METHOCARBAMOL tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Preferred Pharmaceuticals, Inc.

INN (nemzetközi neve):

METHOCARBAMOL

Összetétel:

METHOCARBAMOL 750 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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.

Termék összefoglaló:

  Methocarbamol tablets USP 750 mg are white to off white, capsule shaped, tablets debossed with ‘H’ on one side and ‘115’ on other side .  They are supplied as follows: Bottle of 20 - 68788-9376-2 Bottle of 30 - 68788-9376-3 Bottle of 40 - 68788-9376-4 Bottle of 60 - 68788-9376-6 Bottle of 90 - 68788-9376-9 Bottle of 100 - 68788-9376-1 Bottle of 120 - 68788-9376-8 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container.   Manufactured for:     Camber Pharmaceuticals, Inc. Piscataway, NJ 08854   By: Hetero Labs Limited        2012754 Jeedimetla, Hyderabad- 500 055, India Repackaged by Preferred Pharmaceuticals, Inc.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

METHOCARBAMOL- METHOCARBAMOL TABLET
PREFERRED PHARMACEUTICALS, INC.
----------
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
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