Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X)
Mylan Institutional LLC
METHOCARBAMOL
METHOCARBAMOL 100 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
The injectable form of methocarbamol is 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 this drug has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man. Methocarbamol injection should not be administered to patients with known or suspected renal pathology. This caution is necessary because of the presence of polyethylene glycol 300 in the vehicle. A much larger amount of polyethylene glycol 300 than is present in recommended doses of methocarbamol injection is known to have increased preexisting acidosis and urea retention in patients with renal impairment. Although the amount present in this preparation is well within the limits of safety, caution dictates this contraindication. Methocarbamol injection is contraindicated in patients hypersensitive to methocarbamol or to any of the injec
Methocarbamol Injection USP, 1,000 mg/10 mL (100 mg/mL) is a clear, colorless solution. It is available as follows: NDC 67457-273-10 10 mL single-dose vials per carton of 25 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] This product is preservative free. Discard unused portion. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Mylan Institutional Galway, Ireland Revised: 8/2020 MI:MTHCIJ:R3 1016L101
Abbreviated New Drug Application
METHOCARBAMOL- METHOCARBAMOL INJECTION, SOLUTION MYLAN INSTITUTIONAL LLC ---------- DESCRIPTION Methocarbamol injection, USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. It is a sterile, pyrogen-free solution intended for intramuscular or intravenous administration. Each mL contains: methocarbamol, USP 100 mg, polyethylene glycol 300, NF 0.5 mL, Water for Injection, USP q.s. The pH is adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. The chemical name of methocarbamol is 3- (2-methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula of 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 injection has a pH between 3.5 and 6.0. AFTER MIXING WITH INTRAVENOUS INFUSION FLUIDS, DO NOT REFRIGERATE. CLINICAL PHARMACOLOGY The mechanism of action of methocarbamol in humans has not been established, but may be due to general 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, 69 (± 4) years) was slightly prolonged compared to a younger (mean (± SD) age, 53.3 (± 8.8) year Lire le document complet