METHOCARBAMOL tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

St. Mary's Medical Park Pharmacy

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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.

leaflet_short:

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: NDC 60760-482-90 BOTTLES OF 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 Labs Limited 2012754 Jeedimetla, Hyderabad- 500 055, India

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

METHOCARBAMOL- METHOCARBAMOL TABLET
ST. MARY'S MEDICAL PARK PHARMACY
----------
METHOCARBAMOL TABLETS USP
RX 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 hydroxypropyl 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.
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 prolonged compared to a younger (mean
(±SD) age, 53.3 (±8.8) years