METHOCARBAMOL tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

METHOCARBAMOL

Sammensetning:

METHOCARBAMOL 750 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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.

Produkt oppsummering:

Methocarbamol Tablets USP, 750 mg — Yellow, film coated, modified capsule shaped tablets; one side debossed ‘AP211’ and other side blank; available in bottles of 100 (NDC# 60429-119-01) and 500 (NDC# 60429-119-05). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

METHOCARBAMOL- METHOCARBAMOL TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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METHOCARBAMOL TABLET, FILM COATED 750 MG
DESCRIPTION
Methocarbamol Tablets USP, 750 mg, a carbamate derivative of
guaifenesin, is a central nervous system
(CNS) depressant with sedative and musculoskeletal relaxant
properties.
The chemical name of methocar-bamol 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 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.
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.
11
15
5
SPECIAL POPULATIONS
ELDERLY
The mean (± SD) elimination half-life of methocarbamol in elderly
healthy volunteers (mean (± SD) age,
69 (± 4) years) was slightly p