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- International Nonproprietary Name - lornoxicam ATC Classification Code - M01AC05 Clinical-Pharmacological Group - Nonsteroidal anti-inflammatory drugs; Oxicams Composition and Dosage Form 10 tablets of 4 mg, 8 mg Pharmacological Action Lornoxicam is a nonsteroidal anti-inflammatory drug with a pronounced analgesic effect. The mechanism of action of lornoxicam is complex. It is based on the limitation of prostaglandin synthesis by suppressing the activity of the isoenzyme cyclooxygenase. In addition, lornoxicam suppresses the release of oxygen free radicals from activated leukocytes. The analgesic effect of lornoxicam is not associated with narcotic action. The drug Xefocam does not have an opioid effect on the CNS, unlike narcotic analgesics, it does not cause drug dependence and does not suppress respiration. See blog: Xefocam – a potent analgesic and anti-inflammatory drug Pharmacokinetics After oral administration, lornoxicam is rapidly and almost completely absorbed in the gastrointestinal tract, reaching maximum plasma concentration approximately 1-2 hours later. The absolute bioavailability of lornoxicam is 90-100%. Lornoxicam is mainly present in plasma in unchanged form, and rarely in the form of a hydroxylated metabolite, which does not have pharmacological activity. The binding of lornoxicam to plasma proteins, mainly the albumin fraction, is 99% and is independent of its concentration. The half-life is on average 4 hours and is independent of the drug concentration. Lornoxicam is completely metabolized. Approximately 1/3 of the metabolites are excreted from the body by the kidneys, and 2/3 by the liver. No significant changes in the pharmacokinetics of lornoxicam are observed in elderly patients and patients with renal or hepatic insufficiency. Indications - Moderate or severe pain syndrome; - Symptomatic treatment of pain and inflammation in inflammatory and degenerative rheumatic diseases. Dosage and Administration Parenteral Administration For moderate and severe pain syndrome, the recommended dose is 8-16 mg per day in 2-3 divided doses. The maximum daily dose is 16 mg. For inflammatory and degenerative rheumatic diseases, the recommended starting dose is 12 mg. The standard dose is 8-16 mg per day, depending on the patient's condition. The duration of treatment depends on the course and nature of the disease. Xefocam tablets should be taken before meals with a glass of water. For patients with gastrointestinal diseases, impaired renal or hepatic function, and elderly patients (over 65 years of age), the maximum daily dose of Xefocam is 12 mg per day (4 mg 3 times a day). Side Effects Gastrointestinal and hepatic: abdominal pain, diarrhea, dyspepsia, nausea, vomiting, rarely - flatulence, dry mouth, gastritis, esophagitis, peptic ulcers and/or gastrointestinal bleeding, impaired liver function (including rectal bleeding), stomatitis, glossitis, colitis, dysphagia, hepatitis, pancreatitis, impaired liver function. Allergic reactions: skin rash, hypersensitivity reactions with shortness of breath, tachycardia, bronchospasm, Stevens-Johnson syndrome, exfoliative dermatitis, angiitis, fever, allergic rhinitis, lymphadenopathy. CNS: rarely dizziness, headache, drowsiness, agitation, sleep disturbances, tinnitus, hearing impairment, dysarthria, hallucinations, migraine, peripheral neuropathy, syncopal condition, aseptic meningitis. Sensory organs: visual disturbances, conjunctivitis. Peripheral blood count and hemostasis system: rarely leukopenia, thrombocytopenia. Metabolism: rarely sweating, chills, body weight fluctuations. Cardiovascular system: rarely arterial hypertension, tachycardia, peripheral edema. Urinary system: rarely dysuria, in some cases glomerulonephritis, papillary necrosis and nephrotic syndrome progressing to acute renal failure, interstitial nephritis, crystalluria, polyuria. Contraindications Hypersensitivity/allergy to lornoxicam or any component of the preparation; History of hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs; Individuals with hemorrhagic diathesis or blood clotting disorders, as well as those who have undergone operations associated with incomplete hemostasis or risk of blood loss; Acute gastrointestinal bleeding; Exacerbation of gastric and duodenal ulcer disease, nonspecific ulcerative colitis; Severe hepatic impairment; Individuals with moderate or severe renal impairment (serum creatinine level > 300 µmol/L); Individuals with hypovolemia or dehydration; Individuals with confirmed or suspected cerebrovascular bleeding; Bronchial asthma; Heart failure; Hearing