OZOBAX DS 10 mg/5mL
Baclofen · SOLUTION · Rosemont Pharmaceuticals LLC
OZOBAX DS is a solution containing baclofen at 10 mg/5mL, taken oral. Manufactured by Rosemont Pharmaceuticals LLC.
Key Facts
- Brand Name
- OZOBAX DS
- Generic Name
- Baclofen
- NDC Code (Product)
69528-302- Manufacturer
- Rosemont Pharmaceuticals LLC
- Strength
- 10 mg/5mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- NDA208193
- Drug Class
- gamma-Aminobutyric Acid-ergic Agonist [EPC]
- Marketing Start
- 10/12/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE OZOBAX DS is 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. 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. ( 1 ) OZOBAX DS may also be of some value in patients with spinal cord injuries and other spinal cord diseases. ( 1 ) Limitations of Use OZOBAX DS is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Baclofen oral solution is available in multiple concentrations; include both the total dose in mg and the total dose in volume on prescriptions ( 2.1 ) Initiate OZOBAX DS with a low dosage, preferably in divided doses, administered orally. Increase gradually based on clinical response and tolerability. ( 2.2 ) The maximum dosage is 80 mg daily (20 mg four times a day). ( 2.2 ) When discontinuing, reduce the dosage slowly. ( 2.3 ) 2.1 Important Dosage Information Baclofen oral solution is available in multiple concentrations; ensure accuracy when prescribing, dispensing and administering baclofen oral solution to avoid dosing errors due to confusion between mg and mL, and with other baclofen oral solutions of different concentrations. When writing prescriptions, include both the total dose in mg and the total dose in volume. 2.2 Recommended Dosage Initiate OZOBAX DS with a low dosage, preferably in divided doses, administered orally. The following gradually increasing dosage regimen is suggested, but should be adjusted based on clinical response and tolerability: 5 mg (2.5 mL) three times a day for three days 10 mg (5 mL) three times a day for three days …
Contraindications
4 CONTRAINDICATIONS OZOBAX DS is contraindicated in patients with hypersensitivity to baclofen. Hypersensitivity to baclofen ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 CNS Depressants and Alcohol OZOBAX DS can cause CNS depression, including drowsiness and sedation, which may be additive when used concomitantly with other CNS depressants or alcohol [see Warnings and Precautions ( 5.3 )].
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Adverse Reactions from Abrupt Withdrawal of OZOBAX DS [see Warnings and Precautions ( 5.1 )] Neonatal Withdrawal Symptoms [see Warnings and Precautions ( 5.2 )] Drowsiness and Sedation [see Warnings and Precautions ( 5.3 )] Poor Tolerability in Stroke Patients [see Warnings and Precautions ( 5.4 )] Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States [see Warnings and Precautions ( 5.5 )] Exacerbation of Autonomic Dysreflexia [see Warnings and Precautions ( 5.6 )] Exacerbation of Epilepsy [see Warnings and Precautions ( 5.7 )] Posture and Balance Effects [see Warnings and Precautions ( 5.8 )] Ovarian Cysts [see Warnings and Precautions ( 5.9 )] The most common (up to 15% or more) adverse reactions in patients were drowsiness, dizziness, and weakness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Metacel Pharmaceuticals, LLC at 1-833-469-6229 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical …
Frequently Asked Questions
What is OZOBAX DS used for?
OZOBAX DS contains Baclofen. It is a solution taken oral. Consult your doctor for specific uses.
Is OZOBAX DS a controlled substance?
OZOBAX DS is not classified as a controlled substance by the DEA.
What is the generic name for OZOBAX DS?
The generic name for OZOBAX DS is Baclofen. There are 12 other brand versions of Baclofen.
What is the NDC code for OZOBAX DS 10 mg/5mL?
The NDC (National Drug Code) for OZOBAX DS 10 mg/5mL is 69528-302, listed by Rosemont Pharmaceuticals LLC.