicit use. Injecting alprazolam is highly dangerous. When crushed in water, it will not dissolve, potentially causing severe damage to arteries. While it is somewhat soluble in alcohol, the combination of the two, particularly when injected, can easily cause a serious (and potentially fatal) overdose. Alprazolam is sometimes used with other recreational drugs to relieve the panic or distress of dysphoric reactions to psychedelics such as LSD and also to promote sleep in the "come-down" period following use of recreational drugs with stimulant or insomniac properties (such as LSD, cocaine, amphetamines, DXM, and MDMA). It is also often used in conjunction with marijuana or heroin to potentiate the relaxing effect. Alprazolam is often combined with the drug Methadone to produce a unique, Heroin-like "high". It is also sometimes used by heroin addicts to suppress withdrawal symptoms. Insufflating alprazolam is another popular recreational method of administration. This method is short-acting, lasting anywhere from 30 minutes to 1 hour. Because of fillers, snorting the drug causes moderate nasal inflammation. Users should be very careful when snorting Alprazolam, as when up to 4mg has been insufflated, rare side-effects are more likely to become present. The three dominant ones being 'memory loss', 'loss of motor-function', and 'slurred speech'. [citation needed] Legal status In the United States, alprazolam is a prescription drug and is assigned to Schedule IV of the Controlled Substances Act by the Drug Enforcement Administration. Internationally, alprazolam is included under the United Nations Convention on Psychotropic Substances[3]. The ability of alprazolam to induce human hepatic enzyme systems has not yet been determined. However, this is not a property of benzodiazepines in general. Further, alprazolam did not affect the prothrombin or plasma warfarin levels in male volunteers administered sodium warfarin orally. In vitro, alprazolam is bound (80 percent) to human serum protein. Changes in the absorption, distribution, metabolism and excretion of benzodiazepines have been reported in a variety of disease states including alcoholism, impaired hepatic function and impaired renal function. Changes have also been demonstrated in geriatric patients. A mean half-life of alprazolam of 16.3 hours has been observed in healthy elderly subjects (range: 9.0-26.9 hours, n=16) compared to 11.0 hours (range: 6.3-15.8 hours, n=16) in healthy adult subjects. In patients with alcoholic liver disease the half-life of alprazolam ranged between 5.8 and 65.3 hours (mean: 19.7 hours, n=17) as compared to between 6.3 and 26.9 hours (mean=11.4 hours, n=17) in healthy subjects. In an obese group of subjects the half-life of alprazolam ranged between 9.9 and 40.4 hours (mean=21.8 hours, n=12) as compared to between 6.3 and 15.8 hours (mean=10.6 hours, n=12) in healthy subjects. Because of its similarity to other benzodiazepines, it is assumed that alprazolam undergoes transplacental passage and that it is excreted in human milk. INDICATIONS AND USAGE XANAX Tablets (alprazolam) are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of six months or longer, during which the person has been bothered more days than not by these concerns. At least 6 of the following 18 symptoms are often present in these patients: Motor Tension (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); Autonomic Hyperactivity (shortness of breath or smothering sensations; palpitations or accelerated heart rate; sweating, or cold clammy hands; dry mouth; dizziness or light-headedness; nausea, diarrhea, or other abdominal distress; flushes or chills; frequent urination; trouble swallowing or 'lump in throat'); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or `mind going blank' because of anxiety; trouble falling or staying asleep; irritability). These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor. Anxiety associated with depression is responsive to XANAX. XANAX is also indicated for the treatment of panic disorder, with or without agoraphobia. Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R criteria for panic disorder (see CLINICAL STUDIES ). Panic disorder is an illness characterized by recurrent panic attacks. The panic attacks, at least initially, are unexpected. Later in the course of this disturbance certain situations, eg, driving a car or being in a crowded place, may become associated with having a panic attack. These panic attacks are not triggered by situations in which the person is the focus of others' attention (as in social phobia). The diagnosis requires four such attacks within a four week period, or one or more attacks followed by at least a month of persistent fear of having another attack. The panic attacks must be characterized by at least four of the following symptoms: dyspnea or smothering sensations; dizziness, unsteady feelings, or faintness; palpitations or tachycardia; trembling or shaking; sweating; choking; nausea or abdominal distress; depersonalization or derealization; paresthesias; hot flashes or chills; chest pain or discomfort; fear of dying; fear of going crazy or of doing something uncontrolled. At least some of the panic attack symptoms must develop suddenly, and the panic attack symptoms must not be attributable to some known organic factors. Panic disorder is frequently associated with some symptoms of agoraphobia. Demonstrations of the effectiveness of XANAX by systematic clinical study are limited to four months duration for anxiety disorder and four to ten weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to eight months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient. CONTRAINDICATIONS XANAX Tablets are contraindicated in patients with known sensitivity to this drug or other benzodiazepines. XANAX may be used in patients with open angle glaucoma who are receiving appropriate therapy, but is contraindicated in patients with acute narrow angle glaucoma. XANAX is contraindicated with ketoconazole and itraconazole, since these medications significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP 3A) (see WARNINGS and PRECAUTIONS - Drug Interactions ). WARNINGS Dependence and withdrawal reactions, including seizures: Certain adverse clinical events, some life-threatening, are a direct consequence of physical dependence to XANAX. These include a spectrum of withdrawal symptoms; the most important is seizure (see DRUG ABUSE AND DEPENDENCE ). Even after relatively short-term use at the doses recommended for the treatment of transient anxiety and anxiety disorder (ie, 0.75 to 4.0 mg per day), there is some risk of dependence. Spontaneous reporting system data suggest that the risk of dependence and its severity appear to be greater in patients treated with doses greater than 4 mg/day and for long periods (more than 12 weeks). However, in a controlled postmarketing discontinuation study of panic disorder patients, the duration of treatment (three months compared to six months) had no effect on the ability of patients to taper to zero dose. In contrast, patients treated with doses of XANAX greater than 4 mg/day had more difficulty tapering to zero dose than those treated with less than 4 mg/day. The importance of dose and the risks of XANAX as a treatment for panic disorder: Because the management of panic disorder often requires the use of average daily doses of XANAX above 4 mg, the risk of dependence among panic disorder patients may be higher than that among those treated for less severe anxiety. Experience in randomized placebo-controlled discontinuation studies of patients with panic disorder showed a high rate of rebound and withdrawal symptoms in patients treated with XANAX compared to placebo treated patients. Relapse or return of illness was defined as a return of symptoms characteristic of panic disorder (primarily panic attacks) to levels approximately equal to those seen at baseline before active treatment was initiated. Rebound refers to a return of symptoms of panic disorder to a level substantially greater in frequency, or more severe in intensity than seen at baseline. Withdrawal symptoms were identified as those which were generally not characteristic of panic disorder and which occurred for the first time more frequently during discontinuation than at baseline. In a controlled clinical trial in which 63 patients were randomized to XANAX and where withdrawal symptoms were specifically sought, the following were identified as symptoms of withdrawal: heightened sensory perception, impaired concentration, dysosmia, clouded sensorium, paresthesias, muscle cramps, muscle twitch, diarrhea, blurred vision, appetite decrease and weight loss. Other symptoms, such as anxiety and insomnia, were frequently seen during discontinuation, but it could not be determined if they were due to return of illness, rebound or withdrawal. In a larger database comprised of both controlled and uncontrolled studies in which 641 patients received XANAX, discontinuation-emergent symptoms which occurred at a rate of over 5% in patients treated with XANAX and at a greater rate than the placebo treated group were as follows: From the studies cited, it has not been determined whether these symptoms are clearly related to the dose and duration of therapy with XANAX in patients with panic disorder. In two controlled trials of six to eight weeks duration where the ability of patients to discontinue medication was measured, 71%-93% of XANAX treated patients tapered completely off therapy compared to 89%-96% of placebo treated patients. In a controlled postmarketing discontinuation study of panic disorder patients, the duration of treatment (three months compared to six months) had no effect on the ability of patients to taper to zero dose. Seizures attributable to XANAX were seen after drug discontinuance or dose reduction in 8 of 1980 patients with panic disorder or in patients participating in clinical trials where doses of XANAX greater than 4 mg/day for over 3 months were permitted. Five of these cases clearly occurred during abrupt dose reduction, or discontinuation from daily doses of 2 to 10 mg. Three cases occurred in situations where there was not a clear relationship to abrupt dose reduction or discontinuation. In one instance, seizure occurred after discontinuation from a single dose of 1 mg after tapering at a rate of 1 mg every three days from 6 mg daily. In two other instances, the relationship to taper is indeterminate; in both of these cases the patients had been receiving doses of 3 mg daily prior to seizure. The duration of use in the above 8 cases ranged from 4 to 22 weeks. There have been occasional voluntary reports of patients developing seizures while apparently tapering gradually from XANAX. The risk of seizure seems to be greatest 24-72 hours after discontinuation (see DOSAGE AND ADMINISTRATION for recommended tapering and discontinuation schedule). The medical event voluntary reporting system shows that withdrawal seizures have been reported in association with the discontinuation of XANAX. In most cases, only a single seizure was reported; however, multiple seizures and status epilepticus were reported as well. Ordinarily, the treatment of status epilepticus of any etiology involves use of intravenous benzodiazepines plus phenytoin or barbiturates, maintenance of a patent airway and adequate hydration. For additional details regarding therapy, consultation with an appropriate specialist may be considered. Early morning anxiety and emergence of anxiety symptoms between doses of XANAX have been reported in patients with panic disorder taking prescribed maintenance doses of XANAX. These symptoms may reflect the development of tolerance or a time interval between doses which is longer than the duration of clinical action of the administered dose. In either case, it is presumed that the prescribed dose is not sufficient to maintain plasma levels above those needed to prevent relapse, rebound or withdrawal symptoms over the entire course