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Baclofen (Baclofen) - Indications and Dosage

 
 



INDICATIONS & USAGE

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

DOSAGE & ADMINISTRATION

The determination of optimal dosage requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 4080 mg daily).
The following dosage titration schedule is suggested:
5 mg t.i.d. for 3 days
10 mg t.i.d. for 3 days
15 mg t.i.d. for 3 days
20 mg t.i.d. for 3 days
Thereafter additional increases may be necessary but the total daily dose should not exceed a maximum of 80 mg daily (20 mg q.i.d.).
The lowest dose compatible with an optimal response is recommended. If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS Abrupt Drug Withdrawal).

HOW SUPPLIED

Baclofen Tablets, USP 10 mg are off-white, scored, oval-shaped tablets debossed "2265" on one side and debossed "V" on the reverse side. Supplied in bottles of 10, 30, 90, 100, 500 and 1000.
Baclofen Tablets, USP 20 mg are off-white, scored, capsule-shaped tablets debossed "2266" on one side and debossed "V" on the reverse side. Supplied in bottles of 10, 30, 100, 500 and 1000.

STORAGE AND HANDLING

Store at 20(68[see USP Controlled Room Temperature].
Dispense in a tight container with child-resistant closure.

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