Ketonal retard coated pills 150mg N20
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Active ingredients
Ketoprofen
Release form
Pills
Composition
The active substance is ketoprofen. Excipients: magnesium stearate, colloidal silicon dioxide, povidone, microcrystalline cellulose, hypromellose
Pharmacological effect
NSAID, a derivative of propionic acid. It has an analgesic, anti-inflammatory and antipyretic effect. Due to inhibition of COX-1 and COX-2 and, in part, of lipoxygenase, ketoprofen inhibits the synthesis of prostaglandins and bradykinin, stabilizes lysosomal membranes. Ketoprofen does not adversely affect the state of articular cartilage
Pharmacokinetics
Absorption When ingested, ketoprofen is easily absorbed from the gastrointestinal tract. Bioavailability - 90%. When taking the drug in a dose of 100 mg Cmax in the blood plasma is reached after 1 h 22 min and is 10.4 mcg / ml. Meal does not affect the bioavailability of ketoprofen.Cmax when administered parenterally is 15-30 minutes. The distribution of Vd is 0.1-0.2 l / kg. Plasma protein binding is 99%. Ketoprofen penetrates well into the synovial fluid. Metabolism Exposure to intense metabolism in the liver through microsomal enzymes, conjugates with glucuronic acid. Excretion of ketoprofen T1 / 2 - 1.6-1.9 h. Ketoprofen is mainly metabolized in the liver. About 80% of ketoprofen is excreted in the urine, mostly as a conjugate with glucuronic acid (90%). About 10% is excreted unchanged through the intestines. Pharmacokinetics in special clinical situations In patients with renal insufficiency, ketoprofen is eliminated more slowly, T1 / 2 increases by 1 hour. In patients with hepatic insufficiency, ketoprofen may accumulate in the tissues. In elderly patients, metabolism and elimination Ketoprofena occur more slowly, but this is of clinical significance only for patients with reduced kidney function.
Indications
Ketonal retard is a non-steroid anti-rheumatic drug with anti-inflammatory, analgesic and antipyretic effects. It is used to relieve pain in a number of pain syndromes and to treat inflammatory, degenerative and metabolic rheumatic diseases.
Contraindications
Peptic ulcer of the stomach and duodenum in the acute phase; - UC,Crohn's disease; - hemophilia and other bleeding disorders; - severe hepatic impairment; - severe renal insufficiency; - uncompensated heart failure; - the postoperative period after coronary artery bypass surgery; - gastrointestinal, cerebrovascular and other bleeding or suspected bleeding; - chronic dyspepsia - III trimester of pregnancy; - lactation (breastfeeding); - children up to 15 years old; - hypersensitivity to ketoprofen, acetylsalicylic acid or other NSAIDs - indications of a history of bronchial asthma, urticaria, and rhinitis caused by taking acetylsalicylic acid or other NPVS.S caution should be prescribed a drug for a history of peptic ulcer, clinically expressed cardiovascular, cerebrovascular diseases, diseases of the peripheral arteries, disipideal diseases, disipideal diseases, disipideal diseases, disipidemic diseases of the heart, cerebrovascular diseases, diseases of the peripheral arteries, disipidemic arteries, clinically expressed cardiovascular, cerebrovascular diseases, diseases of the peripheral arteries, disipideal diseases, disipideal diseases of the urethra, cardiovascular diseases. , liver failure, kidney failure, chronic heart failure, arterial hypertension, blood diseases, dehydration, diabetes mellitus, given in history se of developing ulcerative shock syndrome, smoking, concomitant therapy with anticoagulants (warfarin), antiplatelet agents (acetylsalicylic acid), oral corticosteroids (prednisolone), selective serotonin reuptake inhibitors (citalopram, sertraline).
Precautionary measures
The drug can be taken with milk or taken with antacids to reduce the frequency of gastrointestinal disorders (milk and antacids do not affect the absorption of ketoprofen). With prolonged use requires regular monitoring of hematological parameters, indicators of liver function and kidney, especially in elderly patients. Ketoprofen should be used with caution in patients with hypertension and heart disease, accompanied by fluid retention in the body, it is recommended to monitor blood pressure. Ketonal retard can mask the symptoms of infectious diseases. There are no data on the negative effect of the drug in recommended doses on the ability to drive a car and work with mechanisms. However, when using the drug, care should be taken to persons whose activities require quick psychomotor reactions (driving a car, working with mechanisms)
Use during pregnancy and lactation
Contraindicated
Dosage and administration
Adults are prescribed 1-2 capsules. 2-3 times / day, or 1 tab. 2 times / day, or 1 tab. prolonged action 1 time / day. Capsules and pills should be taken during or immediately after a meal, without chewing, drinking plenty of water or milk (the volume of the liquid is at least 100 ml). Oral forms can be combined with the use of rectal suppositories or Ketonal dosage forms for external use (cream, gel). The maximum daily dose (including when using various dosage forms) is 200 mg. Parenteral administration can be combined with the use of oral forms (capsules , pills) or rectal suppositories. The maximum daily dose (including the use of various dosage forms) is 200 mg.
Side effects
The incidence of side reactions: very common (more than 10%), common (more than 1%, but less than 10%), not common (more than 0.1%, but less than 1%), rare (more than 0.01%, but less than 0.1%), very rare (less than 0.01%). On the part of the digestive system: common - dyspepsia (nausea, flatulence, diarrhea or constipation, vomiting, decrease or increase in appetite), abdominal pain, stomatitis, dry mouth; not common (with long-term use in large doses - ulceration of the gastrointestinal mucosa, impaired liver function); rare - perforation of gastrointestinal organs, 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, nightmares; rare - migraine, peripheral neuropathy; very rare - hallucinations, disorientation, speech disorder. On the part of the sense organs: rare - tinnitus, change in taste, blurred vision, conjunctivitis. On the part of the cardiovascular system: not common - tachycardia, arterial hypertension, peripheral edema. On the part of the system blood formation: decrease in platelet aggregation; rare - anemia, thrombocytopenia, agranulocytosis, purpura. From the urinary system: rare - renal dysfunction, interstitial nephritis, nephrotic syndrome, hematuria (with long-term NSAIDs and diuretics). Allergic reactions: common - itching, urticaria; not common - rhinitis, shortness of breath, bronchospasm, angioedema, anaphylactoid reactions. Other: rare - hemoptysis, metrorrhagia
Overdose
Symptoms: nausea, vomiting, abdominal pain, vomiting of blood, melena, impaired consciousness, respiratory depression, convulsions, impaired renal function, renal failure. Treatment: gastric lavage, the appointment of activated carbon, carry out symptomatic therapy. The use of histamine H2-receptor blockers, proton pump inhibitors, and prostaglandin inhibitors has been shown. There is no specific antidote
Interaction with other drugs
Ketoprofen reduces the effect of diuretics, antihypertensive drugs. Strengthens the effect of oral hypoglycemic drugs. Strengthens the effect of some anticonvulsants (such as phenytoin). When used simultaneously with other NSAIDs, salicylates, GCS and ethanol increases the risk of gastrointestinal bleeding. , thrombolytic agents, antiplatelet agents increase the risk of bleeding. The risk of developing impaired renal function is increased when taken simultaneously with iuretikami or inhibitors APF.Pri applied simultaneously increases the concentration of cardiac glycosides, calcium channel blockers slow, lithium preparations cyclosporin metotreksata.Ketoprofen may reduce the effectiveness of mifepristone. Acceptance of NSAIDs should begin no earlier than 8-12 days after the abolition of mifepristone.
special instructions
Side effects (especially of the digestive tract and the cardiovascular system) can be prevented by taking the minimum effective dose for the shortest possible time. Caution should be prescribed ketoprofen patients with gastrointestinal diseases in history. Bleeding and perforation may develop suddenly without prior symptoms. The risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs, in patients with a peptic ulcer in a history, especially with complications of hemorrhagic type or perforation, and in elderly people. These patients should begin treatment with a minimum dose. For such patients, as well as patients who need concomitant therapy with low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal bleeding, you should use a combination of protective therapy drugs (for example, misoprostol or protonic pump).Patients with a previously noted side effect of the digestive tract, especially the elderly, should report any unusual abdominal symptoms (in particular, gastrointestinal bleeding), especially at the beginning of treatment. The drug should be taken with caution to patients using concomitant drugs that can increase the risk of bleeding or ulceration, such as oral GCS, anticoagulants (warfarin), selective serotonin reuptake inhibitors, antithrombotic drugs (acetylsalicylic acid).