Country: United States
Language: English
Source: NLM (National Library of Medicine)
ALPRAZOLAM (UNII: YU55MQ3IZY) (ALPRAZOLAM - UNII:YU55MQ3IZY)
Direct Rx
ORAL
PRESCRIPTION DRUG
Anxiety Disorders Alprazolam Tablets, USP (alprazolam) 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 clam
Alprazolam Tablets,USP are available as follows: 0.25 mg (White to off white, oval, biconvex tablets with break line on one side and debossed "B704" on the other side.) 0.5 mg (Light orange to orange, oval, biconvex tablets with break line on one side and debossed "B705" on the other side.) 1 mg (Light blue to blue, oval, biconvex tablets with break line on one side and debossed "B706" on the other side.) 2 mg (Light blue to blue, rectangle tablets with three breaklines on one side and two notches in between two breaklines, debossed 'B707' on other side.) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] Protect from light. Dispense in tight (USP), light-resistant, child-resistant containers. Rx only
Abbreviated New Drug Application
ALPRAZOLAM- ALPRAZOLAM TABLET Direct Rx ---------- MEDICATION GUIDE Alprazolam Tablets USP C-IV (al pra' zoe lam) What is the most important information I should know about alprazolam tablets? Alprazolam Tablets 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 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 tablets affects you. Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking alprazolam tablets without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, alprazolam tablets may make your sleepiness or dizziness much worse Do not take more alprazolam tablets than prescribed. What are alprazolam Tablets? Alprazolam Tablets are 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 tablets in a safe place to prevent misuse and abuse. Selling or giving away alprazolam 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 tablets are safe and effective in children. Elderly patients are especially susceptible to dose related adverse effects when taking alprazolam tablets. It is not known if alprazolam tablets are safe and effective when used to treat anxiety disorder for longer than 4 months. It is not known if alprazolam tablets are safe a Read the complete document
ALPRAZOLAM- ALPRAZOLAM TABLET DIRECT RX ---------- ALPRAZOLAM 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. Alprazolam 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-4H-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is represented to the right: [Chemical Structure] 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, USP, for oral administration, contains 0.25, 0.5, 1 or 2 mg of alprazolam Alprazolam Tablets USP, 2 mg, are multi-scored and may be divided as shown below: [Image] [Image] [Image] Complete 2 mg Tablet Two 1 mg segments Four 0.5 mg segments Inactive ingredients: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, hydroxy propyl cellulose, sodium lauryl sulfate and magnesium stearate. In addition, the 0.5 mg tablet contains FD & C Yellow 6 lake and the 1 mg and 2 mg tablet contains FD & C Blue 2 lake. 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 Read the complete document