BACLOFEN- baclofen tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Preferred Pharmaceuticals, Inc

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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.

Огляд продуктів:

Baclofen Tablets USP 10 mg are scored, round, white tablets imprinted DAN 5730 and 10 supplied in: Bottles of 30 tablets, NDC 68788-0522-3 Bottles of 60 tablets, NDC 68788-0522-6 Bottles of 90 tablets, NDC 68788-0522-9 Bottles of 100 tablets, NDC 68788-0522-1 Bottles of 120 tablets, NDC 68788-0522-8 Dispense in a tight container with a child-resistant closure. Store at controlled room temperature 15°-30°C (59°-86°F). Watson Laboratories, Inc. Corona, CA 92880 USA Rev: January 2004

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

BACLOFEN- BACLOFEN TABLET
PREFERRED PHARMACEUTICALS, INC
----------
BACLOFEN TABLETS USP
REVISED: JANUARY 2004
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:
C10H12CLNO2 M.W. 213.66
Baclofen Tablets USP 10 mg and 20 mg contain the following inactive
ingredients: magnesium stearate,
microcrystalline cellulose, povidone and starch (corn).
ACTIONS
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
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 treatmen