Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
ALPRAZOLAM (UNII: YU55MQ3IZY) (ALPRAZOLAM - UNII:YU55MQ3IZY)
Aphena Pharma Solutions - Tennessee, LLC
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, USP are available containing 0.25 mg, 0.5 mg, 1 mg or 2 mg of alprazolam, USP. The 0.25 mg tablets are white, round, scored tablets debossed with MYLAN over A on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-4001-05 bottles of 500 tablets The 0.5 mg tablets are peach, round, scored tablets debossed with MYLAN over A3 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-4003-05 bottles of 500 tablets The 1 mg tablets are blue, round, scored tablets debossed with MYLAN over A1 on one side of the tablet and scored on the other side. They are available as follows: NDC 0378-4005-05 bottles of 500 tablets The 2 mg tablets are white, round, scored tablets debossed with MYLAN over A4 on one side of the tablet and quadrisect scored on the other side. They are available as follows: NDC 0378-4007-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
Abbreviated New Drug Application
Aphena Pharma Solutions - Tennessee, LLC ---------- MEDICATION GUIDE Alprazolam Tablets, USP (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. o Do not drive, operate heavy machinery, or do other dangerous activities until you know how alprazolam tablets affect you. o 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: o to treat anxiety disorders o for the short-term relief of the symptoms of anxiety o 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 they 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 month Prečítajte si celý dokument
ALPRAZOLAM- ALPRAZOLAM TABLET APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- 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 and PRECAUTIONS: Drug Interactions). • • • 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-4_H_-s-triazolo [4,3-α] [1,4] benzodiazepine. The structural formula is represented below: Alprazolam, USP 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 mg, 0.5 mg, 1 mg or 2 mg of alprazolam, USP. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium benzoate and sodium lauryl sulfate. In addition, the 0.5 mg tablet contains FD&C Yellow No. 6 Aluminum Lake and the 1 mg tablet contains FD&C Blue No. 2 Aluminum Lake. 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. 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 administr Prečítajte si celý dokument