1.The control of spasticity caused by multiple sclerosis and spinal cord lesions.
2.The control of spasticity in children caused by cerebral palsy.
3.The adjunctive management of neurogenic bladder.
4.The management of refractory trigeminal neuralgia.
Dosage & Administration
The dose should be titrated to gain maximum benefit and minimize adverse reactions.Tablets should be taken with food or milk to reduce gastrointestinal intolerance. Baclofen should be withdrawn gradually if cessation of therapy is indicated. Adult: The usual starting dose of Baclofen for adults is 5 mg given three times daily. Based on the response, the dose can be increased gradually every three days by 5 mg to a maximum of 80 mg/day in several doses. It benefits are not evident after a 6 to 8 weeks trial period, patients should be slowly withdrawn from the drug. Children: In children aged 12-24 months, the recommended daily dose is10-20 mg, and in children aged 2-10 years, 20-60 mg per day (from starting dose 0.3 -0.75 mg/kg body weight per day up-to 2 mg/kg body weight per day). Elderly: Dosages should be cautiously administered and the patient kept under appropriate surveillance. Toxicity due to Baclofen may be mistaken for uraemic encephalopathy. Impaired Renal Function: Baclofen should be used with caution. Lower doses (approximately 5 mg per day) should be used for
patients with impaired renal function or those undergoing chronic haemodialysis.
Baclofen should be used with caution in patients who use their spasticity to maintain posture or to increase function. In patient with epilepsy, the clinical state and electroencephalogram should be monitored at regular intervals, since deterioration in seizure control and EEG have been reported occasionally in patient taking Baclofen. Because possibility of sedation, patient should be cautioned regarding the operation of automobiles or other dangerous machinery and activities made hazardous by decreased alertness. Patient should be cautioned that the CNS depressant effects of Baclofen may be additive to those of alcohol and other CNS depressants. Use in pregnancy & lactation: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Baclofen should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In mothers treated with oral Baclofen in therapeutic doses, the active substance passes into the breast milk. Therefore, administration to nursing mothers is not recommended.