METHOCARBAMOL tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

Methocarbamol (UNII: 125OD7737X) (Methocarbamol - UNII:125OD7737X)

Предлага се от:

Oxford Pharmaceuticals, LLC

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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

Каталог на резюме:

Methocarbamol Tablets, USP 500 mg — white, round, convex face, debossed “611” over bisect and “O” below bisect on one side and plain on the reverse side. Available in: Bottles of 90, NDC number 69584-611-09 bottles of 100, NDC number 69584-611-10 bottles of 500, NDC number 69584-611-50 bottles of 1000, NDC number 69584-611-90 Methocarbamol Tablets, USP 750 mg — white, capsule shape, convex face, debossed “612” on one side and debossed “O” on the reverse side. Available in: bottles of 90, NDC number 69584-612-09 bottles of 100, NDC number 69584-612-10 bottles of 500, NDC number 69584-612-50 bottles of 1000, NDC number 69584-612-90 Store at 20°– 25°C (68°– 77°F) [See USP Controlled Room Temperature]. Dispense in tight container. For more information, call Oxford Pharmaceuticals, LLC at 1-844-508‑1455, 8:00 AM to 4.30 PM ET, Monday – Friday Manufactured by: OXFORD PHARMACEUTICALS Birmingham, AL 35211 8200004 Rev 12/20 R01

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

METHOCARBAMOL- METHOCARBAMOL TABLET
OXFORD PHARMACEUTICALS, LLC
----------
METHOCARBAMOL TABLETS, USP 500 MG
METHOCARBAMOL TABLETS, USP 750 MG
RX ONLY
DESCRIPTION
Methocarbamol Tablets, USP, 500 mg and 750 mg, 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.
Each tablet, for oral administration, contains either 500 mg or 750 mg
of
methocarbamol, USP. The inactive ingredients present are colloidal
silicon dioxide,
magnesium stearate, povidone, pregelatinized corn starch, purified
water, sodium
starch glycolate, 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%.
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 [