Xefokam Rapid pills p/o 8mg №6×1

NameKsefokam Rapid tabl p / film.ob. 8mg in bl. in pack. No. 6×1 Main active ingredient Lornoxicam Form of release tablets Dosage 8 mg Pharmacological properties Pharmacodynamics Mechanism of action Lornoxicam is a non-steroidal anti-inflammatory drug, has a pronounced analgesic and anti-inflammatory effect, belongs to the class of oxycams. The mechanism of action of lornoxicam is based on the suppression of prostaglandin synthesis (inhibition of the cyclooxygenase enzyme), leading to the suppression of inflammation. Presumably has a central effect on nociception that is independent of the anti-inflammatory effect. Pharmacodynamic properties Lornoxicam does not affect the main indicators of the state of the body (body temperature, heart rate, blood pressure, electrocardiogram data, spirometry). Clinical efficacy and safety The analgesic properties of lornoxicam have been successfully demonstrated in several clinical trials during the drug development period. Frequent adverse effects after treatment with lornoxicam, as with other NSAIDs, are disorders of the gastrointestinal tract due to its local irritation and systemic ulcerogenic effect associated with inhibition of prostaglandin (PG) synthesis. Clinical studies of patients with pain after surgical removal of the third molar showed a faster action of Xefocam Rapid tablets in comparison with Xefocam tablets. Pharmacokinetics Absorption Lornoxicam is rapidly and almost completely absorbed from the gastrointestinal tract. Peak plasma concentrations are reached in about 30 minutes. The maximum concentration of Cmax for Xefocam Rapid tablets is higher than the Cmax for Xefocam tablets, and is equivalent to the Cmax for lornoxicam intended for parenteral administration. The absolute bioavailability of Xefocam Rapid tablets is 90-100% and is equivalent to the bioavailability of Xefocam tablets. The effect of the first passage of the drug through the liver is not observed. The half-life is 3-4 hours. There are no data on taking Xefocam Rapid tablets with food, but based on data on taking Xefocam tablets with meals, a decrease in Cmax, an increase in Tmax, and a decrease in absorption (AUC) of lornoxicam can be expected. Distribution Lornoxicam is found in plasma unchanged and in the form of its hydroxylated metabolite. Plasma protein binding of lornoxicam is 99% and is independent of concentration. Biotransformation Lornoxicam is completely metabolized in the liver, initially to inactive 5-hydroxylornoxicam. The CYP2C9 isoenzyme is involved in metabolism. As a result of genetic polymorphism, there are fast and slow metabolizers, which can be expressed in a marked increase in plasma levels of lornoxicam in individuals with a slow metabolism. The hydroxylated metabolite does not show pharmacological activity. Lornoxicam is completely metabolized to a pharmacologically inactive metabolite; about 2/3 is excreted through the liver and 1/3 through the kidneys. Animal tests have shown that lornoxicam does not induce liver enzymes. Clinical trial data do not provide any evidence of accumulation of lornoxicam after repeated dosing at the recommended dosage. This conclusion was supported by drug monitoring data after one year of studies. Withdrawal The half-life is 3-4 hours. After oral administration, about 50% is excreted in the feces and 42% through the kidneys, mainly in the form of 5-hydroxylornoxicam. The half-life of 5-hydroxylornoxicam is approximately 9 hours after parenteral dosing once or twice a day. In elderly patients, clearance is reduced by 30-40%. With the exception of reduced clearance, there are no significant changes in the kinetics of lornoxicam in elderly patients. In patients with impaired liver or kidney function, there are also no significant changes in the kinetic profile of lornoxicam, with the exception of cumulation in patients with chronic liver disease after 7 days of treatment at a daily dose of 12 mg and 16 mg. Indications for use Short-term relief of acute mild and moderate pain. Route of administration and doses Dosage For all patients, the appropriate dosing regimen should be based on the individual response to treatment. Acute pain syndrome 8-16 mg of lornoxicam is taken in doses of 8 mg. The initial dose is 16 mg, on the first day of treatment after 12 hours, the next dose of 8 mg can be taken. After the first day of treatment, the maximum recommended daily dose is 16 mg. Additional Information for Special Patient Populations Children and Adolescents Lornoxicam is not recommended for use in children and adolescents under 18 years of age due to lack of safety and efficacy data. Elderly patients Dose adjustment for elderly patients is not required in the absence of impaired renal or hepatic function. Lornoxicam should be used with caution as gastrointestinal adverse