of the interdosing interval. In these situations, it is recommended that the same total daily dose be given divided as more frequent administrations (see DOSAGE AND ADMINISTRATION ). Risk of dose reduction: Withdrawal reactions may occur when dosage reduction occurs for any reason. This includes purposeful tapering, but also inadvertent reduction of dose (eg, the patient forgets, the patient is admitted to a hospital, etc.). Therefore, the dosage of XANAX should be reduced or discontinued gradually (see DOSAGE AND ADMINISTRATION ). XANAX Tablets are not of value in the treatment of psychotic patients and should not be employed in lieu of appropriate treatment for psychosis. Because of its CNS depressant effects, patients receiving XANAX should be cautioned against engaging in hazardous occupations or activities requiring complete mental alertness such as operating machinery or driving a motor vehicle. For the same reason, patients should be cautioned about the simultaneous ingestion of alcohol and other CNS depressant drugs during treatment with XANAX. Benzodiazepines can potentially cause fetal harm when administered to pregnant women. If XANAX is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Because of experience with other members of the benzodiazepine class, XANAX is assumed to be capable of causing an increased risk of congenital abnormalities when administered to a pregnant woman during the first trimester. Because use of these drugs is rarely a matter of urgency, their use during the first trimester should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug. Alprazolam interaction with drugs that inhibit metabolism via cytochrome P450 3A: The initial step in alprazolam metabolism is hydroxylation catalyzed by cytochrome P450 3A (CYP 3A). Drugs that inhibit this metabolic pathway may have a profound effect on the clearance of alprazolam. Consequently, alprazolam should be avoided in patients receiving very potent inhibitors of CYP 3A. With drugs inhibiting CYP 3A to a lesser but still significant degree, alprazolam should be used only with caution and consideration of appropriate dosage reduction. For some drugs, an interaction with alprazolam has been quantified with clinical data; for other drugs, interactions are predicted from in vitro data and/or experience with similar drugs in the same pharmacologic class. The following are examples of drugs known to inhibit the metabolism of alprazolam and/or related benzodiazepines, presumably through inhibition of CYP 3A. Potent CYP 3A inhibitors: Azole antifungal agents --Although in vivo interaction data with alprazolam are not available, ketoconazole and itraconazole are potent CYP 3A inhibitors and the coadministration of alprazolam with them is not recommended. Other azole-type antifungal agents should also be considered potent CYP 3A inhibitors and the coadministration of alprazolam with them is not recommended (see CONTRAINDICATIONS ). Drugs demonstrated to be CYP 3A inhibitors on the basis of clinical studies involving alprazolam (caution and consideration of appropriate alprazolam dose reduction are recommended during coadministration with the following drugs): Nefazodone --Coadministration of nefazodone increased alprazolam concentration two-fold. Fluvoxamine --Coadministration of fluvoxamine approximately doubled the maximum plasma concentration of alprazolam, decreased clearance by 49%, increased half-life by 71%, and decreased measured psychomotor performance. Cimetidine --Coadministration of cimetidine increased the maximum plasma concentration of alprazolam by 86%, decreased clearance by 42%, and increased half-life by 16%. Other drugs possibly affecting alprazolam metabolism: Other drugs possibly affecting alprazolam metabolism by inhibition of CYP 3A are discussed in the PRECAUTIONS section (see PRECAUTIONS -- Drug Interactions ). PRECAUTIONS General: If XANAX Tablets are to be combined with other psychotropic agents or anticonvulsant drugs, careful consideration should be given to the pharmacology of the agents to be employed, particularly with compounds which might potentiate the action of benzodiazepines (see DRUG INTERACTIONS ). As with other psychotropic medications, the usual precautions with respect to administration of the drug and size of the prescription are indicated for severely depressed patients or those in whom there is reason to expect concealed suicidal ideation or plans. It is recommended that the dosage be limited to the smallest effective dose to preclude the development of ataxia or oversedation which may be a particular problem in elderly or debilitated patients. (See DOSAGE AND ADMINISTRATION .) The usual precautions in treating patients with impaired renal, hepatic or pulmonary function should be observed. There have been rare reports of death in patients with severe pulmonary disease shortly after the initiation of treatment with XANAX. A decreased systemic alprazolam elimination rate (eg, increased plasma half-life) has been observed in both alcoholic liver disease patients and obese patients receiving XANAX (see CLINICAL PHARMACOLOGY ). Episodes of hypomania and mania have been reported in association with the use of XANAX in patients with depression. Alprazolam has a weak uricosuric effect. Although other medications with weak uricosuric effect have been reported to cause acute renal failure, there have been no reported instances of acute renal failure attributable to therapy with XANAX. Information for Patients: For all users of XANAX: To assure safe and effective use of benzodiazepines, all patients prescribed XANAX should be provided with the following guidance. In addition, panic disorder patients, for whom doses greater than 4 mg/day are typically prescribed, should be advised about the risks associated with the use of higher doses. Inform your physician about any alcohol consumption and medicine you are taking now, including medication you may buy without a prescription. Alcohol should generally not be used during treatment with benzodiazepines. Not recommended for use in pregnancy. Therefore, inform your physician if you are pregnant, if you are planning to have a child, or if you become pregnant while you are taking this medication. Inform your physician if you are nursing. Until you experience how this medication affects you, do not drive a car or operate potentially dangerous machinery, etc. Do not increase the dose even if you think the medication "does not work anymore" without consulting your physician. Benzodiazepines, even when used as recommended, may produce emotional and/or physical dependence. Do not stop taking this medication abruptly or decrease the dose without consulting your physician, since withdrawal symptoms can occur. Additional advice for panic disorder patients: The use of XANAX at doses greater than 4 mg/day, often necessary to treat panic disorder, is accompanied by risks that you need to carefully consider. When used at doses greater than 4 mg/day, which may or may not be required for your treatment, XANAX has the potential to cause severe emotional and physical dependence in some patients and these patients may find it exceedingly difficult to terminate treatment. In two controlled trials of six to eight weeks duration where the ability of patients to discontinue medication was measured, 7 to 29% of patients treated with XANAX did not completely taper off therapy. In a controlled postmarketing discontinuation study of panic disorder patients, the patients treated with doses of XANAX greater than 4 mg/day had more difficulty tapering to zero dose than patients treated with less than 4 mg/day. In all cases, it is important that your physician help you discontinue this medication in a careful and safe manner to avoid overly extended use of XANAX. In addition, the extended use at doses greater than 4 mg/day appears to increase the incidence and severity of withdrawal reactions when XANAX is discontinued. These are generally minor but seizure can occur, especially if you reduce the dose too rapidly or discontinue the medication abruptly. Seizure can be life-threatening. Laboratory Tests: Laboratory tests are not ordinarily required in otherwise healthy patients. Drug Interactions: The benzodiazepines, including alprazolam, produce additive CNS depressant effects when co-administered with other psychotropic medications, anticonvulsants, antihistaminics, ethanol and other drugs which themselves produce CNS depression. The steady state plasma concentrations of imipramine and desipramine have been reported to be increased an average of 31% and 20%, respectively, by the concomitant administration of XANAX Tablets in doses up to 4 mg/day. The clinical significance of these changes is unknown. Drugs that inhibit alprazolam metabolism via cytochrome P450 3A: The initial step in alprazolam metabolism is hydroxylation catalyzed by cytochrome P450 3A (CYP 3A). Drugs which inhibit this metabolic pathway may have a profound effect on the clearance of alprazolam (see CONTRAINDICATIONS and WARNINGS for additional drugs of this type). Drugs demonstrated to be CYP 3A inhibitors of possible clinical significance on the basis of clinical studies involving alprazolam (caution is recommended during coadministration with alprazolam): Fluoxetine--Coadministration of fluoxetine with alprazalom increased the maximum plasma concentration of alprazolam by 46%, decreased clearance by 21%, increased half-life by 17%, and decreased measured psychomotor performance. Propoxyphene--Coadministration of propoxyphene decreased the maximum plasma concentration of alprazolam by 6%, decreased clearance by 38%, and increased half-life by 58%. Oral Contraceptives--Coadministration of oral contraceptives increased the maximum plasma concentration of alprazolam by 18%, decreased clearance by 22%, and increased half-life by 29%. Drugs and other substances demonstrated to be CYP 3A inhibitors on the basis of clinical studies involving benzodiazepines metabolized similarly to alprazolam or on the basis of in vitro studies with alprazolam or other benzodiazepines (caution is recommended during coadministration with alprazolam): Available data from clinical studies of benzodiazepines other than alprazolam suggest a possible drug interaction with alprazolam for the following: diltiazem, isoniazid, macrolide antibiotics such as erythromycin and clarithromycin, and grapefruit juice. Data from in vitro studies of alprazolam suggest a possible drug interaction with alprazolam for the following: sertraline and paroxetine. Data from in vitro studies of benzodiazepines other than alprazolam suggest a possible drug interaction for the following: ergotamine, cyclosporine, amiodarone, nicradipine, and nifedipine. Caution is recommended during the coadministration of any of these with alprazolam (see WARNINGS ). Drug/Laboratory Test Interactions: Although interactions between benzodiazepines and commonly employed clinical laboratory tests have occasionally been reported, there is no consistent pattern for a specific drug or specific test. Carcinogenesis, Mutagenesis, Impairment of Fertility: No evidence of carcinogenic potential was observed during 2-year bioassay studies of alprazolam in rats at doses up to 30 mg/kg/day (150 times the maximum recommended daily human dose of 10 mg/day) and in mice at doses up to 10 mg/kg/day (50 times the maximum recommended daily human dose). Alprazolam was not mutagenic in the rat micronucleus test at doses up to 100 mg/kg, which is 500 times the maximum recommended daily human dose of 10 mg/day. Alprazolam also was not mutagenic in vitro in the DNA Damage/Alkaline Elution Assay or the Ames Assay. Alprazolam produced no impairment of fertility in rats at doses up to 5 mg/kg/day, which is 25 times the maximum recommended daily human dose of 10 mg/day. Pregnancy: Teratogenic Effects: Pregnancy Category D: (See WARNINGS Section). Nonteratogenic Effects: It should be considered that the child born of a mother who is receiving benzodiazepines may be at some