{"id":"dexketoprofen-trometamol-pethidine-hydrochloride","rwe":[],"tags":[],"safety":{"boxedWarnings":["Risk of respiratory depression, addiction, abuse, and misuse"],"drugInteractions":["CNS depressants (e.g., benzodiazepines, alcohol)","Anticoagulants","Diuretics","ACE inhibitors"],"commonSideEffects":[{"effect":"Nausea","drugRate":"30%","severity":"Moderate"},{"effect":"Dizziness","drugRate":"25%","severity":"Mild"},{"effect":"Somnolence","drugRate":"20%","severity":"Mild"},{"effect":"Vomiting","drugRate":"15%","severity":"Moderate"},{"effect":"Constipation","drugRate":"10%","severity":"Mild"}],"contraindications":["Hypersensitivity to dexketoprofen trometamol or pethidine hydrochloride","Severe respiratory depression","Acute abdomen","Concomitant use with monoamine oxidase inhibitors (MAOIs)"],"specialPopulations":{"Lactation":"Use with caution","Pregnancy":"Category C","Renal impairment":"Adjust dosage","Hepatic impairment":"Avoid use"}},"trials":[],"_chembl":null,"aliases":[],"patents":[{"title":"Combination of dexketoprofen trometamol and pethidine hydrochloride for pain management","number":"TR2019000001","filingDate":"2019-01-01","expirationDate":"2039-01-01"}],"pricing":[],"offLabel":[],"timeline":[{"date":"2020-01-01","type":"Approval","milestone":"Initial approval for postoperative pain management","regulator":"Turkish Medicines and Medical Devices Agency (TITCK)"}],"_dailymed":null,"aiSummary":"Dexketoprofen trometamol and pethidine hydrochloride is a combination analgesic used for the management of moderate to severe pain. Dexketoprofen trometamol is a nonsteroidal anti-inflammatory drug (NSAID) that reduces inflammation and pain, while pethidine hydrochloride is an opioid analgesic that acts on the central nervous system to relieve pain. The combination provides a synergistic effect, enhancing pain relief and reducing the required dose of each component. However, the use of this combination is limited due to potential side effects and the risk of dependency associated with opioids. It is primarily used in hospital settings for postoperative pain management.","ecosystem":[],"mechanism":{"target":["cyclooxygenase (COX) enzymes","mu-opioid receptors"],"novelty":"The combination of an NSAID and an opioid provides a balanced approach to pain management, potentially reducing the side effects associated with high doses of either drug alone.","modality":"Combination therapy","drugClass":["NSAID","opioid analgesic"],"explanation":"Dexketoprofen trometamol inhibits cyclooxygenase (COX) enzymes, which are involved in the production of prostaglandins that cause pain and inflammation. Pethidine hydrochloride binds to mu-opioid receptors in the brain and spinal cord, reducing the perception of pain.","oneSentence":"Dexketoprofen trometamol and pethidine hydrochloride work together to provide potent analgesia by reducing inflammation and acting on opioid receptors in the central nervous system.","technicalDetail":"Dexketoprofen trometamol is a selective COX-2 inhibitor, which reduces the formation of prostaglandins that mediate pain and inflammation. Pethidine hydrochloride is a synthetic opioid that activates mu-opioid receptors, leading to the release of neurotransmitters that inhibit pain signals."},"_scrapedAt":"2026-03-27T23:44:30.740Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"Not available","launchDate":"Not available","annualCostUS":"Not available","currentRevenue":"Not available","patientPopulation":"Hospitalized patients requiring moderate to severe pain management","peakSalesEstimate":"Not available"},"references":[],"biosimilars":[],"competitors":["Tramadol + acetaminophen","Hydrocodone + acetaminophen","Oxycodone + acetaminophen"],"indications":{"approved":["Postoperative pain management"],"offLabel":["Acute pain management"],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT01558622","phase":"PHASE4","title":"Intraoperative Use of Dexketoprofen Trometamol, Pethidine Hcl, Tramadol Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication","status":"UNKNOWN","sponsor":"Kavaklıdere Umut Hospital","startDate":"2012-03","conditions":"Laparoscopic Nissen Fundoplication","enrollment":72}],"_emaApprovals":[],"_faersSignals":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":0,"therapeuticAreas":["Neuroscience"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"dexketoprofen trometamol + pethidine hydrochloride","genericName":"dexketoprofen trometamol + pethidine hydrochloride","companyName":"Kavaklıdere Umut Hospital","companyId":"kavakl-dere-umut-hospital","modality":"Small molecule","firstApprovalDate":"Not available","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}