BACLOFEN tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Mckesson Corporation DBA SKY Packaginng

INN (International Name):

Baclofen

Sammensetning:

Baclofen 10 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 tablet 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 tablets in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions. Hypersensitivity to baclofen. Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

Produkt oppsummering:

Baclofen Tablets, USP are supplied as: 10 mg: White colored, circular, flat, uncoated tablets with ‘N029’ debossed on one side and scoreline on the other side. Boxes of 10X10 UD 100, NDC 63739-479-10 20 mg: White colored, circular, flat, uncoated tablets with ‘N030’ debossed on one side and scoreline on the other side. Boxes of 10x10 UD 100, NDC 63739-480-10 PHARMACIST: Dispense in a well-closed container as defined in the USP. Use child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Split tablet to be stored at controlled room temperature (20° to 25°C) for not more than 2 weeks. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured by: Piramal Pharma Limited, Plot No 67-70, Sector - 2, Pithampur, Madhya Pradesh 454775 INDIA. Distributed by: McKesson Corporation dba SKY Packaging Memphis, TN 38141 21340-1 December 2022

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

BACLOFEN- BACLOFEN TABLET
MCKESSON CORPORATION DBA SKY PACKAGINNG
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RX ONLY
DESCRIPTION
Baclofen 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 10 mg or 20 mg
Baclofen. In addition, each
tablet contains the following inactive ingredients: colloidal silicon
dioxide, microcrystalline
cellulose, magnesium stearate, potato starch, povidone.
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 tablet
treatment will aid in