BACLOFEN tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8)

Disponible desde:

Mylan Pharmaceuticals Inc.

Designación común internacional (DCI):

BACLOFEN

Composición:

BACLOFEN 10 mg

tipo de receta:

PRESCRIPTION DRUG

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

BACLOFEN- BACLOFEN TABLET
MYLAN PHARMACEUTICALS INC.
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DESCRIPTION
Baclofen is a muscle relaxant and antispastic. Its chemical name is
4-amino-3-(4-chlorophenyl) butanoic
acid with a molecular formula of C
H ClNO and a molecular weight of 213.66. The structural
formula is:
Baclofen, USP is a white to almost white, odorless or practically
odorless crystalline powder. It is
slightly soluble in water, very slightly soluble in methanol, and
insoluble in chloroform.
Each tablet, for oral administration, contains 10 mg or 20 mg of
baclofen. In addition, each tablet
contains the following inactive ingredients: corn starch, magnesium
stearate, microcrystalline cellulose,
povidone and yellow iron oxide.
CLINICAL PHARMACOLOGY
The precise mechanism of action of baclofen is not fully known.
Baclofen is capable of inhibiting both
monosynaptic and polysynaptic reflexes at the spinal level, possibly
by hyperpolarization of afferent
terminals, although actions at supraspinal sites may also occur and
contribute to its clinical effect.
Although baclofen is an analog of the putative inhibitory
neurotransmitter gamma-aminobutyric acid
(GABA), there is no conclusive evidence that actions on GABA systems
are involved in the production
of its clinical effects. In studies with animals, baclofen has been
shown to have general CNS depressant
properties as indicated by the production of sedation with tolerance,
somnolence, ataxia, and respiratory
and cardiovascular depression. Baclofen is rapidly and extensively
absorbed and eliminated. Absorption
may be dose-dependent, being reduced with increasing doses. Baclofen
is excreted primarily by the
kidney in unchanged form and there is relatively large intersubject
variation in absorption and/or
elimination.
INDICATIONS AND USAGE
Baclofen tablets are useful for the alleviation of signs and symptoms
of spasticity resulting from
multiple sclerosis, particularly for the relief of flexor spasms and
concomitant pain, clonus, and
muscular rigidity.
Patients should have reversible spasticity