Ketonal rectal suppositories 100mg N12
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Active ingredients
Ketoprofen
Release form
Suppositories
Composition
1 supp. contains: Active substance: ketoprofen 100 mg. Auxiliary substances: solid fat - 1850 mg, glyceryl caprylocaprate (miglyol 812) - 200 mg.
Pharmacological effect
NSAIDs, 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
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. Ketoprofen is eliminated more slowly in patients with renal insufficiency, T1 / 2 is increased by 1 hour. In elderly patients, ketoprofen is excreted more slowly and slowly, but this has clinical significance only for patients with reduced kidney function.
Contraindications
diseases of the gastrointestinal tract in the acute phase, marked abnormal liver function, pronounced renal dysfunction, blood disorders (leukopenia, thrombocytopenia, disorders of the blood coagulation system), children under 15, hemorrhoids and proctitis (for suppositories), hypersensitivity to ketoprofen acetylsalicylic acid or other NSAIDs (indications of a history of bronchospasm, urticaria, and rhinitis, caused by taking acetylsalicylic acid).
Use during pregnancy and lactation
The use of ketoprofen in the third trimester of pregnancy is contraindicated. In the first and second trimesters of pregnancy, the prescription of a drug is possible only if the intended benefit to the mother outweighs the potential risk to the fetus. There are no data on the excretion of ketoprofen with breast milk. If necessary, long-term use of the drug during lactation should decide on the termination of breastfeeding.
Dosage and administration
Suppositories prescribe 1 pc.1-2 times / day. Suppositories are injected deep into the rectum. The maximum daily dose is 300 mg.
Side effects
Allergic reactions: common - skin reactions (itching, urticaria); non-prevalent - rhinitis, shortness of breath, bronchospasm, angioedema, anaphylactoid reactions. Digestive system: common - dyspepsia (nausea, diarrhea or constipation, flatulence, vomiting, decreased or increased appetite), abdominal pain, stomatitis, dry mouth, non-spreading long-term use in large doses) - ulceration of the gastrointestinal mucosa, impaired liver function; rare - perforation of the digestive tract, exacerbation of Crohn's disease, melena, gastrointestinal bleeding. CNS: common - headache, dizziness, sleep disturbance, fatigue, nervousness, nightmarish dreams; rare - migraine, peripheral polyneuropathy; very rare - hallucinations, disorientation and speech disorder. Sensory organs: rare - tinnitus, change in taste, blurred visual perception, conjunctivitis. CCC: unpredictable - tachycardia, arterial hypertension, peripheral edema. The urinary system: rare - impaired kidney function, interstitial; nephritis, nephrotic syndrome, hematuria (most often develop in people who take NSAIDs for a long time and diuretics). Others: rare - hemoptysis, menometerorrhagia. Laboratory values: ketoprofen reduces aggregation mbotsitov; transient increase in the level of liver enzymes; rare - anemia, thrombocytopenia, agranulocytosis, purpura.
Overdose
Overdose cases were obtained with ketoprofen in doses up to 2.5 g. In most cases, the symptoms were mild, limited to sleepiness, nausea, vomiting and epigastric pain. Treatment: there are no specific antidotes for ketoprofen. In cases of suspected overdose when taking large doses, gastric lavage is recommended along with symptomatic and supportive therapy to compensate for dehydration, monitor diuresis and correct acidosis, if one develops. In patients with renal insufficiency, it is advisable to conduct hemodialysis to remove the drug from the systemic circulation.
Interaction with other drugs
Ketoprofen can weaken the effect of diuretics and antihypertensive drugs and enhance the effect of oral hypoglycemic and some anticonvulsant drugs (phenytoin). Combined use with other NSAIDs, salicylates (including acetylsalicylic acid), GCS, ethanol increases the risk of gastrointestinal complications. Simultaneous Administration with anticoagulants (heparin, warfarin), thrombolytics, antiplatelet agents (ticlopidine, clopidogrel) increases the risk of bleeding. When NSAIDs are taken with diuretics or ACE inhibitors increase the risk of renal dysfunction. The drug increases the plasma concentration of cardiac glycosides, slow calcium channel blockers, lithium preparations, cyclosporine, methotrexate. NSAIDs can reduce the effectiveness of mifepristone. NSAIDs should be started no earlier than 8-12 days after discontinuation of mifepristone. When combined with pentoxifylline, there is an increased risk of bleeding. Be sure to conduct more frequent monitoring of the clinical condition and bleeding time. When combined with probenecid, the rate of plasma clearance of ketoprofen may decrease.
special instructions
At the beginning of NSAID therapy, it is necessary to monitor the condition of the blood, liver, it is necessary to monitor the renal function in patients with heart failure, cirrhosis and nephrosis, patients undergoing diuretic therapy, patients with chronic kidney disease, especially the elderly. Acceptance of ketoprofen by such patients can lead to a decrease in renal blood flow, which is associated with an inhibitory effect on prostaglandins, and to decompensation of renal function. Care must be taken and more often to control blood pressure when using ketoprofen to treat patients with arterial hypertension, cardiovascular diseases that lead to fluid retention in the body. As with other NSAIDs, ketoprofen can mask signs of infectious diseases. Patients with bronchial asthma associated with chronic p nit, chronic sinusitis and / or nasal polyposis are more prone to allergic reactions to aspirin and / or NSAIDs, so this group of patients the risk of attack uvelichivaetsya.Zhenschinam planning pregnancy should refrain from taking the drug, becauseThe chance of implantation of the egg cell may decrease. Treatment with Ketonalom should be stopped when the skin rash, mucous membranes or other signs of hypersensitivity occur. ability to drive a motor vehicle and control the mechanisms of the Data, indicating that the use of Keto in the recommended doses a decline in the ability to drive a car or moving machinery has not been identified. However, drowsiness and dizziness have been reported, so when these symptoms appear, patients are not recommended to either drive or do other activities that require concentration and psychomotor speed.