METHOCARBAMOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Methocarbamol (UNII: 125OD7737X) (Methocarbamol - UNII:125OD7737X)

Available from:

Key Therapeutics

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 is contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

Product summary:

Methocarbamol Tablets, USP 500 mg — white, round, convex face, debossed “611” over bisect and “O” below bisect on one side and plain on the reverse side. Available in: bottles of 100, NDC number 70868-910-10 Store at 20°– 25°C (68°– 77°F) [See USP Controlled Room Temperature]. Dispense in tight container. For more information, call Key Therapeutics, LLC at 1-888-981-8337 Manufactured by: OXFORD PHARMACEUTICALS Birmingham, AL 35211 Manufactured for: KEY THERAPEUTICS Flowood, MS 39042 8200011 Rev 03/20 R00

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHOCARBAMOL- METHOCARBAMOL TABLET
KEY THERAPEUTICS
----------
METHOCARBAMOL TABLETS 500MG
METHOCARBAMOL TABLETS, USP 500 MG
RX ONLY
DESCRIPTION
Methocarbamol Tablets, USP, 500 mg, a carbamate derivative of
guaifenesin, is a central
nervous system (CNS) depressant with sedative and musculoskeletal
relaxant
properties.
The chemical name of methocarbamol is 3-(2-methoxyphenoxy)-1,
2-propanediol 1-
carbamate and has the empirical formula 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.
Each tablet, for oral administration, contains either 500 mg of
methocarbamol, USP. The
inactive ingredients present are colloidal silicon dioxide, magnesium
stearate, povidone,
pregelatinized corn starch, purified water, sodium starch glycolate,
and stearic acid.
CLINICAL PHARMACOLOGY
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
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 compared to
a younger (mean
[± SD] age, 53.3 [± 8.8] years), healthy population (1.5 [±0.4]
hours versus 1.1 [±
0.27] hours