METHOCARBAMOL- methocarbamol tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

METHOCARBAMOL

Composition:

METHOCARBAMOL 750 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Methocarbamol Tablets 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 are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

Product summary:

Methocarbamol Tablets 500 mg:  White, Round Tablets; Debossed "West-ward 290" on one side and Scored on the other side.    Bottles of 100 tablets    Bottles of 500 tablets    Bottles of 1000 tablets Methocarbamol Tablets 750 mg:  White, Capsule Shaped Tablets; Debossed "WEST-WARD 292" on one side and Scored on the other side.     Bottles of 100 tablets    Bottles of 500 tablets    Bottles of 1000 tablets Store at 20 o to 25 o C (68 o to 77 o F) [See USP Controlled Room Temperature].  Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ  07724 Revised March 2016

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHOCARBAMOL- METHOCARBAMOL TABLET
REMEDYREPACK INC.
----------
METHOCARBAMOL TABLETS
METHOCARBAMOL TABLETS, USP
Rev. 03/16
RX ONLY
DESCRIPTION:
Methocarbamol Tablets, USP, a carbamate derivative of guaifenesin, are
a central nervous system
(CNS) depressant with sedative and musculoskeletal relaxant
properties. The structural formula is:
The chemical name for Methocarbamol is
3-(2-Methoxyphenoxy)-1,2-propanediol 1-carbamate and has
the empirical formula C
H
NO
. Its molecular weight is 241.24.
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 500 mg or 750 mg of
methocarbamol, USP. In addition each
tablet contains the following inactive ingredients: Colloidal Silicon
Dioxide, Lactose Monohydrate,
Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose,
Pregelatinized Starch and Sodium
Starch Glycolate.
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.
SPECIAL POPULATIONS:
11
15
5
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 (±