Instructions for use KETOPROFEN-LF
Avoid using the drug in combination with other NSAIDs, incl. with selective COX-2 inhibitors.
The severity of side effects can be reduced by using the minimum effective dose for the minimum time required to improve the condition.
Elderly patients are more likely to experience adverse reactions to NSAIDs, especially GI bleeding and perforation, which can be life-threatening.
Gastrointestinal bleeding, ulcer formation or perforation, in some cases with fatal outcome, have been reported for all NSAIDs at various stages of treatment, regardless of the presence of warning symptoms or a history of serious gastrointestinal pathology. According to epidemiological data, the use of ketoprofen may be associated with a high risk of severe gastrointestinal toxicity, which is typical for some other NSAIDs, especially when taken in high doses.
The risk of gastrointestinal bleeding, ulcer formation or perforation increases with increasing doses of NSAIDs in patients with a history of ulcers, especially those complicated by bleeding or perforation, as well as in elderly patients. In this case, treatment begins with a minimum dose. For these patients, as well as for patients taking low doses of acetylsalicylic acid or other drugs that increase the risk of gastrointestinal complications, combination therapy with protective drugs, such as misoprostol or proton pump inhibitors, should be considered. Patients with a history of gastrointestinal toxicity, especially elderly patients, should report any unusual symptoms to the physician, especially during the initial stages of treatment. The drug should be prescribed with extreme caution to patients concomitantly receiving medications that may increase the risk of ulcers or bleeding:
- oral corticosteroids, anticoagulants (eg, warfarin), selective serotonin reuptake inhibitors, or antiplatelet agents such as aspirin.
If gastrointestinal bleeding develops, use of the drug should be discontinued. NSAIDs are prescribed with caution to patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn's disease), because Exacerbations of these diseases may occur. The relative risk of developing gastrointestinal bleeding increases in patients with low body weight; if bleeding develops, treatment should be discontinued immediately.
Patients with hypertension and/or mild to moderate congestive heart failure require appropriate monitoring and counseling as fluid retention and edema have been reported with the use of NSAIDs. According to the results of clinical studies and epidemiological data, the use of some NSAIDs, especially in high doses and for a long time, may be accompanied by an increased risk of arterial thrombosis, such as myocardial infarction or stroke. There is insufficient data to exclude such a danger when using ketoprofen.
Patients with bronchial asthma in combination with chronic allergic rhinitis, chronic allergic sinusitis and/or nasal polyps are at high risk of allergy to aspirin and/or NSAIDs. The use of ketoprofen may cause asthma attacks or bronchospasm, especially in patients with an allergy to aspirin or NSAIDs.
It is necessary to monitor renal function at the beginning of treatment in patients with heart failure, cirrhosis and impaired liver function, especially in patients receiving diuretics, patients with chronic renal failure, especially in elderly patients. In these patients, ketoprofen may cause a decrease in renal blood flow by inhibiting prostaglandins and lead to renal failure.
In patients with impaired liver function, the activity of hepatic transaminases should be regularly assessed, especially during long-term therapy. Treatment should be discontinued if visual disturbances such as blurred vision occur. Prescribe with caution to persons suffering from alcohol dependence.
Extremely rare cases of the development of serious skin reactions (some with fatal outcomes) have been described due to the use of NSAIDs, incl. exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis. Patients are at greatest risk in the first month of treatment. If a skin rash, signs of damage to the mucous membranes or other symptoms of hypersensitivity appear, the drug should be discontinued.
With prolonged treatment, it is necessary to monitor the number of blood cells, as well as liver and kidney function.
Like other NSAIDs, ketoprofen, due to its anti-inflammatory, antipyretic or analgesic effect, can mask symptoms of infection progression, such as increased body temperature.
Before major surgery, the drug must be discontinued. In case of hyperkalemia due to diabetes mellitus or concomitant therapy with potassium-sparing drugs, it is necessary to regularly monitor potassium levels.
For severe pain, ketoprofen can be used in combination with morphine.
