Ketodexa
Release Forms:
The composition 1 tablet:
- active substance: dexketoprofen;
- 1 film-coated tablet contains 36.9 mg of dexketoprofen trometamol, which is equivalent to 25 mg dexketoprofen;
- excipients: microcrystalline cellulose; corn starch; sodium starch glycolate; glycerol distearate; coating: hypromellose, titanium dioxide (E 171), polyethylene glycol 6000.
Dosage form. Film-coated tablets.
Main physical and chemical properties: round tablets with a biconvex surface, with a risk on the one hand, covered with a film coating of white or almost white color.
10 tablets in a blister; 1 or 3 blisters in a cardboard box.
Indications for use.
Nonsteroidal anti-inflammatory and anti-rheumatic drugs. Symptomatic treatment of pain from mild to moderate, for example musculoskeletal pain, painful menstruation (dysmenorrhea), toothache.
Contraindications.
- Hypersensitivity to dexketoprofen, to any other non-steroidal anti-inflammatory drug, or to the excipients of the drug.
- Use in patients with a similar mechanism of action, such as acetylsalicylic acid and other NSAIDs, causes asthma attacks, bronchospasm, acute rhinitis, or polyps in the nose, urticaria, or angioneurotic edema.
- The active phase of peptic ulcer disease/bleeding in the digestive tract or suspicion of its presence, recurrent course of peptic ulcer disease/bleeding in the digestive tract in the anamnesis (at least 2 confirmed facts of ulcer or bleeding), as well as chronic dyspepsia.
- Bleeding or perforation in the digestive tract in the anamnesis is associated with the use of NSAIDs.
- Bleeding in the digestive tract, another bleeding in the active phase, or increased bleeding.
- Crohn’s disease or nonspecific ulcerative colitis.
- History of bronchial asthma.
- Severe heart failure.
- Moderate or severe renal impairment (creatinine clearance <50 ml / min).
- Severe hepatic impairment (10-15 points on the Child-Pew scale).
- Hemorrhagic diathesis or other blood clotting disorders.
- III trimester of pregnancy and breastfeeding.
Method of application.
Adults. Depending on the type and intensity of pain, the recommended dose is 12.5 mg (½ film-coated tablets) every 4-6 hours or 25 mg (1 film-coated tablet) every 8 hours. The daily dose should not exceed 75 mg. Adverse events of the drug can be minimized by applying the minimum effective doses for the shortest period of time necessary to eliminate the symptoms. KETODEX is not intended for long-term therapy; treatment lasts until the symptoms disappear. Concomitant food intake reduces the rate of absorption of the active substance, so it is recommended to take the drug at least 30 minutes before eating.
Elderly patients are advised to start treatment with low doses. The daily dose is 50 mg. If the drug is well-tolerated, the dose can be increased to normal.
At disturbances of the function of a liver of easy and moderate degree. Treatment should begin with the minimum recommended dose and under strict medical supervision. The daily dose is 50 mg.
In mild renal impairment. For patients with mild renal impairment (creatinine clearance 50-80 ml/min), the initial total daily dose should be reduced to 50 mg.
Children.
The use of the drug in children has not been studied, so patients in this age group are not recommended to prescribe dexketoprofen.