reactions are less well tolerated in this group of patients (see Precautions section). Patients with impaired renal function It is recommended to reduce the frequency of taking the drug to 1 time per day. Patients with impaired liver function It is recommended to reduce the frequency of taking the drug to 1 time per day. Adverse reactions can be minimized by using the lowest effective dose for the shortest period of time necessary to control the symptoms of the disease (see section “Precautions”). Directions for use Film-coated tablets of Xefocam Rapid are intended for oral administration and should be taken with a sufficient amount of liquid. Use in Pregnancy and Lactation Pregnancy Lornoxicam is contraindicated in the third trimester of pregnancy, and should also not be used in the first and second trimesters of pregnancy and during childbirth, as there are no clinical data on use during pregnancy. There are currently insufficient data on the use of lornoxicam in pregnant women. Animal studies have shown reproductive toxicity. Inhibition of prostaglandin synthesis can adversely affect pregnancy and/or embryonic/fetal development. Data from epidemiological studies suggest an increased risk of miscarriage and cardiac malformations after the use of prostaglandin synthesis inhibitors in early pregnancy. The risk is believed to increase with increasing dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to increase embryo/fetal mortality before and after implantation. During the first and second trimester of pregnancy, prostaglandin synthesis inhibitors should not be used unless absolutely necessary. The administration of prostaglandin synthesis inhibitors during the third trimester of pregnancy can lead to fetal cardiopulmonary toxicity (premature ductus arteriosus and pulmonary hypertension) and impaired renal function, which can lead to renal failure and, consequently, a decrease in the amount of amniotic fluid. At the end of pregnancy, prostaglandin synthesis inhibitors can lead to increased bleeding time and delayed uterine contractions, which can delay or delay labor. Therefore, the use of lornoxicam is contraindicated in the third trimester of pregnancy (see section “Contraindications”). Lactation There are currently no clinical data on the excretion of lornoxicam in breast milk. Lornoxicam has been found in relatively high concentrations in the milk of lactating rats. Thus, lornoxicam should not be taken by breastfeeding women. Precautions For the following disorders, lornoxicam should be prescribed only after a careful assessment of the benefit-risk ratio: Renal insufficiency: the drug should be administered with caution to patients with mild (serum creatinine 150-300 µmol/l) and moderate (serum creatinine 300-700 µmol/l) renal insufficiency, due to the dependence of maintaining renal blood flow on renal prostaglandins. If renal function worsens, treatment with lornoxicam should be discontinued. Renal function should be monitored in patients who have undergone major surgery, have heart failure, are treated with diuretics, and are receiving concomitant treatment with drugs that are suspected or known to cause kidney damage Patients with bleeding disorders: Close clinical observation and evaluation of laboratory parameters (eg, prothrombin index) is recommended. “enzymes”), since accumulation of lornoxicam (increased area under the concentration curve (AUC)) may occur at a daily dose of 12-16 mg. Otherwise, the use of the drug by patients with impaired liver function does not affect the pharmacokinetics of valornoxicam compared with healthy people. Long-term treatment (more than 3 months): it is recommended to regularly evaluate hematological parameters (hemoglobin), kidney function (creatinine) and liver enzymes. Elderly patients (over 65 years): monitoring of kidney and liver function is recommended. Caution should be exercised in elderly patients undergoing surgery. It is necessary to avoid concomitant administration of the drug with other NSAIDs, including selective cyclooxygenase-2 inhibitors. Undesirable reactions can be minimized by using the lowest effective dose for the shortest period necessary to control symptoms (see section “Method of application and dosage”, as well as gastrointestinal and cardiovascular risks below). Gastrointestinal bleeding, ulceration, and perforation: Gastrointestinal bleeding, ulceration, or perforation, which can be fatal, has been reported at any time during treatment with all NSAIDs, with or without warning symptoms or a history of serious gastrointestinal problems. The risk of gastrointestinal bleeding, ulceration or perforation increases with an increase in the dose of NSAIDs, in patients with a history of peptic ulcer, especially complicated by bleeding or perforation (see section “Contraindications”), and in old