Contraindications
Hypersensitivity to baclofen.
Warnings and Precautions
Abrupt discontinuation of baclofen has resulted in serious adverse reactions including death; reduce the dosage slowly when OZOBAX DS is discontinued.
Neonatal withdrawal symptoms can occur; gradually reduce the dosage and discontinue OZOBAX DS before delivery.
OZOBAX DS 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 DS can cause exacerbation of the following: psychotic disorders, schizophrenia or confusional states; autonomic dysreflexia; epilepsy. Use with caution in patients with these conditions.
Adverse Events
The most common adverse reaction is transient drowsiness. In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen compared to 36% of those in the placebo group. Other common adverse reactions (up to 15%) are dizziness and weakness. Adverse reactions with a frequency of <1% are listed below.
| ADVERSE REACTION | PERCENT |
|---|---|
| Drowsiness | 10% – 63% |
| Dizziness | 5% – 15% |
| Weakness | 5% – 15% |
| Nausea | 4% – 12% |
| Confusion | 1% – 11% |
| Hypotension | 0% – 9% |
| Headache | 4% – 8% |
| Insomnia | 2% – 7% |
| Constipation | 2% – 6% |
| Urinary Frequency | 2% – 6% |
| Fatigue | 2% – 4% |
Pregnancy
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.
Drug Interactions
OZOBAX DS can cause CNS depression, including drowsiness and sedation, which may be additive when used concomitantly with other CNS depressants or alcohol.