BACLOFEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

New Horizon Rx Group, LLC

INN (International Name):

BACLOFEN

Composition:

BACLOFEN 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic 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 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.

Product summary:

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: Bottles of 30: NDC 58517-440-30 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]. Distributed by: New Horizon Rx Group, LLC Kenner, LA 70062 1-855-465-5545 Manufactured by: Vintage Pharmaceuticals 120 Vintage Dr. NE Huntsville, AL 35811 Issue date: November 2013

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BACLOFEN - BACLOFEN TABLET
NEW HORIZON RX GROUP, LLC
----------
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 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 reversibl