Description
Release form
Film-coated tablets.
Packing
20 tablets, 100 mg each.
Pharmacological action of
NSAIDs, a derivative of propionic acid. It has analgesic, anti-inflammatory and antipyretic effects. Due to the inhibition of COX-1 and COX-2 and, in part, lipoxygenase, ketoprofen inhibits the synthesis of prostaglandins and bradykinin, stabilizes lysosomal membranes.
Ketoprofen does not adversely affect articular cartilage.
Indications
Symptomatic therapy of painful and inflammatory processes of various origins, including:
Inflammatory and degenerative diseases of the musculoskeletal system: Rheumatoid arthritis.
Seronegative arthritis (ankylosing spondylitis / ankylosing spondylitis /, psoriatic arthritis, reactive arthritis / Reiter’s syndrome /).
Gout, pseudogout.
Osteoarthrosis.
Pain: Headache.
Tendonitis, bursitis, myalgia, neuralgia, sciatica.
Post-traumatic and postoperative pain syndrome.
Algodismenorea.
Cancer pain syndrome.
Contraindications
A history of asthma, rhinitis, and urticaria caused by acetylsalicylic acid or other NSAIDs.
Peptic ulcer of the stomach and duodenum in the acute phase.
ULC, Crohn’s disease.
Hemophilia and other bleeding disorders.
Severe liver failure.
Severe renal failure.
Progressive kidney disease.
Uncompensated heart failure.
Postoperative period after coronary artery bypass grafting.
Gastrointestinal, cerebrovascular, and other bleeding (or suspected bleeding).
Chronic dyspepsia.
Children under 15 years old.
III trimester of pregnancy.
Lactation (breastfeeding).
Hypersensitivity to ketoprofen or other components of the drug, as well as salicylates or other NSAIDs.
With caution: a drug should be prescribed for a history of peptic ulcer, a history of bronchial asthma, clinically expressed cardiovascular, cerebrovascular diseases, diseases of the peripheral arteries, dyslipidemia, liver failure, hyperbilirubinemia, alcoholic cirrhosis, liver failure, liver failure hypertension, blood diseases, dehydration, diabetes, anamnestic data on the development of gastrointestinal ulcer, smoking, concomitant therapy with anticoagulants (e.g. warfarin), antiplatelet agents (e.g. acetylsalicylic acid), oral glucocorticosteroids (e.g., prednisone), selective serotonin reuptake inhibitors (e.g. citalopram, sertraline).
Use during pregnancy and lactation
The use of ketoprofen in the third trimester of pregnancy 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.
When taking the drug during lactation should decide on the termination of breastfeeding.
Special instructions
Ketonal ® can be washed down with milk or taken with antacids to reduce the incidence of gastrointestinal upsets (milk and antacids do not affect the absorption of ketoprofen). With prolonged use of NSAIDs, it is necessary to monitor the state of the blood, as well as the function of the liver and kidneys, especially in elderly patients.
Caution must be exercised and blood pressure monitored more often when using ketoprofen for the treatment of patients with arterial hypertension, cardiovascular disease, which lead to fluid retention.
Like other NSAIDs, ketoprofen can mask the symptoms of an infectious disease.
Influence on the ability to drive vehicles and operate machinery
There is no evidence of a negative effect of Ketonal in recommended doses on the ability to drive a car or operate machinery. At the same time, patients who notice non-standard effects while taking the Ketonal ® preparation should be careful when practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
Composition
1 tablet contains:
Active ingredient: ketoprofen – 100 mg.
Excipients: magnesium stearate, colloidal silicon dioxide, corn starch, povidone, talc, lactose.
Shell composition: hypromellose, macrogol 400, indigo carmine (E132), titanium dioxide, talc, carnauba wax.
Dosage and administration of
Adults: 1-2 caps. 2-3 times / day, or 1 tab. 2 times / day, or 1 tab. prolonged action 1 time / day. Capsules and tablets should be taken during or immediately after a meal, without chewing, drinking plenty of water or milk (liquid volume – at least 100 ml).
Oral forms can be combined with the use of rectal suppositories or dosage forms of Ketonal for external use (cream, gel).
The maximum daily dose (including when using various dosage forms) is 200 mg.
Side effects
Incidence of adverse reactions: Very common (> 10%).
Common (> 1%, but <10%). Not common (> 0.1%, but <1%). Rare (> 0.01%, but <0.1%). Very rare (<0.01%). From the digestive system: common – dyspepsia (nausea, flatulence, diarrhea or constipation, vomiting, decreased or increased appetite), abdominal pain, stomatitis, dry mouth is uncommon (with prolonged use in large doses – ulceration of the gastrointestinal mucosa, impaired liver function) rare – perforation of the gastrointestinal tract, exacerbation of Crohn’s disease, melena, bleeding from the gastrointestinal tract, transient increase in liver enzymes. From the side of the central nervous system and peripheral nervous system: common – headache, dizziness, drowsiness, fatigue, nervousness, rare nightmares – migraines, peripheral neuropathy are very rare – hallucinations, disorientation, speech disorder. From the sensory organs: rare – tinnitus, taste change, blurred visual perception, conjunctivitis. From the cardiovascular system: not common – tachycardia, arterial hypertension, peripheral edema. From the hematopoietic system: decreased platelet aggregation rare – anemia, thrombocytopenia, agranulocytosis, purpura. From the urinary system: rare – impaired renal function, interstitial nephritis, nephrotic syndrome, hematuria (with prolonged use of NSAIDs and diuretics). Allergic reactions: common – itching, urticaria, not common – rhinitis, shortness of breath, bronchospasm, angioedema, anaphylactoid reactions. Other: rare – hemoptysis, metrorrhagia. Drug Interactions Ketoprofen reduces the effects of diuretics, antihypertensive drugs. Enhances the effect of oral hypoglycemic drugs. Enhances the effect of certain anticonvulsants (eg, phenytoin). When used simultaneously with other NSAIDs, salicylates, corticosteroids and ethanol, the risk of developing gastrointestinal bleeding increases. With simultaneous use with anticoagulants, thrombolytics, antiplatelet agents, the risk of bleeding increases. The risk of developing impaired renal function is increased while taking it with diuretics or ACE inhibitors. With simultaneous use, it increases the concentration of cardiac glycosides, slow calcium channel blockers, lithium preparations, cyclosporine, methotrexate. Ketoprofen may decrease the effectiveness of mifepristone. NSAIDs should be started no earlier than 8-12 days after the withdrawal of mifepristone. Overdose Symptoms: nausea, vomiting, abdominal pain, vomiting with blood, melena, impaired consciousness, respiratory depression, cramps, impaired renal function, renal failure. Treatment: gastric lavage, the appointment of activated carbon, conduct symptomatic therapy. The use of histamine H2 receptor blockers, proton pump inhibitors, and prostaglandin inhibitors has been demonstrated. There is no specific antidote. Storage conditions Keep out of the reach and sight of children at temperatures not exceeding 25 ° C. Shelf life 5 years. The active substance Ketoprofen Terms and conditions prescription dosage form tablets Possible product names KETONAL 0.1 N20 TABLE P / O Ketonal 100mg Tab. captivity. about. X20 B (R) Ketonal 100mg No. 20 KETONAL 100MG. No. 20 TAB. P / O / LEK / Ketonal tab p / o 100mg x 20 Lek dd, Switzerland
