Ksefokam lyophilisates for solution fl 5 pieces for injection 8mg


Ksefokam lyophilisates for solution fl 5 pieces for injection 8mg



Active substance:
1 vial contains: 8.0 mg of lornoxicam.
Mannitol 100.0 mg, trometamol 12.0 mg Disodium edetate 0.2 mg.
A dense mass of yellow.
The reconstituted solution – a clear yellow solution.
Product form:
Lyophilizate for preparation of solution for intravenous and intramuscular administration of 8 mg. The amount of drug, containing 8 mg of the active substance, were placed in a bottle made of dark glass (glass type I Eur. Pharm.) 10 ml or 6 ml, a sealed rubber stopper and crimped aluminum cap covered by a plastic cover, which provides control of the first opening. 5 Vials with lyophilized in a plastic tray or without a pallet placed together with instruction for use in a cardboard box.
Hypersensitivity to lornoxicam or any of the excipients; complete or partial combination of asthma, recurrent nasal polyposis or paranasal sinuses, rhinitis, angioedema, urticaria, and intolerance to acetylsalicylic acid and other NSAIDs (including history); thrombocytopenia; hemorrhagic diathesis or bleeding disorders, as well as those who underwent surgery, coupled with the risk of bleeding or incomplete hemostasis; since the aortocoronary bypass surgery; decompensated heart failure; erosive and ulcerative changes in gastric mucosa and 12 duodenal ulcer, active gastrointestinal bleeding; cerebrovascular bleeding or otherwise; gastrointestinal bleeding or perforation ulcer history associated with taking NSAIDs; active peptic ulcer or recurrent peptic ulcer history; inflammatory bowel disease (Crohn’s disease, ulcerative colitis) in acute phase; severe hepatic failure; severe renal impairment (serum creatinine 700 umol / L), progressive renal disease, confirmed hyperkalemia; pregnancy and lactation; Patients under the age of 18 years (due to insufficient clinical experience)
In the following cases the drug Ksefokam should only after careful assessment of therapy expected benefits and possible risk: Renal dysfunction: mild (serum creatinine 150300 mol / l) and moderate (serum creatinine 300 700 .mu.mol / l), since the maintenance of renal blood flow depends the level of renal prostaglandins. Receiving Ksefokam drug should be stopped in case of deterioration of renal function during treatment. Monitoring of renal function should be performed in patients who underwent major surgery, heart failure patients receiving diuretics, as well in the case of drugs with proven or presumed 4 nephrotoxicity. Violation of the blood coagulation system: recommended careful clinical monitoring and assessment of laboratory parameters such as the activated partial thrombin time (APTT). Abnormal liver function (hepatic cirrhosis) should be regular clinical observation and evaluation of laboratory parameters, as in the treatment of lornoxicam at a daily dose of 1216 mg of drug accumulation is possible. Long-term treatment (more than 3 months): Recommended Regular assessment laboratory blood parameters (hemoglobin), renal function (creatinine) and liver enzymes. Patients older than 65 years: the recommended monitoring of liver and kidney function. Use with caution in the elderly in the postoperative period. It is necessary to avoid simultaneous reception with other NSAIDs, including selective inhibitors tsiklooksigenazy2. Undesirable effects may be minimized by using the lowest effective dose for the least amount of time sufficient to control the symptoms. Gastrointestinal bleeding, ulcers, perforation, noted earlier in the application of NSAIDs at any stage of treatment and may lead to death. The presence of Helicobacter pylori. Gastrointestinal toxicity phenomenon in history, particularly in the elderly. When simultaneous administration of such drugs as oral corticosteroids (e.g., prednisone), anticoagulants (eg, warfarin), selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, paroxetine, sertraline), and antiplatelet drugs (e.g., aspirin, clopidogrel) . With simultaneous use of NSAIDs and heparin during spinal or epidural anesthesia increases the risk of hematoma. The pathology of the digestive tract in history (ulcerative colitis, Crohn’s disease), as the patient’s condition may deteriorate. Hypertension and / or heart failure history, as observed in the application of NSAIDs fluid retention and development of edema. In the presence of peripheral arterial disease or cerebrovascular disease, the presence of risk factors for cardiovascular diseases such as hypertension, hyperlipidemia, diabetes, smoking, should be administered Ksefokam only after careful assessment of the expected benefit of therapy and the possible risk. Ksefokam, like other NSAIDs, may increase the risk of arterial thromboembolic events (e.g., myocardial infarction or stroke).
