displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Alprazolam extended-release tablets contain alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam is 8-chloro-1-methyl-6-phenyl-4H–s-triazolo [4,3-α] [1,4] benzodiazepine. The molecular formula is C17H13ClN4 which corresponds to a molecular weight of 308.76. The structural formula is represented to the right:Alprazolam, USP is a white to off-white crystalline powder, which is freely soluble in chloroform, soluble in alcohol, sparingly soluble in acetone, slightly soluble in ethyl acetate and practically insoluble in water. Each alprazolam extended-release tablet intended for oral administration contains 0.5 mg or 1 mg or 2 mg or 3 mg of alprazolam. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate and magnesium stearate. Additionally, each 1 mg tablet contains D&C yellow No. 10 and 3 mg tablet contains lake green blend.
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
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 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. 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.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Alprazolam extended-release tablets are contraindicated in patients with known sensitivity to this drug or other benzodiazepines. Alprazolam extended-release 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 extended-release tablets are contraindicated with ketoconazole and itraconazole, since these medications significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP3A) (see CLINICAL PHARMACOLOGY, WARNINGS and PRECAUTIONS: Drug Interactions).
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
The information included in the subsection on Adverse Events Observed in Short-Term, Placebo-Controlled Trials with alprazolam extended-release tablets is based on pooled data of five 6- and 8-week placebo-controlled clinical studies in panic disorder. Adverse event reports were elicited either by general inquiry or by checklist, and were recorded by clinical investigators using terminology of their own choosing. The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened during therapy following baseline evaluation. In the tables and tabulations that follow, standard MedDRA terminology (version 4.0) was used to classify reported adverse events.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
Alprazolam extended-release tablets may be administered once daily, preferably in the morning. The tablets should be taken intact; they should not be chewed, crushed, or broken. The suggested total daily dose ranges between 3 to 6 mg/day. Dosage should be individualized for maximum beneficial effect. While the suggested total daily dosages given will meet the needs of most patients, there will be some patients who require doses greater than 6 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Alprazolam Extended-Release Tablets, 0.5 mg are white to off-white, round, biconvex, uncoated tablets, debossed with ‘EM’ on one side and ‘105’ on other side and are supplied as follows:NDC 68382-060-06 in bottle of 30 tabletsNDC 68382-060-14 in bottle of 60 tablets NDC 68382-060-16 in bottle of 90 tablets Alprazolam Extended-Release Tablets, 1 mg are yellow colored, round, biconvex, uncoated tablets, debossed with ‘EM’ on one side and ‘104’ on other side and are supplied as follows:NDC 68382-061-06 in bottle of 30 tabletsNDC 68382-061-14 in bottle of 60 tablets NDC 68382-061-16 in bottle of 90 tablets Alprazolam Extended-Release Tablets, 2 mg are white to off-white, round, biconvex, uncoated tablets, debossed with ‘EM’ on one side and ‘103’ on other side and are supplied as follows:NDC 68382-062-06 in bottle of 30 tabletsNDC 68382-062-14 in bottle of 60 tablets NDC 68382-062-16 in bottle of 90 tablets Alprazolam Extended-Release Tablets, 3 mg are green colored, round, biconvex, uncoated tablets, debossed with ‘EM’ on one side and ‘102’ on other side and are supplied as follows: NDC 68382-063-06 in bottle of 30 tabletsNDC 68382-063-14 in bottle of 60 tablets NDC 68382-063-16 in bottle of 90 tablets