BACLOFEN- baclofen tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Asclemed USA, Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 so that baclofen tablets treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets 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, round, flat-faced, beveled-edge scored tablet debossed with “B” above score line and “10” below score line on one side and plain on other side. They are supplied as follows: Bottles of 30   NDC 76420-241-30 (repackaged from NDC 59651-394-XX) Bottles of 60   NDC 76420-241-60 (repackaged from NDC 59651-394-XX) Bottles of 90   NDC 76420-241-90 (repackaged from NDC 59651-394-XX) Baclofen Tablets USP, 20 mg are white to off-white, round, flat-faced, beveled-edge scored tablet debossed with “B” above score line and “20” below score line on one side and plain on other side. They are supplied as follows: Bottles of 30 NDC 76420-242-30 (repackaged from NDC 59651-395-XX) Bottles of 60 NDC 76420-242-60 (repackaged from NDC 59651-395-XX) Bottles of 90 NDC 76420-242-90 (repackaged from NDC 59651-395-XX) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). Repackaged by: Enovachem PHARMACEUTICALS Torrance, CA 90501

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

BACLOFEN - BACLOFEN TABLET
ASCLEMED USA, INC.
----------
BACLOFEN TABLETS USP
RX ONLY
DESCRIPTION
Baclofen USP, is a muscle relaxant and antispastic, available as 10 mg
and 20 mg tablets
for oral administration. Its chemical name is
4-amino-3-(4-chlorophenyl)- butanoic acid,
and its structural formula is
Baclofen USP is a white to off-white crystalline powder, with a
molecular weight of
213.66. It is slightly soluble in water, very slightly soluble in
methanol and in 96%
ethanol, practically insoluble in acetone, insoluble in chloroform,
dissolves in dilute
mineral acids and in dilute solutions of alkali hydroxides.
_Inactive Ingredients. _Colloidal silicon dioxide, magnesium stearate,
microcrystalline
cellulose and pregelatinized starch (maize).
FDA approved dissolution test specifications differ from USP.
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
flex