País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
ALPRAZOLAM (UNII: YU55MQ3IZY) (ALPRAZOLAM - UNII:YU55MQ3IZY)
Rising Pharmaceuticals, Inc.
ALPRAZOLAM
ALPRAZOLAM 0.25 mg
ORAL
PRESCRIPTION DRUG
Alprazolam tablets, USP 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; dizz
Alprazolam Tablets USP, 0.25 mg are white, oval shaped, uncoated tablets with breakline on one side debossed with ‘1’ and ‘8’ on either sides of the breakline and ‘Y’ on the other side. Bottles of 100 NDC 64980-396-01 Bottles of 500 NDC 64980-396-50 Bottles of 1,000 NDC 64980-396-10 Alprazolam Tablets USP, 0.5 mg are peach colored, oval shaped, uncoated tablets with breakline on one side debossed with ‘1’ and ‘9’ on either sides of the breakline and ‘Y’ on the other side. Bottles of 100 NDC 64980-397-01 Bottles of 500 NDC 64980-397-50 Bottles of 1,000 NDC 64980-397-10 Alprazolam Tablets USP, 1 mg are blue colored, oval shaped, uncoated tablets with breakline on one side debossed with ‘2’ and ‘0’ on either sides of the breakline and ‘Y’ on the other side. Bottles of 100 NDC 64980-398-01 Bottles of 500 NDC 64980-398-50 Bottles of 1,000 NDC 64980-398-10 Alprazolam Tablets USP, 2 mg are white, oblong, uncoated tablets with three breaklines on both sides debossed with ‘2’ and ‘1’ on either sides of the center breakline and ‘Y’ on the other side. Bottles of 100 NDC 64980-399-01 Bottles of 500 NDC 64980-399-50 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Abbreviated New Drug Application
ALPRAZOLAM - ALPRAZOLAM TABLET Rising Pharmaceuticals, Inc. ---------- MEDICATION GUIDE Alprazolam Tablets, USP CIV (al pra' zoe lam) 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. • 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 mightcause panic, helplessness, or embarrassment (agoraphobia) • Alprazolam 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 Leia o documento completo
ALPRAZOLAM - ALPRAZOLAM TABLET RISING PHARMACEUTICALS, INC. ---------- ALPRAZOLAM TABLETS, USP CIV 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]._ 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, 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: Alprazolam USP is a white to off-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 mg, 0.5 mg, 1 mg or 2 mg of alprazolam USP. Alprazolam tablets USP, 2 mg, are multi-scored and may be divided as shown below: Inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium 85% with sodium benzoate 15%, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. In addition, the 0.5 mg tablet contains FD&C Yellow # 6 aluminum lake and the 1 mg tablet contains FD&C Blue No. 2 lake. 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 t Leia o documento completo