METHOCARBAMOL injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

METHOCARBAMOL (UNII: 125OD7737X) (METHOCARBAMOL - UNII:125OD7737X)

Tilgjengelig fra:

Mylan Institutional LLC

INN (International Name):

METHOCARBAMOL

Sammensetning:

METHOCARBAMOL 100 mg in 1 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

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

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

METHOCARBAMOL- METHOCARBAMOL INJECTION, SOLUTION
MYLAN INSTITUTIONAL LLC
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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