METHOCARBAMOL- methocarbamol tablets tablet, coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Granules India Ltd

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

Dettagli prodotto:

Methocarbamol tablets, USP 500 mg are light orange colored, roundshaped film coated tablets debossed with "G" above the score line on one side and "500" on other side. They are supplied as follows Bottles of 24 tablets NDC 62207-754-41 Bottles of 100 tablets NDC 62207-754-43 Bottles of 500 tablets NDC 62207-754-47 Bottles of 1000 tablets NDC 62207-754-49 Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets debossed with "G" on one side and"750" on other side. Bottles of 24 tablets NDC 62207-770-41 Bottles of 100 tablets NDC 62207-770-43 Bottles of 500 tablets NDC 62207-770-47 Bottles of 1000 tablets NDC 62207-770-49 Store between 20ºC and 25ºC (68ºF and 77º F) [see USP Controlled Room Temperature]. Dispense in tight container. Manufactured for: Granules USA, Inc. Parsippany, NJ 07054 Toll-free: 1-877-770-3183 Manufactured by: Granules India Limited Hyderabad-500 081 Made in India Issued: January 2017

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

METHOCARBAMOL- METHOCARBAMOL TABLETS TABLET, COATED
GRANULES INDIA LTD
----------
METHOCARBAMOL TABLETS
RX ONLY
DESCRIPTION
Methocarbamol tablet, 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
1,2-Propanediol,3-(2-methoxyphenoxy)-,1-Carbamate,(±)-.(or)
(±)-3-(o-Methoxyphenoxy)-1,2-Propanediol 1-carbamate and has the
empirical formula C
H
NO
.
Its molecular weight is 241.24g/mol. The structural formula is shown
below.
Methocarbamol is a white powder, sparingly soluble in water and in
chloroform, soluble in alcohol
(only with heating), insoluble in benzene and in n-hexane.
Methocarbamol tablets, USP are available as 500 mg and 750 mg tablets
for oral administration.
Methocarbamol tablets, USP 500 mg are light orange colored, round
shaped film coated tablets
debossed with "G" above the score line on one side and "500" on other
side.
Methocarbamol tablets, USP 750 mg are light orange colored, caplet
shaped film coated tablets
debossed with "G" on one side and "750" on other side.
Methocarbamol tablets, USP 500 mg and 750 mg contain the following
inactive ingredients: colloidal
silicon dioxide, maize starch, povidone, sodium lauryl sulfate, sodium
starch glycolate, and stearic acid.
The tabets are coated with Aquarius Prime which contains FD&C yellow
6, hydroxypropylcellulose,
hypromellose, polysorbate 80, propylene glycol, and 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