impairment; Glucose-6-phosphate dehydrogenase deficiency; Pregnancy and lactation; Age under 18 years. Use with caution in arterial hypertension and anemia. Xefocam should be used in patients with the following conditions only after careful assessment of the benefit/risk factor: Gastrointestinal bleeding, history of gastrointestinal ulcerations; Renal impairment, diabetes mellitus with impaired renal function. Special Instructions Like other nonsteroidal anti-inflammatory drugs, Xefocam may cause peptic ulcers and gastrointestinal bleeding. Treatment of patients with peptic ulcers with Xefocam may be carried out concurrently with H2-receptor antagonists and omeprazole. It should be noted that long-term treatment with Xefocam may slow down the healing process of peptic ulcers. In case of gastrointestinal bleeding, it is necessary to discontinue the drug and take appropriate emergency measures. Special attention should be paid to individuals with gastrointestinal pathology who are undergoing a course of treatment with Xefocam for the first time. Like other oxicams, Xefocam suppresses platelet aggregation and therefore may increase bleeding time. When using this drug, it is necessary to carefully monitor the condition of patients for whom normal functioning of the hemostasis system is essential (e.g., those preparing for surgery), those with impaired hemostasis, or those undergoing treatment that suppresses coagulation (including low doses of heparin) to detect signs of bleeding in a timely manner. For patients with severe renal impairment caused by massive bleeding or fluid loss, Xefocam, as a prostaglandin synthesis inhibitor, may be prescribed after avoiding hypovolemia and reducing the risk of associated renal perfusion. Like other nonsteroidal anti-inflammatory drugs, Xefocam may cause an increase in blood urea and creatinine levels, as well as water and sodium retention, peripheral edema, arterial hypertension, and other early signs of nephropathy. Long-term treatment of such patients with Xefocam may lead to glomerulonephritis, papillary necrosis, and nephrotic syndrome progressing to acute renal failure. Xefocam should not be prescribed to patients with severe renal impairment (see contraindications). Blood pressure control is necessary in elderly patients and patients with hypertension and/or overweight. Monitoring of renal function is particularly necessary for elderly patients and patients: who are simultaneously taking diuretics; who are simultaneously taking drugs that can cause kidney damage. During long-term treatment with Xefocam, periodic monitoring of hematological parameters and liver and kidney function is necessary. Patients should refrain from consuming alcohol and performing activities that require increased attention, rapid psychomotor reactions while taking Xefocam. Overdose Symptoms: possible intensification of the described side effects of Xefocam. Treatment: symptomatic. Administration of activated charcoal after taking Xefocam may reduce the absorption of this drug. Antacid preparations can be used to eliminate gastrointestinal disorders caused by Xefocam. Drug Interactions Pharmacodynamic: Concomitant administration of Xefocam and: Anticoagulants or platelet aggregation inhibitors: possible prolongation of bleeding time (increased risk of bleeding); Sulfonylureas: may increase the hypoglycemic effect of the latter; Other nonsteroidal anti-inflammatory drugs or glucocorticoids: increases the risk of side effects in the gastrointestinal tract; Diuretics: reduces diuretic and hypotensive effects; Beta-blockers and angiotensin-converting enzyme inhibitors: may reduce hypotensive effect; Enhances the action of fibrinolytics. The risk of side effects on the kidneys increases when using paracetamol, cyclosporine, gold preparations, and other nephrotoxic agents. Prostaglandin analogs or ranitidine: increases the risk of side effects in the gastrointestinal tract. Cefamandole, cefoperazone, cefotetan, valproic acid increase the risk of bleeding. Pharmacokinetic: Concomitant administration of Xefocam and: Lithium salts: may cause an increase in peak plasma lithium concentration and thus enhance lithium-induced side effects; Methotrexate: increases serum methotrexate concentration; Cimetidine: increases plasma lornoxicam concentration; Digoxin: reduces renal clearance of digoxin. Storage Conditions and Shelf Life Store at 15-25 °C. Keep out of reach of children. Shelf life Tablets 4mg: glass bottle and blister - 5 years. Tablets 8mg: glass bottle - 5 years and blister 5 years. Do not use after the expiry date. Dispensing from Pharmacy Available by prescription only.
