Product InformationRegistration Status: Active
KETESSE GRANULES FOR ORAL SOLUTION 25mg/sachet is approved to be sold in Singapore with effective from 2015-10-29. It is marketed by A. MENARINI SINGAPORE PTE LTD, with the registration number of SIN14889P.
This product contains Dexketoprofen 25mg in the form of GRANULE, FOR SOLUTION. It is approved for ORAL use.
This product is manufactured by LABORATORIOS MENARINI S.A. in SPAIN.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Dexketoprofen is a non-steroidal anti-inflammatory drug. It is available in the various countries in Europe, Asia and Latin America. It has analgesic, antipyretic and anti-inflammatory properties [L1298].
For short-term treatment of mild to moderate pain, including dysmenorrhoea, musculoskeletal pain and toothache [L1302].
Mechanism of Action
It is a non-steroidal anti-inflammatory drug (NSAID) that reduces prostaglandin synthesis via inhibition of cyclooxygenase pathway (both COX-1 and COX-2) activity [L1299].
- After oral ingestion, the Dexketoprofen onset of action is within 30 minutes. The plasma half-life of Dexketoprofen is about 4-6 hours. The Cmax is about 30 minutes [L1204]
- <0.25 L/kg [L1299]
- Dexketoprofen is highly lipophilic, and is metabolized in the liver by glucuronidation [L1304]. In one study, after oral administration of 25 mg of dexketoprofen to young healthy adults, Tmax was approximately 30 min for a Cmax of 3.7 ± 0.72 mg/l [L1305]. Dexketoprofen trometamol is metabolized by the hepatic cytochrome P450 enzymes (CYP2C8 and CYP2C9) [L1305]. Dexketoprofen trometamol has a number of metabolites, with hydroxyl derivatives making up the greatest volume [L1305]. In humans, hydroxylation plays a minor role. Dexketoprofen is primarily conjugated to an acyl-glucuronide [L1305]
Mainly cleared via glucuronide conjugation and followed by renal excretion, mainly unchanged [L1299].
Nausea and/or vomiting, stomach pain, diarrhea, digestive problems (dyspepsia) are the most common symptoms of toxicity. More toxicity symptoms include dizziness, sleepiness, disturbed sleep, nervousness, headache, palpitations, flushing, stomach problems, constipation, dry mouth, flatulence, skin rash, tiredness, pain, feeling feverish and shivering, and malaise. Severe toxicity can lead to thrombocytopenia and anemia with bleeding episodes. Dexketoprofen is associated with a small increased risk of myocardial infarction [L1302].
Dexketoprofen | Dexketoprofen |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.