risk for withdrawal symptoms from the drug during the postnatal period. Also, neonatal flaccidity and respiratory problems have been reported in children born of mothers who have been receiving benzodiazepines. Labor and Delivery: XANAX has no established use in labor or delivery. Nursing Mothers: Benzodiazepines are known to be excreted in human milk. It should be assumed that alprazolam is as well. Chronic administration of diazepam to nursing mothers has been reported to cause their infants to become lethargic and to lose weight. As a general rule, nursing should not be undertaken by mothers who must use XANAX. Pediatric Use: Safety and effectiveness of XANAX in individuals below 18 years of age have not been established. Geriatric Use: The elderly may be more sensitive to the effects of benzodiazepines. They exhibit higher plasma alprazolam concentrations due to reduced clearance of the drug as compared with a younger population receiving the same doses. The smallest effective dose of XANAX should be used in the elderly to preclude the development of ataxia and oversedation (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION ). ADVERSE REACTIONS Side effects to XANAX Tablets, if they occur, are generally observed at the beginning of therapy and usually disappear upon continued medication. In the usual patient, the most frequent side effects are likely to be an extension of the pharmacological activity of alprazolam, eg, drowsiness or light-headedness. The data cited in the two tables below are estimates of untoward clinical event incidence among patients who participated under the following clinical conditions: relatively short duration (ie, four weeks) placebo-controlled clinical studies with dosages up to 4 mg/day of XANAX (for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety) and short-term (up to ten weeks) placebo-controlled clinical studies with dosages up to 10 mg/day of XANAX in patients with panic disorder, with or without agoraphobia. These data cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice where patient characteristics, and other factors often differ from those in clinical trials. These figures cannot be compared with those obtained from other clinical studies involving related drug products and placebo as each group of drug trials are conducted under a different set of conditions. Comparison of the cited figures, however, can provide the prescriber with some basis for estimating the relative contributions of drug and non-drug factors to the untoward event incidence in the population studied. Even this use must be approached cautiously, as a drug may relieve a symptom in one patient but induce it in others. (For example, an anxiolytic drug may relieve dry mouth [a symptom of anxiety] in some subjects but induce it [an untoward event] in others.) Additionally, for anxiety disorders the cited figures can provide the prescriber with an indication as to the frequency with which physician intervention (eg, increased surveillance, decreased dosage or discontinuation of drug therapy) may be necessary because of the untoward clinical event. In addition to the relatively common (ie, greater than 1%) untoward events enumerated in the table above, the following adverse events have been reported in association with the use of benzodiazepines: dystonia, irritability, concentration difficulties, anorexia, transient amnesia or memory impairment, loss of coordination, fatigue, seizures, sedation, slurred speech, jaundice, musculoskeletal weakness, pruritus, diplopia, dysarthria, changes in libido, menstrual irregularities, incontinence and urinary retention. PANIC DISORDER Treatment-Emergent Symptom Incidence * XANAX PLACEBO Number of Patients % of Patients Reporting: In addition to the relatively common (ie, greater than 1%) untoward events enumerated in the table above, the following adverse events have been reported in association with the use of XANAX: seizures, hallucinations, depersonalization, taste alterations, diplopia, elevated bilirubin, elevated hepatic enzymes, and jaundice. There have also been reports of withdrawal seizures upon rapid decrease or abrupt discontinuation of XANAX Tablets (see WARNINGS ). To discontinue treatment in patients taking XANAX, the dosage should be reduced slowly in keeping with good medical practice. It is suggested that the daily dosage of XANAX be decreased by no more than 0.5 mg every three days (see DOSAGE AND ADMINISTRATION ). Some patients may benefit from an even slower dosage reduction. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. Panic disorder has been associated with primary and secondary major depressive disorders and increased reports of suicide among untreated patients. Therefore, the same precaution must be exercised when using doses of XANAX greater than 4 mg/day in treating patients with panic disorders as is exercised with the use of any psychotropic drug in treating depressed patients or those in whom there is reason to expect concealed suicidal ideation or plans. As with all benzodiazepines, paradoxical reactions such as stimulation, increased muscle spasticity, sleep disturbances, hallucinations and other adverse behavioral effects such as agitation, rage, irritability, and aggressive or hostile behavior have been reported rarely. In many of the spontaneous case reports of adverse behavioral effects, patients were receiving other CNS drugs concomitantly and/or were described as having underlying psychiatric conditions. Should any of the above events occur, alprazolam should be discontinued. Isolated published reports involving small numbers of patients have suggested that patients who have borderline personality disorder, a prior history of violent or aggressive behavior, or alcohol or substance abuse may be at risk for such events. Instances of irritability, hostility, and intrusive thoughts have been reported during discontinuation of alprazolam in patients with post-traumatic stress disorder. Laboratory analyses were performed on patients participating in the clinical program for XANAX. The following incidences of abnormalities shown below were observed in patients receiving XANAX and in patients in the corresponding placebo group. Few of these abnormalities were considered to be of physiological signficance. When treatment with XANAX is protracted, periodic blood counts, urinalysis and blood chemistry analyses are advisable. Minor changes in EEG patterns, usually low-voltage fast activity have been observed in patients during therapy with XANAX and are of no known signficance. Post Introduction Reports: Various adverse drug reactions have been reported in association with the use of XANAX since market introduction. The majority of these reactions were reported through the medical event voluntary reporting system. Because of the spontaneous nature of the reporting of medical events and the lack of controls, a causal relationship to the use of XANAX cannot be readily determined. Reported events include: liver enzyme elevations, hepatitis, hepatic failure, Stevens-Johnson syndrome, hyperprolactinemia, gynecomastia and galactorrhea. DRUG ABUSE AND DEPENDENCE Physical and Psychological Dependence: Withdrawal symptoms similar in character to those noted with sedative/hypnotics and alcohol have occurred following discontinuance of benzodiazepines, including XANAX. The symptoms can range from mild dysphoria and insomnia to a major syndrome that may include abdominal and muscle cramps, vomiting, sweating, tremors and convulsions. Distinguishing between withdrawal emergent signs and symptoms and the recurrence of illness is often difficult in patients undergoing dose reduction. The long term strategy for treatment of these phenomena will vary with their cause and the therapeutic goal. When necessary, immediate management of withdrawal symptoms requires re-institution of treatment at doses of XANAX sufficient to suppress symptoms. There have been reports of failure of other benzodiazepines to fully suppress these withdrawal symptoms. These failures have been attributed to incomplete cross-tolerance but may also reflect the use of inadequate dosing regimen of the substituted benzodiazepine or the effects of concomitant medications. While it is difficult to distinguish withdrawal and recurrence for certain patients, the time course and the nature of the symptoms may be helpful. A withdrawal syndrome typically includes the occurrence of new symptoms, tends to appear toward the end of taper or shortly after discontinuation, and will decrease with time. In recurring panic disorder, symptoms similar to those observed before treatment may recur either early or late, and they will persist. While the severity and incidence of withdrawal phenomena appear to be related to dose and duration of treatment, withdrawal symptoms, including seizures, have been reported after only brief therapy with XANAX at doses within the recommended range for the treatment of anxiety (eg, 0.75 to 4 mg/day). Signs and symptoms of withdrawal are often more prominent after rapid decrease of dosage or abrupt discontinuance. The risk of withdrawal seizures may be increased at doses above 4 mg/day (see WARNINGS ). Patients, especially individuals with a history of seizures or epilepsy, should not be abruptly discontinued from any CNS depressant agent, including XANAX. It is recommended that all patients on XANAX who require a dosage reduction be gradually tapered under close supervision (see WARNINGS and DOSAGE AND ADMINISTRATION ). Psychological dependence is a risk with all benzodiazepines, including XANAX. The risk of psychological dependence may also be increased at doses greater than 4 mg/day and with longer term use, and this risk is further increased in patients with a history of alcohol or drug abuse. Some patients have experienced considerable difficulty in tapering and discontinuing from XANAX, especially those receiving higher doses for extended periods. Addiction-prone individuals should be under careful surveillance when receiving XANAX. As with all anxiolytics, repeat prescriptions should be limited to those who are under medical supervision. Controlled Substance Class: Alprazolam is a controlled substance under the Controlled Substance Act by the Drug Enforcement Administration and XANAX Tablets have been assigned to Schedule IV. OVERDOSAGE Manifestations of alprazolam overdosage include somnolence, confusion, impaired coordination, diminished reflexes and coma. Death has been reported in association with overdoses of alprazolam by itself, as it has with other benzodiazepines. In addition, fatalities have been reported in patients who have overdosed with a combination of a single benzodiazepine, including alprazolam, and alcohol; alcohol levels seen in some of these patients have been lower than those usually associated with alcohol-induced fatality. The acute oral LD 50 in rats is 331-2171 mg/kg. Other experiments in animals have indicated that cardiopulmonary collapse can occur following massive intravenous doses of alprazolam (over 195 mg/kg; 975 times the maximum recommended daily human dose of 10 mg/day). Animals could be resuscitated with positive mechanical ventilation and the intravenous infusion of norepinephrine bitartrate. Animal experiments have suggested that forced diuresis or hemodialysis are probably of little value in treating overdosage. General Treatment of Overdose: Overdosage reports with XANAX Tablets are limited. As in all cases of drug overdosage, respiration, pulse rate, and blood pressure should be monitored. General supportive measures should be employed, along with immediate gastric lavage. Intravenous fluids should be administered and an adequate airway maintained. If hypotension occurs, it may be combated by the use of vasopressors. Dialysis is of limited value. As with the management of intentional overdosing with any drug, it should be borne in mind that multiple agents may have been ingested. Flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdosage. Patients