BACLOFEN tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Baclofen (UNII: H789N3FKE8) (Baclofen - UNII:H789N3FKE8)

Commercializzato da:

McKesson Contract Packaging

INN (Nome Internazionale):

Baclofen

Composizione:

Baclofen 10 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

BACLOFEN- BACLOFEN TABLET
MCKESSON CONTRACT PACKAGING
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BACLOFEN TABLETS USP
DESCRIPTION
Baclofen is a muscle relaxant and antispastic.
Its chemical name is 4-amino-3-(4- chlorophenyl)-butanoic acid. The
structural formula is:
C
H ClNO M.W. 213.66
Baclofen USP is a white to off-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
baclofen. In addition, each tablet contains
the following inactive ingredients: anhydrous lactose, colloidal
silicon dioxide, dibasic calcium
phosphate dihydrate, magnesium stearate, microcrystalline cellulose
and sodium starch glycolate.
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 is 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