age. These patients should start treatment at the lowest dose. For such patients, and for patients requiring concomitant low-dose acetylsalicylic acid or other active substances that may increase gastrointestinal risk, combination therapy with protective agents (eg, misoprostol or proton pump inhibitors) should be considered ( see below and section “Interaction with other medicinal products and other forms of interaction”). Clinical observation at regular intervals is recommended. Patients with a history of gastrointestinal toxicity, especially elderly patients, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly during the initial stages of treatment. Caution should be exercised in patients receiving concomitant medicinal products that may increase the risk of ulceration or bleeding, such as oral corticosteroids and anticoagulants (warfarin), selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section “Interaction with other medicines and other forms of interaction). With the development of gastrointestinal bleeding or ulceration in patients taking lornoxicam, treatment should be discontinued. NSAIDs should be prescribed with caution to patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn’s disease), as their condition may worsen (see section “Side Effects”). In elderly patients, the frequency of adverse reactions to NSAIDs is increased, especially gastrointestinal bleeding and perforation, which can be fatal (see section “Contraindications”). Appropriate monitoring and counseling is necessary for patients with hypertension and/or a history of mild to moderate heart failure, as fluid retention and edema have been reported in the treatment of NSAIDs. Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and in long-term treatment) may be associated with a slight increase in the risk of arterial thrombosis (eg, myocardial infarction or stroke). There are insufficient data to rule out this risk for lornoxicam. In patients with uncontrolled hypertension, heart failure, ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease, treatment with lornoxicam should only be initiated after careful consideration. A similar consideration should be made before initiating long-term treatment in patients with cardiovascular risk factors (eg, hypertension, hyperlipidemia, diabetes mellitus, smoking). NSAIDs increase the risk of spinal or epidural hematoma when used simultaneously with heparin in spinal or epidural anesthesia (see section “Interaction with other medicinal products and other forms of interaction”). Very rarely reported serious skin reactions that can be fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis when using NSAIDs (see section “Side effect”). Patients are most at risk in the early stages of therapy, with the onset of a reaction occurring in most cases within the first month of treatment. Lornoxicam should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. With caution, NSAIDs should be prescribed to patients with a history of bronchial asthma, as this can lead to bronchospasm. Patients with systemic lupus erythematosus (SLE) and mixed connective tissue disease may be at an increased risk of developing aseptic meningitis. Lornoxicam reduces platelet aggregation and prolongs bleeding time, therefore, caution should be exercised when prescribing to patients with an increased tendency to bleed. Simultaneous treatment with NSAIDs and tacrolimus may increase the risk of nephrotoxicity due to a decrease in prostacyclin synthesis in the kidneys. Thus, in patients receiving combination therapy, careful monitoring of renal function should be carried out. As with most NSAIDs, lornoxicam occasionally results in elevated serum transaminases, elevated bilirubin or other liver function parameters, and elevated serum creatinine, blood urea nitrogen, and other laboratory abnormalities. If there are any abnormalities, lornoxicam should be discontinued and appropriate investigations should be ordered. The use of lornoxicam, as well as any other drugs that can inhibit cyclooxygenase/prostaglandin synthesis, can affect fertility, so the drug is not recommended for women planning pregnancy. In women who have difficulty conceiving or who are being evaluated for reasons of infertility, discontinuation of lornoxicam treatment should be considered. In exceptional cases, chickenpox can cause serious infectious complications of the skin and soft tissues. To date, the contribution of NSAIDs to the exacerbation of these infections cannot be ruled out, so it is advisable to avoid the use of lornoxicam in case of chickenpox. Interaction with other drugs Simultaneous use of lornoxicam and cimetidine: increased plasma concentrations of lornoxicam (no interaction has been found between lornoxicam and ranitidine, or lornoxicam and antacids). . INR should be closely monitored. Phenprocoumon: