METHOCARBAMOL tablet, coated METHOCARBAMOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

DIRECT RX

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 are white to off white, capsule shaped, tablets debossed with ‘H’ on scored side and ‘114’ on unscored side . Methocarbamol tablets, USP 750 mg are light orange colored, capletshaped film coated tablets debossed with "G" on one side and"750" on other side. Store between 20ºC and 25ºC (68ºF and 77º F) [see USP Controlled Room Temperature]. Dispense in tight container. Manufactured for: Granules USA, Inc. Parsippany, NJ 07054 Toll-free: 1-877-770-3183 Manufactured by: Granules India Limited Hyderabad-500 081 Made in India Issued: January 2017

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHOCARBAMOL- METHOCARBAMOL TABLET, COATED
METHOCARBAMOL- METHOCARBAMOL TABLET
DIRECT RX
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METHOCARBAMOL 750MG 120TABS
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 C11H15NO5. Its molecular
weight is 241.24.
The structural formula is shown below.
[Methocarbamol Chemical Structure]
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.
INDICATIONS AND USAGE
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 seda