Therapy with the injectable form of ketoprofen should be carried out under close medical supervision. When eliminating acute pain, it is advisable to switch to other dosage forms that are less likely to cause serious adverse reactions. IM administration for a long time is recommended to be carried out in a hospital under the supervision of a physician.
Excipients
The solution contains about 8% ethanol by volume, i.e. up to 197.2 mg/ampule of ethanol, which corresponds to 4 ml of beer or 1.6 ml of wine. The drug may have a negative effect on persons suffering from alcoholism. The ethanol content should be taken into account when prescribing the drug during pregnancy and lactation, children and patients at risk, for example, with liver diseases, as well as those suffering from epilepsy.
Propylene glycol in doses of 400 mg/kg for adults may cause symptoms similar to those caused by alcohol consumption.
The drug contains sodium in an amount of less than 1 mmol/ampoule and is therefore considered sodium-free.
Use in pediatrics
Use in children is contraindicated.
Due to the benzyl alcohol content, the drug should not be administered to premature infants or newborns; benzyl alcohol can cause toxic and anaphylactoid reactions in children under 3 years of age.
Propylene glycol at a dose of 200 mg/kg in children can cause symptoms similar to those caused by alcohol consumption.
Impact on the ability to drive vehicles and operate machinery
Patients should be warned that this drug may cause drowsiness, dizziness, or seizures and advised not to drive or operate machinery if these symptoms occur.
Patients should be warned about the possible occurrence of visual impairment. In this case, you should not drive vehicles or operate machinery.
Ketoprofen 100 mg 20 pcs. pills
pharmachologic effect
Non-steroidal anti-inflammatory drug.
Directions for use and doses
Orally, during or after meals, 1 tablet (100 mg) 2 times a day. The tablets should be swallowed whole, without chewing, with a large amount (at least 100 ml) of water or milk.
The minimum effective dose should be used for the shortest possible short course.
Pharmacodynamics
A nonsteroidal anti-inflammatory drug that has anti-inflammatory, analgesic and antipyretic effects associated with suppression of the activity of cyclooxygenases 1 and 2, which regulate the synthesis of prostaglandins and bradykinin; stabilizes lysosomal membranes.
Does not have a negative effect on the condition of articular cartilage.
Pharmacokinetics
Absorption is fast, bioavailability is more than 90%. Communication with plasma proteins - 99%. The minimum effective concentration is determined after 45-60 minutes. When taking ketoprofen tablets orally, the maximum concentration of the drug in plasma is achieved after 1 hour. The therapeutic concentration in the synovial fluid remains for 6-8 hours. It does not penetrate the blood-brain barrier in a significant amount.
It is almost completely metabolized in the liver by glucuronidation and has a “first pass” effect through the liver.
Excreted by the kidneys (mainly in the form of ketoprofen glucuronide) and intestines (1%). The half-life is 1.6-1.9 hours. It does not accumulate.
Indications for use Ketoprofen 100 mg 20 pcs. pills
Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid, psoriatic arthritis, ankylosing spondylitis, gouty arthritis, osteoarthritis.
The drug 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, radiculitis, adnexitis, otitis, headache and toothache, with cancer; post-traumatic and postoperative pain syndrome, accompanied by inflammation, algodismenorrhea.
Contraindications
Hypersensitivity to ketoprofen and other components of the drug, as well as to other non-steroidal anti-inflammatory drugs. History of bronchial asthma, rhinitis or urticaria caused by taking acetylsalicylic acid or other NSAIDs.
Peptic ulcer of the stomach and/or duodenum (acute stage), ulcerative colitis (exacerbation stage), 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 (creatinine clearance less than 30 ml/min), progressive kidney disease; children's age (up to 12 years); pregnancy (III trimester), breastfeeding period.
