BACLOFEN tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Dispensing Solutions, Inc.

INN:

BACLOFEN

composition:

BACLOFEN 10 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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.

leaflet_short:

Baclofen Tablets, USP 10 mg are off-white, scored, oval-shaped tablets debossed “2265” on one side and debossed “V” on the reverse side; and supplied as follows: Baclofen Tablets, USP 20 mg are off-white, scored, capsule-shaped tablets debossed “2266” on one side and debossed “V” on the reverse side; and are supplied as follows:

authorization_status:

Abbreviated New Drug Application

SPC

BACLOFEN- BACLOFEN TABLET
DISPENSING SOLUTIONS, INC.
----------
BACLOFEN TABLETS, USP
RX ONLY
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:
Baclofen Tablets, USP 10 mg and 20 mg contain the following inactive
ingredients: colloidal silicon
dioxide, crospovidone, magnesium stearate, microcrystalline cellulose
and pregelatinized starch.
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-amino-butyric 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 b