Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
ALPRAZOLAM (UNII: YU55MQ3IZY) (ALPRAZOLAM - UNII:YU55MQ3IZY)
Preferred Pharmaceuticals Inc.
ALPRAZOLAM
ALPRAZOLAM 1 mg
ORAL
PRESCRIPTION DRUG
Alprazolam extended-release tablets, USP 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 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 dyi
Alprazolam extended-release tablets, USP are available as follows: 1 mg — Each yellow, round tablet imprinted with on one side and 84 on the other contains 1 mg of Alprazolam, USP. Tablets are supplied in bottles of 60 (NDC 0228-3084-06). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. ANIMAL STUDIES When rats were treated with alprazolam at 3, 10, and 30 mg/kg/day (15 to 150 times the maximum recommended human dose) orally for 2 years, a tendency for a dose related increase in the number of cataracts was observed in females and a tendency for a dose related increase in corneal vascularization was observed in males. These lesions did not appear until after 11 months of treatment. Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 40-9181 Revised – May 2017
Abbreviated New Drug Application
Preferred Pharmaceuticals Inc. ---------- MEDICATION GUIDE Alprazolam (al pra' zoe lam) Extended-Release Tablets, USP C-IV What is the most important information I should know about alprazolam extended-release tablets? • Alprazolam extended-release tablets are a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma and death. • Alprazolam extended-release tablets can make you sleepy or dizzy, and can slow your thinking and motor skills. • Do not drive, operate heavy machinery, or do other dangerous activities until you know how alprazolam extended-release tablets affect you. • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking alprazolam extended-release tablets without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, alprazolam extended-release tablets may make your sleepiness or dizziness much worse. • Do not take more alprazolam extended-release tablets than prescribed. What are alprazolam extended-release tablets? • Alprazolam extended-release tablets are a prescription medicine used to treat panic disorder, with or without a fear of places and situations that might cause panic, helplessness, or embarrassment (agoraphobia) • Alprazolam extended-release tablets are a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep alprazolam extended-release tablets in a safe place to prevent misuse and abuse. Selling or giving away alprazolam extended-release tablets may harm others, and is against the law. Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs. • It is not known if alprazolam extended-release tablets are safe and effective in children. • Elderly patients are especially susceptible to dose related adverse effects when ta Přečtěte si celý dokument
ALPRAZOLAM EXTENDED RELEASE- ALPRAZOLAM TABLET, EXTENDED RELEASE PREFERRED PHARMACEUTICALS INC. ---------- ALPRAZOLAM EXTENDED-RELEASE TABLETS, USP C-IV 40-9181 Revised – May 2017 RX ONLY WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH _[_SEE _WARNINGS, DRUG_ _INTERACTIONS]_. • • • DESCRIPTION Alprazolam extended-release tablets, USP 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-4_H_-_s_-triazolo [4,3-α] [1,4] benzodiazepine. The molecular formula is C H ClN which corresponds to a molecular weight of 308.76. The structural formula is represented below: Alprazolam, USP is a white crystalline powder, which is soluble in methanol or ethanol RESERVE CONCOMITANT PRESCRIBING OF THESE DRUGS FOR USE IN PATIENTS FOR WHOM ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE. LIMIT DOSAGES AND DURATIONS TO THE MINIMUM REQUIRED. FOLLOW PATIENTS FOR SIGNS AND SYMPTOMS OF RESPIRATORY DEPRESSION AND SEDATION. 17 13 4 but which has no appreciable solubility in water at physiological pH. Each alprazolam extended-release tablet, for oral administration, contains 0.5 mg, 1 mg, 2 mg, or 3 mg of alprazolam. The inactive ingredients are lactose monohydrate, hypromellose, and magnesium stearate. In addition, the 1 mg tablets also contain D&C yellow #10 aluminum lake. The 2 mg tablets also contain FD&C Yellow #6 aluminum lake, and the 3 mg tablets also contain D&C Yellow #10 aluminum lake, and FD&C Blue #2 aluminum lake. Product meets USP Dissolution Test 2. CLINICAL PHARMACOLOGY PHARMACODYNAMICS CNS agents of the 1,4 benzodiazepine class presumably exert their effects by binding at stereospecific receptors at several sites within the central nervous system. Their exact mechanism of action is unknown. Clinically, all benzodiazepines cause a dose-related central nervous system depre Přečtěte si celý dokument