- Active
- lornoxicam
What is it?
International Nonproprietary Name - lornoxicam ATC Classification Code - M01AC05 Clinical-Pharmacological Group - Nonsteroidal anti-inflammatory drugs; Oxicams Composition and Dosage Form 10 tablets of 4 mg, 8 mg Pharmacological Action Lornoxicam is a nonsteroidal anti-inflammatory drug with a pronounced analgesic effect. The mechanism of action of lornoxicam is complex. It is based on the limitation of prostaglandin synthesis by suppressing the activity of the isoenzyme cyclooxygenase. In addition, lornoxicam suppresses the release of oxygen free radicals from activated leukocytes. The analgesic effect of lornoxicam is not associated with narcotic action. The drug Xefocam does not have an opioid effect on the CNS, unlike narcotic analgesics, it does not cause drug dependence and does not suppress respiration. See blog: Xefocam – a potent analgesic and anti-inflammatory drug Pharmacokinetics After oral administration, lornoxicam is rapidly and almost completely absorbed in the gastrointestinal tract, reaching maximum plasma concentration approximately 1-2 hours later. The absolute bioavailability of lornoxicam is 90-100%. Lornoxicam is mainly present in plasma in unchanged form, and rarely in the form of a hydroxylated metabolite, which does not have pharmacological activity. The binding of lornoxicam to plasma proteins, mainly the albumin fraction, is 99% and is independent of its concentration. The half-life is on average 4 hours and is independent of the drug concentration. Lornoxicam is completely metabolized. Approximately 1/3 of the metabolites are excreted from the body by the kidneys, and 2/3 by the liver. No significant changes in the pharmacokinetics of lornoxicam are observed in elderly patients and patients with renal or hepatic insufficiency. Indications - Moderate or severe pain syndrome; - Symptomatic treatment of pain and inflammation in inflammatory and degenerative rheumatic diseases. Dosage and Administration Parenteral Administration For moderate and severe pain syndrome, the recommended dose is 8-16 mg per day in 2-3 divided doses. The maximum daily dose is 16 mg. For inflammatory and degenerative rheumatic diseases, the recommended starting dose is 12 mg. The standard dose is 8-16 mg per day, depending on the patient's condition. The duration of treatment depends on the course and nature of the disease. Xefocam tablets should be taken before meals with a glass of water. For patients with gastrointestinal diseases, impaired renal or hepatic function, and elderly patients (over 65 years of age), the maximum daily dose of Xefocam is 12 mg per day (4 mg 3 times a day). Side Effects Gastrointestinal and hepatic: abdominal pain, diarrhea, dyspepsia, nausea, vomiting, rarely - flatulence, dry mouth, gastritis, esophagitis, peptic ulcers and/or gastrointestinal bleeding, impaired liver function (including rectal bleeding), stomatitis, glossitis, colitis, dysphagia, hepatitis, pancreatitis, impaired liver function. Allergic reactions: skin rash, hypersensitivity reactions with shortness of breath, tachycardia, bronchospasm, Stevens-Johnson syndrome, exfoliative dermatitis, angiitis, fever, allergic rhinitis, lymphadenopathy. CNS: rarely dizziness, headache, drowsiness, agitation, sleep disturbances, tinnitus, hearing impairment, dysarthria, hallucinations, migraine, peripheral neuropathy, syncopal condition, aseptic meningitis. Sensory organs: visual disturbances, conjunctivitis. Peripheral blood count and hemostasis system: rarely leukopenia, thrombocytopenia. Metabolism: rarely sweating, chills, body weight fluctuations. Cardiovascular system: rarely arterial hypertension, tachycardia, peripheral edema. Urinary system: rarely dysuria, in some cases glomerulonephritis, papillary necrosis and nephrotic syndrome progressing to acute renal failure, interstitial nephritis, crystalluria, polyuria. Contraindications Hypersensitivity/allergy to lornoxicam or any component of the preparation; History of hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs; Individuals with hemorrhagic diathesis or blood clotting disorders, as well as those who have undergone operations associated with incomplete hemostasis or risk of blood loss; Acute gastrointestinal bleeding; Exacerbation of gastric and duodenal ulcer disease, nonspecific ulcerative colitis; Severe hepatic impairment; Individuals with moderate or severe renal impairment (serum creatinine level > 300 