treated with flumazenil should be monitored for re-sedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert including CONTRAINDICATIONS , WARNINGS and PRECAUTIONS should be consulted prior to use. DOSAGE AND ADMINISTRATION Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who require doses greater than 4 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects. Anxiety disorders and transient symptoms of anxiety: Treatment for patients with anxiety should be initiated with a dose of 0.25 to 0.5 mg given three times daily. The dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. The lowest possible effective dose should be employed and the need for continued treatment reassessed frequently. The risk of dependence may increase with dose and duration of treatment. In elderly patients, in patients with advanced liver disease or in patients with debilitating disease, the usual starting dose is 0.25 mg, given two or three times daily. This may be gradually increased if needed and tolerated. The elderly may be especially sensitive to the effects of benzodiazepines. If side effects occur at the recommended starting dose, the dose may be lowered. In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction. Panic disorder: The successful treatment of many panic disorder patients has required the use of XANAX at doses greater than 4 mg daily. In controlled trials conducted to establish the efficacy of XANAX in panic disorder, doses in the range of 1 to 10 mg daily were used. The mean dosage employed was approximately 5 to 6 mg daily. Among the approximately 1700 patients participating in the panic disorder development program, about 300 received XANAX in dosages of greater than 7 mg/day, including approximately 100 patients who received maximum dosages of greater than 9 mg/day. Occasional patients required as much as 10 mg a day to achieve a successful response. Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Thereafter, the dose can be increased at intervals equal to at least 5 times the elimination half-life (about 11 hours in young patients, about 16 hours in elderly patients). Longer titration intervals should probably be used because the maximum therapeutic response may not occur until after the plasma levels achieve steady state. Dose should be advanced until an acceptable therapeutic response (ie, a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained. For patients receiving doses greater than 4 mg/day, periodic reassessment and consideration of dosage reduction is advised. In a controlled postmarketing dose-response study, patients treated with doses of XANAX greater than 4 mg/day for three months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit. Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided. (See WARNINGS , PRECAUTIONS , DRUG ABUSE AND DEPENDENCE ). The following regimen is one that follows the principles outlined above: Treatment may be initiated with a dose of 0.5 mg three times daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg per day. Slower titration to the dose levels greater than 4 mg/day may be advisable to allow full expression of the pharmacodynamic effect of XANAX. To lessen the possibility of interdose symptoms, the times of administration should be distributed as evenly as possible throughout the waking hours, that is, on a three or four times per day schedule. The necessary duration of treatment for panic disorder patients responding to XANAX is unknown. After a period of extended freedom from attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena. In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every three days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Rx only PRODUCT PHOTO(S): NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size. The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis. ANIMAL STUDIES When rats were treated with alprazolam at 3, 10, and 30 mg/kg/day (15 to 150 times the maximum recommended human dose) orally for 2 years, a tendency for a dose related increase in the number of cataracts was observed in females and a tendency for a dose related increase in corneal vascularization was observed in males. These lesions did not appear until after 11 months of treatment. CLINICAL STUDIES Anxiety Disorders: XANAX Tablets were compared to placebo in double blind clinical studies (doses up to 4 mg/day) in patients with a diagnosis of anxiety or anxiety with associated depressive symptomatology. XANAX was significantly better than placebo at each of the evaluation periods of these four week studies as judged by the following psychometric instruments: Physician's Global Impressions, Hamilton Anxiety Rating Scale, Target Symptoms, Patient's Global Impressions and Self-Rating Symptom Scale. Panic Disorder: Support for the effectiveness of XANAX in the treatment of panic disorder came from three short-term, placebo-controlled studies (up to 10 weeks) in patients with diagnoses closely corresponding to DSM-III-R criteria for panic disorder. The average dose of XANAX was 5-6 mg/day in two of the studies, and the doses of XANAX were fixed at 2 and 6 mg/day in the third study. In all three studies, XANAX was superior to placebo on a variable defined as "the number of patients with zero panic attacks" (range, 37-83% met this criterion), as well as on a global improvement score. In two of the three studies, XANAX was superior to placebo on a variable defined as "change from baseline on the number of panic attacks per week" (range, 3.3-5.2), and also on a phobia rating scale. A subgroup of patients who were improved on XANAX during short-term treatment in one of these trials was continued on an open basis up to eight months, without apparent loss of benefit. The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you. The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products Avoid Dangerous Statins Use a Natural Cholesterol Remedy Safely Drop 30 Points, Guaranteed! High-Cholesterol.IsCurable.com Drug Guides for PDAs Skyscape offers up-to-date drug info & interactions on PDAs! www.skyscape.com Drug Cocaine Answers Cocaine Information, Detox, Treatment and Family Support www.cocainetreatment.info

Xenical 120mg ( 90 pills) 166.88 Xenical 120mg (180 pills) 319.88 Xenical 120mg (270 pills) 479.88 Xenical 120mg (30 pills) 56 Xenical 120mg (60 pills) 109.88 IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug. USES: This medication is used with a reduced-calorie diet to help significantly overweight persons lose weight. It also helps to prevent regaining weight previously lost. Orlistat works by blocking some of the fat normally digested by the intestine. HOW TO USE: Take this drug by mouth, generally three times daily during (or up to one hour after) each main meal that contains fat. Your daily intake of fat, protein and carbohydrate should be evenly spread over three main meals. If a meal is occasionally missed or contains no fat, skip that dose of the medication. Because this drug can interfere with absorption of fat-soluble vitamins (e.g., A,D,E,K), a daily multivitamin supplement containing these nutrients is recommended. Take the multivitamin at least 2 hours before or 2 hours after this drug (e.g., at bedtime). The effects of this drug may begin as soon as 1-2 days after treatment begins; noticeable weight loss will take longer. SIDE EFFECTS: Fatty/oily stool, oily spotting, intestinal gas with discharge, bowel movement urgency, poor bowel control, or headaches may occur. If these effects persist or worsen, notify your doctor promptly. Intestinal side effects (e.g., oily stool) may increase in intensity if you exceed your daily dietary fat allowance. If you notice other effects not listed above, contact your doctor or pharmacist. PRECAUTIONS: Tell your doctor your medical history, including: allergies, digestive disorders (malabsorption or cholestasis), low thyroid function (hypothyroidism), other metabolism problems (e.g., oxalate kidney stones, hyperoxaluria). This drug should not be used if you have anorexia nervosa or bulimia-type eating disorders. Tell your doctor if you are pregnant before using this medication. The manufacturer does not recommend use of this drug during pregnancy. It is not known whether this drug is excreted into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding. DRUG INTERACTIONS: Tell your doctor of all prescription and nonprescription medication you use, especially of: cyclosporine, "blood thinners" (e.g., warfarin), drugs for diabetes (e.g., insulin), other drugs used for weight loss. Cyclosporine should be taken at least 2 hours before or after orlistat to assure maximum absorption of the cyclosporine into your bloodstream. Do not start or stop any medicine without doctor or pharmacist approval. OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. NOTES: Do not share this medication with others. Follow your doctor-approved nutritional, reduced-calorie diet containing about 30 percent calories from fat. Also, exercise is recommended; however, first consult your doctor or pharmacist. MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. STORAGE: Store at room temperature (77 degrees F, 25 degrees C) away from light and moisture. Welcome to XENICAL.com! XENICAL is a prescription medication that can help considerably overweight people lose weight and keep it off. We know that managing your weight can be frustrating, and sometimes you need a little extra support. Support you can't find in a pill alone. To succeed you may have to change the way you feel about food and about your body. To determine if you may be a candidate for XENICAL, your doctor will check your Body Mass Index -- a measure of weight which takes height into account. To find out your BMI now, use the convenient calculator below.Then be sure to register to receive an Evaluation Tool and personalized diet and exercise tips From our sponsors Learn about a treatment for nail fungus infection Breast Cancer: What you should know Internet Results Canadian Pharmacy Offers Xenical Compare these prices at a Canadian pharmacy. Xenical 120 mg - 84 for $97, 168 for $185, 252 for $274. Free shipping with no additional costs at Planetdrugsdirect. www.planetdrugsdirect.com Xenical 120mg: 84 Capsules for $95 Official site: Canada Drugs Online - licensed Canadian pharmacy. Providing great service, fast shipping and savings on medication. www.canadadrugsonline.com More internet results for xenical... Sponsored Results Xenical Orlistat blocks some of the fat that you eat from being absorbed by your body. Xenical (Advanced Consumer) Orlistat (OR-li-stat) is used as an aid to help you lose weight. The medicine prevents the digestion of some of the fat you eat. Fats that are not d... Spanish information for xenical... More Consumer Information for xenical... Professional Information Xenical Capsules XENICAL (orlistat) is a lipase inhibitor for obesity management that acts by inhibiting the absorption of dietary fats. More Professional Information results for xenical... Additional Resources Internet Results for xenical See also Obesity Having trouble finding what you want? Try posting your query on the Drugs.com Community Discussion Boards A-Z List of Drug Names may help if you don't quite know how to spell the drug name. Drug Interactions Checker provides detailed information on drug-drug and drug-food interactions. Pill Identifier will help you identify an unknown pill by imprint code or shape/color. Image Search is helpful if you want to know what a certain pill looks like. News, FDA Approvals or In The Pipeline may help if the drug you are looking for is a new drug. Success With XENICAL Have you tried dieting, exercise and support groups, but found they never seem to work? Did you lose weight only to quickly gain it back? Your doctor will want to know these things before prescribing a medicine, to make sure that you've considered your options seriously and that your request for XENICAL isn't a hasty one. XENICAL is a prescription medication, not a magic pill that simply melts pounds