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:

Med Health Pharma, LLC

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 scored, round, white tablets imprinted DAN 5730 and 10 supplied in bottles of 30. Baclofen Tablets USP 20 mg are scored, round, white tablets imprinted DAN 5731 and 20 supplied in bottles of 30. Dispense in a tight container with a child-resistant closure. Store at controlled room temperature 15°-30°C (59°-86°F). Watson Laboratories, Inc. Corona, CA 92880 USA Rev: January 2004 Repackaged By: Med-Health Pharma, LLC North Las Vegas, NV 89032 MHP LB-60001 rev00

授权状态:

Abbreviated New Drug Application

产品特点

BACLOFEN - BACLOFEN TABLET
MED HEALTH PHARMA, LLC
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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.
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. The structural formula
is represented below:
C
H ClNO M.W. 213.66
Baclofen Tablets USP 10 mg and 20 mg contain the following inactive
ingredients: magnesium stearate,
microcrystalline cellulose, povidone and starch (corn).
ACTIONS
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 gammaaminobutyric 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
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
10
12
2
function.
Baclofen ma