Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X)
Contract Pharmacy Services-PA
METHOCARBAMOL
METHOCARBAMOL 750 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 750 mg: White, Capsule Shaped, Scored Tablet; Debossed “West-ward 292” Blister of 30 tablets NDC:67046-466-30 Store at 20-25o C (68-77o F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724 Revised July 2009 Repackaged by: Contract Pharmacy Services-PA 125 Titus Ave Suite 200 Warrington, PA 18976 USA Original--09/2009--NJW Updated--08/2010--NJW
Abbreviated New Drug Application
METHOCARBAMOL - METHOCARBAMOL TABLET CONTRACT PHARMACY SERVICES-PA ---------- METHOCARBAMOL TABLETS METHOCARBAMOL TABLETS, USP Rev. 07/09 RX ONLY DESCRIPTION: Methocarbamol Tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The structural formula is: The chemical name for Methocarbamol is 3-(2-Methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C H NO . Its molecular weight is 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. Each tablet, for oral administration, contains 500 mg or 750 mg of methocarbamol, USP. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Pregelatinized Starch and Sodium Starch Glycolate. 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 (± 8.8) years), healthy popula Prečítajte si celý dokument