Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X)
H.J. Harkins Company, Inc.
METHOCARBAMOL
METHOCARBAMOL 500 mg
ORAL
PRESCRIPTION DRUG
Methocarbamol tablets are 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 tablets are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.
Methocarbamol Tablets USP 500 mg are scored, round, white tablets imprinted DAN DAN and 5381 supplied in bottles of 100 and 500. Methocarbamol Tablets USP 750 mg are scored, capsule shaped, white tablets imprinted DAN DAN and 5382 supplied in bottles of 100 and 500. Dispense in a tight container with a child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Manufactured by: Watson Pharma Private Ltd. Verna, Salcette Goa 403 722 INDIA Distributed By: Watson Pharma Inc. Corona, CA 92880 USA Revised : September 2008 0908B 173752
Abbreviated New Drug Application
METHOCARBAMOL - METHOCARBAMOL TABLET H.J. HARKINS COMPANY, INC. ---------- METHOCARBAMOL TABLETS USP REVISED: SEPTEMBER 2008 RX ONLY 173752 RX ONLY DESCRIPTION Methocarbamol, a carbamate derivative of gualfenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is a 3-(2 methoxyphenoxy)-1,2-propanediol 1-carbamate. The structural formula is shown below: STRUCTURAL FORMULA OF METHOCARBAMOL C H NO M.W. 241.24 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. Methocarbamol Tablets USP 500 mg and 750 mg, contain the follwing inactive ingredients: colloidal silicon dioxide, magnesium stearate, pregelatinized starch, 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. 11 15 5 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), healthy population (1.5 (± 0.4) hours versus 1.1 (± 0.27) hours, respectively). The fraction of bound methocarbamol was slightly decreased in the eld Preberite celoten dokument