INDICATIONS AND USAGE Alprazolam extended-release tablets are indicated for the treatment of panic disorder, with or without agoraphobia. This claim is supported on the basis of two positive studies with alprazolam extended-release tablets conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL EFFICACY TRIALS ). 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. The longer-term efficacy of alprazolam extended-release tablets has not been systematically evaluated. Thus, the physician who elects to use this drug for periods longer than 8 weeks should periodically reassess the usefulness of the drug for the individual patient.
Mylan Pharmaceuticals Inc.
HOW SUPPLIED Alprazolam Extended-release Tablets, USP are available containing 0.5 mg, 1 mg, 2 mg or 3 mg of alprazolam, USP. The 0.5 mg tablets are white to off-white, round, unscored tablets debossed with M on one side of the tablet and A21 on the other side. They are available as follows: NDC 0378-5021-91 bottles of 60 tablets NDC 0378-5021-05 bottles of 500 tablets The 1 mg tablets are light orange, round, unscored tablets debossed with M on one side of the tablet and A22 on the other side. They are available as follows: NDC 0378-5022-91 bottles of 60 tablets NDC 0378-5022-05 bottles of 500 tablets The 2 mg tablets are light Lavender, round, unscored tablets debossed with M on one side of the tablet and A23 on the other side. They are available as follows: NDC 0378-5023-91 bottles of 60 tablets NDC 0378-5023-05 bottles of 500 tablets The 3 mg tablets are light pink, round, unscored tablets debossed with M on one side of the tablet and A24 on the other side. They are available as follows: NDC 0378-5024-91 bottles of 60 tablets NDC 0378-5024-05 bottles of 500 tablets Store at 20Â° to 25Â°C (68Â° to 77Â°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Mylan Pharmaceuticals Inc.
A-S Medication Solutions LLC
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