Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X)
American Health Packaging
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 white to off white, capsule shaped, tablets debossed with ‘H’ on scored side and ‘114’ on unscored side . They are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 68084-056-01 Methocarbamol tablets USP, 750 mg are white to off white, capsule shaped, tablets debossed with ‘H’ on one side and ‘115’ on other side . They are supplied as follows: Unit dose packages of 100 (10 x 10) NDC 68084-057-01 Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken. PACKAGING INFORMATION American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Camber Pharmaceuticals Inc. as follows: (500 mg / 100 UD) NDC 68084-056-01 packaged from NDC 31722-533 (750 mg / 100 UD) NDC 68084-057-01 packaged from NDC 31722-534 Distributed by: American Health Packaging Columbus, OH 43217 8205601/0418
Abbreviated New Drug Application
METHOCARBAMOL- METHOCARBAMOL TABLET AMERICAN HEALTH PACKAGING ---------- METHOCARBAMOL TABLETS USP 8205601/0418 RX ONLY DESCRIPTION Methocarbamol tablets USP 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 USP 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 are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets USP 500 mg and 750 mg contain the following inactive ingredients: sodium lauryl sulfate, sodium starch glycolate, povidone K 90, polyethylene glycol, magnesium stearate, colloidal silicon dioxide, low substituted hydroxypropyl cellulose 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, 11 15 5 69 (±4) years) was slightly prolonged compared to a younger (mean (±SD) age, 53.3 (± read_full_document