Duloxetine (APO-Duloxetine)
Duloxetine risk profile, scheduling, and guidance for claims professionals and care workers . Also known as APO-Duloxetine, Duloxetine Sandoz 60, Tixol 60, DYTREX 60, Duloxetine Sandoz and 6 more.
Duloxetine (brand names: APO-Duloxetine, Duloxetine Sandoz 60, Tixol 60, DYTREX 60, Duloxetine Sandoz and 6 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. SNRI antidepressant with moderate sedation and potential interaction risks affecting work performance.
Key Takeaways
- TGA Schedule: S4 in Australia
- Risk level: Low (2 points)
- Serotonergic: Risk of serotonin syndrome when combined with other serotonergic drugs
- 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
SNRI antidepressant with moderate sedation and potential interaction risks affecting work performance.
Regulatory and Compliance Guidance
When Duloxetine 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.
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
NICE guidelines recommend certain antidepressants (amitriptyline, duloxetine) for chronic pain management. For personal injury claims, antidepressant prescribing should be assessed for injury relatedness.
United States FDA / CDC / State WC
FDA approved for use in the United States.
FDA Boxed Warning: WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1) ] . In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1) ] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants ( 5.1 ) Monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.1 )
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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.