decreased effect of action during treatment with phenprocoumon. Heparin: NSAIDs increase the risk of spinal or epidural hematoma when used simultaneously with heparin during spinal or epidural anesthesia (see section “Precautions”). angiotensin-converting enzyme inhibitors (ACE): antihypertensive effect of ACE inhibitors may decrease. Diuretics: decrease in diuretic and antihypertensive effect of loop diuretics, thiazide diuretics and potassium-sparing diuretics. beta-blockers: decrease in antihypertensive effect, angiotensin II receptor blockers: decrease in antihypertensive effect. Corticosteroids: increased risk of gastrointestinal ulcers and bleeding (see Precautions section). Quinolone antibiotics: increased risk of seizures. Antiplatelet drugs: increased risk of gastrointestinal bleeding (see section “Precautions”). other NSAIDs: increased risk of gastrointestinal bleeding. methotrexate: increased serum concentrations of methotrexate. As a result, the toxic effect of methotrexate may increase. If concomitant treatment with methotrexate is necessary, the patient should be closely monitored. Selective serotonin reuptake inhibitors: increased risk of gastrointestinal bleeding (see Precautions section). Lithium: NSAIDs suppress the renal clearance of lithium, which can lead to an increase in serum concentration lithium above the limit of permissible toxicity. As a result, the level of lithium in the blood serum should be monitored, especially at the beginning of treatment, during the selection of the dose and the termination of therapy. Cyclosporine: an increase in the serum concentration of cyclosporine. The nephrotoxicity of cyclosporine may increase due to the mediated action of renal prostaglandins. With combined treatment, renal function should be monitored. Sulfonylureas (eg, glibenclamide): increased risk of hypoglycemia. Known inducers and inhibitors of CYP2C9 isoenzymes: lornoxicam (like other NSAIDs that are metabolized with the participation of cytochrome P450 2C9 (CYP2C9 isoenzyme), interacts with known inducers and inhibitors of CYP2C9 isoenzymes (see Pharmacokinetics section). reduce the renal clearance of pemetrexed, which leads to an increase in nephrotoxicity, gastrointestinal toxicity and myelosuppression. When Xefocam Rapid is taken with food, the absorption of lornoxicam slows down. As a result, Xefocam Rapid should not be taken with food if a rapid onset is required analgesic effect. Food can reduce drug absorption by approximately 20% and increase Tmax. Contraindications Hypersensitivity to the active substance of the drug or any of its components listed in the Composition section. Thrombocytopenia Hypersensitivity (symptoms including asthma, rhinitis, angioedema or urticaria) to other non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid Severe heart failure Gastrointestinal bleeding , cerebrovascular bleeding or bleeding of other origin Gastrointestinal bleeding or perforation in anamnesis associated with previous NSAID therapy Acute ulcer or repeated cases of duodenal ulcer / bleeding (two or more clear cases of proven ulceration or bleeding). Severe liver failure Severe renal failure (serum creatinine >700 µmol/l) Third trimester of pregnancy (see the Pregnancy and lactation section). Composition One film-coated tablet contains the active substance: Lornoxicam 8.0 mg. Overdose There is currently no experience of overdose to determine the effects of overdose or suggest special measures. However, the following symptoms can be expected in case of an overdose of lornoxicam: nausea, vomiting, cerebral symptoms (dizziness, blurred vision). Severe symptoms include ataxia leading to coma and seizures, liver and kidney damage, and possible bleeding disorders. In case of real or suspected overdose, the drug should be discontinued. Due to the short half-life, lornoxicam is rapidly eliminated from the body. Lornoxicam is not removed by dialysis. There is currently no specific antidote known. Routine emergency procedures, including gastric lavage, should be considered. Based on general principles, the use of activated charcoal only if it is taken immediately after taking lornoxicam can lead to a decrease in the absorption of the drug. Prostaglandin analogs and ranitidine can be used to treat gastrointestinal disorders. Side effects The most common adverse reactions of NSAIDs are reactions from the gastrointestinal tract. Possible development of peptic ulcers, perforation or gastrointestinal bleeding, in some cases, life-threatening, especially in elderly patients (see section “Precautions”). After the use of NSAIDs, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, vomiting of blood, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease were noted (see section “Precautions”). In more rare cases, gastritis developed. About 20% of