away. The nice part about the XENICAL program is that it doesn't involve a complicated diet. In fact, the reduced-calorie diet with no more than 30% calories from fat is the same one recommended by the American Heart Association for all Americans. Keeping to a diet with no more than 30% calories from fat can be challenging for some people, especially if you enjoy things like fried foods and ice cream. If you can stay on the recommended diet, you will be on your way to achieving your weight-loss goals! XENICAL may be right for you if you have a Body Mass Index of 30 or greater, or have a BMI of 27 or greater and have other risk factors, such as high blood pressure, high cholesterol, heart disease or diabetes. Click here to calculate your BMI and find out if you might be a candidate for XENICAL. It is very important to talk to your doctor if you're considering using XENICAL as part of a weight-loss program. Click here for information and materials that you can print out and take to your next doctor XENICAL At Work If you eat an excessive amount of fat or calories, the excess is stored as fat by the body, resulting in weight gain. When you eat fat, your body breaks it down into its simplest components so that it can be digested. Unlike other weight-loss drugs you may have heard about that act in the brain or central nervous system to suppress appetite or to speed up metabolism, XENICAL works in your digestive system to block about one-third of the fat in the food you eat from being digested. Enzymes in your digestive system, called lipases, help digest (or break down) fat. When taken with meals, XENICAL attaches to the lipases and blocks them from breaking down some of the fat you have eaten. The undigested fat cannot be absorbed and is eliminated in your bowel movements. By working this way, XENICAL helps block about one-third of the fat in the foods you eat from being absorbed by your body. Taking XENICAL The recommended dose is one 120-mg capsule by mouth with liquid at each main meal that contains fat. You should take XENICAL up to three times a day in conjunction with a reduced-calorie diet. Each time you take XENICAL, your nutritionally balanced meal should contain no more than about 30% of calories from fat. You should evenly divide your daily intake of fat, carbohydrates and protein over three main meals. Take XENICAL during meals or up to 1 hour after a meal. If you occasionally miss a meal or have a meal without fat, you can omit your dose of XENICAL. Doses above 120-mg three times daily have not been shown to provide an additional weight-loss benefit. You should try to follow a healthy eating plan, such as the one developed by the American Heart Association. Following this eating plan will help you lose weight while decreasing some of the possible gastrointestinal effects you may experience while taking XENICAL. XENICAL interferes with your body's absorption of some fat-soluble vitamins. Therefore, when you use XENICAL, you should take a daily multivitamin supplement that contains vitamins D, E, and K and beta carotene. Take your multivitamin once a day at least 2 hours before or after taking XENICAL, such as at bedtime. To find out more about taking XENICAL properly, talk with your doctor. Click here for important patient information. How Do I Get XENICAL? Before your doctor can prescribe XENICAL, he or she will need to determine if this weight-loss approach is right for you. To do this, your doctor will need to review your medical history and evaluate your level of commitment. It is very important to talk to your doctor if you're considering using XENICAL as part of a weight-loss program. Your doctor will help you: Set realistic goals for weight loss Determine the right caloric level for your well-balanced, reduced-calorie diet that contains no more than 30% of calories from fat at each main meal Understand how to take XENICAL properly and why taking a multivitamin is so important To make your doctor visit most productive, you should be prepared to discuss your weight history, your goals and your level of commitment to a weight-loss program. We've put together a variety of resources to help make it easier for you: Materials to Take to Your Doctor Simply print out your Daily Food Diary and Personal Weight-Loss Worksheet, fill them in, and take them with you to your next doctor appointment. Preparing for Your Office Visit Talking with your doctor about weight loss can be difficult. To prepare for that conversation, check out this information that details what you can expect from a typical visit. Insurance Coverage and Reimbursement Find out if your insurance provider will cover the cost of XENICAL, and get tips on submitting your insurance claim. Controlling your weight is a great way to help stay healthy. Call your doctor or nutritionist today to set up an appointment Important Safety Information Indication XENICAL is for people who are considerably overweight (have a body mass index of 30 or greater). XENICAL is also for people who are overweight (have a body mass index of 27 or greater) and also have other risk factors such as high blood pressure, high cholesterol, heart disease or diabetes. XENICAL should be taken with a [nutritionally balanced] reduced-calorie diet containing no more than 30% of calories from fat. Contraindications/Warnings/Precautions XENICAL shouldn't be taken if you are pregnant, nursing, have food absorption problems or reduced bile flow. If you are taking cyclosporine, speak to your doctor before taking XENICAL. XENICAL reduces the absorption of vitamins, therefore, a daily multivitamin is recommended. Side Effects Because XENICAL works by blocking the absorption of dietary fat, it is likely that you will experience some changes in bowel habits. These bowel changes are a natural effect of blocking the fat from being absorbed. They generally occur during the first weeks of treatment; however, for some people they may continue for 6 months or longer while on XENICAL. These changes may include gas with oily discharge, an increased number of bowel movements, an urgent need to have them, and an inability to control them, particularly after meals containing higher amounts of fat than are recommended. Following a healthy eating plan, such as the one developed by the American Heart Association, will help you lose weight while decreasing some of the possible gastrointestinal effects you may experience while taking XENICAL. If you are concerned about these or any other side effects you experience while taking XENICAL, talk with your doctor or pharmacist. Click here for helpful information about talking with your doctor Manufacturer: Roche Pharmaceuticals Xenical Information: NO PRESCRIPTION IS REQUIRED. A DETAILED QUESTIONNAIRE WILL BE CONDUCTED. NO ORDER OF XENICAL WILL BE PROCESSED WITHOUT COMPLETION OF THIS QUESTIONNAIRE. Weight Loss Medications Xenical (Orlistat) is a gastrointestinal lipase inhibitor used to treat obesity. Xenical (Orlistat) is a medication that can help considerably overweight people lose weight and keep it off. We know that managing your weight can be frustrating, and sometimes you need a little extra support. Support you can't find in a pill alone. To succeed you may have to change the way you feel about food and about your body. If you eat an excessive amount of fat or calories, the excess is stored as fat by the body, resulting in weight gain. When you eat fat, your body breaks it down into its simplest components so that it can be digested. Unlike other weight-loss drugs you may have heard about that act in the brain or central nervous system to suppress appetite or to speed up metabolism, Xenical (Orlistat) works in your digestive system to block about one-third of the fat in the food you eat from being digested. Enzymes in your digestive system, called lipases, help digest (or break down) fat. When taken with meals, Xenical (Orlistat) attaches to the lipases and blocks them from breaking down some of the fat you have eaten. The undigested fat cannot be absorbed and is eliminated in your bowel movements. By working this way,Xenical (Orlistat) helps block about one-third of the fat in the foods you eat from being absorbed by your body. Xenical Side Effects: Xenical side effects that may occur while taking this medicine include oily stools or spotting, increased number of bowel movements, bowel movement urgency, poor bowel movement control, or gas with discharge. If Xenical side effects continue or are bothersome, check with your doctor. If you notice other Xenical side effects not listed above, contact your doctor, nurse, or pharmacist. Follow the directions for using XENICAL provided by your doctor. XENICAL COMES WITH A PATIENT Xenical Information LEAFLET. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. Take XENICAL with or up to 1 hour after each main meal that contains fat. Taking XENICAL with low-fat meals will lessen the side effects that can occur. If you miss a meal or the meal contains no fat, do not take a dose of XENICAL. IF YOU ARE TAKING A MULTIPLE VITAMIN, take it either 2 hours before or 2 hours after taking this medicine. STORE XENICAL at room temperature below 77 degrees F (25 degrees C), away from heat and light. IF YOU MISS A DOSE OF XENICAL, skip the missed dose and go back to your regular dosing schedule. Do NOT take 2 doses at once. Back to Main Drug Information Page Support for XENICAL Users Your doctor will help determine your weight loss goals and total number of daily calories, and provide you with a specific diet plan. Here are some tools and information to get you started. Daily Calorie Target Calculator Determine your caloric needs based on weight and activity level. Goal Activity Calculator Calculate your target weight to help set your weight loss goal. Percentage of Fat Calculator Find out how many grams of fat you should have each day. Per Serving Calculator Find out the calories of fat and the percentage of calories from fat per serving. Enhanced Calorie Calculator Choose from an extensive list of foods and serving sizes to calculate the total number of calories you've eaten in a meal. Guide to Nutrition Label Food packaging has all sorts of misleading claims, like "lite" and "reduced fat." Here you'll find important points to remember when reading nutrition labels. Dietary Fats: Fact or Fiction How much fat should you be eating? Are some fats worse than others? How can you check your diet for fat? Find out here. Bull's Eye Food Guide The Bull's Eye Food Guide system help you learn about the nutritional values of different foods and the recommended serving sizes of the food groups, so you can make wiser choices about what and how much you eat. Sample Diets Download a variety of printable recipes that meet the dietary requirements for XENICAL. BMI Calculator Body Mass Index is a measurement of weight taking height into account. To find out your BMI now, use the calculator located on the home page. Materials to Take to Your Doctor Here are some resources that can help you communicate effectively with your doctor. Simply print these materials out, fill them in and take them with you to your next doctor appointment. Insurance Letter - if your claim has been denied Use this convenient form to help you appeal denial of coverage for XENICAL from your insurance company. Insurance Letter - to request authorization of coverage Use this convenient form to help you request authorization of insurance coverage for your XENICAL prescription. type 2 diabetes treatment New Diabetes Treatment Breakthrough 99% Type 2 and 64% Type I Success Diabetes.IsCurable.com Do You Have Diabetes? Discover the Natural Key to Lose Fat, Gain Energy & Feel Great Diabetes.GlucoFast.com Diet Pills- Reviewed Get the Facts. See what products came out on top. Shop smart. www.ConsumerHealthDigest.com DESCRIPTION XENICAL (orlistat) is a lipase inhibitor for obesity management that acts by inhibiting the absorption of dietary fats. Orlistat is (S)-2-formylamino-4-methyl-pentanoic acid (S)-1-[[(2S, 