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FDC KETOPROFEN+OMEPRAZOLE
This fixed-dose combination reduces pain and inflammation via ketoprofen (NSAID) while protecting the stomach lining via omeprazole (proton pump inhibitor).
This fixed-dose combination reduces pain and inflammation via ketoprofen (NSAID) while protecting the stomach lining via omeprazole (proton pump inhibitor). Used for Chronic pain conditions requiring NSAID therapy with gastric protection, Osteoarthritis or rheumatoid arthritis with high GI ulcer risk.
At a glance
| Generic name | FDC KETOPROFEN+OMEPRAZOLE |
|---|---|
| Sponsor | Sanofi |
| Drug class | NSAID + Proton pump inhibitor combination |
| Target | COX-1/COX-2 (ketoprofen); H+/K+-ATPase (omeprazole) |
| Modality | Small molecule |
| Therapeutic area | Pain management / Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
Ketoprofen inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing pain and inflammation. Omeprazole suppresses gastric acid secretion by inhibiting the H+/K+-ATPase pump, protecting against NSAID-induced gastrointestinal ulceration and damage. The combination allows NSAID efficacy while mitigating GI toxicity.
Approved indications
- Chronic pain conditions requiring NSAID therapy with gastric protection
- Osteoarthritis or rheumatoid arthritis with high GI ulcer risk
Common side effects
- Headache
- Dyspepsia
- Nausea
- Diarrhea
- Abdominal pain
Key clinical trials
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |