METHOCARBAMOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Solco Healthcare LLC

INN (International Name):

METHOCARBAMOL

Composition:

METHOCARBAMOL 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Methocarbamol tablets, USP are 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 tablets, USP are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

Product summary:

Methocarbamol tablets, USP 500 mg tablets are round standard convex, scored, white to off-white tablet, debossed S 225 on one side and plain on the reverse side. They are supplied as follows: Bottles of 100 NDC 43547-405-10 Bottles of 500 NDC 43547-405-50 Methocarbamol tablets, USP 750 mg tablets are modified capsule shape, white to off-white tablet, debossed S 226 on one side and plain on the reverse side. They are supplied as follows: Bottles of 100 NDC 43547-226-10 Bottles of 500 NDC 43547-226-50 Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F). [see USP Controlled Room Temperature]. Dispense in tight container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHOCARBAMOL- METHOCARBAMOL TABLET
SOLCO HEALTHCARE LLC
----------
METHOCARBAMOL TABLETS, USP
R_X_ ONLY
SOLCO HEALTHCARE U.S., LLC
DESCRIPTION
Methocarbamol tablets, USP, a carbamate derivative of guaifenesin, are
a central
nervous system (CNS) depressant with sedative and musculoskeletal
relaxant
properties.
The chemical name of methocarbamol is
3-(2-meth-oxyphenoxy)-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.
Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets
for oral
administration. Methocarbamol tablets, USP 500 mg and 750 mg contain
the following
inactive ingredients: povidone, sodium starch glycolate and magnesium
stearate.
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, respectively). The fraction of