BACLOFEN tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

H.J. Harkins Company, Inc.

INN（国际名称）:

Baclofen

组成:

Baclofen 10 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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.

產品總結:

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 bottles of 100 and 1000 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 bottles of 100 and 1000 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 Repacked by: H.J. Harkins Company, Inc. Nipomo, CA 93444

授权状态:

Abbreviated New Drug Application

产品特点

BACLOFEN - BACLOFEN TABLET
H.J. HARKINS COMPANY, INC.
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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