METHOCARBAMOL- methocarbamol tablet, coated METHOCARBAMOL tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Burel Pharmaceuticals, Inc.

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

Product summary:

Methocarbamol tablets, USP 500 mg are light orange colored, round shaped film coated tablets debossed with "G" above the score line on one side and "500" on other side. They are supplied as follows Bottles of 100 tablets NDC 35573-413-02 Bottles of 500 tablets NDC 35573-413-04 Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets debossed with "G" on one side and "750" on other side. Bottles of 100 tablets NDC 35573-414-02 Bottles of 500 tablets NDC 35573-414-04 Store between 20ºC and 25ºC (68ºF and 77ºF) [see USP Controlled Room Temperature]. Dispense in tight container. Manufactured for: Burel Pharmaceuticals, Inc. Brandon, MS 39042 USA Manufactured by: Granules India Limited Hyderabad – 500 081, India. MADE IN INDIA M.L.No.: 37/RR/AP/2003/F/R Revision Date: December 2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

METHOCARBAMOL - METHOCARBAMOL TABLET, COATED
METHOCARBAMOL- METHOCARBAMOL TABLET, COATED
BUREL PHARMACEUTICALS, INC.
----------
METHOCARBAMOL TABLETS, USP
RX ONLY
DESCRIPTION
Methocarbamol tablet, 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
1,2-Propanediol,3-(2-methoxyphenoxy)-,1-
Carbamate,(±)-(or) (±)-3-(o-Methoxyphenoxy)-1,2-Propanediol
1-carbamate and has
the empirical formula C
H
NO
. Its molecular weight is 241.24g/mol. The structural
formula is shown below.
Methocarbamol is a white powder, sparingly soluble in water and in
chloroform, soluble
in alcohol (only with heating), insoluble in benzene and in n-hexane.
Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets
for oral
administration.
Methocarbamol tablets, USP 500 mg are light orange colored, round
shaped film coated
tablets debossed with "G" above the score line on one side and "500"
on other side.
Methocarbamol tablets, USP 750 mg are light orange colored, caplet
shaped film coated
tablets debossed with "G" on one side and "750" on other side.
Methocarbamol tablets, USP 500 mg and 750 mg contain the following
inactive
ingredients: colloidal silicon dioxide, maize starch, povidone, sodium
lauryl sulfate,
sodium starch glycolate, and stearic acid.
The tablets are coated with Aquarius Prime which contains FD&C yellow
6,
hydroxypropylcellulose, hypromellose, polysorbate 80, propylene
glycol, and titanium
dioxide.
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
11
15
5
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 mea