Symptomatic treatment of chronic inflammation, especially against rheumatic diseases, including rheumatoid arthritis. Symptomatic treatment of severe degenerative joint changes.
Composition:
1 capsule about release contains 100 mg or 200 mg of Ketoprofen (and 12.64 mg or 25.28 sucrose respectively).
Action:
A non-steroidal anti-inflammatory drug (a propionic acid derivative) with anti-inflammatory, antipyretic and analgesic effects. It inhibits platelet aggregation, synthesis of prostaglandins and leukotrienes, exerts a stabilizing effect on the membranes surrounding the lysosomes and inhibits the migration of leukocytes to the synovium of the joints, preventing the formation of inflammatory infiltrates in the joints. Ketoprofen is well absorbed from the gastrointestinal tract (bioavailability around 90%). Food does not affect the bioavailability of the drug, however, it slows down the rate of its absorption. It is approximately 90% bound to plasma proteins. The maximum concentration in the blood occurs after 6-7 h after administration. It is metabolized in the liver, mainly by conjugation with glucuronic acid. It is mainly excreted in the urine.
Contraindications:
Hypersensitivity to ketoprofen or other components of the preparation. Hypersensitivity to other NSAIDs, including Acetylsalicylic acid (due to the risk of aspirin-induced asthma or other allergic hypersensitivity reactions). Active or in history of gastric and / or duodenal ulcers or bleeding or perforation, also occurring after the use of other NSAIDs. Bronchial asthma or other diseases with a history of allergies. Severe heart failure. Severe hepatic failure. Severe renal failure. Active bleeding, e.g. from the gastrointestinal tract or brain vessels. Third trimester of pregnancy. Breastfeeding period.
Precautions:
Do not use in children <15 years. The concomitant use of ketoprofen with other NSAIDs should be avoided, including selective COX-2 inhibitors. In patients with bronchial asthma, chronic rhinitis, chronic sinusitis, nasal polyposis, there is an increased risk of NSAID allergy. Use with caution in patients who are at increased risk of gastrointestinal bleeding, ulceration and perforation (patients with peptic ulcer disease, ulcerative colitis, Crohn's disease, patients with platelet disorders, patients taking anticoagulants or anti-aggregation, general-action corticosteroids, selective serotonin reuptake inhibitors, elderly people, low-weight individuals) - the lowest possible therapeutic dose of ketoprofen should be used in these patients, and combination therapy with curing agents should be considered. In case of ulcerations or gastrointestinal bleeding, the drug should be discontinued. Ketoprofen may mask the symptoms of developing infection. Carefully observe patients with photosensitivity or phototoxicity. In elderly patients and with heart failure or impaired liver function, chronic renal impairment or disturbances in water management (eg dehydrated, postoperative hypovolaemia) - detailed monitoring of cardiac function, diuresis and renal function indicators is recommended. In patients with impaired liver function, transaminase levels should be periodically determined. Due to the increased risk of arterial blockages (eg myocardial infarction, stroke), caution should be used in patients with: uncontrolled hypertension, congestive heart failure, ischemic heart disease, peripheral artery disease, cerebrovascular disease and patients with risk factors for systemic diseases circulation (hypertension, hyperlipidemia, diabetes, smoking). Particularly cautiously used in patients with systemic lupus erythematosus and mixed connective tissue disease.In the event of visual disturbances, skin rash, mucosal lesions or any signs of hypersensitivity, the drug should be immediately discontinued. The product contains sucrose and should not be used in patients with hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.
Pregnancy and lactation:
The drug can be used in the first and second trimester of pregnancy only in case of extreme necessity. The use of the drug is contraindicated in the third trimester of pregnancy. The drug should not be used in women who are breastfeeding. Use of ketoprofen may adversely affect female fertility and is not recommended in women who are planning to become pregnant. For women who have difficulty conceiving or who are being tested for infertility, the end of ketoprofen should be considered.
Side effects:
Rarely: colitis, seizures, interstitial nephritis, nephrotic syndrome, leukopenia with possible agranulocytosis, bone marrow suppression, hepatitis. Very rare: anaphylactic reactions (including anaphylactic shock), angioneurotic edema, bullous reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis). Frequency unknown: nausea, vomiting, diarrhea, bloating, constipation, abdominal pain, gastritis, oral mucositis (including ulcers), gastritis, tarry stools, bloody vomiting, increased colitis and disease Crohn's disease; serious side effects: peptic ulcer of the stomach and / or duodenum, gastrointestinal bleeding and intestinal perforation, sometimes ending in death, especially in elderly patients; dyspnoea, asthma attack, bronchospasm (especially in patients with known hypersensitivity to other NSAIDs), headache, dizziness, drowsiness, mood disorders, hypersensitivity to light, alopecia, rash, redness, pruritus, urticaria, exacerbation of chronic urticaria, acute renal failure (especially in people with pre-existing renal impairment and / or in dehydrated patients), thrombocytopenia, anemia caused by chronic bleeding, increased transaminases, tinnitus, blurred vision (eg blurred vision), vasodilatation, hypertension, hyperkalemia. When using ketoprofen 200 mg daily, the likelihood of gastrointestinal bleeding increases (increasing with increasing dose). Nause, hypertension and heart failure have been reported in relation to NSAID treatment. Clinical and epidemiological studies suggest that the intake of certain NSAIDs (especially long-term at high doses) affects a small increase in the risk of arterial blockages (e.g., myocardial infarction or stroke).
Dosage:
Orally. Adults and adolescents> 15 years: 1 capsule 100 mg once or twice a day or 1 capsule 200 mg once a day. The maximum daily dose is 200 mg - a risk-benefit ratio should be carefully considered before starting treatment with a 200-mg dose, and a higher dose is not recommended.Special groups of patients. Elderly patients have increased levels of ketoprofen in the blood, therefore treatment should be started at a low dose and the lowest effective dose should be used as maintenance therapy. It must not be used in patients with severe renal and / or hepatic failure and in children <15 years.Way of giving. The drug should be taken during a meal. Capsules should be taken with a glass of water and always taken at the same time. In case of symptoms of irritation of the gastrointestinal tract (heartburn, abdominal pain, indigestion), antacids may be used.