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.
Get emergency medical help if you have any of these signs of an allergic reaction : hives; difficult breathing; swelling of your face, lips, tongue, or throat.
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(See WARNINGS, PRECAUTIONS, Drug Abuse And Dependence. Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided. ). In a controlled postmarketing dose-response study, patients treated with doses of XANAX greater than 4 mg/day for 3 months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit. For patients receiving doses greater than 4 mg/day, periodic reassessment and consideration of dosage reduction is advised.
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 lightheadedness.
Call your doctor at once if you have a serious side effect such as:
NDC 2 mg (white, oblong, multi-scored, imprinted "XANAX " on one side and "2" on the reverse side) Bottles of 100 NDC Bottles of 500 NDC Store at controlled room temperature 20° to 25°C (68° to 77°F). NDC Bottles of 1000. 0.5 mg (peach, oval, scored, imprinted "XANAX 0.5") Bottles of 100 Reverse Numbered NDC Unit Dose (100).,. NDC Bottles of 500. NDC Bottles of 1000. NDC Bottles of 500. NDC 1 mg (blue, oval, scored, imprinted "XANAX 1.0") Bottles of 100.
DISCONTINUATION-EMERGENT SYMPTOM INCIDENCE Percentage of 641 XANAX-Treated Panic Disorder Patients Reporting Events Body System/Event Neurologic Gastrointestinal Insomnia 29.5 Nausea/Vomiting 16.5 Light-headedness 19.3 Diarrhea 13.6 Abnormal involuntary movement 17.3 Decreased salivation 10.6 Headache 17.0 Metabolic-Nutritional Muscular twitching 6.9 Weight loss 13.3 Impaired coordination 6.6 Muscle tone disorders 5.9 Weakness 5.8 Dermatological Psychiatric Sweating 14.4 Anxiety 19.2 Fatigue and Tiredness 18.4 Cardiovascular Irritability 10.5 Tachycardia 12.2 Cognitive disorder 10.3 Memory impairment 5.5 Special Senses Depression 5.1 Blurred vision 10.0 Confusional state 5.0.
Cellulose, corn starch, docusate sodium, lactose, magnesium stearate, silicon dioxide and sodium benzoate. 6 and the 1 mg tablet contains FD&C Blue No. In addition, the 0.5 mg tablet contains FD&C Yellow No. 2.
Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see Clinical Studies ).
Distributed by: Pharmacia & Upjohn Co, Division of Pfizer Inc, NY, NY 10017. Revised: September 2013.
XANAX alprazolam tablets, USP.
Panic disorder ( DSM-IV ) is characterized by recurrent unexpected panic attacks, ie, a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking ; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.
Demonstrations of the effectiveness of XANAX by systematic clinical study are limited to 4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.
There have also been reports of withdrawal seizures upon rapid decrease or abrupt discontinuation of XANAX Tablets (see WARNINGS ). 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.
Panic disorder has been associated with primary and secondary major depressive disorders and increased reports of suicide among untreated patients (see PRECAUTIONS, General ).
The chemical name of alprazolam is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo benzodiazepine.
Treatment-Emergent Adverse Events Reported in Placebo-Controlled Trials of Panic Disorder PANIC DISORDER Treatment-Emergent Symptom Incidence* XANAX PLACEBO Number of Patients % of Patients Reporting: 1388 1231 Central Nervous System Drowsiness 76.8 42.7 Fatigue and Tiredness 48.6 42.3 Impaired Coordination 40.1 17.9 Irritability 33.1 30.1 Memory Impairment 33.1 22.1 Light-headedness/Dizziness 29.8 36.9 Insomnia 29.4 41.8 Headache 29.2 35.6 Cognitive Disorder 28.8 20.5 Dysarthria 23.3 6.3 Anxiety 16.6 24.9 Abnormal Involuntary Movement 14.8 21.0 Decreased Libido 14.4 8.0 Depression 13.8 14.0 Confusional State 10.4 8.2 Muscular Twitching 7.9 11.8 Increased Libido 7.7 4.1 Change in Libido (Not Specified) 7.1 5.6 Weakness 7.1 8.4 Muscle Tone Disorders 6.3 7.5 Syncope 3.8 4.8 Akathisia 3.0 4.3 Agitation 2.9 2.6 Disinhibition 2.7 1.5 Paresthesia 2.4 3.2 Talkativeness 2.2 1.0 Vasomotor Disturbances 2.0 2.6 Derealization 1.9 1.2 Dream Abnormalities 1.8 1.5 Fear 1.4 1.0 Feeling Warm 1.3 0.5 Gastrointestinal Decreased Salivation 32.8 34.2 Constipation 26.2 15.4 Nausea/Vomiting 22.0 31.8 Diarrhea 20.6 22.8 Abdominal Distress 18.3 21.5 Increased Salivation 5.6 4.4 Cardio-Respiratory Nasal Congestion 17.4 16.5 Tachycardia 15.4 26.8 Chest Pain 10.6 18.1 Hyperventilation 9.7 14.5 Upper Respiratory Infection 4.3 3.7 Sensory Blurred Vision 21.0 21.4 Tinnitus 6.6 10.4 Musculoskeletal Muscular Cramps 2.4 2.4 Muscle Stiffness 2.2 3.3 Cutaneous Sweating 15.1 23.5 Rash 10.8 8.1 Other Increased Appetite 32.7 22.8 Decreased Appetite 27.8 24.1 Weight Gain 27.2 17.9 Weight Loss 22.6 16.5 Micturition Difficulties 12.2 8.6 Menstrual Disorders 10.4 8.7 Sexual Dysfunction 7.4 3.7 Edema 4.9 5.6 Incontinence 1.5 0.6 Infection 1.3 1.7 *Events reported by 1% or more of XANAX patients are included.
