Safety Profile

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.

Indications and Usage

OZOBAX DS is a gamma-aminobutyric acid (GABA-ergic) agonist indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.

OZOBAX DS  may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

Limitations of Use: OZOBAX DS  is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

Important Safety Information

OZOBAX DS is contraindicated in patients with hypersensitivity to baclofen.

Abrupt discontinuation of baclofen has resulted in serious adverse reactions including death; therefore, 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 machinery until they know how the drug affects them. Advise patients that the central nervous system effects of OZOBAX DS may be additive to those of alcohol and other CNS depressants.

OZOBAX DS should be used with caution in patients who have had a stroke.

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.

The most common adverse reactions (>1%) in patients treated with baclofen for spasticity are drowsiness, dizziness, weakness, nausea, confusion, hypotension, headache, insomnia, constipation, urinary frequency and fatigue.

You are encouraged to report adverse reactions to Metacel Pharmaceuticals, LLC at 1-833-469-6229 or to the FDA:  www.fda.gov/medwatch or 1-800-FDA-1088.

Please see the accompanying Full Prescribing Information.