BACLOFEN tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Par Pharmaceutical, Inc.

INN (International Name):

BACLOFEN

Sammensetning:

BACLOFEN 10 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Baclofen tablets USP 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 so that baclofen treatment will aid in restoring residual function. Baclofen tablets USP may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets USP are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions. Hypersensitivity to baclofen.

Produkt oppsummering:

Baclofen Tablets, USP 10 mg are white to off-white, oval shaped and scored. The upper layer is debossed   “2265”. The lower layer is debossed “V”; and supplied as follows: Baclofen Tablets, USP 20 mg are white to off-white, capsule shaped and scored. The upper layer is debossed “2266”. The lower layer is debossed “V”; and are supplied as follows:

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

BACLOFEN- BACLOFEN TABLET
PAR PHARMACEUTICAL, INC.
----------
BACLOFEN TABLETS, USP
RX ONLY
DESCRIPTION
Baclofen, USP is a muscle relaxant and antispastic.
Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The
structural formula is:
Baclofen, USP is a white to creamy white powder. It is slightly
soluble in water, very
slightly soluble in methanol, and insoluble in chloroform.
Baclofen Tablets USP 10 mg and 20 mg contain the following inactive
ingredients:
colloidal silicon dioxide, crospovidone, magnesium stearate,
microcrystalline cellulose
and pregelatinized starch.
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 USP 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 so that baclofen treatment
will aid in restoring
residual function. Baclofen tablets USP may also be of some value in
pati