BACLOFEN- baclofen tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

McKesson Corporation dba SKY Packaging

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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.

제품 요약:

Product: 63739-007 NDC: 63739-007-10 10 TABLET in a BLISTER PACK / 10 in a BOTTLE, UNIT-DOSE Product: 63739-974 NDC: 63739-974-10 10 TABLET in a BLISTER PACK / 10 in a BOX, UNIT-DOSE

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

BACLOFEN- BACLOFEN TABLET
MCKESSON CORPORATION DBA SKY PACKAGING
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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:
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: microcrystalline cellulose,
pregelatinized starch, colloidal silicon
dioxide, and magnesium stearate.
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 reversible spasticity so that baclofen treatment
will