מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
ALPRAZOLAM (UNII: YU55MQ3IZY) (ALPRAZOLAM - UNII:YU55MQ3IZY)
Aphena Pharma Solutions - Tennessee, LLC
ALPRAZOLAM
ALPRAZOLAM 0.25 mg
ORAL
PRESCRIPTION DRUG
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 l
Alprazolam tablets are available as follows: Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
New Drug Application Authorized Generic
Aphena Pharma Solutions - Tennessee, LLC ---------- MEDICATION GUIDE ALPRAZOLAM TABLETS, C-IV What is the most important information I should know about alprazolam? • Alprazolam is 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 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 affects you. • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking alprazolam without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, alprazolam may make your sleepiness or dizziness much worse. • Do not take more alprazolam than prescribed. What is alprazolam? • Alprazolam is a prescription medicine used: • to treat anxiety disorders • for the short-term relief of the symptoms of anxiety • to treat panic disorder with or without a fear of places and situations that might cause panic, helplessness, or embarrassment (agoraphobia) • Alprazolam is a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep alprazolam in a safe place to prevent misuse and abuse. Selling or giving away alprazolam 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 is safe and effective in children. • Elderly patients are especially susceptible to dose related adverse effects when taking alprazolam. • It is not known if alprazolam is safe and effective when used to treat anxiety disorder for longer than 4 months. • It is not known if alprazolam is safe and effective when used to treat panic disorder for longer than 10 weeks. Do not take alp קרא את המסמך השלם
ALPRAZOLAM- ALPRAZOLAM TABLET APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- ALPRAZOLAM TABLETS, USP CIV 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]_. 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. DESCRIPTION Alprazolam 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 structural formula is represented to the right: Alprazolam is a white crystalline powder, which is soluble in methanol or ethanol but which has no appreciable solubility in water at physiological pH. Each Alprazolam Tablet, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam. Alprazolam Tablets, 2 mg, are multi-scored and may be divided as shown below: Inactive ingredients: Cellulose, corn starch, docusate sodium, lactose, magnesium stearate, silicon dioxide and sodium benzoate. In addition, the 0.5 mg tablet contains FD&C Yellow No. 6 and the 1 mg tablet contains FD&C Blue No. 2. CLINICAL PHARMACOLOGY PHARMACODYNAMICS CNS agents of the 1,4 benzodiazepine class presumably exert their effects by binding at stereo specific 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 depressant activity varying from mild impairment of task performance to hypnosis. PHARMACOKINETICS Absorption Following oral administration, alprazolam is readily absorbed. Peak concentrations in the plasma occur in 1 to 2 hours following administration. Plasma levels are proportio קרא את המסמך השלם