Ksefokam tab n / 8mg film about 10 pc

Description

Composition
Active substance:
1 tablet contains: lornoxicam – 4.0 mg or 8.0 mg.
Excipients:
Magnesium stearate 2.0 mg Povidone K30 5.0 mg croscarmellose sodium, microcrystalline cellulose, lactose monohydrate. film coating: Macrogol 6000, titanium dioxide, talc, hypromellose 5.
Description:
From white to white with yellowish tint oblong tablets, coated membrane liner depression with inscription «LO4» (dosage 4 mg) and «LO8» (8 mg dosage).
Product form:
Film-coated tablets, 4 mg and 8 mg.
10 tablets in a blister of aluminum foil and PVC film. 1, 2, 3, 5 or 10 blisters with instructions for use placed in a cardboard box.
Contraindications
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; 4, active peptic ulcer, or relapsing 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; lactose intolerance, lactase deficiency and glucose-galactose malabsorption; Patients under the age of 18 years (due to insufficient clinical experience).
Carefully:
In the following cases Ksefokam drug should be used only after careful evaluation of therapy and the possible benefits of the expected risk: – Renal function: mild (serum creatinine 150-300 micromol / L) and moderate (serum creatinine 300-700 micromol / L), so as maintaining renal blood flow depends on the level of renal prostaglandins. Receiving lornoxicam should stop 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 suspected of nephrotoxicity. – Report coagulation: 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 12-16 mg 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. – necessary to avoid simultaneous reception with other NSAIDs, including selective cyclooxygenase-2 inhibitors. – Undesirable effects may be minimized by using the lowest effective dose for the least amount of time sufficient to control the symptoms. – Gastrointestinal bleeding ulcer, perforation, noted earlier in the application of NSAIDs at any stage of treatment and may lead to death. – The presence of Helicobacter pylori. – The phenomena of gastrointestinal toxicity in history, particularly in the elderly. – At the same time taking 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 the simultaneous use of NSAIDs and heparin during spinal or epidural anesthesia increases the risk of hematoma. – history of gastrointestinal pathology (ulcerative colitis, Crohn’s disease), as their condition may deteriorate. – arterial 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 disease such as hypertension, hyperlipidemia, diabetes, smoking, lornoxicam should be administered only after a careful assessment of the expected benefits of therapy and the possible risks. – Lornoxicam, 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, Stevens-Johnson syndrome and toxic epidermal necrolysis. – The use of lornoxicam, as with any drug that inhibits cyclooxygenase and 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. – simultaneous use 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.
Dosage
8 mg
Indications
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: -tsimetidina – increases the concentration in plasma of lornoxicam. Interactions with ranitidine and antacids have been identified; -antikoagulyantov or platelet aggregation inhibitors – may increase bleeding time (increased risk of bleeding, requires control of international normalized ratio (INR); -fenprokoumona: reduction in efficacy fenprokoumonom; -geparina: NSAIDs increase the risk of spinal / epidural hematoma while the use of heparin with conducting spinal or epidural anesthesia; -beta-blockers and ACE inhibitors may reduce their hypotensive eff EKT; -diuretikov – reduces the diuretic effect and hypotensive effect of loop and thiazide diuretics; -digoksina – reduces the renal clearance of digoxin; -hinolonovyh antibiotics – increases the risk of seizures; -antiagregantov: increases the risk of gastrointestinal bleeding; -Other NSAIDs or glucocorticoids – It increases the risk of peptic ulcer or digestive tract bleeding; -metotreksata – increases the concentration of methotrexate in serum; -selective reuptake inhibitors (e.g., citalopram, fluokseti n, paroxetine, sertraline) increases the risk of gastrointestinal bleeding; -hydrochloric lithium – may cause an increase in peak plasma concentrations of lithium and thereby amplify the known side effects of lithium; -Ciclosporin – increases cyclosporin nephrotoxicity; -derivatives sulfonylureas – may enhance the hypoglycemic effect of the latter; -tsefamandol, ceftazidime, tsefotetan, valproic acid increases the risk of bleeding; -substance being isoenzyme inducers and inhibitors IIC9 cytochrome P450: lornoxicam (like other NSAIDs, metabolizable IIC9 isoenzyme cytochrome P450), interacts with its inducers and inhibitors; -takrolimusa – increased risk of nephrotoxic effects due to inhibition of the synthesis of prostacyclin in the kidney; -pemetrekseda: NSAIDs can reduce renal clearance pemetrexed, which leads to increased nephrotoxicity and gastrointestinal toxicity of the drug, as well as to inhibition of hematopoiesis.
In case of ingestion Ksefokam, tablets, film-coated, with food slows the absorption of lornoxicam. Therefore, the drug Ksefokam, tablets, film-coated, should not be taken with food if you want a quick onset of action of the drug (pain syndrome). Acceptance with food may reduce the absorption of lornoxicam about 20% and to increase Tmax.
Overdose
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, the following symptoms may occur: nausea and vomiting, cerebral symptoms (dizziness, visual disturbances, ataxia, turning into a coma and convulsions). Possible changes in the liver and kidneys and blood clotting disorders. When real or perceived overdose should stop taking the medication. Due to the short half-life, lornoxicam is rapidly excreted from the body. Dialysis is ineffective. So far, the existence of a specific antidote is not known. It is necessary to provide for the immediate holding of ordinary activities, including gastric lavage. Based on common principles, the use of activated carbon only if its reception immediately after the reception Ksefokam drug may reduce the absorbability of the drug. For the treatment of gastrointestinal disorders, prostaglandin analogues or ranitidine may apply.
pharmachologic effect
Pharmacological group:
Nonsteroidal anti-inflammatory drug (NSAID).
