Index of drugs

Symptomatic treatment of moderate to severe acute pain when oral administration is not adequate, e.g. postoperative pain, renal colic pain and low back pain.

1 ml of solution for injection contains 25 mg of dexketoprofen in the form of the dexketoprofen salt with trometamol. The product contains ethanol.

A non-steroidal anti-inflammatory drug from the group of propionic acid derivatives with analgesic, anti-inflammatory and antipyretic effects. The mechanism of action consists in inhibiting the activity of cyclooxygenase. After intramuscular administration, the maximum concentration occurs after 20 minutes. About 99% is bound to plasma proteins. It is metabolized by glucuronidation, metabolites are excreted in the urine. Only the S (+) enantiomer is found in the urine. T_0,5 in the elimination phase it is 1-2.7 h.

Hypersensitivity to dexketoprofen or other NSAIDs or other components of the preparation. Patients with substances with a similar mechanism of action (eg Acetylsalicylic acid or other NSAIDs) cause an asthma attack, bronchospasm, acute rhinitis or cause nasal polyps, urticaria or angioneurotic edema. Active peptic ulcer or bleeding or their suspicion, an interview for recurrent gastric ulcer or bleeding (two or more distinct episodes of confirmed ulceration or bleeding); chronic indigestion. Gastrointestinal bleeding or history of perforation associated with previous NSAID treatment. Bleeding from the gastrointestinal tract, other active bleeding or other disorders involving bleeding. Leśniowski-Crohn's disease or ulcerative colitis. Bronchial asthma in the interview. Severe heart failure. Moderate or severe renal insufficiency (creatinine clearance <50 ml / min). Severe hepatic impairment (Child-Pugh score 10-15). Hemorrhagic diathesis and other coagulation disorders. III trimester of pregnancy and breastfeeding. Central (intrathecal or epidural) administration of the preparation is contraindicated due to the ethanol content.

Particularly cautiously used in hypertensive patients, congestive heart failure, ischemic heart disease, peripheral artery disease and / or cerebrovascular disease, fluid retention, edema and long-term treatment of patients with risk factors for cardiovascular disease (including hyperlipidemia , diabetes, smoking). Use with caution in patients with a history of allergy. In the case of gastrointestinal bleeding, ulceration and hypersensitivity symptoms, the preparation should be discontinued. In patients with a history of peptic ulcer and / or duodenal ulceration, particularly in combination with bleeding or perforation and in the elderly, the risk of gastrointestinal bleeding, ulceration or perforation is increased when taking high doses of NSAIDs. Elderly people are more likely to experience side effects, particularly gastrointestinal bleeding and perforation that can result in death. As with all NSAIDs, you should have a history of oesophagitis, gastritis and / or stomach ulcer before starting treatment with dexetoprofen trometamol to ensure that they have been completely cured. Patients with a history of gastrointestinal or gastrointestinal disturbances should be monitored for gastrointestinal disorders, particularly gastrointestinal bleeding. In patients with gastrointestinal disease and in patients requiring low-dose acetylsalicylic acid or other drugs that increase the likelihood of gastrointestinal disturbances, the use of a misoprostol or a proton pump inhibitor should be considered. Use cautiously in patients with hematopoiesis, systemic lupus erythematosus, mixed connective tissue disease, liver or kidney disorders.Use with caution in patients taking diuretic, hypovolaemic, elderly and those using medicines that may increase the risk of ulceration or bleeding (oral contraceptives, SSRIs, anticoagulants and antiaggregations). The safety of the preparation in children and adolescents has not been established - it should not be used in this age group.

The preparation is contraindicated in the third trimester of pregnancy and breastfeeding. During the I and II trimester of pregnancy, the preparation should be administered only if definitely necessary. If trametamol dexetoprofen is used in women planning pregnancy or during the first or second trimester of pregnancy, the lowest possible dose should be used for the shortest possible period. The use of the preparation may impair female fertility - it is not recommended for women who plan to become pregnant; in the case of women who have problems getting pregnant or undergoing tests for infertility, discontinuation of dexketoprofen should be considered.

Common: nausea, vomiting, injection site reactions (pain, inflammation, hematoma, haemorrhage). Uncommon: anemia, insomnia, headache and dizziness, drowsiness, blurred vision, hypotension, redness of the face, abdominal pain, indigestion, diarrhea, constipation, vomiting with blood, dry mouth, dermatitis, pruritus, rash, increased sweating , fever, tiredness, pain, feeling cold. Rare: throat edema, hyperglycemia or hypoglycaemia, hypertriglyceridemia, anorexia, paraesthesia, syncope, tinnitus, additional spasms, tachycardia, hypertension, superficial thrombophlebitis, respiratory frequency release, peptic ulcer disease, perforation or bleeding, hepatitis, jaundice, urticaria, acne, stiffness of muscles or joints, muscle cramps, back pain, severe kidney problems, polyuria, kidney pain, ketonuria, proteinuria, menstrual disorders, benign prostatic hyperplasia, stiffness, peripheral edema, abnormal liver function indexes. Very rare: neutropenia, thrombocytopenia, anaphylactic reactions (including anaphylactic shock), bronchospasm, dyspnoea, pancreatitis, hepatocyte damage, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioneurotic edema, facial edema, photosensitivity reactions, nephritis , nephrotic syndrome. In addition, abdominal pain, tarry stools, bloody vomiting, ulcerative oral mucositis, exacerbation of colitis and Crohn's disease, edema, heart failure, and idle meningitis (especially in patients with systemic or mixed-lupus erythematosus) have been observed. connective tissue disease), severity of connective tissue infections, haematological reactions (purpura, aplastic and hemolytic anemia, rarely agranulocytosis and bone marrow hypoplasia), increase in urea nitrogen and creatinine in the blood, renal papillary necrosis and acute renal failure, and in elderly patients peptic ulcer disease, perforation, gastric bleeding and / or duodenal ulceration. The intake of certain NSAIDs, especially long-term at high doses, is associated with a small increase in the risk of arterial embolism (e.g., myocardial infarction or stroke).

Adults: 50 mg every 8-12 h intramuscularly (by slow injection) or intravenously (infusion lasting 10-30 minutes or a bolus lasting not less than 15 s), the dose can be repeated every 6 hours. The maximum daily dose is 150 mg. The preparation should be used for a short time and the treatment should be limited to the period of acute symptoms (no longer than 2 days). Patients should be treated with oral analgesics whenever possible. In the case of moderate to severe post-operative pain, the preparation can be used concomitantly with opioid analgesics, if there are indications, at the same recommended doses in adults. In elderly patients with mild renal impairment, in patients with mild to moderate hepatic impairment (Child-Pugh score of 5-9) and in patients with mild renal impairment (creatinine clearance 50-80 ml / min) the dose should be reduced up to 50 mg daily.