Baclofen
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Baclofen
INDICATIONS
Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) 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 (baclofen (baclofen (baclofen tablets) tablets) tablets) treatment will aid in restoring residual function.
Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.
The efficacy of baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.
DOSAGE AND 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 40-80 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 If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS, Abrupt Drug Withdrawal).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 (baclofen (baclofen (baclofen tablets) tablets) tablets) Tablets USP 10 mg are scored, round, white tablets imprinted DAN 5730 and 10 supplied in bottles of 100 and 500.
Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) Tablets USP 20 mg are scored, round, white tablets imprinted DAN 5731 and 20 supplied in bottles of 100 and 500.
Dispense in a tight container with a child-resistant closure.
Store at controlled room temperature 15°-30°C (59°-86°F).
Watson Laboratories, Inc. Corona, CA 92880 USA. Revised: January 2004. FDA rev date:
Last reviewed on RxList: 11/20/2007
This monograph has been modified to include the generic and brand name in many instances.
Additional Baclofen Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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