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 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
Alprazolam tablets, USP for oral administration are available as: 0.25 mg: Oval, white tablets debossed GG 256 on one side and scored on the reverse side and supplied as: bottles of 100 bottles of 500 bottles of 1000 0.5 mg: Oval, peach tablets debossed GG 257 on one side and scored on the reverse side and supplied as: bottles of 100 bottles of 500 bottles of 1000 1 mg: Oval, blue tablets debossed GG 258 on one side and scored on the reverse side and supplied as: bottles of 100 bottles of 500 bottles of 1000 2 mg: Rectangular white multi-scored tablets debossed GG 249 on one side and plain on the reverse side and supplied as: bottles of 100 bottles of 500 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container.
Abbreviated New Drug Application
XANAX- ALPRAZOLAM TABLET Direct_Rx ---------- What is the most important information I should know about alprazolam tablets? • Alprazolam 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 tablets can make you sleepy or dizzy, and can slow your thinking and motor skills. 1. Do not drive, operate heavy machinery, or do other dangerous activities until you know how alprazolam tablets affect you. 2. 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: 1. to treat anxiety disorders 2. for the short-term relief of the symptoms of anxiety 3. to treat panic disorder with or without a fear of places and situations that might cause panic, helplessness, or embarrassment (agoraphobia) • Alprazolam tablets are 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 and effe Read the complete document
XANAX- 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 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: [Alprazolam Chemical Structure] Alprazolam is a white to off-white crystalline powder, which is soluble in alcohol 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, USP 2 mg, are multi-scored and may be divided as shown below: [Complete 2 mg Tablet] Complete 2 mg Tablet [Two 1 mg segments] Two 1 mg segments [Four 0.5 mg segments] Four 0.5 mg segments Inactive ingredients: docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium benzoate. Additionally, the 0.5 mg also contains FD&C Yellow #6 Aluminum Lake, and the 1 mg also contains FD&C Blue #2 Aluminum 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 in the plasma occur Read the complete document