BACLOFEN- baclofen tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Lake Erie Medical DBA Quality Care Products LLC

INN:

Baclofen

composition:

Baclofen 10 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

INDICATIONS AND USAGE Baclofen tablets are 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. CONTRAINDICATIONS Baclofen tablets are contraindicated in patients with a hypersensitivity to baclofen.

leaflet_short:

HOW SUPPLIED 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, in bottles of 100, 500 and 1000. As 20 mg – Compressed tablet, white, 13/32” diameter, round; one side scored and debossed 832 and BC20, one side plain, bottles of 100, 500 and 1000. Dispense in a tight container as defined in the USP. Keep this and all drugs out of the reach of children. Store at controlled room temperature 15° - 30°C (59° - 86°F). Rx only Rev. 06-02 15133-02 Manufactured by UPSHER-SMITH LABORATORIES, INC. Minneapolis, MN 55447

authorization_status:

Abbreviated New Drug Application

SPC

BACLOFEN- BACLOFEN TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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BACLOFEN 10 MG
HOW SUPPLIED
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, in bottles of 100, 500 and 1000.
As 20 mg – Compressed tablet, white, 13/32” diameter, round; one
side scored and debossed 832 and
BC20, one side plain, bottles of 100, 500 and 1000.
Dispense in a tight container as defined in the USP.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Store at controlled room temperature 15° - 30°C (59° - 86°F).
Rx only
Rev. 06-02
15133-02
Manufactured by
UPSHER-SMITH LABORATORIES, INC.
Minneapolis, MN 55447
Enter section text here
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 tablets are useful for the alleviation of signs and symptoms
of spasticity resulting from
multiple sclerosis, particularly for the relief of flexor spasms and
concomita