BACLOFEN tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Direct_Rx

INN (nemzetközi neve):

BACLOFEN

Összetétel:

BACLOFEN 10 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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.

Termék összefoglaló:

Baclofen Tablets USP, 10 mg are available as a white, round, flat-faced, beveled-edge tablet debossed with “4096” on one side and “TV” with a partial score on the other side, containing 10 mg baclofen, USP packaged in bottles of 100 (NDC 0172-4096-60) and 1000 (NDC 0172-4096-80) tablets. Baclofen Tablets USP, 20 mg are available as a white, round, flat-faced, beveled-edge tablet debossed with “4097” on one side and “TV” with a partial score on the other side, containing 20 mg baclofen, USP packaged in bottles of 100 (NDC 0172-4097-60) and 1000 (NDC 0172-4097-80) tablets. PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

BACLOFEN- BACLOFEN TABLET
DIRECT_RX
----------
BACLOFEN
Baclofen, USP is a muscle relaxant and antispastic.
Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The
structural formula is:
[Structural Formula]
C10H12ClNO2 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 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.
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.
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 treat