Baclofen
TRILAXANT
Regulatory Class: Rx
Generic Name: Baclofen
Formulation/s: 10 mg Baclofen, USP
Indications or Use: Chronic severe spasticity resulting from disorders e.g., multiple sclerosis or traumatic partial section of spinal cord.
Dosage and Directions for Use: : Initially 5 mg tid, increased to 10 mg thrice a day for 3 days then in similar increments & intervals up to 20 mg thrice a day. Childn >10 yr Initially 2.5 mg 4x a day increased every 3 days. Max daily dose: 2.5 mg/kg; 6-10 yr 30-60 mg; 2-6 yr 20-30 mg; 12 mth-2 yr 10-20 mg.
Administration: Take with or without food.
Contraindication: Hypersensitivity to Baclofen or any of the excipients. Peptic Ulceration.
Special Precaution: Patients w/ history or active Peptic ulcer disease; severe psychiatric disorders, epilepsy or convulsive disorders. Renal & respiratory impairment. DM, cerebrovascular disease. Patients using spasticity to maintain posture or to increase function. Hypertonic bladder sphincters. Avoid abrupt withdrawal. May impair ability to drive or operate machinery. Elderly.
Adverse Reaction: Drowsiness, nausea, dizziness, lassitude, lightheadedness, confusion, fatigue, muscular pain & weakness, hypotension.
Interactions: Alcohol & other CNS depressants may exacerbate CNS effects. Lithium may cause severe aggravation of hyperkinetic symptoms. Increased weakness w/ TCAs & hypotensive effect w/ antihypertensive therapy. Ibuprofen & other drugs that produce renal insufficiency may reduce excretion leading to toxicity.
Presentation/ Packaging: Tablet 10 mg x 100’s.
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