METHOCARBAMOL tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,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 750 mg: White, Capsule Shaped Tablets; Debossed WEST-WARD 292 on one side and Scored on the other side. NDC 68071-4365-3 BOTTLES OF 30 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
NUCARE PHARMACEUTICALS,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%.
11
15
5
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
(± SD) age, 53.3 (± 8.8) years), healthy populatio