BACLOFEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Baclofen (UNII: H789N3FKE8) (Baclofen - UNII:H789N3FKE8)

Available from:

Northstar RxLLC

INN (International Name):

Baclofen

Composition:

Baclofen 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.  Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

Product summary:

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. Bottles of 100           NDC   16714 – 071 – 04 Bottles of 1000         NDC   16714 – 071 – 06 20 mg:  White colored, circular, flat, uncoated tablets with ‘N030’ debossed on one side and scoreline on the other side. Bottles of 100           NDC   16714 – 072 – 04 Bottles of 500           NDC   16714 – 072 – 05 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 for: Northstar Rx LLC                                    Memphis, TN 38141 Toll Free Number:   1-800-206-7821 Manufactured by:     Piramal Pharma Limited,                                      Plot No 67-70, Sector - 2,                                      Pithampur, Madhya Pradesh 454775                                      INDIA. October 2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BACLOFEN - BACLOFEN TABLET
NORTHSTAR RXLLC
----------
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 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 treatment
will aid in restoring residual
functi