Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X)
Burel Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Methocarbamol tablets, USP 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 light orange colored, round shaped film coated tablets debossed with "G" above the score line on one side and "500" on other side. They are supplied as follows Bottles of 100 tablets NDC 35573-413-02 Bottles of 500 tablets NDC 35573-413-04 Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets debossed with "G" on one side and "750" on other side. Bottles of 100 tablets NDC 35573-414-02 Bottles of 500 tablets NDC 35573-414-04 Store between 20ºC and 25ºC (68ºF and 77ºF) [see USP Controlled Room Temperature]. Dispense in tight container. Manufactured for: Burel Pharmaceuticals, Inc. Brandon, MS 39042 USA Manufactured by: Granules India Limited Hyderabad – 500 081, India. MADE IN INDIA M.L.No.: 37/RR/AP/2003/F/R Revision Date: December 2020
Abbreviated New Drug Application
METHOCARBAMOL - METHOCARBAMOL TABLET, COATED METHOCARBAMOL- METHOCARBAMOL TABLET, COATED BUREL PHARMACEUTICALS, INC. ---------- METHOCARBAMOL TABLETS, USP RX ONLY DESCRIPTION Methocarbamol tablet, 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 1,2-Propanediol,3-(2-methoxyphenoxy)-,1- Carbamate,(±)-(or) (±)-3-(o-Methoxyphenoxy)-1,2-Propanediol 1-carbamate and has the empirical formula C H NO . Its molecular weight is 241.24g/mol. The structural formula is shown below. Methocarbamol is a white powder, sparingly soluble in water and in chloroform, soluble in alcohol (only with heating), insoluble in benzene and in n-hexane. Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets for oral administration. Methocarbamol tablets, USP 500 mg are light orange colored, round shaped film coated tablets debossed with "G" above the score line on one side and "500" on other side. Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets debossed with "G" on one side and "750" on other side. Methocarbamol tablets, USP 500 mg and 750 mg contain the following inactive ingredients: colloidal silicon dioxide, maize starch, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid. The tablets are coated with Aquarius Prime which contains FD&C yellow 6, hydroxypropylcellulose, hypromellose, polysorbate 80, propylene glycol, and titanium dioxide. 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 11 15 5 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 mea Lesen Sie das vollständige Dokument