BACLOFEN tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Lannett Company, Inc.

INN (שם בינלאומי):

BACLOFEN

הרכב:

BACLOFEN 10 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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

leaflet_short:

Baclofen Tablets USP, 5 mg are available as a white round convex tablet debossed with “LCI” on one side and “1333” on the other side. Available in bottles of 100 (NDC 0527-1333-01). Baclofen Tablets USP, 10 mg are available as a white round flat-faced beveled edge bisected tablet debossed with "LCI" over "1330" on one side and plain on the other side, containing 10 mg Baclofen USP. Available in bottles of 100 (NDC 0527-1330-01), 500 (NDC 0527-1330-05) and 1000 (NDC 0527-1330-10). Baclofen Tablets USP, 20 mg are available as a white round flat-faced beveled edge bisected tablet debossed with "LCI" over "1337" on one side and plain on the other side, containing 20 mg Baclofen USP. Available in bottles of 100 (NDC 0527-1337-01), 500 (NDC 0527-1337-05) and 1000 (NDC 0527-1337-10). PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 CIB70280E Rev. 02/21

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

BACLOFEN- BACLOFEN TABLET
LANNETT COMPANY, INC.
----------
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:
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. In
addition, each tablet contains the following inactive ingredients:
microcrystalline cellulose,
pregelatinized starch, colloidal silicon dioxide, and magnesium
stearate.
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 USP 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
wil