Ketesse Dosage/Direction for Use

Adults: Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see Precautions).
Tablet: 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.
Ketesse tablets are not intended for long-term use and the treatment must be limited to the symptomatic period.
Solution for injection: 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.
KETESSE Solution for injection/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.
In case of moderate to severe postoperative pain, KETESSE Solution for injection /infusion can be used in combination with opioid analgesics, if indicated, at the same recommended doses in adults (see Pharmacology: Pharmacodynamics under Actions).
Elderly: Tablet: 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.
Solution for injection: No dosage adjustment is generally necessary in older 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 (see Precautions).
Hepatic impairment: KETESSE should not be used in patients with severe hepatic impairment (Child-Pugh score 10-15) (see Contraindications).
Tablet: Patients with mild to moderate hepatic impairment should start therapy at reduced doses (50 mg total daily dose) and be closely monitored. Ketesse tablets should not be used in patients with severe hepatic impairment.
Solution for injection: 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 (see Precautions).
Renal impairment: The initial dosage should be reduced to 50 mg total daily dose in patients with mildly impaired renal function (creatinine clearance 60-89 ml/min) (see Precautions). KETESSE should not be used in patients with moderate to severe renal impairment (creatinine clearance ≤59 ml/min) (see Contraindications).
Pediatric population: Ketesse has not been studied in children and adolescents. Therefore, the safety and efficacy in children and adolescents have not been established and the product should not be used in children and adolescents.
Method of administration: Tablet: The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water).
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 minutes before meals.
Solution for injection: KETESSE Solution for injection/infusion can be administered either by intramuscular or by intravenous route: Intramuscular use: the content of one ampoule (2 ml) of KETESSE Solution for injection/infusion should be administered by slow injection deep into the muscle.
Intravenous use: Intravenous infusion: the diluted solution, prepared as described in Special precautions for disposal and other handling under Cautions for Usage, 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 KETESSE Solution for injection/infusion can be administered in a slow intravenous bolus over no less than 15 seconds.