Ketoprofen solution 50mg/ml 2ml ampoules, 5pcs

Composition

>1 ml of the drug contains: Active ingredient: Ketoprofen 50 mgsupport Substances: Propylene glycol 400 mg Ethanol 95% 100 mg (in terms of anhydrous substance)Benzyl alcohol 20 mhatre hydroxide solution 10 M to pH 6.0 – 7.5 Water for injection to 1 ml.

Pharmacological action

Farmakodinamicakimi – steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic and antipyretic actions associated with the suppression of the activity of cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), which regulates the synthesis of prostaglandins (Pg). Pharmacokinetics-absorption: bioavailability-more than 90%. The time to reach the maximum concentration (TCmax) with parenteral use is 15-30 minutes. It doesn’t accumulate. – metabolism: almost completely metabolized in the liver by glucuronidation, has the effect of “first pass” through the liver. – distribution: binding to plasma proteins – 99%. The therapeutic concentration in synovial fluid is maintained for 6-8 hours. It does not penetrate the blood-brain barrier (BBB) in a significant amount. – excretion: mainly excreted by the kidneys.

Indications

Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gouty arthritis, osteoarthritis. It is intended for symptomatic therapy, reducing pain and inflammation at the time of use, and does not affect the progression of the disease. Pain syndrome: myalgia, ossalgia, neuralgia, tendinitis, arthralgia, bursitis, sciatica, adnexitis, otitis media, headache and toothache, cancer pain, post-traumatic and postoperative pain syndrome accompanied by inflammation. Algodismenorrhea.

Contraindications

Hypersensitivity (including to other NSAIDs);complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis, and nonperformance with acetylsalicylic acid or other NSAIDs (including in the anamnesis), gastric and duodenal ulcer (exacerbation), ulcerative colitis (exacerbation), diverticulitis, peptic ulcer, hemophilia and other blood clotting disorders, active use of the drug in patients with hypersensitivity (including to other NSAIDs). gastrointestinal bleeding; cerebrovascular or other active bleeding (including intracranial hemorrhage); severe renal failure (creatinine clearance less than 30 ml/min), progressive kidney disease, severe hepatic insufficiency or active liver disease, condition after coronary artery bypass grafting, confirmed hyperkalemia, inflammatory bowel diseases (Crohn’s disease (acute stage)); childhood (under 18 years), pregnancy (third trimester), breast-feeding period feeding sessions.

Side effects

the incidence of adverse reactions is given in accordance with the who classification: very common: >1/10, often from > 1/100 to <1/10, uncommon: from > 1/1000 to <1/100, rare: from >1/10000 to <1/1000, very rare: from <1/10000, including individual messages. From the digestive system: often-NSAIDs – gastropathy, abdominal pain, dyspepsia (nausea, vomiting, heartburn, flatulence, decreased appetite, diarrhea), infrequently – stomatitis, impaired liver function, rarely – ulceration of the gastrointestinal mucosa; very rarely-gingival, gastrointestinal, hemorrhoidal bleeding, increased activity of “liver” transaminases, taste changes. From the nervous system: often-headache, dizziness, asthenia, insomnia, agitation, nervousness, drowsiness, depression; rarely-confusion or loss of consciousness, forgetfulness, migraine, peripheral neuropathy. From the sensory organs: rarely-noise or ringing in the ears, blurred visual perception, conjunctivitis, dryness of the eye mucosa, pain in the eyes, conjunctival hyperemia, hearing loss, vertigo. From the cardiovascular system: infrequently-increased blood pressure; rarely-tachycardia. Hematopoietic disorders: rarely-agranulocytosis, anemia, hemolytic anemia, thrombocytopenia, leukopenia. From the urinary system: infrequently-edematous syndrome; rarely-cystitis, urethritis, renal dysfunction, interstitial nephritis, nephrotic syndrome; very rarely-hematuria. Allergic reactions: often-skin rash (including erythematous, urticaria), itchy skin; infrequently-rhinitis, bronchospasm, rarely-exfoliative dermatitis; very rarely-angioedema, anaphylactic shock. Other: infrequently-increased sweating, hemoptysis; rarely-nosebleeds, myalgia, muscle twitching, shortness of breath, thirst, photosensitization, with prolonged use in large doses – vaginal bleeding. If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Pharmacologically incompatible with tramadol solution. Reduces the effectiveness of uricosuric drugs, 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, and corticotropin may lead to ulceration and gastrointestinal bleeding, and may increase the risk of developing renal dysfunction. Concomitant use 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 necessary). Concomitant use with angiotensin-converting enzyme (ACE) inhibitors, angiotensin II antagonists, cyclosporine, tacrolimus increases the risk of hyperkalemia and renal impairment. Increases plasma concentrations of cardiac glycosides, verapamil and nifedipine, lithium (Li+), methotrexate, and cyclosporine. Concomitant use with probenecid significantly reduces the clearance of ketoprofen in blood plasma. Ketoprofen may reduce the effectiveness of mifepristone. Ketoprofen should be started no earlier than 8-12 days after mifepristone is discontinued. Inducers of microsomal oxidation in the liver (phenytoin, barbiturates, rafampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites. When used concomitantly with pentoxifylline, the anticoagulant effect increases and the risk of hemorrhagic complications increases. Myelotoxic drugs increase the manifestations of hematotoxicity of the drug. If you are taking other medications, you should consult your doctor.

How to take, course of use and dosage

Intravenously, intramuscularly. Intramuscularly (in/m) – 100 mg (1 ampoule) 1-2 times a day. Intravenous (IV) infusion should be administered only in a hospital setting. Short-term intravenous infusion: 100-200 mg (1-2 ampoules) is dissolved in 100 ml of 0.9% sodium chloride solution and administered within 0.5-1 hour; repeated use is possible after 8 hours. Prolonged intravenous infusion: 100-200 mg (1-2 ampoules) is dissolved in 500 ml of infusion solution (0.9% sodium chloride solution, Ringer’s solution,5% dextrose solution) and administered for 8 hours; repeated use is possible after 8 hours. Due to photosensitivity, the bottle or plastic bag containing 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-acting analgesics; it can be mixed with morphine in a single bottle. The drug should not be taken for more than 2-3 days, if necessary, use other dosage forms.

Overdose

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

Special instructions

During treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. Taking ketoprofen may mask the signs of an infectious disease. In case of impaired renal and hepatic function, dose reduction and careful monitoring are necessary. To reduce the risk of adverse events from the gastrointestinal tract, the minimum effective dose should be used in the shortest possible course. During treatment, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Storage conditions

At a temperature not exceeding 25°C. Keep out of reach of children.

Shelf life

2 years

Active ingredient

Ketoprofen

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection and infusion