methocarbamol- Methocarbamol tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

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Download Productkenmerken (SPC)
19-06-2007

Werkstoffen:

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

Beschikbaar vanaf:

Lannett Company, Inc.

INN (Algemene Internationale Benaming):

Methocarbamol

farmaceutische vorm:

TABLET

Samenstelling:

500 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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.

Product samenvatting:

Methocarbamol Tablets, USP, 500 mg are white, round, bisected tablets, debossed with LAN over 1302, supplied in bottles of 100 and 500 tablets. 100 Tablets     NDC 0527-1302-01 500 Tablets     NDC 0527-1302-05 Methocarbamol Tablets, USP, 750 mg are white, scored, capsule-shaped tablets debossed with LAN besides 1152, supplied in bottles of 100 and 500 tablets. 100 Tablets     NDC 0527-1152-01 500 Tablets     NDC 0527-1152-05 Store at controlled room temperature, between 20°C and 25°C (68°F and 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP with a child-resistant closure (as required).

Productkenmerken

                                METHOCARBAMOL- METHOCARBAMOL TABLET
LANNETT COMPANY, INC.
----------
METHOCARBAMOL TABLETS, USP
RX ONLY
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-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: acacia,
calcium stearate, colloidal silicon dioxide, corn starch,
croscarmellose sodium, and methylcellulose.
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 (± 0.4) hours versus 1.1 (± 0.27) hours,
respectiv
                                
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