INDICATIONS AND USAGE Anxiety Disorders 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: 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 â€˜lump in throatâ€™); Vigilance and Scanning (feeling keyed up or on edge; exaggerated startle response; difficulty concentrating or â€˜mind going blankâ€™ 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. panic disorder 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, i.e., 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.
Mylan Pharmaceuticals Inc.
HOW SUPPLIED Alprazolam Tablets, USP are available containing 0.25 mg, 0.5 mg, 1 mg or 2 mg of alprazolam, USP. The 0.25 mg tablets are white, round, scored tablets debossed with MYLAN over A on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-4001-05 bottles of 500 tablets The 0.5 mg tablets are peach, round, scored tablets debossed with MYLAN over A3 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-4003-05 bottles of 500 tablets The 1 mg tablets are blue, round, scored tablets debossed with MYLAN over A1 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-4005-05 bottles of 500 tablets The 2 mg tablets are white, round, scored tablets debossed with MYLAN over A4 on one side of the tablet and quadrisect scored on the other side. They are available as follows: NDC 0378-4007-01 bottles of 100 tablets Store at 20Â° to 25Â°C (68Â° to 77Â°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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