Caution should be used in patients with asthma drug in the active phase or history since it is known that NSAIDs may provoke bronchospasm in such patients. In very rare cases, severe skin reactions, leading to fatal, including exfoliative dermatitis, StivensaDzhonsona syndrome and toxic epidermal necrolysis. Application Ksefokam preparation, as well as any drug that suppresses prostaglandin synthesis, may interfere with the ability to fertilize therefore not recommended for women wishing to become pregnant. In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease may be at increased risk of aseptic meningitis. Lornoxicam inhibits platelet aggregation and prolong bleeding time, therefore, should be used with caution when it increased tendency to bleed. The simultaneous use of NSAIDs and tacrolimus may increase the risk nephrotoxic action due to inhibition of synthesis of prostacyclin in the kidney. It is recommended to avoid the use of lornoxicam in infections caused by varicella-zoster virus.
8 mg
Short-term treatment of mild to moderate acute pain. Symptomatic treatment of pain and inflammation of osteoarthritis in the background. Symptomatic treatment of pain and inflammation in the background of rheumatoid arthritis.
Interaction with other drugs
Simultaneous use of the drug and Ksefokam: cimetidine – increases the concentration in plasma of lornoxicam. Interactions with ranitidine and antacids have been identified; anticoagulants or platelet aggregation inhibitors – may increase bleeding time (increased risk of bleeding, requires monitoring of the international normalized ratio (INR)); fenprokumona – reduces the effectiveness of treatment phenprocoumon; Heparin – NSAIDs increase the risk of spinal / epidural hematoma while the use of heparin during spinal or epidural anesthesia; Beta-blockers – reduces the hypotensive efficacy of angiotensin II receptor blockers; diuretics – reduces the diuretic effect and hypotensive effect of thiazide and loop diuretics, potassium-sparing; digoxin – reduces the renal clearance of digoxin; quinolone antibiotics – increases the risk of seizures; antiplatelet drugs – increases the risk of gastrointestinal bleeding; other NSAIDs or glucocorticoids – increases the risk of gastrointestinal ulceration or bleeding; methotrexate – increases serum concentration of methotrexate. This may lead to increased toxicity. If necessary, co-administration of these drugs requires close monitoring of the patient; selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, paroxetine, sertraline) – increases the risk of gastrointestinal bleeding; salts of lithium – NSAIDs inhibit the renal clearance of lithium ions, so the lithium concentration in serum may exceed the limit of toxicity. Therefore, a constant need to monitor the level of lithium ion in serum, especially in the initial stage of treatment, when changing the dosage and stopping treatment; Cyclosporine – increases cyclosporin nephrotoxicity; sulfonylurea derivatives – can enhance the hypoglycemic effect of the latter; cefamandole, ceftazidime, tsefotetan, valproic acid – increases the risk of bleeding; substances which isoenzyme inducers and inhibitors of CYP2C9 cytochrome P450: lornoxicam (like other NSAIDs, metabolizable isoenzyme CYP2C9 cytochrome P450) – interacts with its inducers and inhibitors; tacrolimus – increases the risk nephrotoxic effect due to inhibition of synthesis of prostacyclin in the kidney; Pemetrexed – NSAIDs can reduce renal clearance pemetrexed, which leads to increased nephrotoxicity and gastrointestinal toxicity of the drug, as well as to inhibition of hematopoiesis.
There is currently no data on overdose, which would allow it to assess the consequences or suggest specific treatment. In the event of an overdose of the drug Ksefokam following symptoms may occur: nausea and vomiting, cerebral symptoms (dizziness, visual disturbances, ataxia, turning into a coma, and convulsions). Possible changes in liver and kidney function and blood clotting. In case of overdose or suspected overdose of a drug therapy immediately cease. Because of its short half-life, lornoxicam rapidly removed from the body. Dialysis is ineffective. So far, the existence of a specific antidote is not known. For the treatment of gastrointestinal disorders, prostaglandin analogues or ranitidine may apply.
pharmachologic effect
Pharmacological group:
Nonsteroidal anti-inflammatory drug (NSAID).
