Contact Us

Headquarters

Metacel Pharmaceuticals
1272 Virgil Langford Road
Suite 201E
Watkinsville, GA 30677

Phone Numbers / Email Addresses

General Information
Phone: (844) METACEL

Contact a Sales Representative
Phone: (844) METACEL

Client Services
Phone: (844) METACEL

Medical Information
Phone: (833) 469-6229

Adverse events may also be reported to the FDA’s MedWatch Program at fda.gov/medwatch or call (800) FDA-1088.

Business Development
busdev@metacelrx.com

All Other Inquiries
info@metacelrx.com

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.