Last reviewed · How we verify
dexketoprofen trometamol + tramadol hydrochloride
dexketoprofen trometamol + tramadol hydrochloride is a NSAID + opioid analgesic combination Small molecule drug developed by Kavaklıdere Umut Hospital. It is currently FDA-approved for Moderate to moderately severe acute pain.
This combination product uses dexketoprofen (a nonsteroidal anti-inflammatory drug) to reduce inflammation and pain, and tramadol (an opioid analgesic) to provide additional pain relief through multiple mechanisms.
This combination product uses dexketoprofen (a nonsteroidal anti-inflammatory drug) to reduce inflammation and pain, and tramadol (an opioid analgesic) to provide additional pain relief through multiple mechanisms. Used for Moderate to moderately severe acute pain.
At a glance
| Generic name | dexketoprofen trometamol + tramadol hydrochloride |
|---|---|
| Sponsor | Kavaklıdere Umut Hospital |
| Drug class | NSAID + opioid analgesic combination |
| Target | COX-1/COX-2 (dexketoprofen); mu-opioid receptor, norepinephrine transporter, serotonin transporter (tramadol) |
| Modality | Small molecule |
| Therapeutic area | Pain Management |
| Phase | FDA-approved |
Mechanism of action
Dexketoprofen trometamol is the active S-enantiomer of ketoprofen that inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis and thereby decreasing inflammation, pain, and fever. Tramadol hydrochloride is a synthetic opioid that acts as a mu-receptor agonist and also inhibits the reuptake of norepinephrine and serotonin, providing multimodal analgesia. Together, they provide synergistic pain relief for moderate to moderately severe acute pain.
Approved indications
- Moderate to moderately severe acute pain
Common side effects
- Nausea
- Dizziness
- Constipation
- Gastrointestinal upset
- Headache
- Somnolence
Key clinical trials
- Study Evaluating Dexketoprofen Trometamol/Tramadol Hydrochloride Analgesic Efficacy in Acute Low Back Pain (PHASE4)
- Tramadol Hydrochloride and Dexketoprofen Trometamol for the Oral Treatment of Moderate to Severe Acute Pain Following Removal of Impacted Lower Third Molar (PHASE4)
- Oral Use of Dexketoprofen/Tramadol for Acute Postoperative Pain in Total Hip Replacement With a Direct Anterior Approach. (PHASE2)
- Oral Treatment for Gynaecological Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride (PHASE3)
- Oral Treatment for Orthopaedic Post-operative Pain With Dexketoprofen Trometamol and Tramadol Hydrochloride (PHASE3)
- Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain (PHASE2)
- Intraoperative Use of Dexketoprofen Trometamol, Pethidine Hcl, Tramadol Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication (PHASE4)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- dexketoprofen trometamol + tramadol hydrochloride CI brief — competitive landscape report
- dexketoprofen trometamol + tramadol hydrochloride updates RSS · CI watch RSS
- Kavaklıdere Umut Hospital portfolio CI
Frequently asked questions about dexketoprofen trometamol + tramadol hydrochloride
What is dexketoprofen trometamol + tramadol hydrochloride?
How does dexketoprofen trometamol + tramadol hydrochloride work?
What is dexketoprofen trometamol + tramadol hydrochloride used for?
Who makes dexketoprofen trometamol + tramadol hydrochloride?
What drug class is dexketoprofen trometamol + tramadol hydrochloride in?
What development phase is dexketoprofen trometamol + tramadol hydrochloride in?
What are the side effects of dexketoprofen trometamol + tramadol hydrochloride?
What does dexketoprofen trometamol + tramadol hydrochloride target?
Related
- Drug class: All NSAID + opioid analgesic combination drugs
- Target: All drugs targeting COX-1/COX-2 (dexketoprofen); mu-opioid receptor, norepinephrine transporter, serotonin transporter (tramadol)
- Manufacturer: Kavaklıdere Umut Hospital — full pipeline
- Therapeutic area: All drugs in Pain Management
- Indication: Drugs for Moderate to moderately severe acute pain
- Compare: dexketoprofen trometamol + tramadol hydrochloride vs similar drugs
- Pricing: dexketoprofen trometamol + tramadol hydrochloride cost, discount & access