METHOCARBAMOL tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Rebel Distributors Corp

INN (Kansainvälinen yleisnimi):

METHOCARBAMOL

Koostumus:

METHOCARBAMOL 500 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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.

Tuoteyhteenveto:

Methocarbamol tablets USP 500 mg are white to off white, capsule shaped, tablets debossed with ‘H’ on scored side and ‘114’ on unscored side . They are supplied as follows: Bottles of 7 NDC 42254-038-07 Bottles of 40 NDC 42254-038-40 Methocarbamol tablets USP 750 mg are white to off white, capsule shaped, tablets debossed with ‘H’ on one side and ‘115’ on other side .  They are supplied as follows: Bottles of 7 NDC 42254-035-07 Bottles of 30 NDC 42254-035-30 Bottles of 40 NDC 42254-035-40 Bottles of 60 NDC 42254-035-60 Bottles of 90 NDC 42254-035-90 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container. Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Drugs Limited Jeedimetla, Hyderabad – 500 055, India.                                                   2007243-00 Repackage by: Rebel Distributors Corp Thousand Oaks, CA 91320

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

METHOCARBAMOL- METHOCARBAMOL TABLET
REBEL DISTRIBUTORS CORP
----------
METHOCARBAMOL TABLETS USP
R ONLY
DESCRIPTION
Methocarbamol tablets USP 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.
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: sodium
lauryl sulfate, sodium starch glycolate, povidone K 90, polyethylene
glycol, magnesium stearate,
colloidal silicon dioxide, low substituted hydroxy propyl cellulose
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
_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 po