Ketesse Dosage/Direction for Use

Ketesse FC tab: General Population: According to the nature and severity of pain, the recommended dosage is generally 12.5 mg every 4-6 hours or 25 mg every 8 hours. The total daily dose should not exceed 75 mg. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Dexketoprofen (KETESSE) tablets are not intended for long-term use and the treatment must be limited to the symptomatic period.
Concomitant administration with food delays the absorption rate of the drug (see Pharmacology: Pharmacokinetics under Actions), thus in case of acute pain, it is recommended that administration is at least 30 min before meals.
Elderly: In elderly patients it is recommended to start the therapy at the lower end of the dosage range (50 mg total daily dose). The dosage may be increased to that recommended for the general population only after good general tolerance has been ascertained.
Hepatic Dysfunction: Patients with mild to moderate hepatic dysfunction should start therapy at reduced doses (50 mg total daily dose) and be closely monitored. Dexketoprofen (KETESSE) tablets should not be used in patients with severe hepatic dysfunction.
Renal Dysfunction: The initial dosage should be reduced to 50 mg total daily dose in patients with mildly impaired renal function. Dexketoprofen (KETESSE) tablets should not be used in patients with moderate to severe renal dysfunction (see Contraindications).
Children and adolescents: Dexketoprofen (KETESSE) tablets has not been studied in children and adolescent. Therefore, safety and efficacy have not been established and the product should not be used in children and adolescent.
Ketesse Solution for Injection or Concentrate for Solution for Infusion (I.V./I.M.): Adults: The recommended dose is 50 mg every 8-12 hours. If necessary, the administration can be repeated 6 hours apart. The total daily dose should not exceed 150 mg.
Dexketoprofen (KETESSE) Solution for Injection or concentrate for solution for infusion is intended for short term use and the treatment must be limited to the acute symptomatic period (no more than two days). Patients should be switched to an oral analgesic treatment when possible.
Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
In case of moderate to severe postoperative pain, Dexketoprofen (KETESSE) Solution for Injection or concentrate for solution for infusion can be used in combination with opioid analgesics, if indicated, at the same recommended doses in adults.
Elderly: No dosage adjustment is generally necessary in elderly patients. However because of the physiological decline in renal function in elderly patients a lower dose is recommended in case of mild renal function impairment: 50 mg total daily dose.
Liver Disease: The dosage should be reduced to 50 mg total daily dose in patients with mild to moderate (Child-Pugh score 5 - 9) hepatic impairment and hepatic function should be closely monitored. Dexketoprofen (KETESSE) Solution for Injection or concentrate for solution for infusion should not be used in patients with severe hepatic dysfunction (Child-Pugh score 10 - 15).
Renal dysfunction: The dosage should be reduced to 50 mg total daily dose in patients with mildly impaired renal function (creatinine clearance 50 - 80 mL/min). Dexketoprofen (KETESSE) Solution for Injection or concentrate for solution for infusion should not be used in patients with moderate to severe renal dysfunction (creatinine clearance <50 mL/min).
Dexketoprofen (KETESSE) Solution for Injection or concentrate for solution for infusion should not be used in patients with moderate to severe renal dysfunction (creatinine clearance <50 mL/min).
Children and adolescents: Dexketoprofen (KETESSE) Solution for Injection or concentrate for solution for infusion has not been studied in children and adolescents. Therefore, safety and efficacy have not been established and the product should not be used in children and adolescents.
Administration: Ketesse Solution for Injection or Concentrate for Solution for Infusion (I.V./I.M.): Dexketoprofen (KETESSE) Solution for Injection or concentrate for solution for infusion can be administered either by intramuscular or by intravenous route: Intramuscular use: The content of one ampoule (2 mL) of Dexketoprofen (KETESSE) Solution for Injection or concentrate for solution for infusion should be administered by slow Injection deep into the muscle.
Intravenous use: Intravenous infusion: the diluted solution, should be administered as a slow intravenous infusion, lasting 10 to 30 min. The solution must be always protected from natural daylight.
Intravenous bolus: if necessary, the content of one ampoule (2 mL) of Dexketoprofen (KETESSE) Solution for Injection or concentrate for solution for infusion can be administered in a slow intravenous bolus over no less than 15 seconds.
Instructions on handling the product: When Dexketoprofen (KETESSE) is administered intramuscularly or as intravenous bolus, the solution should be injected immediately after its removal from the coloured ampoule. For administration as intravenous infusion, the solution should be diluted aseptically and protected from natural daylight.