KETRUM 100 [Ketoprofen] 100 mg Tablets
KETRUM
instructions for medical use of the medicinal product
Tradename
Ketrum, Ketrum
International non-proprietary name
Ketoprofen, Ketoprofen
Composition
Each film-coated tablet contains:
active substance: ketoprofen 100 mg
excipients: starch, dextrin, microcrystalline cellulose, hypromellose, magnesium stearate, talc
Dosage form
Tablets.
Pharmacotherapeutic group
Non-steroidal anti-inflammatory drugs.
Pharmacological properties
Pharmacodynamics
Non-steroidal anti-inflammatory drug (NSAID), has anti-inflammatory, analgesic and antipyretic effects associated with the suppression of the activity of cyclooxygenases 1 and 2, which regulate the synthesis of prostaglandins and bradykinin; stabilizes lysosomal membranes.
Does not adversely affect the condition of the articular cartilage.
Pharmacokinetics
Absorption - fast, bioavailability - more than 90%. Communication with plasma proteins - 99%. The minimum effective concentration is determined after 45-60 minutes. With oral administration of ketoprofen, the maximum plasma concentration is reached after 1 hour.
Therapeutic concentration in the synovial fluid lasts 6-8 hours. It does not penetrate the blood-brain barrier in a significant amount.
Almost completely metabolized in the liver by glucuronidation, has the effect of "first pass" through the liver.
It is excreted by the kidneys (mainly in the form of ketoprofen glucuronide) and intestines (1%). The half-life is 1.6-1.9 hours. Does not accumulate.
Indications for use
Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid, psoriatic arthritis, Bechterew's disease (ankylosing spondylitis), gouty arthritis, osteoarthritis.
The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.
Pain syndrome: myalgia, ossalgia, neuralgia, tendinitis, arthralgia, bursitis, sciatica, adnexitis, otitis media, headache and toothache, in oncological diseases; post-traumatic and postoperative pain syndrome, accompanied by inflammation, algomenorrhea.
Contraindications
Hypersensitivity to ketoprofen and other components of the drug, as well as to other non-steroidal anti-inflammatory drugs.
Bronchial asthma, rhinitis or urticaria in history caused by taking acetylsalicylic acid or other NSAIDs.
Peptic ulcer of the stomach and / or duodenal ulcer (stage of exacerbation), ulcerative colitis (stage of exacerbation), Crohn's disease; hemophilia and other blood clotting disorders; confirmed hyperkalemia; diverticulitis, peptic ulcer, active gastrointestinal bleeding, inflammatory bowel disease; decompensated heart failure, the period after coronary artery bypass grafting; severe liver failure or active liver disease; severe renal failure (CC less than 30 ml / min), progressive kidney disease; children's age (up to 12 years); pregnancy (III trimester), breastfeeding period.
Dosage and administration
Inside, during or after meals, 1 tablet (100 mg) 2 times a day.
Tablets should be swallowed whole, without chewing, with a large amount (at least 100 ml) of water or milk.
The lowest effective dose should be used for the shortest possible course.
Special instructions and precautions
Ketoprofen can be taken with milk or with antacids to reduce the incidence of gastrointestinal upset; antacids and milk do not affect the absorption of the drug.
During treatment, it is necessary to control the picture of peripheral blood and the functional state of the liver and kidneys, especially in elderly patients.
In case of impaired renal and hepatic function, dose reduction and careful monitoring are necessary.
If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.
Taking the drug may mask the signs of an infectious disease.
Do not use the drug simultaneously with other NSAIDs.
Influence on the ability to drive vehicles and mechanisms
During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions.
Use during pregnancy and during breastfeeding
In the III trimester of pregnancy, the use of Ketrum is contraindicated.
In the I and II trimesters of pregnancy, the appointment of the drug is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.
During lactation, when taking the drug, it is necessary to resolve the issue of stopping breastfeeding.
Interaction with other drugs
Ketoprofen can weaken the effect of diuretics and antihypertensive drugs and increase the effect of oral hypoglycemic and some anticonvulsants (phenytoin).
Joint reception with other NSAIDs, glucocorticosteroids, salicylates, ethanol, corticotropin increases the risk of adverse events from the gastrointestinal tract.
Simultaneous administration with anticoagulants, thrombolytics, antiplatelet agents, as well as with cefaperazone, cefamandol, cefotetan and moxalactam increases the risk of bleeding.
With the simultaneous use of non-steroidal anti-inflammatory drugs with diuretics and ACE inhibitors, the risk of impaired renal function increases.
Increases the plasma concentration of cardiac glycosides, slow calcium channel blockers, lithium preparations, cyclosporine, methotrexate.
Non-steroidal anti-inflammatory drugs may reduce the effectiveness of mifepristone. NSAIDs should be started no earlier than 8-12 days after the abolition of mifepristone.
Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites.
Co-administration with sodium valproate causes a violation of platelet aggregation.
Increases the hypoglycemic effect of insulin and oral hypoglycemic drugs.
Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.
Side effect
From the digestive system: dyspepsia (nausea, diarrhea or constipation,
flatulence, vomiting, heartburn, loss of appetite,) NSAID gastropathy, abdominal pain, stomatitis,
abnormal liver function, perforation of the gastrointestinal tract, exacerbation of Crohn's disease, melena, gingival, gastrointestinal, hemorrhoidal bleeding.
From the side of the central nervous system: headache, dizziness, insomnia, drowsiness, fatigue, agitation, nervousness, depression, asthenia, confusion or loss of consciousness, forgetfulness, migraine, peripheral neuropathy, hallucinations, disorientation and speech disorder.
From the senses: noise or ringing in the ears, blurred vision, change in taste, conjunctivitis, hearing loss, dryness of the mucous membrane of the eye, eye pain, conjunctival hyperemia, vertigo.
From the side of the cardiovascular system: tachycardia, arterial hypertension, peripheral edema.
On the part of the hematopoietic organs: reduces platelet aggregation, transient increase in liver enzymes, agranulocytosis, anemia, thrombocytopenia, purpura, hemolytic anemia, leukopenia.
From the urinary system: impaired renal function, cystitis, urethritis, interstitial nephritis, nephrotic syndrome, hematuria (more often develop in people who take NSAIDs and diuretics for a long time).
Allergic reactions: skin reactions (itching, urticaria), rhinitis, shortness of breath, bronchospasm, angioedema, anaphylactoid reactions, exfoliative dermatitis.
Others: increased sweating, hemoptysis, epistaxis, menometrorrhagia, muscle twitching, thirst, photosensitivity.
If any of the side effects listed in the instructions get worse, or if you notice any other side effects not listed in the instructions, tell your doctor.
Overdose
Symptoms: nausea, vomiting, vomiting of blood, abdominal pain, melena, impaired consciousness, respiratory depression, convulsions, impaired renal function and renal failure.
Treatment : gastric lavage and the use of activated charcoal, symptomatic therapy. The effect of ketoprofen on the gastrointestinal tract can be reduced with the help of H2 receptor antagonists, proton pump inhibitors and prostaglandins. There is no specific antidote.
Storage conditions
Store in a cool and dry place, at a temperature not exceeding 30 0 C.
Keep out of the reach of children.
Best before date
3 years. Do not use after the expiry date stated on the package.
Holiday conditions
Released by prescription.
Release form
10 tablets in an aluminum foil blister. 3 blisters with instructions for use in a cardboard box.