This information is not for clinical use. These highlights do not include all the information needed to use Alprazolam safely and effectively. Before taking Alprazolam please consult with your doctor. See full prescribing information for Alprazolam.

Indications And Usage

Alprazolam tablets 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 6 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: (trembling, twitching, or feeling shaky; muscle tension, aches, or soreness; restlessness; easy fatigability); (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’); (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 alprazolam tablets. Alprazolam tablets are 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/IV criteria for panic disorder (see CLINICAL STUDIES). 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 alprazolam tablets 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. Anxiety Disorders Motor Tension Autonomic Hyperactivity Vigilance and Scanning Panic Disorder

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Contraindications

Alprazolam tablets are contraindicated in patients with known sensitivity to this drug or other benzodiazepines. Alprazolam tablets may be used in patients with open angle glaucoma who are receiving appropriate therapy, but is contraindicated in patients with acute narrow angle glaucoma. Alprazolam tablets are 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).

Adverse Reactions

Side effects to alprazolam 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 alprazolam tablets (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 alprazolam tablets 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. Treatment-Emergent Adverse Events Reported in Placebo-Controlled Trials of Anxiety Disorders ANXIETY DISORDERS Treatment-Emergent Symptom Incidence Events reported by 1% or more of alprazolam tablet patients are included. Incidence of Intervention Because of Symptom Alprazolam Tablets Placebo Alprazolam Tablets Number of Patients 565 505 565 % of Patients Reporting: Drowsiness Central Nervous System 41 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 0.9 Insomnia 8.9 18.4 1.3 Nervousness 4.1 10.3 1.1 Syncope 3.1 4 None reported Dizziness 1.8 0.8 2.5 Akathisia 1.6 1.2 Tiredness/Sleepiness 1.8 Dry Mouth Gastrointestinal 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 Tachycardia/Palpitations Cardiovascular 7.7 15.6 0.4 Hypotension 4.7 2.2 Blurred Vision Sensory 6.2 6.2 0.4 Rigidity Musculoskeletal 4.2 5.3 Tremor 4 8.8 0.4 Dermatitis/Allergy Cutaneous 3.8 3.1 0.6 Nasal Congestion Other 7.3 9.3 Weight Gain 2.7 2.7 Weight Loss 2.3 3 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. Treatment-Emergent Adverse Events Reported in Placebo-Controlled Trials of Panic Disorder PANIC DISORDER Treatment-Emergent Symptom Incidence Events reported by 1% or more of alprazolam tablet patients are included. Alprazolam Tablets Placebo Number of Patients 1388 1231 % of Patients Reporting: Drowsiness Fatigue and Tiredness Impaired Coordination Irritability Memory Impairment Light-headedness/Dizziness Insomnia Headache Cognitive Disorder Dysarthria Anxiety Abnormal Involuntary Movement Decreased Libido Depression Confusional State Muscular Twitching Increased Libido Change in Libido (Not Specified) Weakness Muscle Tone Disorders Syncope Akathisia Agitation Disinhibition Paresthesia Talkativeness Vasomotor Disturbances Derealization Dream Abnormalities Fear Feeling Warm Central Nervous System 76.8 48.6 40.1 33.1 33.1 29.8 29.4 29.2 28.8 23.3 16.6 14.8 14.4 13.8 10.4 7.9 7.7 7.1 7.1 6.3 3.8 3 2.9 2.7 2.4 2.2 2 1.9 1.8 1.4 1.3 42.7 42.3 17.9 30.1 22.1 36.9 41.8 35.6 20.5 6.3 24.9 21 8 14 8.2 11.8 4.1 5.6 8.4 7.5 4.8 4.3 2.6 1.5 3.2 1 2.6 1.2 1.5 1 0.5 Decreased Salivation Constipation Nausea/Vomiting Diarrhea Abdominal Distress Increased Salivation Gastrointestinal 32.8 26.2 22 20.6 18.3 5.6 34.2 15.4 31.8 22.8 21.5 4.4 Nasal Congestion Tachycardia Chest Pain Hyperventilation Upper Respiratory Infection Cardio-Respiratory 17.4 15.4 10.6 9.7 4.3 16.5 26.8 18.1 14.5 3.7 Blurred Vision Tinnitus Sensory 21 6.6 21.4 10.4 Muscular Cramps Muscle Stiffness Musculoskeletal 2.4 2.2 2.4 3.3 Sweating Rash Cutaneous 15.1 10.8 23.5 8.1 Increased Appetite Decreased Appetite Weight Gain Weight Loss Micturition Difficulties Menstrual Disorders Sexual Dysfunction Edema Incontinence Infection Other 32.7 27.8 27.2 22.6 12.2 10.4 7.4 4.9 1.5 1.3 22.8 24.1 17.9 16.5 8.6 8.7 3.7 5.6 0.6 1.7 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 alprazolam tablets: seizures, hallucinations, depersonalization, taste alterations, diplopia, elevated bilirubin, elevated hepatic enzymes, and jaundice. Panic disorder has been associated with primary and secondary major depressive disorders and increased reports of suicide among untreated patients (see PRECAUTIONS, General). Adverse Events Reported as Reasons for Discontinuation in Treatment of Panic Disorder in Placebo-Controlled Trials In a larger database comprised of both controlled and uncontrolled studies in which 641 patients received alprazolam tablets, discontinuation-emergent symptoms which occurred at a rate of over 5% in patients treated with alprazolam tablets and at a greater rate than the placebo treated group were as follows: DISCONTINUATION-EMERGENT SYMPTOM INCIDENCE Percentage of 641 Alprazolam Tablets-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 Metabolic-Nutritional Muscular twitching 6.9 Weight loss 13.3 Impaired coordination 6.6 Decreased appetite 12.8 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 Confusional state 5 From the studies cited, it has not been determined whether these symptoms are clearly related to the dose and duration of therapy with alprazolam tablets in patients with panic disorder. There have also been reports of withdrawal seizures upon rapid decrease or abrupt discontinuation of alprazolam tablets (see WARNINGS). To discontinue treatment in patients taking alprazolam tablets, the dosage should be reduced slowly in keeping with good medical practice. It is suggested that the daily dosage of alprazolam tablets 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. 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 posttraumatic stress disorder. Various adverse drug reactions have been reported in association with the use of alprazolam tablets 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 alprazolam tablets cannot be readily determined. Reported events include: gastrointestinal disorder, hypomania, mania, liver enzyme elevations, hepatitis, hepatic failure, Stevens-Johnson syndrome, angioedema, peripheral edema, hyperprolactinemia, gynecomastia, and galactorrhea (see PRECAUTIONS). Post Introduction Reports:

Drug Interactions

Drug Interactions If alprazolam 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. The benzodiazepines, including alprazolam, produce additive CNS depressant effects when coadministered 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 alprazolam tablets in doses up to 4 mg/day. The clinical significance of these changes is unknown. : The initial step in alprazolam metabolism is hydroxylation catalyzed by cytochrome P450 3A (CYP3A). 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). Fluoxetine—Coadministration of fluoxetine with alprazolam 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%. 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 studies of alprazolam suggest a possible drug interaction with alprazolam for the following: sertraline and paroxetine. However, data from an drug interaction study involving a single dose of alprazolam 1 mg and steady state dose of sertraline (50 to 150 mg/day) did not reveal any clinically significant changes in the pharmacokinetics of alprazolam. Data from studies of benzodiazepines other than alprazolam suggest a possible drug interaction for the following: ergotamine, cyclosporine, amiodarone, nicardipine, and nifedipine. Caution is recommended during the coadministration of any of these with alprazolam (see WARNINGS). Carbamazepine can increase alprazolam metabolism and therefore can decrease plasma levels of alprazolam. Use with other CNS depressants Use with imipramine and desipramine Drugs that inhibit alprazolam metabolism via cytochrome P450 3A Drugs demonstrated to be CYP3A inhibitors of possible clinical significance on the basis of clinical studies involving alprazolam (caution is recommended during coadministration with alprazolam): Drugs and other substances demonstrated to be CYP3A 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): in vitro in vivo in vitro Drugs demonstrated to be inducers of CYP3A: