BACLOFEN- baclofen tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Baclofen (UNII: H789N3FKE8) (Baclofen - UNII:H789N3FKE8)

Available from:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (International Name):

Baclofen

Composition:

Baclofen 20 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. Baclofen tablets are contraindicated in patients with a hypersensitivity to baclofen.

Product summary:

Baclofen tablets, USP for oral use, are supplied in the following forms: As 10 mg – Compressed tablet, white, 5/16” diameter, round; one side scored and debossed BAC and 10, one side debossed 832 As 20 mg – Compressed tablet, white, 13/32” diameter, round; one side scored and debossed 832 and BC20, one side plain Dispense in a tight container as defined in the USP. Keep out of reach of children. Store at controlled room temperature 15°- 30°C (59°- 86°F). Rev. 0910 Manufactured by UPSHER-SMITH LABORATORIES, INC. Minneapolis, MN 55447

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BACLOFEN- BACLOFEN TABLET
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
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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. Its molecular formula is C
H ClNO and its structural formula is:
Baclofen USP is a white to off-white, odorless or practically odorless
crystalline powder, with a
molecular weight of 213.66. 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: Crospovidone, anhydrous lactose,
magnesium stearate and povidone.
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 s