Source: Health Products Regulatory Authority (ZA) Revision Year: 2021 Publisher: LeBasi Pharmaceuticals (Pty) Ltd, San Domenico Building, Unit 6, Ground Floor, 10 Church Street, Durbanville, 7551
Symptomatic short term treatment of pain of mild to moderate intensity, such as musculoskeletal pain, dysmenorrhoea, dental pain.
According to the nature and severity of pain, the recommended dosage is 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 minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4). Ketesse tablets are not intended for long term use and the treatment must be limited to the symptomatic period.
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.
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 (see section 4.3).
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 section 4.4). Ketesse tablets should not be used in patients with moderate to severe renal dysfunction (creatinine clearance ≤59 mL/min) (see section 4.3).
Ketesse has not been studied in children and adolescents. Therefore the safety and efficacy in children and adolescents have not been established and Ketesse should not be used in children and adolescents.
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 medicine (see Pharmacokinetic Properties), thus in case of acute pain it is recommended that administration is at least 30 minutes before meals.
The symptomatology following overdose is not known. Similar medicines have produced gastrointestinal (vomiting, anorexia, abdominal pain) and neurological (somnolence, vertigo, disorientation, headache) disorders.
In case of accidental or excessive intake, immediately institute symptomatic therapy according to the patient’s clinical condition. Activated charcoal should be administered if more than 5 mg/kg has been ingested by an adult or a child within an hour.
Dexketoprofen trometamol may be removed by dialysis.
2 years.
Store at or below 25°C.
Keep the blister strips in the outer carton until required for use.
Do not remove the tablets from the blister strips until required for use.
Opaque white or transparent PVC/aluminium or aluminium/aluminium blister strips in an outer carton.
Pack sizes: 4, 10, 20, 30, 50 or 500 film coated tablets.
Not all pack sizes may be marketed.
Any unused medicine or waste material should be disposed of in accordance with local requirements.
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