BACLOFEN- baclofen tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Major Pharmaceuticals

INN (שם בינלאומי):

BACLOFEN

הרכב:

BACLOFEN 10 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 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. Available in cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-3365-61 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. Available in cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-5222-61 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]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured in Croatia By: PLIVA HRVATSKA d.o.o. Zagreb, Croatia Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA  18960 Rev.A 5/2010 Distributed by Major Pharmaceuticals Livonia, MI  48150 REFER TO PACKAGE LABEL FOR DISTRIBUTOR'S NDC NUMBER PN:2543

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

BACLOFEN- BACLOFEN TABLET
MAJOR PHARMACEUTICALS
----------
BACLOFEN TABLETS, USP
Rx only
DESCRIPTION
Baclofen 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 or 20 mg of
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 reversible spastic