BACLOFEN tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Lifestar Pharma LLC

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are 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.

ملخص المنتج:

Baclofen Tablets USP, 5 mg are available as a white to off white, round, flat-faced, beveled edge tablet, debossed with "LS" on one side and "85" on the other side, containing 5 mg baclofen, USP are supplied as follows: NDC 70756-085-11 in bottle of 100 tablets, with child-resistant closure Baclofen Tablets USP, 10 mg are available as a white to off white, round, flat-faced, beveled edge tablet, debossed with "LS 288" on one side and functional scored on the other side, containing 10 mg baclofen, USP are supplied as follows: NDC  70756-288-11 in bottle of 100 tablets, with child-resistant closure. NDC 70756-288-12 in bottle of 1000 tablets. This package is not child resistant. Baclofen Tablets USP, 20 mg are available as a white to off white, round, flat-faced, beveled edge tablet debossed with "LS 289" on one side and functional scored on the other side, containing 20 mg baclofen, USP are supplied as follows: NDC 70756-289-11 in bottle of 100 tablets, with child-resistant closure. NDC 70756-289-51 in bottle of 500 tablets. This package is not child resistant. NDC 70756-289-12 in bottle of 1000 tablets. This package is not child resistant. Dispense in a well-closed container as defined in the USP, with a child-resistant closure. 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 for: Lifestar Pharma LLC   1200 MacArthur Blvd. Mahwah, NJ 07430 USA Product of Poland Revised: January 2022, V-04

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

BACLOFEN - BACLOFEN TABLET
LIFESTAR PHARMA LLC
----------
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. 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 5 mg, 10 mg or 20 mg
baclofen, USP. 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.
10
12
2
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 muscul