METHOCARBAMOL tablet, coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

AustarPharma LLC

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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. Methocarbamol may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that methocarbamol therapy does not adversely affect their ability to engage in such activities. Safety and effectiveness of methocarbamol in pediatric patients below the age of 16 have not been established.

Tuoteyhteenveto:

Methocarbamol Tablets USP, 500 mg — Orange, film coated, round concave tablets with one side debossed 'AP212', the other side bisected. They are supplied as follows: Bottles of 100, NDC 35561-212-12 Bottles of 500, NDC 35561-212-13 Methocarbamol Tablets USP, 750 mg — Yellow, film coated, modified capsule shaped tablets; one side debossed 'AP211' and other side blank. They are supplied as follows: Bottles of 100, NDC 35561-211-1 Bottles of 500, NDC 35561-211-13 Methocarbamol Tablets USP, 1000 mg — Orange, film coated, oblong-shaped tablets; one side debossed 'AP349' and other side biscted. They are supplied as follows: Bottles of 100, NDC 35561-349-12 Bottles of 500, NDC 35561-349-13 Store at controlled room temperature, between 20° to 25°C (68° to 77°F). Dispense in tight container. LBL136 REV050622 revised: May 2022 Manufactured by: AustarPharma, LLC 18 Mayfield Ave Edison, NJ 08837, USA

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

METHOCARBAMOL- METHOCARBAMOL TABLET, COATED
AUSTARPHARMA LLC
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DESCRIPTION
Methocarbamol Tablets USP, 500 mg, 750 mg, and 1000 mg, a carbamate
derivative of
gualfenesin, is a central nervous system (CNS) depressant with
sedative and
musculoskeletal relaxant properties.
The chemical name of methocarbamol is a 3-(2
methoxyphenoxy)-1,2-propanediol 1-
carbamate and has the empirical formula C11H15NO5. 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 Tablet, 500 mg is available as an orange, film coated,
round concave
tablet containing 500 mg of methocarbamol, USP for oral
administration. The inactive
ingredients present are microcrystalline cellulose, croscarmellose
sodium, FD&C Yellow 6
aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium
stearate,
polyethylene glycol, triacetin, titanium dioxide.
Methocarbamol Tablet, 750 mg is available as a yellow, film coated,
modified capsule
shaped tablet containing 750 mg of methocarbamol, USP for oral
administration. The
inactive ingredients present are microcrystalline cellulose,
croscarmellose sodium, iron
oxide yellow, iron oxide red, hydroxypropyl cellulose, hypromellose,
magnesium
stearate, polyethylene glycol, triacetin, titanium dioxide.
Methocarbamol tablet, 1000 mg is available as an orange, film coated,
oblong-shaped
tablet containing 1000 mg of methocarbamol, USP for oral
administration. The inactive
ingredients present in methocarbamol tablets 1000 mg are same as those
present in
methocarbamol tablets 500 mg.
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 cl