OZOBAX DS

Clinical summary

Indications and 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 and 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 15 mg (7.5 mL) three times a day for three days 20 mg (10 mL) 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). 2.3 Discontinuation of OZOBAX DS When discontinuing OZOBAX DS, reduce the dosage slowly and avoid abrupt withdrawn from the drug to help minimize the risk of adverse reactions [see Warnings and Precautions ( 5.1 )]. Warnings and cautions 5 WARNINGS AND PRECAUTIONS Abrupt discontinuation of baclofen has resulted in serious adverse reactions including death; therefore, reduce the dosage slowly when OZOBAX DS is discontinued. ( 5.1 ) Neonatal withdrawal symptoms can occur; gradually reduce the dosage and discontinue OZOBAX DS before delivery. ( 5.2 ) 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. Advise patients that the central nervous system effects of OZOBAX DS may be additive to those of alcohol and other CNS depressants. ( 5.3 ) 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 ( 5.5 , 5.6 , 5.7 ) 5.1 Adverse Reactions from Abrupt Withdrawal of OZOBAX DS Abrupt discontinuation of baclofen, regardless of the cause, has resulted in adverse reactions that include hallucinations, seizures, high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure, and death. Therefore, reduce the dosage slowly when OZOBAX DS is discontinued, unless the clinical situation justifies a rapid withdrawal. 5.2 Neonatal Withdrawal Symptoms Withdrawal symptoms in neonates whose mothers were treated with oral baclofen throughout pregnancy have been reported starting hours to days after delivery. The symptoms of withdrawal in these infants have included increased muscle tone, tremor, jitteriness, and seizure. If the potential benefit justifies the potential risk to the fetus and OZOBAX DS is continued during pregnancy, gradually reduce the dosage and discontinue OZOBAX DS before delivery. If slow withdrawal is not feasible, advise the parents or caregivers of the exposed neonate of the potential for neonatal withdrawal. 5.3 Drowsiness and Sedation Drowsiness and sedation have been reported in up to 63% of patients taking baclofen, the active ingredient in OZOBAX DS [see Adverse Reactions ( 6.1 )] . Patients should avoid operation of automobiles or other dangerous machinery and activities made hazardous by decreased alertness when starting OZOBAX DS or increasing the dose until they know how the drug affects them. Advise patients