국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
ALPRAZOLAM (UNII: YU55MQ3IZY) (ALPRAZOLAM - UNII:YU55MQ3IZY)
Aphena Pharma Solutions - Tennessee, LLC
ORAL
PRESCRIPTION DRUG
Anxiety Disorders 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; dr
Alprazolam tablets, USP are supplied as follows: 0.25 mg — Each white, round tablet imprinted with on one side and 027 and bisect on the other contains 0.25 mg of alprazolam, USP. Tablets are supplied in bottles of 100 (NDC 0228-2027-10), 500 (NDC 0228-2027-50), and 1000 (NDC 0228-2027-96). 0.5 mg — Each peach, round tablet imprinted with on one side and 029 and bisect on the other contains 0.5 mg of alprazolam, USP. Tablets are supplied in bottles of 100 (NDC 0228-2029-10), 500 (NDC 0228-2029-50), and 1000 (NDC 0228-2029-96). 1 mg — Each blue, round tablet imprinted with on one side and 031 and bisect on the other contains 1 mg of alprazolam, USP. Tablets are supplied in bottles of 100 (NDC 0228-2031-10), 500 (NDC 0228-2031-50), and 1000 (NDC 0228-2031-96). 2 mg — Each yellow, rectangle shaped, flat faced, beveled edge tablet imprinted with and 039 on one side and multi-scored on both sides contains 2 mg of alprazolam, USP. Tablets are supplied in bottles of 100 (NDC 0228-2039-10). Dispense in tight, light-resistant containers as defined in the USP. Keep container tightly closed. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. ANIMAL STUDIES When rats were treated with alprazolam at 3, 10, and 30 mg/kg/day (15 to 150 times the maximum recommended human dose) orally for 2 years, a tendency for a dose related increase in the number of cataracts was observed in females and a tendency for a dose related increase in corneal vascularization was observed in males. These lesions did not appear until after 11 months of treatment. Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA 40-9170 Revised — July 2017
Abbreviated New Drug Application
ALPRAZOLAM- ALPRAZOLAM TABLET Aphena Pharma Solutions - Tennessee, LLC ---------- MEDICATION GUIDE Alprazolam (al pra' zoe lam) Tablets, USP C-IV 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 affect 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 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 t 전체 문서 읽기
ALPRAZOLAM- ALPRAZOLAM TABLET APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ---------- ALPRAZOLAM TABLETS, USP C-IV Revised — July 2017 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, USP which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. The chemical name of alprazolam, USP is 8-Chloro-1-methyl-6-phenyl-4H-s-triazolo [4,3-α] [1,4] benzodiazepine and its 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 tablet, for oral administration, contains 0.25 mg, 0.5 mg, 1 mg, and 2 mg of alprazolam, USP. The 2 mg tablets are multi-scored and may be divided in half to provide two 1 mg segments, or quarters to provide four 0.5 mg segments. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, docusate sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium benzoate. The 0.5 mg tablet also contains FD&C yellow #6 aluminum lake (sunset yellow lake). The 1 mg tablet also contains FD&C blue #2 aluminum lake. The 2 mg tablet also contains D&C yellow #10 aluminum 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 전체 문서 읽기