With caution: anemia, bronchial asthma, coronary heart disease, cerebrovascular diseases and peripheral arterial diseases, chronic heart failure, history of peptic ulcer, dyslipidemia/hyperlipidemia, liver failure, hyperbilirubinemia, alcoholic cirrhosis of the liver, renal failure (creatinine clearance less than 60 ml/min ), arterial hypertension, edema, blood diseases (including leukopenia), stomatitis, dehydration, sepsis, diabetes mellitus, anamnestic data on the development of ulcerative lesions of the gastrointestinal tract, the presence of Helicobacter pylori infection, tobacco smoking, alcoholism, concomitant anticoagulant therapy (for example, warfarin), antiplatelet agents (for example, acetylsalicylic acid), oral glucocorticosteroids (for example, prednisolone), selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine, sertraline), long-term use of NSAIDs, severe somatic diseases, old age, pregnancy ( I, II trimester).
Application Ketoprofen 100 mg 20 pcs. pills during pregnancy and breastfeeding
In the third trimester of pregnancy, the use of ketoprofen is contraindicated.
In the first and second trimesters of pregnancy, the drug can be prescribed only if the expected benefit to the mother outweighs the potential risk to the fetus.
During lactation, when taking the drug, it is necessary to decide whether to stop breastfeeding.
special instructions
Ketoprofen can be washed down with milk or taken with antacids to reduce the frequency of gastrointestinal disorders; Antacids and milk do not affect the absorption of the drug.
During treatment, monitoring of the peripheral blood picture and the functional state of the liver and kidneys is necessary, especially in elderly patients.
If renal or liver function is impaired, 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 signs of an infectious disease. The drug should not be used simultaneously with other NSAIDs.
Impact on the ability to drive vehicles and operate machinery
During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Overdose
In case of an overdose of ketoprofen, like other non-steroidal anti-inflammatory drugs, nausea, vomiting, hematemesis, abdominal pain, melena, impaired consciousness, respiratory depression, convulsions, impaired renal function and renal failure may occur.
There is no specific antidote. Treatment is symptomatic. The effects of ketoprofen on the gastrointestinal tract can be weakened with the help of H2 receptor antagonists, proton pump inhibitors and prostaglandins. Gastric lavage and the use of activated carbon are indicated.
Side effects Ketoprofen 100 mg 20 pcs. pills
From the digestive system: often - dyspepsia (nausea, diarrhea or constipation, flatulence, vomiting, heartburn, loss of appetite), NSAID gastropathy, abdominal pain, stomatitis, impaired liver function; rarely - perforation of the gastrointestinal tract, exacerbation of Crohn's disease, melena, gingival, gastrointestinal, hemorrhoidal bleeding.
From the central nervous system: often - headache, dizziness, insomnia, drowsiness, fatigue, agitation, nervousness, depression, asthenia; rarely - confusion or loss of consciousness, forgetfulness, migraine, peripheral neuropathy; very rarely - hallucinations, disorientation and speech disorder.
From the senses: rarely - noise or ringing in the ears, blurred vision, change in taste, conjunctivitis, hearing loss, dry mucous membrane of the eye, pain in the eyes, conjunctival hyperemia, vertitis.
From the cardiovascular system: rarely - tachycardia, arterial hypertension, peripheral edema.
From the hematopoietic organs: ketoprofen reduces platelet aggregation, transient increase in the level of liver enzymes, rarely - agranulocytosis, anemia, thrombocytopenia, purpura, hemolytic anemia, leukopenia.
From the urinary system: rarely - impaired renal function, cystitis, urethritis, interstitial nephritis, nephrotic syndrome, hematuria (more often develops in people taking NSAIDs and diuretics for a long time).
Allergic reactions: often - skin reactions (itching, urticaria); rarely - rhinitis, shortness of breath, bronchospasm, angioedema, anaphylactoid reactions, exfoliative dermatitis.
Other: increased sweating, rarely - hemoptysis, nosebleeds, menometrorrhagia, muscle twitching, thirst, photosensitivity.
Drug interactions
Ketoprofen may weaken the effect of diuretics and antihypertensive drugs and enhance the effect of oral hypoglycemic and some anticonvulsants (phenytoin).