3S)-3-hexyl-4-oxo-2-oxetanyl] methyl]-dodecyl ester. Its empirical formula is C 29 H 53 NO 5 , and its molecular weight is 495.7. It is a single diastereomeric molecule that contains four chiral centers, with a negative optical rotation in ethanol at 529 nm. Orlistat is a white to off-white crystalline powder. Orlistat is practically insoluble in water, freely soluble in chloroform, and very soluble in methanol and ethanol. Orlistat has no p K a within the physiological pH range. XENICAL is available for oral administration in dark-blue, hard-gelatin capsules, with light-blue imprinting. Each capsule contains 120 mg of the active ingredient, orlistat. The capsules also contain the inactive ingredients microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, povidone, and talc. Each capsule shell contains gelatin, titanium dioxide, and FD&C Blue No.1, with printing of pharmaceutical glaze NF, titanium dioxide, and FD&C Blue No.1 aluminum lake. CLINICAL PHARMACOLOGY Mechanism of Action Orlistat is a reversible inhibitor of lipases. It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine residue site of gastric and pancreatic lipases. The inactivated enzymes are thus unavailable to hydrolyze dietary fat in the form of triglycerides into absorbable free fatty acids and monoglycerides. As undigested triglycerides are not absorbed, the resulting caloric deficit may have a positive effect on weight control. Systemic absorption of the drug is therefore not needed for activity. At the recommended therapeutic dose of 120 mg three times a day, orlistat inhibits dietary fat absorption by approximately 30%. Pharmacokinetics Absorption Systemic exposure to orlistat is minimal. Following oral dosing with 360 mg 14 C-orlistat, plasma radioactivity peaked at approximately 8 hours; plasma concentrations of intact orlistat were near the limits of detection (<5 ng/mL). In therapeutic studies involving monitoring of plasma samples, detection of intact orlistat in plasma was sporadic and concentrations were low (<10 ng/mL or 0.02 [micro ]M), without evidence of accumulation, and consistent with minimal absorption. The average absolute bioavailability of intact orlistat was assessed in studies with male rats at oral doses of 150 and 1000 mg/kg/day and in male dogs at oral doses of 100 and 1000 mg/kg/day and found to be 0.12%, 0.59% in rats and 0.7%, 1.9% in dogs, respectively. Distribution In vitro orlistat was >99% bound to plasma proteins (lipoproteins and albumin were major binding proteins). Orlistat minimally partitioned into erythrocytes. Metabolism Based on animal data, it is likely that the metabolism of orlistat occurs mainly within the gastrointestinal wall. Based on an oral 14 C-orlistat mass balance study in obese patients, two metabolites, M1 (4-member lactone ring hydrolyzed) and M3 (M1 with N-formyl leucine moiety cleaved), accounted for approximately 42% of total radioactivity in plasma. M1 and M3 have an open (beta)-lactone ring and extremely weak lipase inhibitory activity (1000- and 2500-fold less than orlistat, respectively). In view of this low inhibitory activity and the low plasma levels at the therapeutic dose (average of 26 ng/mL and 108 ng/mL for M1 and M3, respectively, 2 to 4 hours after a dose), these metabolites are considered pharmacologically inconsequential. The primary metabolite M1 had a short half-life (approximately 3 hours) whereas the secondary metabolite M3 disappeared at a slower rate (half-life approximately 13.5 hours). In obese patients, steady-state plasma levels of M1, but not M3, increased in proportion to orlistat doses. Elimination Following a single oral dose of 360 mg 14 C-orlistat in both normal weight and obese subjects, fecal excretion of the unabsorbed drug was found to be the major route of elimination. Orlistat and its M1 and M3 metabolites were also subject to biliary excretion. Approximately 97% of the administered radioactivity was excreted in feces; 83% of that was found to be unchanged orlistat. The cumulative renal excretion of total radioactivity was <2% of the given dose of 360 mg 14 C-orlistat. The time to reach complete excretion (fecal plus urinary) was 3 to 5 days. The disposition of orlistat appeared to be similar between normal weight and obese subjects. Based on limited data, the half-life of the absorbed orlistat is in the range of 1 to 2 hours. Special Populations Because the drug is minimally absorbed, studies in special populations (geriatric, different races, patients with renal and hepatic insufficiency) were not conducted. Pediatrics Plasma concentrations of orlistat and its metabolites M1 and M3 were similar to those found in adults at the same dose level. Daily fecal fat excretions were 27% and 7% of dietary intake in orlistat and placebo treatment groups, respectively. Drug-Drug Interactions Drug-drug interaction studies indicate that XENICAL had no effect on pharmacokinetics and/or pharmacodynamics of alcohol, digoxin, glyburide, nifedipine (extended-release tablets), oral contraceptives, phenytoin, pravastatin, or warfarin. Alcohol did not affect the pharmacodynamics of orlistat. Other Short-term Studies Adults In several studies of up to 6-weeks duration, the effects of therapeutic doses of XENICAL on gastrointestinal and systemic physiological processes were assessed in normal-weight and obese subjects. Postprandial cholecystokinin plasma concentrations were lowered after multiple doses of XENICAL in two studies but not significantly different from placebo in two other experiments. There were no clinically significant changes observed in gallbladder motility, bile composition or lithogenicity, or colonic cell proliferation rate, and no clinically significant reduction of gastric emptying time or gastric acidity. In addition, no effects on plasma triglyceride levels or systemic lipases were observed with the administration of XENICAL in these studies. In a 3-week study of 28 healthy male volunteers, XENICAL (120 mg three times a day) did not significantly affect the balance of calcium, magnesium, phosphorus, zinc, copper, and iron. Pediatrics In a 3-week study of 32 obese adolescents aged 12 to 16 years, XENICAL (120 mg three times a day) did not significantly affect the balance of calcium, magnesium, phosphorus, zinc, or copper. The iron balance was decreased by 64.7 [micro ]mole/24 hours and 40.4 [micro ]mole/24 hours in orlistat and placebo treatment groups, respectively. Dose-response Relationship A simple maximum effect (E max ) model was used to define the dose-response curve of the relationship between XENICAL daily dose and fecal fat excretion as representative of gastrointestinal lipase inhibition. The dose-response curve demonstrated a steep portion for doses up to approximately 400 mg daily, followed by a plateau for higher doses. At doses greater than 120 mg three times a day, the percentage increase in effect was minimal. CLINICAL STUDIES Observational epidemiologic studies have established a relationship between obesity and visceral fat and the risks for cardiovascular disease, type 2 diabetes, certain forms of cancer, gallstones, certain respiratory disorders, and an increase in overall mortality. These studies suggest that weight loss, if maintained, may produce health benefits for obese patients who have or are at risk of developing weight-related comorbidities. The long-term effects of orlistat on morbidity and mortality associated with obesity have not been established. The effects of XENICAL on weight loss, weight maintenance, and weight regain and on a number of comorbidities (eg, type 2 diabetes, lipids, blood pressure) were assessed in the 4-year XENDOS study and in seven long-term (1- to 2-years duration) multicenter, double-blind, placebo-controlled clinical trials. During the first year of therapy, the studies of 2-year duration assessed weight loss and weight maintenance. During the second year of therapy, some studies assessed continued weight loss and weight maintenance and others assessed the effect of orlistat on weight regain. These studies included over 2800 patients treated with XENICAL and 1400 patients treated with placebo. The majority of these patients had obesity-related risk factors and comorbidities. In the XENDOS study, which included 3304 patients, the time to onset of type 2 diabetes was assessed in addition to weight management. In all these studies, treatment with XENICAL and placebo designates treatment with XENICAL plus diet and placebo plus diet, respectively. During the weight loss and weight maintenance period, a well-balanced, reduced-calorie diet that was intended to result in an approximate 20% decrease in caloric intake and provide 30% of calories from fat was recommended to all patients. In addition, all patients were offered nutritional counseling. One-year Results: Weight Loss, Weight Maintenance, and Risk Factors Weight loss was observed within 2 weeks of initiation of therapy and continued for 6 to 12 months. Pooled data from five clinical trials indicated that the overall mean weight loss from randomization to the end of 6 months and 1 year of treatment in the intent-to-treat population were 12.4 lbs and 13.4 lbs in the patients treated with XENICAL and 6.2 lbs and 5.8 lbs in the placebo-treated patients, respectively. During the 4-week placebo lead-in period of the studies, an additional 5 to 6 lb weight loss was also observed in the same patients. Of the patients who completed 1 year of treatment, 57% of the patients treated with XENICAL (120 mg three times a day) and 31% of the placebo-treated patients lost at least 5% of their baseline body weight. The percentages of patients achieving >/=5% and >/=10% weight loss after 1 year in five large multicenter studies for the intent-to-treat populations are presented in Table 1. The diet utilized during year 1 was a reduced-calorie diet. * Treatment designates XENICAL 120 mg three times a day plus diet or placebo plus diet **/* Last observation carried forward **/** All studies, with the exception of 14161, were conducted at centers specialized in treating obesity and complications of obesity. Study 14161 was conducted with primary care physicians. The relative changes in risk factors associated with obesity following 1 year of therapy with XENICAL and placebo are presented for the population as a whole and for the population with abnormal values at randomization. Population as a Whole The changes in metabolic, cardiovascular and anthropometric risk factors associated with obesity based on pooled data for five clinical studies, regardless of the patient's risk factor status at randomization, are presented in Table 2. One year of therapy with XENICAL resulted in relative improvement in several risk factors. * Treatment designates XENICAL 120 mg three times a day plus diet or placebo plus diet **/* Intent-to-treat population at week 52, observed data based on pooled data from 5 studies Xenical (orlistat) No Prescription for Xenical? Please email orders@planetdrugsdirect.com for help. BRAND NAME QTY 120mg - 84 capsule - $97.00 120mg - 168 capsule - $185.00 120mg - 252 capsule - $274.00 Manufacturer: Hoffmann-La Roche Rx: Only available by Prescription Description Chemical Name: ORLISTAT (OR-li-stat) This medicine is a gastrointestinal lipase inhibitor used in the management of obesity in adult and adolescent patients age 12 and older. This medicine may be used during the weight loss phase or following weight loss to assist in weight management. This medicine works by inhibiting the digestion of fats from the diet and should be used with a reduced-calorie diet. Directions Follow the directions for using this medicine provided by your doctor. THIS MEDICINE COMES WITH A PATIENT INFORMATION LEAFLET. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. Take this medicine with or up to 1 hour after each main meal that contains fat up to three per day. Taking this medicine with low-fat meals will lessen the side effects that can occur. If you miss a meal or the meal contains no fat, do not take a dose of this medicine. IF YOU ARE TAKING A MULTIPLE VITAMIN, take it either 2 hours before or 2 hours after taking this medicine. STORE THIS MEDICINE at room temperature below 77 degrees F (25 degrees C) in a tightly-closed container, away from heat and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. IF YOU MISS A DOSE OF THIS MEDICINE, skip the missed dose and go back to your regular dosing schedule. Do NOT take 2 doses at once. Cautions DO NOT TAKE THIS MEDICINE if you are allergic to it or are allergic to any ingredient in this product. DO NOT EXCEED THE RECOMMENDED DOSE. Exceeding the recommended dose will not make you lose more weight and may increase side effects. This medicine may reduce the absorption of necessary fat-soluble vitamins. To ensure that you are receiving adequate amounts of these vitamins, ask your doctor or pharmacist about the use of a vitamin supplement that would be right for you. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. This includes any other medicines used for weight loss/management. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. This medicine is not recommended for use during pregnancy. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED in breast milk. DO NOT BREAST-FEED while taking this medicine. IF YOU HAVE DIABETES, this medicine may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine. SIDE EFFECTS that may occur while taking this medicine include oily stools or spotting, increased number of bowel movements, bowel movement urgency, poor bowel movement control, or gas with discharge. If they continue or are bothersome, check with your doctor. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. Active Ingredients orlistat Losing weight. Of course it can make you look better. But even more important, it can make you feel better. Because the fact is that, in many cases, weight and health are closely related. Excess weight can contribute to high blood pressure, cholesterol and type 2 diabetes. The prescription medication from Roche is called XENICAL. XENICAL is a pill that is taken with meals and has been shown to reduce weight in considerably overweight people. It is FDA approved for people who are at least 30 pounds overweight depending on height. XENICAL does not act directly on the central nervous system. XENICAL should be taken with a reduced calorie diet containing no more than 30% of calories from fat. As with any prescription medication, XENICAL has possible side effects. Click here for important safety information. The long-term benefits of XENICAL on weight-related illnesses and life expectancy have not been evaluated. XENICAL is a prescription medication that can help considerably overweight people lose weight and keep it off. We know that managing your weight can be frustrating, and sometimes you need a little extra support. Support you can't find in a pill alone. To succeed you may have to change the way you feel about food and about your body. To determine if you may be a candidate for XENICAL, your doctor will check your Body Mass Index -- a measure of weight which takes height into account. To find out your BMI now, use the convenient calculator below.Then be sure to register to receive an Evaluation Tool and personalized diet and exercise tips If you eat an excessive amount of fat or calories, the excess is stored as fat by the body, resulting in weight gain. When you eat fat, your body breaks it down into its simplest components so that it can be digested. Unlike other weight-loss drugs you may have heard about that act in the brain or central nervous system to suppress appetite or to speed up metabolism, XENICAL works in your digestive system to block about one-third of the fat in the food you eat from being digested. Enzymes in your digestive system, called lipases, help digest (or break down) fat. When taken with meals, XENICAL attaches to the lipases and blocks them from breaking down some of the fat you have eaten. The undigested fat cannot be absorbed and is eliminated in your bowel movements. By working this way, XENICAL helps block about one-third of the fat in the foods you eat from being absorbed by your body. Xenical blocks absorption of dietary fat into the bloodstream, thereby reducing the number of calories you get from a meal. At the usual dosage level, it cuts fat absorption by almost one-third. Combined with a low-calorie diet, it is used to promote weight loss and discourage the return of unwanted pounds. The drug is prescribed for the frankly obese and for merely overweight people who have other health problems such as high blood pressure, diabetes, or high cholesterol levels. Your weight status is determined by your body mass index (BMI), a comparison of height to weight. -------------------------------------------------------------------------------- Most important fact about this drug Return to top Along with dietary fat, Xenical decreases the absorption of some fat-soluble vitamins and beta-carotene. To compensate, you should take a multivitamin containing vitamins A, E, D, and K once a day, at least 2 hours before or 2 hours after taking Xenical. -------------------------------------------------------------------------------- How should you take this medication? Return to top Take a capsule of Xenical during, or up to 1 hour after, each main meal. You should follow a nutritionally balanced, low-calorie diet that provides no more than 30 percent of its calories from fat. If you miss a meal, or the meal contains no fat, you can skip the accompanying dose of Xenical. --If you miss a dose... Resume taking Xenical at the next meal. Don't try to make up the loss with a double dose. The extra drug won't help. --Storage instructions... Store at room temperature, in a tightly sealed container. -------------------------------------------------------------------------------- What side effects may occur? Return to top Side effects of Xenical are more common during the first year of treatment. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Xenical. More common side effects may include: Abdominal discomfort or pain, anxiety, arthritis, back pain, diarrhea, dizziness, earache, fatigue, fatty or oily stools, fecal urgency or incontinence, flu, gas with fecal discharge, gum problems, headache, increased defecation, menstrual problems, muscle pain, nausea, oily discharge, rectal discomfort or pain, respiratory tract infections, skin rash, sleep problems, tooth problems, urinary tract infections, vaginal inflammation, vomiting Less common side effects may include: Dry skin, ear/nose/throat problems, joint disorders Side effects that usually occur after the first year of treatment with Xenical include: depression, leg pain, swollen feet, and tendonitis. -------------------------------------------------------------------------------- Why should this drug not be prescribed? Return to top Do not take Xenical if you suffer from "chronic malabsorption syndrome"--a condition that prevents nutrients from passing from your stomach into your bloodstream--or from cholestasis, a blockage in the supply of bile needed for digestion. You'll also need to avoid Xenical if it gives you an allergic reaction. -------------------------------------------------------------------------------- Special warnings about this medication Return to top Weight loss begins within 2 weeks and continues for 6 to 12 months. The effect of using Xenical for more than 2 years is still unknown. Side effects such as diarrhea and abdominal pain may be worse if you continue eating a high fat diet or even take a high-fat meal. Limit your fat intake. Your doctor will test your thyroid function before starting you on Xenical to make sure that your weight problem is not due to an underactive thyroid gland (hypothyroidism). Xenical is not an appropriate remedy for this problem. Xenical increases the likelihood of kidney stones. Use it with caution if you have a history of this problem. If you have diabetes, weight-loss is likely to reduce your blood sugar levels. If you're taking an oral diabetes medication or insulin, your dose may have to be reduced. Note that the safety and efficacy of this drug in children have not been established. -------------------------------------------------------------------------------- Possible food and drug interactions when taking this medication Return to top If Xenical is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Xenical with the following: Cyclosporine (Neoral and Sandimmune) Warfarin (Coumadin) -------------------------------------------------------------------------------- Special information if you are pregnant or breastfeeding Return to top The effects of Xenical during pregnancy have not been adequately studied and the drug is not recommended for pregnant women. If you are pregnant or plan to become pregnant, inform your doctor immediately. It is not known whether Xenical appears in breast milk. Do not take it while breastfeeding. -------------------------------------------------------------------------------- Recommended dosage Return to top ADULTS -------------------------------------------------------------------------------- The recommended dose is one 120-milligram capsule 3 times daily with each main meal containing fat. -------------------------------------------------------------------------------- Overdosage Return to top The results of a massive overdose of Xenical are unknown, although the drug seems relatively harmless. However, any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention.

Important Safety Information: XANAX XR should not be used if you are allergic to benzodiazepines, have a condition called acute narrow angle glaucoma, or are taking the anti-fungal medications ketoconazole or itraconazole. XANAX XR is not recommended for use in pregnancy. Therefore, let your doctor know if you are pregnant, if you are planning to become pregnant, or if you become pregnant while you are taking this medication. Let your doctor know if you are nursing. The most common side effect is sedation, but this often decreases or goes away in most people after their bodies get used to the drug. Until you experience how XANAX XR affects you, do not drive a car or operate potentially dangerous machinery, etc. Other common side effects, which occur in fewer patients, include sleepiness, memory impairment, impaired speech, abnormal coordination and/or muscle action, and reduced sexual drive. Some patients may experience side effects associated with psychological and/or physical dependence on XANAX XR. Medications like XANAX XR, even when used as recommended, may produce psychological and/or physical dependence. This may make it very difficult to discontinue treatment with XANAX XR. Discontinuation symptoms, including the possibility of seizures, may occur following abrupt discontinuation from any dose, but the risk may be increased with extended use at doses greater than 4 mg/day. It is important that you get your doctor's advice on how to discontinue treatment safely and carefully. Gradually tapering your XANAX XR dose will help to decrease the possibility of discontinuation symptoms. Xanax is a tranquilizer used in the short-term relief of symptoms of anxiety or the treatment of anxiety disorders. Anxiety disorder is marked by unrealistic worry or excessive fears and concerns. Anxiety associated with depression is also responsive to Xanax. Xanax and the extended-release formulation, Xanax XR, are also used in the treatment of panic disorder, which appears as unexpected panic attacks and may be accompanied by a fear of open or public places called agoraphobia. Only your doctor can diagnose panic disorder and best advise you about treatment. Some doctors prescribe Xanax to treat alcohol withdrawal, fear of open spaces and strangers, depression, irritable bowel syndrome, and premenstrual syndrome. -------------------------------------------------------------------------------- Most important fact about this drug Return to top Tolerance and dependence can occur with the use of Xanax. You may