Lornoxicam is a nonsteroidal anti-inflammatory agent, has a pronounced analgesic and antiinflammatory action, refers to a class of oxicams. The basis of the mechanism of action is inhibition of prostaglandin synthesis (inhibition of the cyclooxygenase enzyme), resulting in suppression of inflammation. Lornoxicam has no effect on vital signs: body temperature, heart rate (HR), blood pressure (BP), the data of an electrocardiogram (ECG), spirometry. The analgesic effect of lornoxicam not associated with narcotic action. The drug has no Ksefokam opiate action on the central nervous system (CNS) and, in contrast to narcotic analgesics without respiratory depression does not cause drug dependence. Due to the locally irritating action on the gastrointestinal tract (GIT) and systemic ulcerogenic effect associated with inhibition of prostaglandin synthesis, complications from the gastrointestinal tract are frequent undesirable effects in the treatment of non-steroidal anti-inflammatory drugs.
The maximum concentration of lornoxicam in plasma after intramuscular administration is achieved after about 0.4 hours. Absolute bioavailability (calculated by AUC – area under the curve “concentration-time”) after intramuscular administration is 97%.
Lornoxicam is found in the plasma in unchanged form and in the form of a hydroxylated metabolite. Lornoxicam degree of binding to plasma proteins is approximately 99% and is independent of concentration
Lornoxicam largely metabolized in the liver, primarily by hydroxylation to inactive 5-gidroksilornoksikama. lornoxicam biotransformation is carried out by isoenzyme CYP2C9. Due to the polymorphism of the gene encoding this enzyme, there are people with slow and rapid metabolism of the drug, which can lead to a significant increase in plasma levels of lornoxicam in patients with a slow metabolism. Hydroxylated metabolite has no pharmacological activity. Lornoxicam completely metabolized: about 2/3 of the drug is excreted by the liver, and the third – the kidneys as an inactive metabolite.
The half-life of lornoxicam in an average of 3 to 4 hours. In the elderly (over 65 years) clearance of the drug is reduced by 30-40%. Patients with impaired renal or hepatic function is not observed significant changes lornoxicam kinetics, except for accumulation in patients with chronic liver disease after 7 days of treatment at a daily dose of 12 mg or 16 mg.
Pregnancy and breast-feeding
Due to the lack of use of these drugs Ksefokam during pregnancy and lactation the drug should not be used. Suppression of prostaglandin synthesis can have side effects on pregnancy and / or fetal development. The use of inhibitors of prostaglandin synthesis in early pregnancy increases the risk of miscarriage or development of heart disease. It is believed that the risk is proportional to the dose and duration of treatment. Purpose of inhibitors of prostaglandin synthesis in the third trimester of pregnancy can lead to toxic effects on the heart and lungs of the fetus (premature closure of the ductus arteriosus and pulmonary hypertension), as well as renal dysfunction and, consequently, reduce the amniotic fluid. The use of the later stages can cause prolonged bleeding in the mother and the fetus, as well as the suppression of uterine activity, which could delay or extend the delivery period.
Conditions of supply of pharmacies
side effects
In each particular category of side effects grouped by system-organ class and presented in decreasing order of frequency: very common (> 1/10); often (> 1/100 to 1/1000 and 1/10 000
Infectious and parasitic diseases
Rare: Pharyngitis.
Blood disorders and lymphatic system
Rare: anemia, thrombocytopenia, leukopenia, increased bleeding time.
Very rare: ecchymosis. It has been reported that NSAIDs can cause potentially severe hematologic disorders such as neutropenia, agranulocytosis, aplastic anemia and hemolytic anemia (class-specific effects).
Violations by the immune system
Rare: hypersensitivity, anaphylactoid and anaphylactic reactions.
Violations by the metabolism and nutrition
Uncommon: Anorexia, weight changes.
mental disorders
Uncommon: sleep disorders, depression.
Rare: confusion, nervousness, agitation.
Disorders of the nervous system
Common: transient headaches weak intensity, dizziness.
Rare: somnolence, paraesthesia, taste disturbance, tremor, migraine.
Very rare: aseptic meningitis in patients with SLE and mixed connective tissue disease.
Violations by the organ of vision
Uncommon: conjunctivitis.
Rare: visual disturbances.
Violations by the organ of hearing and labyrinth disorders
Uncommon: vertigo, tinnitus.
Violations of the heart
Uncommon: palpitations, tachycardia, edema, heart failure.
Violations by vessels
Uncommon: a rush of blood to the face, swelling.
