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The determination of optimal dosage of pms-BACLOFEN (baclofen) requires individual titration. Start therapy at a low dosage and increase gradually until optimum effect is achieved (usually between 40-80 mg daily).
Treatment should be started with a dosage of 15 mg daily, preferably in divided doses.
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 If benefits are not evident after a reasonable trial period, patients should be slowly withdrawn from the drug (see WARNINGS).
Discontinuation of the treatment should always be gradual by successively reducing the dosage over a period of approximately 1 to 2 weeks, except in overdose-related emergencies, or where serious adverse effects have occurred (see WARNINGS).
Special Populations: Renal Impairment: Because baclofen is primarily excreted unchanged through the kidneys, it should be given with caution in patients with renal insufficiency, and generally with a reduced dose. In patients dependent on dialysis, a particularly low dose of pms-BACLOFEN should be selected (i.e., approximately 5 mg daily) (see Renal Impairment under WARNINGS).
pms-BACLOFEN should only be administered to end stage renal failure patients when benefit outweighs risk. These patients should be closely monitored for prompt diagnosis of early signs and/or symptoms of toxicity (see Renal Impairment under WARNINGS).
Since unwanted effects are more likely to occur in elderly patients or in patients with spastic states of cerebral origin, it is recommended that a very cautious dosage schedule be adopted in such cases and that the patient should be kept under appropriate surveillance. Patients should be monitored for signs of overdose, central nervous system depression and toxic encephalopathy such as drowsiness, impairment of consciousness, coma, respiratory depression, hallucinations, agitation, and convulsions (see OVERDOSAGE).
Hepatic Impairment: No studies have been performed in patients with hepatic impairment under baclofen therapy. The liver does not play significant role in the metabolism of baclofen after oral administration of baclofen (see ACTION AND CLINICAL PHARMACOLOGY). However, baclofen has the potential of elevating liver enzymes. pms-BACLOFEN should be prescribed with caution in patients with hepatic impairment, although no dosage adjustment is needed (see Hepatic Impairment under PRECAUTIONS).
Geriatrics (aged 65 years or above): Since unwanted effects are more likely to occur in elderly patients, it is recommended that a cautious dosage schedule be adopted in such cases and that the patient is kept under appropriate surveillance.
Patients with Spastic States of Cerebral Origin: Since unwanted effects are more likely to occur in patients with spastic states of cerebral origin, it is recommended that a cautious dosage schedule be adopted in such cases and that the patient is kept under appropriate surveillance.