experience withdrawal symptoms if you stop using the drug abruptly. The drug dosage should be gradually reduced and only your doctor should advise you on how to discontinue or change your dose. -------------------------------------------------------------------------------- How should you take this medication? Return to top Xanax may be taken with or without food. Take it exactly as prescribed. Do not chew, crush, or break the Xanax XR tablets. --If you miss a dose... If you are less than 1 hour late, take it as soon as you remember. Otherwise skip the dose and go back to your regular schedule. Never take 2 doses at the same time. --Storage instructions... Store Xanax at room temperature. -------------------------------------------------------------------------------- What side effects may occur? Return to top Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Xanax. Your doctor should periodically reassess the need for this drug. Side effects of Xanax are usually seen at the beginning of treatment and disappear with continued medication. However, if dosage is increased, side effects will be more likely. More common side effects may include: Abdominal discomfort, abnormal involuntary movement, agitation, allergies, anxiety, blurred vision, chest pain, confusion, constipation, decreased or increased sex drive, depression, diarrhea, difficult urination, dream abnormalities, drowsiness, dry mouth, fainting, fatigue, fluid retention, headache, hyperventilation (too frequent or too deep breathing), inability to fall asleep, increase or decrease in appetite, increased or decreased salivation, impaired memory, irritability, lack of or decreased coordination, light-headedness, low blood pressure, menstrual problems, muscular twitching, nausea and vomiting, nervousness, painful menstruation, palpitations, rapid heartbeat, rash, restlessness, ringing in the ears, sedation, sexual dysfunction, skin inflammation, speech difficulties, stiffness, stuffy nose, sweating, tiredness/sleepiness, tremors, upper respiratory infections, weakness, weight gain or loss Less common or rare side effects may include: Abnormal muscle tone, arm or leg pain, concentration difficulties, dizziness, double vision, fear, hallucinations, hot flushes, inability to control urination or bowel movements, infection, itching, joint pain, loss of appetite, muscle cramps, muscle spasticity, rage, seizures, shortness of breath, sleep disturbances, slurred speech, stimulation, talkativeness, taste alterations, temporary memory loss, tingling or pins and needles, uninhibited behavior, urine retention, weakness in muscle and bone, yellow eyes and skin Side effects due to decrease or withdrawal from Xanax or Xanax XR: Anxiety, blurred vision, decreased concentration, decreased mental clarity, depression, diarrhea, headache, heightened awareness of noise or bright lights, hot flushes, impaired sense of smell, insomnia, loss of appetite, loss of reality, muscle cramps, nervousness, rapid breathing, seizures, tingling sensation, tremor, twitching, weight loss -------------------------------------------------------------------------------- Why should this drug not be prescribed? Return to top If you are sensitive to or have ever had an allergic reaction to Xanax or other tranquilizers, you should not take this medication. Also avoid Xanax while taking the antifungal drugs Sporanox or Nizoral. Make sure that your doctor is aware of any drug reactions that you have experienced. Do not take this medication if you have been diagnosed with the eye condition called narrow-angle glaucoma. Anxiety or tension related to everyday stress usually does not require treatment with Xanax. Discuss your symptoms thoroughly with your doctor. -------------------------------------------------------------------------------- Special warnings about this medication Return to top Xanax may cause you to become drowsy or less alert; therefore, driving or operating dangerous machinery or participating in any hazardous activity that requires full mental alertness is not recommended. If you are being treated for panic disorder, you may need to take a higher dose of Xanax than for anxiety alone. High doses--more than 4 milligrams a day--of this medication taken for long intervals may cause emotional and physical dependence. It is important that your doctor supervise you carefully when you are using this medication. Remember that withdrawal symptoms can occur when Xanax is stopped suddenly or the doctor lowers your dosage. These include abnormal skin sensations, blurred vision, decreased appetite, diarrhea, distorted sense of smell, heightened senses, muscle cramps or twitching, problems concentrating, weight loss, and rarely, seizures. Withdrawal symptoms can be minimized or even avoided altogether by decreasing the Xanax dose gradually. As with all antianxiety medication, there is a small chance that Xanax could encourage suicidal thoughts or episodes of euphoria known as mania. If you notice any new or unusual symptoms after starting Xanax, call your doctor immediately. Xanax should be used with caution in elderly or weak patients, and in those with lung disease, alcoholic liver disease, or any disorder that could hinder the elimination of the drug. -------------------------------------------------------------------------------- Possible food and drug interactions when taking this medication Return to top Xanax may intensify the effect of alcohol. Do not drink alcohol while taking this medication. Never combine Xanax with Sporanox or Nizoral. These drugs cause a buildup of Xanax in the body. If Xanax is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is important to check with your doctor before combining Xanax with the following: Amiodarone (Cordarone) Antihistamines such as Benadryl and Tavist Carbamazepine (Tegretol) Certain antibiotics such as Biaxin and erythromycin Certain antidepressant drugs, including Elavil, Norpramin, and Tofranil Cimetidine (Tagamet) Cyclosporine (Neoral, Sandimmune) Digoxin (Lanoxin) Diltiazem (Cardizem) Disulfiram (Antabuse) Ergotamine Fluoxetine (Prozac) Fluvoxamine (Luvox) Grapefruit juice Isoniazid (Rifamate) Major tranquilizers such as Mellaril and Thorazine Nefazodone (Serzone) Nicardipine (Cardene) Nifedipine (Adalat, Procardia) Oral contraceptives Other central nervous system depressants such as Valium and Demerol Paroxetine (Paxil) Propoxyphene (Darvon) Sertraline (Zoloft) -------------------------------------------------------------------------------- Special information if you are pregnant or breastfeeding Return to top Do not take this medication if you are pregnant or planning to become pregnant. There is an increased risk of respiratory problems and muscular weakness in your baby. Infants may also experience withdrawal symptoms. Xanax may appear in breast milk and could affect a nursing infant. If this medication is essential to your health, your doctor may advise you to stop breastfeeding until your treatment with this medication is finished. -------------------------------------------------------------------------------- Recommended dosage Return to top ADULTS -------------------------------------------------------------------------------- Anxiety disorder The usual starting dose of Xanax is 0.25 to 0.5 milligram taken 3 times a day. The dose may be increased every 3 to 4 days to a maximum daily dose of 4 milligrams, divided into smaller doses. Panic disorder The usual starting dose of regular Xanax is 0.5 milligram 3 times a day. This dose can be increased by 1 milligram a day every 3 or 4 days. You may be given a dose from 1 up to a total of 10 milligrams, according to your needs. The typical dose is 5 to 6 milligrams a day. If you're taking Xanax XR, the usual starting dose is 0.5 to 1 milligram once a day taken in the morning. Depending on your response, the dose may be gradually increased by no more than 1 milligram every 3 or 4 days. The usual effective dose is 3 to 6 milligrams a day. Some people may need a larger dose to relieve their symptoms. Others, including older adults and those with liver disease or other serious illnesses, may need to use lower doses. Your doctor will reassess your treatment periodically to be sure you're getting the right amount of medication. CHILDREN -------------------------------------------------------------------------------- Safety and effectiveness have not been established in children under 18 years of age. OLDER ADULTS -------------------------------------------------------------------------------- The usual starting dose for an anxiety disorder is 0.25 milligram, 2 or 3 times daily. The starting dose of Xanax XR is 0.5 milligrams once a day. This dose may be gradually increased if needed and tolerated. PATIENTS SWITCHING FROM XANAX TO XANAX XR -------------------------------------------------------------------------------- If you're taking divided doses of Xanax, the doctor will switch you to a once-daily dose of Xanax XR that equals the current amount you're taking. If your symptoms return after switching, the dose can be increased as needed. -------------------------------------------------------------------------------- Symptom Relief. XANAX XR is a prescription medicine proven effective in the treatment of patients with panic disorder with or without agoraphobia. It boosts the effects of GABA, a natural chemical in your body that sends messages to your brain that tell it to "calm down." Do you have panic symptoms? Once-a-Day Convenience. XANAX XR gives you the benefits of a benzodiazepine to treat panic disorder, in a once-daily formula. You won't have to "watch the clock" or worry about where you'll be when you have to take your next dose. And that can help you relax. Learn how XANAX XR can help you. All Day Relief. Most benzodiazepines have to be taken 2 to 4 times within 24 hours for all day relief. With other medicines, you may feel calm after you take the medicine but then lose that feeling before it's time to take the next dose. Learn how once-daily treatment can work for you. Advanced Formula. XANAX XR is a long-acting formulation of XANAX® (alprazolam), the most prescribed medication of its kind in the United States.1 Learn more about what makes it different. Could XANAX XR help you? XANAX XR is a prescription medication for the treatment of patients with panic disorder, with or without agoraphobia. XANAX XR is an advanced form of XANAX® (alprazolam). It is the first and only medicine of its kind made to be taken just once a day for panic disorder. It works quickly and keeps working all day long. Explore this section to learn more about the benefits of XANAX XR and how it may help you focus on everyday living, instead of when to take your next Nine-wk, open label, switch study of 30 patients with panic disorder, with or without agoraphobia (DSM-IV™). Dosage— patients were stabilized for 3 wk on XANAX (0.75-10 mg/d), then switched to equivalent dose of XANAX XR. Results depicted are from Wk 3 and 4 for XANAX and XANAX XR, respectively, and based on patient diary data, in which patients kept an hourly record of degree (on a 0- to 10-point scale) of anxiolytic benefit they received from each dose of medication. Diaries were compiled and analyzed to determine the time it took, in hours, to reach a maximum score after the first morning dose. While all patients are different, some patients may begin to see improvement in their symptoms as early as the first week. However, the full effect may take several weeks. To get the full benefit of your medicine, be sure to take it as prescribed by your doctor. When you start taking XANAX XR, you may not feel its effects right away. This is because it is released slowly into your system so that it will last throughout the day. As shown in the chart below, XANAX XR took 1.6 hours to reach maximum benefit, compared to 1.5 hours with XANAX® (alprazolam), suggesting that it essentially works just as quickly. If you're wondering if XANAX XR may help you, talk to your doctor. He or she may suggest that XANAX X