As near as I can tell, this garbage is still technically "on the market", no action has been taken by the FDA since approval. However, it appears to be no longer available from the manufacturer. It comes off patent in 2031 so you can bet your bottom dollars generics will hit the market, despite the fact that no one should actually use this.
Tramadol and celecoxib (commonly branded as Seglentis) are combined to treat acute, moderate-to-severe pain, offering improved relief over either drug alone by combining an NSAID (celecoxib) with an opioid (tramadol). This combination allows lower doses of each component, reducing overall opioid exposure, though it carries risks of addiction, misuse, severe cardiovascular events, and gastrointestinal bleeding. [
1,
2,
3,
4,
5]
Key Aspects of the Combination:
- Uses: Used for short-term management of acute pain that requires an opioid and for which alternative treatments are inadequate.
- Mechanism: The combo acts on the central nervous system (tramadol) to block pain signals while reducing inflammation (celecoxib).
- Dosage: Common dosing involves 112 mg of celecoxib/88 mg of tramadol (often as 100 mg tablets, 2 tablets per dose) every 12 hours as needed.
- Side Effects: Potential side effects include nausea, vomiting, dizziness, headache, somnolence, and constipation.
- Serious Risks: Increased risk of fatal heart attack, stroke, and stomach or intestinal bleeding.
- Warnings: Contraindicated shortly after heart bypass surgery (CABG) and in patients with known hypersensitivity to NSAIDs or opioids. [1, 2, 3, 4, 5, 6]
Common Combination Products & Approvals:
- Seglentis: An FDA-approved 56mg celecoxib/44mg tramadol immediate-release tablet.
- Co-crystal (CTC): Clinical trials suggest that a 1:1 molecular co-crystal (CTC) improves the pharmacokinetic profile of both drugs. [4, 5, 6, 7, 8]
Important Considerations:
- Addiction & Dependence: Although intended for short-term use, this combination is a Schedule IV controlled substance due to the tramadol component, which can lead to dependence.
- Drug Interactions: Over 1,000 interactions are known, including with other serotonergic medications which can cause serotonin syndrome.
- Older Adults: Increased risk of serious GI events, particularly in elderly or debilitated patients. [4, 5, 9, 10, 11]
Disclaimer: This information is for educational purposes only and does not constitute medical advice. Consult a healthcare provider for any questions regarding medications.
AI can make mistakes, so double-check responses
[1]
https://www.mayoclinic.org/drugs-su...-tramadol-oral-route/description/drg-20524738
[2]
https://www.drugs.com/mtm/celecoxib-and-tramadol.html
[3]
https://my.clevelandclinic.org/health/drugs/23625-celecoxib-tramadol-tablets
[4]
https://www.empr.com/home/news/celecoxib-tramadol-combo-tablet-approved-for-acute-pain/
[5]
https://pmc.ncbi.nlm.nih.gov/articles/PMC10084286/
[6]
https://www.tandfonline.com/doi/full/10.1080/03007995.2023.2276118
[7]
https://pubmed.ncbi.nlm.nih.gov/35686380/
[8]
https://pmc.ncbi.nlm.nih.gov/articles/PMC9826359/
[9]
https://reference.medscape.com/drug/seglentis-celecoxib-tramadol-4000087
[10]
https://www.drugs.com/drug-interactions/celebrex-with-tramadol-560-284-2221-0.html
[11]
https://www.drugs.com/drug-interactions/celecoxib-tramadol.html