INDICATIONS AND USAGE
- Baclofen 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)
- Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases. ( 1)
Limitations of Use
Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders ( 1)
CONTRAINDICATIONS
- Hypersensitivity to baclofen ( 4)
WARNINGS AND PRECAUTION
- Abrupt discontinuation of baclofen has resulted in serious adverse reactions including death; therefore, reduce the dosage slowly when baclofen is discontinued. ( 5.1)
- Neonatal withdrawal symptoms can occur; gradually reduce the dosage and discontinue baclofen before delivery. ( 5.2)
- Baclofen 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 baclofen may be additive to those of alcohol and other CNS depressants. ( 5.3)
- Baclofen 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)
ADVERSE REACTIONS
- 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 Trifluent Pharma, at 210-944-6920 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Full Safety and Prescribing Information: DailyMed
