Concise Prescribing Info
Alleviation of signs & symptoms of spasticity resulting from multiple sclerosis. Patients w/ spinal cord injuries & other spinal cord diseases.
Dosage/Direction for Use
Initial dose: 15 mg daily in divided doses. Dose titration schedule: 5 mg tds for 3 days; 10 mg tds for 3 days; 15 mg tds for 3 days; 20 mg tds for 3 days. Max daily dose: 80 mg daily (20 mg qds). Dialysis-dependent patient 5 mg daily.
Should be taken with food.
Special Precautions
Associated w/ CNS depression including sedation, somnolence, loss of consciousness, as well as serious cases of resp depression. Potentiated risk of resp depression, profound sedation, syncope & death w/ concomitant use of opioids. Avoid abrupt w/drawal; reduce dose slowly when discontinuing. Carefully monitor neonates w/ risk of intrauterine exposure for the development of signs consistent w/ w/drawal. Use w/ caution where spasticity is utilized to sustain upright posture & balance in locomotion or whenever spasticity is utilized to obtain increased function. Patients w/ stroke; epilepsy or history of convulsive disorders; peptic ulceration; resp impairment; underlying bladder sphincter hypertonia; psychiatric disorders; spastic states of cerebral origin. Elevated AST, blood alkaline phosphatase & blood sugar; periodically perform appropriate laboratory tests to ensure that no drug-induced changes have occurred in patients w/ liver diseases or DM. Psychomotor impairment; may impair ability to drive or operate machinery. Patients w/ renal impairment; end-stage renal failure; hepatic impairment. Pregnancy & lactation. Childn <12 yr. Elderly ≥65 yr especially those w/ cerebrovascular disorders.
Adverse Reactions
Transient somnolence, sedation, dizziness, weakness & fatigue.
Drug Interactions
Potentiated CNS effects w/ anesthetics. Potentiated pharmacological effects w/ TCAs. Aggravated hyperkinetic symptoms w/ lithium. Increased CNS depressant effects w/ MAOIs. Additive effect in BP w/ antihypertensives. Risk of mental confusion, hallucinations, headache, nausea, agitation & worsening of symptoms of Parkinsonism w/ levodopa/carbidopa. Adjust dose of antidiabetic agents due to increased blood glucose conc w/ baclofen. Potential synergistic effect w/ Mg sulfate or other neuromuscular blocking agents. Reduced excretion w/ drugs or medicinal products that can significantly impact renal function (eg, memantine, NSAIDs). Increased sedation w/ other drugs causing CNS depression, including other muscle relaxants (eg, tizanidine), synthetic opiates, hypnotics, anxiolytics, alcohol.
MIMS Class
Muscle Relaxants
ATC Classification
M03BX01 - baclofen ; Belongs to the class of other centrally-acting muscle relaxants.
pms-Baclofen tab 10 mg
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