Baclofen (Sintetica Baclofen Intrathecal)
What to know about Baclofen — also sold as Sintetica Baclofen Intrathecal, APO-Baclofen, Clofen 25, Stelax 25, Lioresal 25 and 5 more: uses, side effects, interactions, and safety considerations for people taking it or caring for someone who is.
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.
How Baclofen is regulated
Baclofen is overseen by medicines regulators in each country. The rules below explain how it's scheduled, what oversight applies, and what to discuss with your doctor or pharmacist before starting, changing, or stopping this medication.
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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Important: This page is general health information, not personal medical advice. If you have questions about your medication — including starting it, stopping it, changing the dose, or combining it with something else — speak with your doctor or pharmacist. For an emergency or suspected overdose, call your local emergency number or poison information service immediately. Information is drawn from regulator and clinical guideline sources (TGA, FDA, MHRA, NICE, PBS, CDC); see our methodology for details.