METHOCARBAMOL tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Proficient Rx LP

INN (International Name):

METHOCARBAMOL

Sammensetning:

METHOCARBAMOL 750 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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.

Produkt oppsummering:

Methocarbamol tablets, USP 750 mg tablets are modified capsule shape, white to off-white tablet, debossed S 226 on one side and plain on the reverse side. They are supplied as follows: Bottles of 30 NDC 63187-130-30 Bottles of 40 NDC 63187-130-40 Bottles of 45 NDC 63187-130-45 Bottles of 60 NDC 63187-130-60 Bottles of 90 NDC 63187-130-90 Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F). [see USP Controlled Room Temperature]. Dispense in tight container.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

METHOCARBAMOL- METHOCARBAMOL TABLET
PROFICIENT RX LP
----------
METHOCARBAMOL TABLETS, USP
R_X_ ONLY
SOLCO HEALTHCARE U.S., LLC
DESCRIPTION
Methocarbamol tablets, USP, a carbamate derivative of guaifenesin, are
a central nervous system (CNS)
depressant with sedative and musculoskeletal relaxant properties.
The chemical name of methocarbamol is
3-(2-meth-oxyphenoxy)-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: povidone,
sodium starch glycolate and magnesium stearate.
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
ELDERLY
11
15
5
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 (± 0.4) hours versus 1.1 (± 0.27) hours,
respectively). The fraction of bound