METHOCARBAMOL tablet METHOCARBAMOL- methocarbamol tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

A-S Medication Solutions

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:

Product: 50090-0184 NDC: 50090-0184-0 40 TABLET in a BOTTLE Product: 50090-1783 NDC: 50090-1783-0 90 TABLET in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHOCARBAMOL- METHOCARBAMOL TABLET
METHOCARBAMOL - METHOCARBAMOL TABLET
A-S MEDICATION SOLUTIONS
----------
METHOCARBAMOL TABLETS USP
RX ONLY
DESCRIPTION
Methocarbamol tablets USP 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.
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: sodium lauryl sulfate, sodium starch glycolate,
povidone K 90,
polyethylene glycol, magnesium stearate, colloidal silicon dioxide,
low substituted
hydroxypropyl cellulose 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
11
15
5
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