BACLOFEN tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Eywa Pharma Inc

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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.

Termék összefoglaló:

For 5 mg strength: White to off-white, round flat faced beveled edged tablets debossed with ‘E’ on one side and ‘8’ on the other side. They are supplied as follows: NDC 71930-066-12 bottles of 100 tablets NDC 71930-066-52 bottles of 500 tablets NDC 71930-066-13 bottles of 1000 tablets For 10 mg strength: White to off-white, round flat-faced beveled edged tablets debossed with ‘E’ and ‘6’ on one side and scored on the other side. They are supplied as follows: NDC 71930-006-12 bottles of 100 tablets NDC 71930-006-52 bottles of 500 tablets NDC 71930-006-13 bottles of 1000 tablets For 20 mg strength: White to off-white, round flat-faced beveled edged tablets debossed with ‘E’ and ‘9’ on one side and scored on the other side. They are supplied as follows: NDC 71930-007-12 bottles of 100 tablets NDC 71930-007-52 bottles of 500 tablets NDC 71930-007-13 bottles of 1000 tablets Storage Store at 20°C to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children Distributed by: Eywa Pharma Inc. 2 Research Way, 3rd Floor Princeton, NJ 08540 Manufactured By: Eywa Pharma Inc, 1 Duncan Drive, Cranbury, NJ 08512, USA Rev. Feb 2022

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

BACLOFEN - BACLOFEN TABLET
EYWA PHARMA 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:
C
H
ClNO M.W. 213.66
Baclofen USP is a white to off-white odorless or practically odorless
crystalline powder,
with a molecular weight of 213.66. 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:
Microcrystalline Cellulose,
Mannitol, Pre-Gelatinized Starch, Hypromellose, Sodium Starch
Glycolate, Colloidal Silicon
Dioxide, 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
10
12
2
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