Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X)
Direct_Rx
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, roundshaped film coated tablets debossed with "G" above the score line onone side and "500" on other side. They are supplied as follows Bottles of 24 tablets Bottles of 100 tablets N Bottles of 500 tablets Bottles of 1000 tablets Methocarbamol tablets, USP 750 mg are light orange colored, capletshaped film coated tablets debossed with "G" on one side and"750" on other side. Bottles of 24 tablets Bottles of 100 tablets Bottles of 500 tablets Bottles of 1000 tablets Store between 20ºC and 25ºC (68ºF and 77º F) [see USP Controlled Room Temperature]. Dispense in tight container. Manufactured for: Granules USA, Inc. Parsippany, NJ 07054 Toll-free: 1-877-770-3183 Manufactured by: Granules India Limited Hyderabad-500 081 Made in India Issued: January 2017
Abbreviated New Drug Application
METHOCARBAMOL- METHOCARBAMOL TABLET, COATED DIRECT_RX ---------- METHOCARBAMOL 750MG 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 C11H15NO5. Its molecular weight is 241.24g/mol. The structural formula is shown below. [str] 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 tabets are coated with Aquarius Prime which contains FD&C yellow 6, hydroxypropylcellulose, hypromellose, polysorbate 80, propylene glycol, and titanium dioxide 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 m Přečtěte si celý dokument