Hypersensitivity to baclofen.
Warnings and Precautions
Abrupt discontinuation of baclofen has resulted in serious adverse reactions including death; reduce the dosage slowly when OZOBAX is discontinued.
Neonatal withdrawal symptoms can occur; gradually reduce the dosage and discontinue OZOBAX before delivery.
OZOBAX can cause drowsiness and sedation. Patients should avoid the operation of automobiles or other dangerous machinery until they know how the drug affects them. OZOBAX can cause exacerbation of the following: psychotic disorders, schizophrenia or confusional states; autonomic dysreflexia; epilepsy. Use with caution in patients with these conditions.
The most common (15% or more) adverse reactions in patients were drowsiness, dizziness, and weakness.
Based on animal data, may cause fetal harm.
Because baclofen is excreted unchanged through the kidneys, it may be necessary to reduce the dosage in patients with impaired renal function.
OZOBAX can cause CNS depression, including drowsiness and sedation, which may be additive when used concomitantly with other CNS depressants or alcohol.