Ketoprofen solution for injection 50mg / ml, 2ml No. 10

• Articular syndrome (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout); symptomatic treatment of inflammatory and degenerative diseases of the musculoskeletal system (periarthritis, arthrosynovitis, tendinitis, tendosynovitis, bursitis, lumbago), back pain, neuralgia, myalgia.

• Uncomplicated injuries, in particular sports, dislocations, sprains or ruptures of ligaments and tendons, bruises, post-traumatic pain.

• As part of the combined therapy of inflammatory diseases of the veins, lymphatic vessels, lymph nodes (phlebitis, periphlebitis, lymphangitis, superficial lymphadenitis).

Intravenous, intramuscular.

Intramuscularly (intramuscularly) - 100 mg (1 ampoule) 1-2 times a day.

Intravenous (intravenous) infusion should be administered only in a hospital setting. Short-term intravenous infusion: 100-200 mg (1-2 ampoules) are dissolved in 100 ml of 0.9% sodium chloride solution and administered over 0.5-1 hours; re-introduction is possible after 8 hours.

Prolonged intravenous infusion: 100-200 mg (1-2 ampoules) are dissolved in 500 ml of an infusion solution (0.9% sodium chloride solution, Ringer's solution, 5% dextrose solution) and administered over 8 hours; re-introduction is possible after 8 hours. Due to photosensitivity, the vial or plastic bag with ketoprofen infusion solution should be wrapped in dark paper or aluminum foil. The maximum daily dose is 200 mg. Ketoprofen can be used in combination with central analgesics; it can be mixed with morphine in one bottle. The drug should not be taken for more than 2-3 days, if necessary, use other dosage forms.

Active substance: ketoprofen

• Hypersensitivity (including to other NSAIDs),

• complete or incomplete combination of bronchial asthma,

• recurrent polynosis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including a history),

• peptic ulcer and 12 duodenal ulcer (exacerbation),

• ulcerative colitis (exacerbation),

• diverticulitis

• peptic ulcer,

• hemophilia and other blood clotting disorders,

• active gastrointestinal bleeding;

• severe renal failure (CC less than 30 ml / min),

• progressive kidney disease

• severe liver failure or active liver disease,

• condition after coronary artery bypass grafting,

• confirmed hyperkalemia,

• inflammatory bowel disease

• children's age (up to 18 years old),

• pregnancy (III trimester),

• lactation period.

pharmachologic effect

Pharmacodynamics

Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) that has anti-inflammatory, analgesic and antipyretic effects associated with the suppression of the activity of cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), which regulate the synthesis of prostaglandins (Pg).

Pharmacokinetics

Bioavailability is more than 90%. Communication with plasma proteins - 99%. The time to reach the maximum concentration (TCmax) for parenteral administration is 15-30 minutes. The therapeutic concentration in the synovial fluid is maintained for 6-8 hours. In a significant amount, it does not penetrate the blood-brain barrier (BBB). It is almost completely metabolized in the liver by glucuronidation, has a 'first pass' effect through the liver. It is excreted mainly by the kidneys. Does not cumulate.

Application during pregnancy and lactation

The use of ketoprofen in the I and II trimesters of pregnancy is possible only when the potential benefit to the mother outweighs the risk to the fetus. The use of the drug in the third trimester of pregnancy is contraindicated. If it is necessary to use ketoprofen during lactation, the question of stopping breastfeeding should be resolved.

