Ketodex tablets are indicated for the symptomatic treatment of mild to moderate pain, for example: musculoskeletal pain, painful menstruation (dysmenorrhea), toothache.
Composition
Active ingredient: dexketoprofen;
1 film-coated tablet contains 36.9 mg of dexketoprofen trometamol, equivalent to 25 mg of dexketoprofen;
Excipients: microcrystalline cellulose; corn starch; sodium starch glycolate; glycerol distearate; coating: hydroxypropylmethylcellulose, titanium dioxide (E 171), polyethylene glycol 6000.
Contraindication
hypersensitivity to dexketoprofen, any other NSAID (NSAID) or to the excipients of the drug; if substances with similar action, such as acetylsalicylic acid or other NSAIDs, provoke the development of asthma attacks, bronchospasm, acute rhinitis or cause the development of nasal polyps, urticaria or angioedema; if photoallergic and phototoxic reactions were known during treatment with ketoprofen or fibrates; gastrointestinal bleeding or perforation in history, associated with previous NSAID therapy; active phase of peptic ulcer disease / gastrointestinal bleeding or gastrointestinal bleeding, ulcer disease, perforation in history; chronic dyspepsia; other bleeding in the active phase or increased bleeding; Crohn's disease or ulcerative colitis; severe heart failure; moderate or severe renal impairment (creatinine clearance ≤ 59 ml/min); severe liver dysfunction (10-15 points on the Child-Pugh scale); with hemorrhagic diathesis and other blood clotting disorders; with severe dehydration caused by vomiting, diarrhea or insufficient fluid intake; 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 tablet) every 4-6 hours or 25 mg (1 film-coated tablet) every 8 hours. The daily dose should not exceed 75 mg. Undesirable effects of the drug can be minimized by using the minimum effective dose for the shortest period of time necessary to eliminate symptoms. KETODEXA is not intended for long-term therapy; treatment continues until symptoms disappear. Simultaneous food intake reduces the rate of absorption of the active substance, so the drug is recommended to be taken at least 30 minutes before meals.
Elderly patients are recommended to start treatment with low doses. The daily dose is 50 mg. If the drug is well tolerated, the dose can be increased to the usual dose.
In case of mild to moderate liver dysfunction. Treatment should be started 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.
Application features
Pregnant women
Contraindicated in the third trimester of pregnancy.
Children
Should not be used.
Drivers
With caution.
Overdose
Symptoms of overdose are unknown. Similar drugs cause disorders of the digestive tract (vomiting, anorexia, abdominal pain) and the nervous system (drowsiness, dizziness, disorientation, headache).
In case of accidental overdose, symptomatic treatment should be initiated immediately according to the patient's condition. Dexketoprofen trometamol is removed from the body by dialysis.
Side effects
From the blood system: neutropenia, thrombocytopenia. From the immune system: laryngeal edema; anaphylactic reactions, including anaphylactic shock. From the metabolism: lack of appetite. From the psyche: insomnia, anxiety. From the nervous system: headache, dizziness, drowsiness, paresthesia, syncope. From the organs of vision: blurred vision. From the organs of hearing: vertigo, tinnitus. From the cardiovascular system: increased heartbeat, tachycardia, hot flashes, arterial hypertension / hypotension. From the respiratory system: bradypnea, bronchospasm, dyspnea. Gastrointestinal tract: nausea, vomiting, abdominal pain, diarrhea, dyspepsia, gastritis, constipation, dry mouth, flatulence, peptic ulcer, ulcer bleeding or perforation, pancreatitis. Hepatobiliary system: hepatitis, hepatocellular damage. Skin: rash, urticaria, acne, increased sweating, Stevens-Johnson syndrome, Lyell syndrome, itching, angioedema of the face, photosensitization. Musculoskeletal system: back pain. Urinary system: acute renal failure, polyuria, nephritis or nephrotic syndrome. Reproductive system: menstrual disorders, prostate dysfunction. General disorders: fatigue, pain, asthenia, muscle stiffness, malaise, peripheral edema.
Interaction
Anticoagulants NSAIDs enhance the effect of anticoagulants, such as warfarin, due to the high degree of binding of dexketoprofen to blood plasma proteins, as well as inhibition of platelet function and damage to the gastric and duodenal mucosa. If simultaneous use is necessary, it should be carried out under the supervision of a physician and monitoring of relevant laboratory parameters.
Heparin increases the risk of bleeding (due to inhibition of platelet function and damage to the gastric and duodenal mucosa). If concomitant use is necessary, it should be carried out under the supervision of a physician with monitoring of relevant laboratory parameters.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Shelf life - 2 years.
