Ozobax - baclofen oral solution
Go to Healthcare Provider Site

How to Take OZOBAX®1

OZOBAX oral solution contains 5 mg/5 mL baclofen. It is a clear, colorless solution with a grape aroma and is supplied in 473 mL bottles.

OZOBAX must be refrigerated. 2°C to 8°C (36°F to 46°F). It is dispensed in a tight, light-resistant container with a child-resistant closure.

Your doctor will determine the appropriate dosage for your treatment. Doctors generally start patients with a low dosage of OZOBAX, administered orally. They may gradually increase the dosage based on how you respond and how well you tolerate OZOBAX. Here is a generally recommended dosage schedule.

  • 5 mL (5 mg) three times a day for three days
  • 10 mL (10 mg) three times a day for three days
  • 15 mL (15 mg) three times a day for three days
  • 20 mL (20 mg) three times a day for three days

Additional increases may be necessary up to the maximum recommended dosage of 80 mg daily (20 mg four times a day).

References:

  1. OZOBAX [prescribing information]. Athens, GA: Metacel Pharmaceuticals, LLC; 2019.

Important Safety Information

OZOBAX® 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 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 machinery until they know how the drug affects them. Advise patients that the central nervous system effects of OZOBAX may be additive to those of alcohol and other CNS depressants.

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

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 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.