Rare: hypertension, bleeding, hematoma.
Violations of the respiratory system, organs, thoracic and mediastinal disorders
Uncommon: Rhinitis.
Rare: dyspnoea, cough, bronchospasm.
Disorders of the gastrointestinal tract
Common: nausea, abdominal pain, dyspepsia, diarrhea, vomiting.
Uncommon: constipation, flatulence, belching, dry mouth, gastritis, gastric ulcer, epigastric pain, duodenal ulcer, ulcerations in the mouth.
Rare: melena, bloody vomiting, stomatitis, esophagitis, gastroesophageal reflux, dysphagia, aphthous stomatitis, glossitis, perforated peptic ulcer, gastrointestinal bleeding.
Disorders of the liver and biliary tract
Infrequently: improving performance tests of liver function, alanine aminotransferase (ALT) or aspartate aminotransferase (AST).
Rare: abnormal liver function.
Very rare: damage to hepatocytes. Hepatotoxicity, which can lead to liver failure, hepatitis, jaundice and cholestasis.
Violations of the skin and subcutaneous tissue
Uncommon: rash, itching, sweating, erythematous rash, urticaria, angioedema, alopecia.
Rare: dermatitis, eczema, purpura.
Very rarely, edema, bullous reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Violations by musculoskeletal and connective tissue
Uncommon: arthralgia.
Rare: bone pain, muscle cramps, myalgia.
Violations of the kidneys and the urinary tract
Rare: Nocturia, micturition disorders, increase in urea and creatinine in the blood.
Very rarely, patients with pre-existing renal disease, for which maintaining renal blood flow needed renal prostaglandins, lornoxicam can cause acute renal failure. Nephrotoxicity in various forms, including nephritis and nephrotic syndrome, is a class-specific effect of NSAIDs.
General disorders and injection site
Uncommon: malaise, swelling of the face.
Rare: asthenia.
special instructions
You should not use the drug in conjunction with other NSAIDs. The risk of gastrointestinal bleeding, ulceration or perforation of the gastrointestinal tract increases with increasing doses of NSAIDs in patients with gastric ulcer history, especially if it is accompanied by complications such as bleeding or perforation in the elderly. Such patients should initiate therapy with the lowest possible dose. Such patients and patients who require concomitant use of acetylsalicylic acid in low doses or other drugs that may increase the risk of adverse effects on the gastrointestinal tract is shown co-administration of drugs that have a protective effect (e.g., misoprostol or proton pump inhibitors). Recommended regular monitoring. When the liver disease symptoms (itching, yellowing of the skin, nausea, vomiting, abdominal pain, dark urine, increased levels of “hepatic transaminases”) should stop taking the drug and consult a doctor. The preparation may modify the properties of platelets, but does not replace the prophylactic effect of aspirin in cardiovascular diseases.
Effect on the ability to drive mechanisms and
Patients who marked dizziness and / or drowsiness during treatment with lornoxicam should refrain from driving and machine control.
Storage conditions
At a temperature of not higher than 25 C.
Keep out of the reach of children!.
Dosing and Administration
Parenterally. injectable solution is prepared immediately before use by dissolving the contents of one vial (8 mg of lornoxicam) water for injection (2 mL). After cooking the solution was replaced with a needle. Intramuscular injections were long needle. The thus prepared solution was administered intravenously or intramuscularly at postoperative pain and intramuscularly with an acute attack of lumbago / sciatica. The duration of intravenous administration of the solution should be at least 15 seconds, intramuscular – at least 5 seconds. The recommended single dose: 8 mg intravenously or intramuscularly. The daily dose should not exceed 16 mg. Some patients may require administration of additional doses of 8 mg in the first 24 hours. It should use the minimum effective dose of the lowest possible short course
Additional information for special patient groups
Children and adolescents
Lornoxicam is not intended for use in children and adolescents younger than 18 years, since the data on its safety and effectiveness is not enough
Aged people
Specially adjust the dose in elderly patients (over 65 years) is not required if there is impaired renal or hepatic function. The drug should be used with caution, because in this age group, undesirable effects on the gastrointestinal tract are transported worse
Renal function
Patients with mild or moderate renal impairment may require dose adjustment.
Abnormal liver function
Patients with moderate hepatic impairment may require dosage adjustment. Undesirable effects may be minimized by using the lowest effective dose for the least amount of time sufficient to control the symptoms.
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg


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