Ketonal injection for 50mg ml ampoules 2ml N10
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Active ingredients
Ketoprofen
Release form
Solution
Composition
1 ml of solution (1 ampoule) contains: Active substance: ketoprofen 50 mg (100 mg). Additional substances: propylene glycol - 800 mg, ethanol - 200 mg, benzyl alcohol - 40 mg, water d / and - up to 2 ml.
Pharmacological effect
NSAIDs. It has an analgesic, anti-inflammatory and antipyretic effect. Ketoprofen blocks the action of the COX-1 and COX-2 enzymes and, in part, of lipo-oxygenase, which leads to the suppression of the synthesis of prostaglandins (including in the CNS, most likely in the hypothalamus). The liposomal membranes, at high In vitro concentrations of ketoprofen inhibits the synthesis of bradykinin and leukotrienes. Ketoprofen does not adversely affect the state of articular cartilage.
Pharmacokinetics
Absorption Bioavailability - 90%. Cmax when administered parenterally is 15-30 minutes. The distribution of Vd is 0.1 l / kg. Ketoprofen is 99% bound to plasma proteins, mainly with the albumin fraction. Ketoprofen enters the synovial fluid and there reaches a concentration equal to 50% concentration in the blood plasma. Plasma clearance of ketoprofen is approximately 0.08 l / kg / h. Metabolism and elimination Ketoprofen is extensively metabolized by microsomal liver enzymes, T1 / 2 is less than 2 h. Ketoprofen binds to glucuronic acid. There are no active metabolites of ketoprofen. Up to 80% of ketoprofen is excreted by the kidneys within 24 hours, mainly in the form of ketoprofen glucuronide. Pharmacokinetics in special clinical situations In patients with hepatic insufficiency, plasma concentration of ketoprofen is doubled (probably due to hypoalbuminemia, and consequently a high level of unbound active ketoprofen) , such patients should be prescribed the drug in the minimum therapeutic dose. In patients with renal insufficiency, ketoprofen clearance is reduced, but dose adjustment is required only in cases of e severe renal nedostatochnosti.U elderly patients, metabolism and excretion of ketoprofen are slower, which has clinical significance only for patients with severe renal insufficiency.
Contraindications
diseases of the gastrointestinal tract in the acute phase, pronounced abnormal liver function, pronounced renal dysfunction, blood disorders (leukopenia, thrombocytopenia, disorders of the blood coagulation system), Children up to 15 years old, 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
Inhibition of prostaglandin synthesis can have an undesirable effect on the course of pregnancy and / or embryonic development. The data obtained during epidemiological studies with the use of inhibitors of prostaglandin synthesis in early pregnancy confirm an increased risk of spontaneous abortion and the formation of heart defects (approximately 1-1.5%). It is possible to prescribe the drug to pregnant women in the first and second trimesters of pregnancy only when Benefits for the mother justify the possible risk to the fetus. The use of ketoprofen in pregnant women during the third trimester of pregnancy is contraindicated due to the possibility of developing weak and the generic activity of the uterus and / or premature closure of the ductus arteriosus, a possible increase in bleeding time, water scarcity and renal nedostatochnosti.Na the moment there are no data on the allocation of ketoprofen into breast milk, so the need for appointing ketoprofen nursing mothers should decide the issue of termination of breastfeeding.
Dosage and administration
The solution is administered in / m or / in. In / m injected 100 mg 1-2 times / day. In / in the infusion of ketoprofen is carried out only in a hospital. Short-term / infusion: 100-200 mg, diluted in 100 ml of 0.9% sodium chloride solution, injected within 0.5-1 hours. It is possible to reintroduce after 8 hours. Continuous IV infusion: 100-200 mg, diluted in 500 ml of infusion solution (0.9% sodium chloride solution, lactate-containing Ringer's solution, 5% dextrose solution), administered within 8 hours. It is possible to re-enter after 8 hours. Maximum daily dose (including when using various dosage forms) is 200 mg.
Side effects
Allergic reactions: common - skin reactions (itching, urticaria); not common - 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,undistributed (with 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
Symptoms: overdose may experience nausea, vomiting, abdominal pain, vomiting with blood, melena, impaired consciousness, respiratory depression, convulsions, impaired renal function, renal failure. Treatment: gastric lavage, the appointment of activated carbon, spend symptomatic therapy. The effects of ketoprofen on the gastrointestinal tract can be reduced with proton pump inhibitors and prostaglandins. If kidney failure develops, hemodialysis is recommended.
Interaction with other drugs
Ketoprofen can weaken the effect of diuretics and antihypertensive drugs. Ketoprofen can enhance the effect of oral hypoglycemic and some anticonvulsant drugs (phenytoin). Combined use with other NSAIDs, salicylates, GCS, ethanol increases the risk of developing undesirable effects from the gastrointestinal tract. warfarin), thrombolytic agents, antiplatelet agents (ticlopidine, clopidogrel) increases the risk of bleeding. Simultaneous use with potassium-sparing diuretics, in ACE, NSAIDs, low molecular weight heparins, cyclosporine,tacrolimus and trimethoprim increases the risk of hyperkalemia. Increases plasma concentration of cardiac glycosides, slow calcium channel blockers, lithium drugs, cyclosporine, methotrexate and digoxin. use with GCS and other NSAIDs (including selective COX-2 inhibitors) increases the likelihood of side effects (in particular and, from the gastrointestinal tract) .NPVP may reduce the effectiveness of mifepristone. NSAID administration should begin no earlier than 8-12 days after the abolition of mifepristone.
special instructions
With long-term use of NSAIDs, it is necessary to periodically evaluate a clinical blood test, as well as monitor kidney and liver function, especially in elderly patients (over 65), conduct fecal occult blood analysis. treatment of patients suffering from arterial hypertension, cardiovascular diseases, which lead to fluid retention in the body. If there is a violation of the organs of vision, treatment follows t immediately prekratit.Kak and other NSAIDs, ketoprofen may mask symptoms of infectious and inflammatory diseases. If there is evidence of infection or deterioration of the condition during the use of the drug, it is necessary to consult a doctor immediately. Because of the important role of prostaglandins in maintaining renal blood flow, special care should be taken when prescribing ketoprofen to patients with cardiac or in case of glasses, as well as in the treatment of elderly patients taking diuretics, and patients who, for whatever reason, have decreased BCC (for example, after surgery). The use of ketoprofen may affect female fertility, therefore patients with infertility includingbeing examined) it is not recommended to use the drug. Effect on the ability to drive vehicles and control mechanisms There are no data on the negative effect of the drug Ketonal in the recommended doses on the ability to drive a car or work with mechanisms. However, patients who experience drowsiness, dizziness, or other unpleasant sensations from the nervous system, including visual impairment, on the background of the drug use, are advised to refrain from driving and practicing potentially dangerous activities that require increased concentration and psychomotor speed.