Combined use with other NSAIDs, glucocorticosteroids, salicylates, ethanol, corticotropin increases the risk of developing adverse events from the gastrointestinal tract.
Co-administration with anticoagulants, thrombolytics, antiplatelet agents, as well as cefoperazone, cefamandole, cefotetan and moxalactam increases the risk of bleeding.
When taking non-steroidal anti-inflammatory drugs simultaneously with diuretics and ACE inhibitors, the risk of renal dysfunction increases.
Increases plasma concentrations of cardiac glycosides, slow calcium channel blockers, lithium preparations, cyclosporine, methotrexate.
Nonsteroidal anti-inflammatory drugs may reduce the effectiveness of mifepristone. Taking NSAIDs should be started no earlier than 8-12 days after stopping 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 disruption of platelet aggregation.
Increases the hypoglycemic effect of insulin and oral hypoglycemic drugs (dose recalculation is necessary).
Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.
KETOPROFEN VRAMED GEL TO RELIEF JOINT PAIN
Anti-inflammatory drugs are drugs that suppress the inflammatory process by preventing the mobilization or transformation of arachidonic acid. Anti-inflammatory drugs do not include drugs that can influence the inflammatory process through other mechanisms, in particular cytostatics, “basic” antirheumatic drugs (gold salts, D-penicillamine, sulfasalazine), anti-gout drugs (colchicine), quinoline derivatives (chloroquine). The indications for the use of glucocorticosteroids as anti-inflammatory drugs are predominantly pathoimmune inflammation. They are widely used in the acute phase of systemic connective tissue diseases, arthritis, sarcoidosis, alveolitis, and non-infectious inflammatory skin diseases. Nonsteroidal anti-inflammatory drugs (NSAIDs) are substances of various chemical structures that, in addition to anti-inflammatory, also usually have analgesic and antipyretic activity. The NSAID group consists of derivatives of salicylic acid (acetylsalicylic acid, mesalazine), indole (indomethacin, sulindac), pyrazolone (phenylbutazone, clofezone), phenylacetic acid (diclofenac), propionic acid (ibuprofen, naproxen, flurbiprofen, ketoprofen), oxicam (meloxicam, piroxicam , tenoxicam) and other chemical groups (benzydamine, nabumetone, niflumic acid, etc.).
Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) from the group of propionic acid derivatives, which has an analgesic, anti-inflammatory and antipyretic effect. The main goal of treating most soft tissue injuries (bruised wounds, sprains and ruptures of the ligamentous apparatus of joints, dislocations) is to prevent and reduce swelling. In most cases, there is a need for effective pain relief, for which NSAIDs are most often used. In a randomized, double-blind, placebo-controlled study, oral ketoprofen in 120 patients with tendinitis, bursitis or periarthritis quickly and effectively relieved pain and reduced functional limitations in the joints. The analgesic effect occurred within 30 minutes after taking the drug with tolerability comparable to placebo. More details - ketoprofen for acute soft tissue injury, ketoprofen in postoperative pain relief, the effect of ketoprofen on postoperative complications and reparative processes in bone tissue.
Medicines containing ketoprofen:
Ketoprofen Vramed gel, Actron instructions, Artrozilen instructions, Ketolist retard instructions, Ketonal instructions, Ketonal Duo instructions, Ketoprofen-Verte instructions, Knavon instructions, OKI instructions , Oruvel (Oruveil) instructions, Ostofen (Ostofen) instructions, Prontoket (Prontoket) spray instructions, Profenid (Profenid) instructions, Fastum (Fastum) instructions, Fastum gel instructions, Febrofid (Febrofid) instructions, Flamax (Flamax) instructions, Flexen ( Flexen) instructions, Bystrumgel instructions, Bystrumcaps instructions, synonyms of the drug Ketoprofen: Alreumant instructions, Asozal, Dexal, Kefenid, Ketoprosil, Meprofen, Niflam, Reumoquin, Rofenid, Synpofen, etc. For all drugs, the main active ingredient is ketoprofen.
