Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Akromed
EQUANIL® Tablets EQUANIL® L.A. Tablets SCHEDULING STATUS: S5 PROPRIETARY NAME (and dosage form): EQUANIL ® Tablets EQUANIL ® L.A. Tablets COMPOSITION: Each EQUANIL tablet contains meprobamate 400 mg. Each EQUANIL L.A. tablet contains meprobamate 400 mg as a slow release tablet. Chemically, meprobamate is 2,2-di-(carbamoyl-oxymethyl)-pentane EQUANIL L.A. tablets contain TARTRAZINE. PHARMACOLOGICAL CLASSIFICATION: Category A, 2.6 Tranquillizers PHARMACOLOGICAL ACTION: EQUANIL (meprobamate) is a carbamate derivative which has been shown to have effects at multiple sites in the central nervous system including the thalamus and limbic system. Pharmacokinetics: Meprobamate is well absorbed from the gastrointestinal tract. The drug is widely distributed in the body; there is little binding to plasma protein. Meprobamate undergoes extensive metabolism in the liver with 10 to 20% of the drug eliminated unchanged via the kidneys; the remainder is excreted as hydroxymeprobamate and as the glucoronide. Meprobamate can induce some hepatic microsomal enzymes, but is not clear whether the drug induces the enzymes responsible for its own metabolism. INDICATIONS: For the relief of anxiety and tension; as an adjunct in the treatment of various disease states in which anxiety and tension are manifested. The effectiveness of EQUANIL and EQUANIL L.A. in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient. CONTRA-INDICATIONS: Acute intermittent porphyria and allergic or idiosyncratic reactions to meprobamate or related compounds, such as carisoprodol, mebutamate or carbromal. WARNINGS: Addiction potential: Physical dependence, psychological dependence, and abuse have occurred Read the complete document