Pharmacodynamics:
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.
Pharmacokinetics:
Suction
Lornoxicam is rapidly and almost completely absorbed from the gastrointestinal tract. Maximum plasma concentration is achieved in about 1-2 minutes. The absolute bioavailability of about 90-100%. Effects of the first passage of the drug through the liver is detected. The average half-life of the drug is 3-4 hours. When concomitantly with food lornoxicam Cmax is reduced by about 30% and Tmax increases from 1.5 to 2.3 hours. Absorbance lornoxicam (calculated by AUC) can be reduced to 20%.
Distribution
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.
biotransformation
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.
breeding
The half-life of lornoxicam in the average ranges from 3 to 4 hours after oral administration around 50% of the drug is excreted in the feces and 42% -. Kidney, mainly in the form of 5-gidroksilornoksikama. The half life of 5-gidroksilornoksikama approximately 9 hours after the parenteral administration 1 or 2 times per day
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 lack of data on the use of Ksefokam the drug during pregnancy and lactation Lornoxicam 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
Prescription.
side effects
In each particular category of side effects are grouped according to the organ system-7 class and presented in decreasing order of frequency: very often – 1/10 appointments (> 10%); often – 1/100 assignments (> 1% and 0.1% and 0.01%, and
Infections and infestations
Rare: Pharyngitis.
hematopoietic system and the lymphatic system
Rare: anemia, thrombocytopenia, leukopenia, increased bleeding time.
Very rare: ecchymosis.
Immune system disorders
Rare: hypersensitivity, anaphylactoid and anaphylactic reactions.
Metabolic and nutritional disorders
Uncommon: Anorexia, weight changes.
psychiatric disorders
Uncommon: sleep disorders, depression.
Rare: confusion, nervousness, agitation.
neurological disorders
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.
visual disturbances
Uncommon: conjunctivitis.
Rare: visual disturbances.
Disorders of the vestibular apparatus
Uncommon: vertigo, tinnitus.
cardiac disorders
Uncommon: palpitations, tachycardia, edema, heart failure.
vascular disorders
Uncommon: a rush of blood to the face, swelling.
Rare: hypertension, flushing, bleeding, hematoma.
Disorders in the respiratory system, thoracic and mediastinal disorders
Uncommon: Rhinitis.
Rare: dyspnoea, cough, bronchospasm.
Gastrointestinal Disorders
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, gastro-intestinal bleeding.
Hepatobiliary disorders
Infrequently: improving performance tests of liver function, glutamate-pyruvate transaminase (GPT) or glutamate-oxaloacetate transaminase (AST). Elevated liver enzymes – 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.
Cutaneous manifestations and disorders in the subcutaneous tissues
Uncommon: rash, itching, sweating, erythematous rash, urticaria, angioedema, alopecia.
Rare: dermatitis, eczema, purpura.
Very rarely, edema, bullous reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Disorders of the musculoskeletal system and connective tissue
Uncommon: arthralgia.
Rare: bone pain, muscle cramps, myalgia.
Kidney disorders and urinary disorders
Редко: никтурия, нарушения мочеиспускания, повышение уровня мочевины и креатинина в крови.
Очень редко: у пациентов с уже имеющимся нарушением функции почек, которым для поддержания почечного кровотока необходимы почечные простагландины, лорноксикам может спровоцировать острую почечную недостаточность. Нефротоксичность в различных формах, включая нефрит и нефротический синдром, является класс-специфическим эффектом НПВП.
Общие проявления и состояние места введения препарата
Нечасто: недомогание, отек лица.
Редко: астения.
special instructions
Не следует применять препарат одновременно с другими НПВП. При появлении признаков поражения печени (кожный зуд, пожелтение кожных покровов, тошнота, рвота, боли в животе, потемнение мочи, повышение уровня «печеночных трансаминаз») следует прекратить прием препарата и обратиться к лечащему врачу. Препарат может изменять свойства тромбоцитов, однако не заменяет профилактического действия ацетилсалициловой кислоты при сердечно-сосудистых заболеваниях.
Storage conditions
At a temperature of not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Препарат Ксефокам таблетки, покрытые пленочной оболочкой, предназначен для приема внутрь и его следует запивать достаточным количеством жидкости.
Дозы
Дозы и режим приема для всех пациентов должны быть основаны на индивидуальной реакции на препарат
Pain
Доза 8-16 мг/сутки, поделенная на 2-3 приема. Максимальная рекомендованная дневная доза составляет 16 мг.
Остеоартрит и ревматоидный артрит
Стартовая рекомендованная доза составляет 12 мг лорноксикама, поделенная на 2-3 приема. Поддерживающая доза не должна превышать 16 мг в день.
Дополнительная информация для особых групп пациентов
Дети и подростки
Лорноксикам не предназначен для применения у детей и подростков младше 18 лет, так как данных по его безопасности и эффективности недостаточно.
Пожилые люди
Специально подбирать дозу пожилым пациентам (старше 65 лет) не требуется, однако препарат следует назначать с осторожностью, поскольку в этой возрастной группе нежелательные явления со стороны ЖКТ переносятся хуже.
Patients with impaired renal function
Для пациентов с легким и умеренным нарушением функции почек максимальная рекомендованная доза составляет 12 мг и должна быть поделена на 2 или 3 приема.
Patients with impaired liver function
Для пациентов с умеренным нарушением функции печени максимальная рекомендованная доза составляет 12 мг и должна быть поделена на 2 или 3 приема. Нежелательные эффекты можно минимизировать, используя наименьшую эффективную дозу препарата в течение наименьшего промежутка времени, достаточного для контроля симптомов.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist