Baclofen (Sintetica Baclofen Intrathecal)
Baclofen risk profile, scheduling, and guidance for claims professionals and care workers . Also known as Sintetica Baclofen Intrathecal, APO-Baclofen, Clofen 25, Stelax 25, Lioresal 25 and 5 more.
Baclofen (brand names: Sintetica Baclofen Intrathecal, APO-Baclofen, Clofen 25, Stelax 25, Lioresal 25 and 5 more) is classified as Low risk (2 risk points) by AllMeds. It is a S4 medication under the TGA in Australia. FDA approved in the United States. Centrally acting muscle relaxant with CNS depression and respiratory depression risk.
Key Takeaways
- TGA Schedule: S4 in Australia
- Risk level: Low (2 points)
- CNS depressant: May cause sedation, impair driving, and affect work capacity
- Respiratory depression risk: Requires monitoring, especially with other CNS depressants
- Recommended maximum duration: 28 days
- PBS listed: Subsidised under the Australian Pharmaceutical Benefits Scheme
Scheduling and Classification
| Jurisdiction | Classification | Status |
|---|---|---|
| Australia (TGA) | S4 | PBS listed |
| United States (FDA) | Rx only | FDA approved |
Risk Profile
Centrally acting muscle relaxant with CNS depression and respiratory depression risk.
Regulatory and Compliance Guidance
When Baclofen appears on a claimant's medication list, claims professionals should assess whether the prescribing is appropriate for the compensable injury, whether the duration is within guidelines, and whether there are interactions with other medications on the claim.
Work capacity impact: As a CNS depressant, Baclofen may impair driving, operating machinery, and cognitive function. Work capacity certificates should reflect any medication-related restrictions.
Australia TGA / PBS / State Schemes
Classified as S4 under the Therapeutic Goods Administration (TGA).
Listed on the Pharmaceutical Benefits Scheme (PBS) for subsidised prescribing.
United Kingdom NICE / MHRA / FPM
UK drug driving laws (Section 5A Road Traffic Act 2006) set specific limits for prescription drugs that cause impairment. Employers and occupational health advisors should assess fitness to work.
United States FDA / CDC / State WC
FDA approved for use in the United States.
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Medical Disclaimer: This content is for informational purposes for claims professionals and care workers. It is not medical advice. Always consult a qualified healthcare professional for clinical decisions. Drug information is sourced from TGA, FDA, MHRA, PBS, NICE, and CDC databases and may not reflect the latest updates. AllMeds does not replace clinical judgement.