Each XANAX Tablet, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam.
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.
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 ). 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. Some patients may benefit from an even slower dosage reduction.
If side effects occur at the recommended starting dose, the dose may be lowered. This may be gradually increased if needed and tolerated. 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. The elderly may be especially sensitive to the effects of benzodiazepines.
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. Among the approximay 1700 patients participating in the panic disorder development program, about 300 received XANAX in dosages of greater than 7 mg/day, including approximay 100 patients who received maximum dosages of greater than 9 mg/day. The successful treatment of many panic disorder patients has required the use of XANAX at doses greater than 4 mg daily. The mean dosage employed was approximay 5 to 6 mg daily. Occasional patients required as much as 10 mg a day to achieve a successful response.
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.
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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. Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug.
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: gastrointestinal disorder, hypomania, mania, liver enzyme elevations, hepatitis, hepatic failure, Stevens-Johnson syndrome, photosensitivity reaction, angioedema, peripheral edema, hyperprolactinemia, gynecomastia, and galactorrhea (see PRECAUTIONS ).
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.
Some patients may prove resistant to all discontinuation regimens. It is suggested that the dose be reduced by no more than 0.5 mg every 3 days, with the understanding that some patients may benefit from an even more gradual discontinuation. In any case, reduction of dose must be undertaken under close supervision and must be gradual. 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. 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 such cases, dosage should be increased cautiously to avoid adverse effects. 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. Dosage should be individualized for maximum beneficial effect.
Adverse Events Reported as Reasons for Discontinuation in Treatment of Panic Disorder in Placebo-Controlled Trials.
Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided (see WARNINGS, PRECAUTIONS, Drug Abuse And Dependence ).
XANAX Tablets, 2 mg, are multi-scored and may be divided as shown below:
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:
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). Generalized anxiety disorder is characterized by unrealistic or excessive anxiety and worry (apprehensive expectation) about two or more life circumstances, for a period of 6 months or longer, during which the person has been bothered more days than not by these concerns. These symptoms must not be secondary to another psychiatric disorder or caused by some organic factor.
XANAX is also indicated for the treatment of panic disorder, with or without agoraphobia.
NDC Bottles of 500. NDC Unit dose (100). NDC. NDC Bottles of 1000. 0.25 mg (white, oval, scored, imprinted "XANAX 0.25") Bottles of 100 Reverse Numbered.
Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH.
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. The necessary duration of treatment for panic disorder patients responding to XANAX is unknown.
Treatment-Emergent Adverse Events Reported in Placebo-Controlled Trials of Anxiety Disorders ANXIETY DISORDERS Treatment-Emergent Symptom Incidence* Incidence of Intervention Because of Symptom XANAX PLACEBO XANAX Number of Patients % of Patients Reporting: 565 505 565 Central Nervous System Drowsiness 41.0 21.6 15.1 Light-headedness 20.8 19.3 1.2 Depression 13.9 18.1 2.4 Headache 12.9 19.6 1.1 Confusion 9.9 10.0 0.9 Insomnia 8.9 18.4 1.3 Nervousness 4.1 10.3 1.1 Syncope 3.1 4.0 † Dizziness 1.8 0.8 2.5 Akathisia 1.6 1.2 † Tiredness/Sleepiness † † 1.8 Gastrointestinal Dry Mouth 14.7 13.3 0.7 Constipation 10.4 11.4 0.9 Diarrhea 10.1 10.3 1.2 Nausea/Vomiting 9.6 12.8 1.7 Increased Salivation 4.2 2.4 † Cardiovascular Tachycardia/Palpitations 7.7 15.6 0.4 Hypotension 4.7 2.2 † Sensory Blurred Vision 6.2 6.2 0.4 Musculoskeletal Rigidity 4.2 5.3 † Tremor 4.0 8.8 0.4 Cutaneous Dermatitis/Allergy 3.8 3.1 0.6 Other Nasal Congestion 7.3 9.3 † Weight Gain 2.7 2.7 † Weight Loss 2.3 3.0 † *Events reported by 1% or more of XANAX patients are included. †None reported.
Should any of the above events occur, alprazolam should be discontinued. Instances of irritability, hostility, and intrusive thoughts have been reported during discontinuation of alprazolam in patients with posttraumatic stress disorder. 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. 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. 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.
XANAX Tablets are available as follows:
The structural formula is represented to the right:
Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. XANAX Tablets ( alprazolam ) are indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual diagnosis of generalized anxiety disorder ) or the short-term relief of symptoms of anxiety.
(For example, an anxiolytic drug may relieve dry mouth in some subjects but induce it in others.). 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.
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. In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage.
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. 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. Treatment may be initiated with a dose of 0.5 mg three times daily. Slower titration to the dose levels greater than 4 mg/day may be advisable to allow full expression of the pharmacodynamic effect of XANAX.
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.
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.
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 3 days. In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Some patients may require an even slower dosage reduction.
XANAX Tablets contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system -active compounds.
Anxiety associated with depression is responsive to XANAX.Xanax