ROBAXIN- methocarbamol injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

METHOCARBAMOL

Composition:

METHOCARBAMOL 100 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. ROBAXIN Injectable 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 ROBAXIN Injectable 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. ROBAXIN Injectable is contraindicated in patients hypersensitive to methocarbamol or to any of the injection components.

Product summary:

ROBAXIN Injectable (100 mg/mL) supplied in – 10 mL single dose vials in packages of 10 (NDC 0641-6103-10). Store at 20 ° - 25 ° C (68 ° - 77 ° F), excursions permitted to 15 ° - 30 ° C (59 ° - 86 ° F). Not made with natural rubber latex. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689. Manufactured by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised February 2023 462-153-05

Authorization status:

New Drug Application

Summary of Product characteristics

ROBAXIN- METHOCARBAMOL INJECTION
HIKMA PHARMACEUTICALS USA INC.
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ROBAXIN INJECTABLE
(METHOCARBAMOL INJECTION, USP)
DESCRIPTION
ROBAXIN (methocarbamol injection, USP) Injectable, 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.
ROBAXIN Injectable 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
the urine. Small amounts of unchanged methocarbamol also are excreted
in the urine.
11
15
5
SPECIAL POPULATIONS
_Elderly_
The mean (± SD) elimination half-life of methocarbamol in elderly
healthy volunteers
(mean (± SD) age, 69 (± 4) years) was slightly prolonged