patients taking lornoxicam may experience adverse reactions. When taking lornoxicam, the most common adverse reactions were nausea, dyspepsia, indigestion, abdominal pain, vomiting and diarrhea. In general, the available results of clinical studies indicate the development of these symptoms in less than 10% of patients. In the treatment of NSAIDs, cases of edema, arterial hypertension, and heart failure have been reported. Clinical studies and epidemiological data suggest that the use of certain NSAIDs (especially at high doses and in long-term treatment) may increase the risk of arterial thrombosis (eg, myocardial infarction or stroke) (see section “Precautions”). Chicken pox can rarely cause severe infectious complications of the skin and soft tissues. The following are data on adverse reactions that were detected in more than 0.05% of cases out of 6,417 patients after the use of the drug lornoxicam during phase II, III and IV clinical trials. Very often (?1/10); Common (?1/100 to <1/10); Uncommon (?1/1,000 to <1/100); Rare (?1/10,000 to <1/1,000); Very rare (<1/10,000), frequency unknown (cannot be estimated from the data obtained). Infectious and parasitic diseases Rare: pharyngitis. Blood and lymphatic system disorders Rare: anemia, thrombocytopenia, leukopenia, prolonged bleeding time. Very rare: extensive bleeding into the skin or mucous membranes (ecchymosis). Cases of severe disorders of the hematopoietic system, such as neutropenia, agranulocytosis, aplastic anemia and hemolytic anemia, caused by NSAIDs have been reported. Immune system disorders Rare: hypersensitivity, anaphylactoid and anaphylactic reactions. Metabolic and nutritional disorders Uncommon: anorexia, weight change. Psychiatric disorders Uncommon: insomnia, depression. Rare: confusion, irritability, agitation. Nervous system disorders Common: mild and transient headache, dizziness. Rare: drowsiness, paresthesia, dysgeusia, tremor, migraine. Very rare: aseptic meningitis in patients with SLE and mixed connective tissue diseases (see Precautions section). On the part of the organ of vision Infrequently: conjunctivitis. Rare: visual disturbances. On the part of the organ of hearing and labyrinth Rare: dizziness, tinnitus. Cardiac disorders Uncommon: palpitations, tachycardia, edema, heart failure. Vascular disorders Uncommon: hyperemia, edema. Rare: arterial hypertension, hot flashes, hemorrhage, hematoma. Respiratory, thoracic and mediastinal disorders Uncommon: rhinitis. Rarely: shortness of breath, cough, bronchospasm. Gastrointestinal disorders Common: nausea, abdominal pain, dyspepsia, diarrhea, vomiting. Infrequently: constipation, flatulence, belching, dry mouth, gastritis, stomach ulcer, pain in the upper abdomen, duodenal ulcer, ulcerative stomatitis. Rare: melena, hematemesis, stomatitis, esophagitis, gastroesophageal reflux, dysphagia, aphthous stomatitis, glossitis, perforated peptic ulcer, gastrointestinal bleeding. Liver and biliary tract disorders Uncommon: Increased liver function tests (ACT or ALT). Very rare: hepatotoxicity, which can manifest as liver failure, hepatitis, jaundice and cholestasis. Skin and subcutaneous tissue disorders Uncommon: rash, pruritus, hyperhidrosis, rash erythematous, urticaria and angioedema, alopecia. Rare: dermatitis and eczema, purpura. Very rare: edema and bullous reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis. Muscular, skeletal and connective tissue disorders Uncommon: arthralgia. Rare: bone pain, muscle spasm, myalgia. Renal and urinary tract disorders Rare: nocturia, urination disorders, elevated blood urea nitrogen and creatinine. Very rare: Lornoxicam may cause acute renal failure in patients with a history of impaired renal function, since the maintenance of renal blood flow depends on the level of renal prostaglandins (see section "Precautions"). The development of nephrotoxicity in various forms (including nephritis and nephrotic syndrome) is associated with the use of NSAIDs (class-specific effect). General disorders and reactions at the injection site Uncommon: malaise, swelling of the face. Rare: asthenia. Reporting Suspected Adverse Reactions It is important to report suspected adverse reactions after drug registrations in order to ensure continuous monitoring of the benefit-risk ratio of the medicinal product. If an adverse reaction occurs that is indicated in this package leaflet or not mentioned in it, patients are advised to contact their doctor. Medical professionals are encouraged to report any suspected adverse drug reactions to the Republican Unitary Enterprise "Center for Expertise and Testing in Health Care" (see section "Send information about adverse reactions to the address"). Storage conditionsStore at a temperature not exceeding 30°C. Keep out of the reach of children. Buy Xefokam Rapid pills p/o 8mg No. 6x1