Ketesse Dosage/Direction for Use

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. 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, thus in case of acute pain it is recommended that administration is at least 30 minutes 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. 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. KETESSE tablets should not be used in patients with moderate to severe renal dysfunction.
Children: KETESSE tablets has not been studied in children. Therefore, safety and efficacy have not been established and the product should not be used in children.
Mode of Administration: Oral
Granules for oral soln: Posology: Adults: According to the nature and severity of pain, the recommended dosage is 25 mg every 8 hours. The total daily dose should not exceed 75 mg.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see Precautions).
KETESSE is only intended for short term use and the treatment must be limited to the symptomatic period.
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 adult only after good general tolerance has been ascertained. Due to the possible adverse effect profile (see Precautions), elderly individuals should receive particularly close monitoring.
Hepatic dysfunction: Patients with mild to moderate hepatic dysfunction should start therapy at reduced doses (50 mg total daily dose) and be closely monitored. KETESSE 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 (creatinine clearance 60–89 ml/min) (see Precautions). KETESSE should not be used in patients with moderate to severe renal dysfunction (creatinine clearance ≤59 ml/min) (see Contraindications).
Paediatric population: KETESSE granules 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.
Method of administration: Dissolve the whole contents of each sachet in a glass of water; shake/ stir well to help to dissolve.
The obtained solution should be immediately ingested after reconstitution.
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 15 minutes before meals.
Soln for inj: Posology: 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.
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 minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see Precautions).
In case of moderate to severe postoperative pain, 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 (see Pharmacology: Pharmacodynamics under Actions).
Pediatric population: KETESSE has not been studied in children and adolescent. Therefore the safety and efficacy in children and adolescents have not been established and the product should not be used in children and adolescent.
Older people: 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 dysfunction: 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). 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) (see Contraindications).
Renal dysfunction: The 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 Solution for injection or concentrate for solution for infusion should not be used in patients with moderate to severe renal dysfunction (creatinine clearance ≤59 ml/min) (see Contraindications).
Method of administration: 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 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, prepared as described in Instructions for use and 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 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 KETESSE is administered intramuscularly or as intravenous bolus, the solution should be injected immediately after its removal from the coloured ampoule (see Instructions for use and handling and Incompatibilities under Cautions for Usage).
For administration as intravenous infusion, the solution should be diluted aseptically and protected from natural daylight (see Instructions for use and handling under Cautions for Usage and Shelf-Life under Storage). For instructions on dilution of the medicinal product before administration, see Instructions for use and handling under Cautions for Usage.