BACLOFEN tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Proficient Rx LP

Designación común internacional (DCI):

BACLOFEN

Composición:

BACLOFEN 20 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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.

Resumen del producto:

Baclofen Tablets USP, 20 mg are available as a white, round, flat-faced, beveled-edge tablet debossed with “4097” on one side and “TV” with a partial score on the other side, containing 20 mg baclofen, USP packaged in bottles of 30 (NDC 63187-274-30) 60 (NDC 63187-274-60)and 90 (NDC 63187-274-90) tablets. PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Croatia By: PLIVA HRVATSKA d.o.o. Zagreb, Croatia Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. B 10/2015 Repackaged by: PROFICIENT RX LP Thousand Oaks, CA 91320

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

BACLOFEN- BACLOFEN TABLET
PROFICIENT RX LP
----------
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:
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, USP. 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.
10
12
2
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 rigi