Side effects

From the digestive system: NSAIDs-gastropathy, abdominal pain, dyspepsia (nausea, vomiting, heartburn, flatulence, loss of appetite, diarrhea), stomatitis, abnormal liver function; ulceration of the mucous membrane of the gastrointestinal tract, gingival, gastrointestinal, hemorrhoidal bleeding; change in taste. From the nervous system: headache, dizziness, insomnia, agitation, nervousness, drowsiness, depression, asthenia, confusion or loss of consciousness, forgetfulness, migraine, peripheral neuropathy. From the senses: noise or ringing in the ears, blurred vision, conjunctivitis, dryness of the mucous membrane of the eye, pain in the eyes, conjunctival hyperemia, hearing loss, vertigo. From the side of the cardiovascular system: increased blood pressure, tachycardia. From the side of hematopoietic organs: agranulocytosis,anemia, hemolytic anemia, thrombocytopenia, leukopenia. From the urinary system: edema syndrome, cystitis, urethritis, impaired renal function, interstitial nephritis, nephrotic syndrome, hematuria. Allergic reactions: skin rash (including erythematous, urticaria), itching of the skin, rhinitis, angioedema, bronchospasm, exfoliative dermatitis, anaphylactic shock. Others: increased sweating, hemoptysis, nosebleeds, myalgia, muscle twitching, shortness of breath, thirst, photosensitivity, with prolonged use in large doses - vaginal bleeding. If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor.edema syndrome, cystitis, urethritis, impaired renal function, interstitial nephritis, nephrotic syndrome, hematuria. Allergic reactions: skin rash (including erythematous, urticaria), itching of the skin, rhinitis, angioedema, bronchospasm, exfoliative dermatitis, anaphylactic shock. Others: increased sweating, hemoptysis, nosebleeds, myalgia, muscle twitching, shortness of breath, thirst, photosensitivity, with prolonged use in large doses - vaginal bleeding. If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor.edema syndrome, cystitis, urethritis, impaired renal function, interstitial nephritis, nephrotic syndrome, hematuria. Allergic reactions: skin rash (including erythematous, urticaria), itching of the skin, rhinitis, angioedema, bronchospasm, exfoliative dermatitis, anaphylactic shock. Others: increased sweating, hemoptysis, nosebleeds, myalgia, muscle twitching, shortness of breath, thirst, photosensitivity, with prolonged use in large doses - vaginal bleeding. If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor.rhinitis, angioedema, bronchospasm, exfoliative dermatitis, anaphylactic shock. Others: increased sweating, hemoptysis, nosebleeds, myalgia, muscle twitching, shortness of breath, thirst, photosensitivity, with prolonged use in large doses - vaginal bleeding. If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor.rhinitis, angioedema, bronchospasm, exfoliative dermatitis, anaphylactic shock. Others: increased sweating, hemoptysis, nosebleeds, myalgia, muscle twitching, shortness of breath, thirst, photosensitivity, with prolonged use in large doses - vaginal bleeding. If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor.or if you notice any other side effects not listed in the instructions, tell your doctor.or if you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Pharmaceutically incompatible with tramadol solution. Reduces the effectiveness of uricosuric drugs (MP), enhances the effect of anticoagulants, antiplatelet agents, fibrinolytics, ethanol, side effects of glucocorticosteroids and mineralocorticosteroids, estrogens; reduces the effectiveness of antihypertensive drugs and diuretics. Concomitant use with other NSAIDs, glucocorticosteroids, ethanol, corticotropin can lead to the formation of ulcers and the development of gastrointestinal bleeding, to an increase in the risk of developing renal dysfunction. Concomitant administration with oral anticoagulants, heparin, thrombolytics, antiplatelet agents, cefoperazone, cefamandol and cefotetan increases the risk of bleeding. Increases the hypoglycemic effect of insulin and oral hypoglycemic drugs (dose recalculation is required).Increases plasma concentration of verapamil and nifedipine, lithium preparations (Li +), methotrexate. Myelotoxic drugs increase the manifestations of the drug's hematotoxicity. If you are taking other medications, you should consult your doctor.

Overdose

Symptoms: nausea, vomiting, abdominal pain, vomiting of blood, melena, impaired consciousness, respiratory depression, convulsions, impaired renal function, renal failure. In case of an overdose, symptomatic therapy, monitoring of respiratory and cardiovascular activity should be carried out, the use of H2-histamine receptor blockers and Pg inhibitors is indicated. There is no specific antidote. Hemodialysis is ineffective.