METHOCARBAMOL injection

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Somerset Therapeutics, LLC

INN (mednarodno ime):

METHOCARBAMOL

Sestava:

METHOCARBAMOL 100 mg in 1 mL

Pot uporabe:

INTRAMUSCULAR

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 pre-existing 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 injection components.

Povzetek izdelek:

Methocarbamol Injection USP, 1,000 mg/10 mL (100 mg/mL) is a clear, colorless solution. Total Drug Content: Methocarbamol USP 1,000 mg in 10 mL. 10 mL vials are single dose vials packaged as; - 5 vials per tray, - 10 vials per tray and - 25 vials per tray. Store at 20 °- 25°C (68°F - 77°F), excursions permitted to 15° - 30°C (59°F - 86°F). [see USP Controlled Room Temperature]. Discard unused portion. To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at 1-800-417-9175 or FDA at 1-800 FDA-1088 or www.fda.gov/medwatch   Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024 Made in India Code No.:KR/DRUGS/KTK/28/289/97 ST-MET11/P/03 Revised: July, 2020

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

METHOCARBAMOL- METHOCARBAMOL INJECTION
SOMERSET THERAPEUTICS, LLC
----------
METHOCARBAMOL INJECTION, USP
RX ONLY
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 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 I.V. 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
11
15
5.
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,