מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X)
Preferred Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man. Methocarbamol is contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.
Methocarbamol Tablets, USP 500 mg — white, round, convex face, debossed "4211" bisect over "V" on one side and plain on the reverse side. Available in bottles of; Bottle of 20 - 68788-9075-2 Bottle of 30 - 68788-9075-3 Bottle of 40 - 68788-9075-4 Bottle of 60 - 68788-9075-6 Bottle of 90 - 68788-9075-9 Bottle of 100 - 68788-9075-1 Bottle of 120 - 68788-9075-8 Methocarbamol Tablets, USP 750 mg — white, capsule shape, convex face, debossed "4212" on one side and debossed "V" on the reverse side. Available in bottles of; Bottle of 20 - 68788-9076-2 Bottle of 30 - 68788-9076-3 Bottle of 40 - 68788-9076-4 Bottle of 60 - 68788-9076-6 Bottle of 90 - 68788-9076-9 Bottle of 100 - 68788-9076-1 Bottle of 120 - 68788-9076-8 Store at 20°– 25°C (68°– 77°F) [See USP Controlled Room Temperature]. Dispense in tight container.
Abbreviated New Drug Application
METHOCARBAMOL- METHOCARBAMOL TABLET PREFERRED PHARMACEUTICALS, INC. ---------- METHOCARBAMOL TABLETS, USP 500 MG METHOCARBAMOL TABLETS, USP 750 MG RX ONLY DESCRIPTION Methocarbamol Tablets, USP, 500 mg and 750 mg, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1, 2-propanediol 1-carbamate and has the empirical formula C H NO . Its molecular weight is 241.24. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and _n_-hexane. Each tablet, for oral administration, contains either 500 mg or 750 mg of methocarbamol, USP. The inactive ingredients present are colloidal silicon dioxide, magnesium stearate, povidone, pregelatinized corn starch, purified water, sodium starch glycolate, and stearic acid. CLINICAL PHARMACOLOGY The mechanism of action of methocarbamol in humans has not been established, but may be due to general central nervous system (CNS) depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber. PHARMACOKINETICS In healthy volunteers, the plasma clearance of methocarbamol ranges between 0.20 and 0.80 L/h/kg, the mean plasma elimination half-life ranges between 1 and 2 hours, and the plasma protein binding ranges between 46% and 50%. Methocarbamol is metabolized via dealkylation and hydroxylation. Conjugation of methocarbamol also is likely. Essentially all methocarbamol metabolites are eliminated in the urine. Small amounts of unchanged methocarbamol also are excreted in the urine. SPECIAL POPULATIONS _ELDERLY_ The mean (± SD) elimination half-life of methocarbamol in elderly healthy volunteers (mean (± SD) age, 69 (± 4) years) was slightly prolonged compared to a younger (mean (± SD) age, 53.3 (± 8.8) years), 11 15 5 healthy population (1.5 קרא את המסמך השלם