Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
MEPROBAMATE (UNII: 9I7LNY769Q) (MEPROBAMATE - UNII:9I7LNY769Q)
Cipla USA Inc.
ORAL
PRESCRIPTION DRUG
Meprobamate tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.Anxiety or tension associated with the stress of everyday life usually do not require treatment with an anxiolytic. The effectiveness of meprobamate tablets in long-term use, that is,more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient. Acute intermittent porphyria as well as allergic or idiosyncratic reactions to meprobamate or related compounds such as carisoprodol, mebutamate, tybamate, or carbromal.
Meprobamate Tablets USP 200 mg are white, round, biconvex tablets debossed with I and 7 on one side and bisect on the other. Supplied in bottles of 100. Bottles of 100: NDC 69097-974-07 Meprobamate Tablets USP 400 mg are white, round, biconvex tablets debossed with I and 4 on one side and bisect on the other. Supplied in bottles of 100. Bottles of 100: NDC 69097-975-07 Dispense in well-closed container with child-resistant closure. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 Rev. 04/2020
Abbreviated New Drug Application
MEPROBAMATE- MEPROBAMATE TABLET CIPLA USA INC. ---------- MEPROBAMATE TABLETS DESCRIPTION Meprobamate is a white powder with a characteristic odor and a bitter taste. It is slightly soluble in water, freely soluble in acetone and alcohol, and sparingly soluble in ether. The structural formula of meprobamate is: C H N O M.W.218.25 Meprobamate Tablets USP 200 mg and 400 mg for oral administration contain the following inactive ingredients: microcrystalline cellulose,sodium starch glycolate, pre- gelatinized starch, colloidal silicondioxide, stearic acid and magnesium stearate. CLINICAL PHARMACOLOGY Meprobamate is a carbamate derivative which has been shown in animal studies to have effects at multiple sites in the central nervous system including the thalamus and limbic system. INDICATIONS AND USAGE Meprobamate tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.Anxiety or tension associated with the stress of everyday life usually do not require treatment with an anxiolytic. The effectiveness of meprobamate tablets in long-term use, that is,more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient. CONTRAINDICATIONS Acute intermittent porphyria as well as allergic or idiosyncratic reactions to meprobamate or related compounds such as carisoprodol, mebutamate, tybamate, or carbromal. 9 18 2 4 WARNINGS DRUG DEPENDENCE Physical dependence, psychological dependence, and abuse have occurred. When chronic intoxication from prolonged use occurs, it usually involves ingestion of greater than recommended doses and is manifested by ataxia, slurred speech, and vertigo. Therefore, careful supervision of dose and amounts prescribed is advised, as well as avoidance of prolonged administration, especially for alcoholics and other patients with a known propensity for taking excessive quantities of drugs. Sudden withdrawal of the drug after prolonged and Прочетете целия документ