BACLOFEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NCS HealthCare of KY, LLC dba Vangard Labs

INN (International Name):

BACLOFEN

Composition:

BACLOFEN 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen is 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.

Product summary:

Baclofen Tablets USP, 10 mg are available as a white, round, flat-faced, beveled-edge tablet debossed with "4096" on one side and "TV" with a partial score on the other side, containing 10 mg Baclofen USP packaged in blistercards of 15, 30 and 31 tablets. 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 blistercards of 30 and 31 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]. Rev. A 5/2010 Manufactured In Croatia By: PLIVA HRVATSKA d.o.o. Zagreb, Croatia Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 BACLOFEN TABLETS USP

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BACLOFEN- BACLOFEN TABLET
NCS HEALTHCARE OF KY, INC DBA VANGARD LABS
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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.
Patien