Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
Meprobamate (UNII: 9I7LNY769Q) (meprobamate - UNII:9I7LNY769Q)
Dr.Reddy's Laboratories Limited
Meprobamate
Meprobamate 200 mg
ORAL
PRESCRIPTION DRUG
Meprobamate tablets are indicated for the management of anxietydisorders or for the short-term relief of the symptoms of anxiety.Anxiety or tension associated with the stress of everyday life usuallydo 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 clinicalstudies. The physician should periodically reassess the usefulness ofthe drug for the individual patient. Acute intermittent porphyria as well as allergic or idiosyncraticreactions to meprobamate or related compounds such ascarisoprodol, mebutamate, tybamate, or carbromal.
Meprobamate Tablets USP 200 mg are white, round, biconvex tabletsdebossed with I and 7 on one side and bisect on the other. Supplied in bottles of 100 and 1000. Bottles of 100: NDC 55111-640-01 Bottles of 1000: NDC 55111-640-10 Meprobamate Tablets USP 400 mg are white, round, biconvex tabletsdebossed with I and 4 on one side and bisect on the other. Supplied in bottles of 100 and 500. Bottles of 100: NDC 55111-641-01 Bottles of 500: NDC 55111-641-05 Dispense in well-closed container with child-resistant closure. Store at 20°-25°C (68°-77°F) [see USP Controlled RoomTemperature]. Manufactu red by: In vaGen Pharmaceuticals, Inc Hauppauge, NY 11788 Manufactured for: Dr. Reddy's Laboratories Inc., Bridgewater, NJ 08807 USA Rev: 05/09
Abbreviated New Drug Application
MEPROBAMATE- MEPROBAMATE TABLET DR.REDDY'S LABORATORIES LIMITED ---------- MEPROBAMATE TABLETS DESCRIPTION Meprobamate is awhite powder with a characteristic odor and a bittertaste. It is slightly soluble in water, freely soluble in acetone andalcohol, 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 administrationcontain 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 inanimal studies to have effects at multiple sites in the central nervoussystem including the thalamus and limbic system. INDICATIONS AND USAGE Meprobamate tablets are indicated for the management of anxietydisorders or for the short-term relief of the symptoms of anxiety.Anxiety or tension associated with the stress of everyday life usuallydo 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 clinicalstudies. The physician should periodically reassess the usefulness ofthe drug for the individual patient. CONTRAINDICATIONS Acute intermittent porphyria as well as allergic or idiosyncraticreactions to meprobamate or related compounds such ascarisoprodol, mebutamate, tybamate, or carbromal. WARNINGS DRUG DEPENDENCE Physical dependence, psychological dependence, and abuse haveoccurred. When chronic intoxication from prolonged use occurs, itusually involves ingestion of greater than recommended doses and ismanifested by ataxia, slurred speech, and vertigo. Therefore, carefulsupervision of dose and amounts 9 18 2 4 prescribed is advised, as well asavoidance of prolonged administration, especially for alcoholics andother patients with a known propensity for taking excessive quantitiesof drugs. Sudden withdrawal of the drug after prolonged and exc Preberite celoten dokument