µmol/L); Individuals with hypovolemia or dehydration; Individuals with confirmed or suspected cerebrovascular bleeding; Bronchial asthma; Heart failure; Hearing impairment; Glucose-6-phosphate dehydrogenase deficiency; Pregnancy and lactation; Age under 18 years. Use with caution in arterial hypertension and anemia. Xefocam should be used in patients with the following conditions only after careful assessment of the benefit/risk factor: Gastrointestinal bleeding, history of gastrointestinal ulcerations; Renal impairment, diabetes mellitus with impaired renal function. Special Instructions Like other nonsteroidal anti-inflammatory drugs, Xefocam may cause peptic ulcers and gastrointestinal bleeding. Treatment of patients with peptic ulcers with Xefocam may be carried out concurrently with H2-receptor antagonists and omeprazole. It should be noted that long-term treatment with Xefocam may slow down the healing process of peptic ulcers. In case of gastrointestinal bleeding, it is necessary to discontinue the drug and take appropriate emergency measures. Special attention should be paid to individuals with gastrointestinal pathology who are undergoing a course of treatment with Xefocam for the first time. Like other oxicams, Xefocam suppresses platelet aggregation and therefore may increase bleeding time. When using this drug, it is necessary to carefully monitor the condition of patients for whom normal functioning of the hemostasis system is essential (e.g., those preparing for surgery), those with impaired hemostasis, or those undergoing treatment that suppresses coagulation (including low doses of heparin) to detect signs of bleeding in a timely manner. For patients with severe renal impairment caused by massive bleeding or fluid loss, Xefocam, as a prostaglandin synthesis inhibitor, may be prescribed after avoiding hypovolemia and reducing the risk of associated renal perfusion. Like other nonsteroidal anti-inflammatory drugs, Xefocam may cause an increase in blood urea and creatinine levels, as well as water and sodium retention, peripheral edema, arterial hypertension, and other early signs of nephropathy. Long-term treatment of such patients with Xefocam may lead to glomerulonephritis, papillary necrosis, and nephrotic syndrome progressing to acute renal failure. Xefocam should not be prescribed to patients with severe renal impairment (see contraindications). Blood pressure control is necessary in elderly patients and patients with hypertension and/or overweight. Monitoring of renal function is particularly necessary for elderly patients and patients: who are simultaneously taking diuretics; who are simultaneously taking drugs that can cause kidney damage. During long-term treatment with Xefocam, periodic monitoring of hematological parameters and liver and kidney function is necessary. Patients should refrain from consuming alcohol and performing activities that require increased attention, rapid psychomotor reactions while taking Xefocam. Overdose Symptoms: possible intensification of the described side effects of Xefocam. Treatment: symptomatic. Administration of activated charcoal after taking Xefocam may reduce the absorption of this drug. Antacid preparations can be used to eliminate gastrointestinal disorders caused by Xefocam. Drug Interactions Pharmacodynamic: Concomitant administration of Xefocam and: Anticoagulants or platelet aggregation inhibitors: possible prolongation of bleeding time (increased risk of bleeding); Sulfonylureas: may increase the hypoglycemic effect of the latter; Other nonsteroidal anti-inflammatory drugs or glucocorticoids: increases the risk of side effects in the gastrointestinal tract; Diuretics: reduces diuretic and hypotensive effects; Beta-blockers and angiotensin-converting enzyme inhibitors: may reduce hypotensive effect; Enhances the action of fibrinolytics. The risk of side effects on the kidneys increases when using paracetamol, cyclosporine, gold preparations, and other nephrotoxic agents. Prostaglandin analogs or ranitidine: increases the risk of side effects in the gastrointestinal tract. Cefamandole, cefoperazone, cefotetan, valproic acid increase the risk of bleeding. Pharmacokinetic: Concomitant administration of Xefocam and: Lithium salts: may cause an increase in peak plasma lithium concentration and thus enhance lithium-induced side effects; Methotrexate: increases serum methotrexate concentration; Cimetidine: increases plasma lornoxicam concentration; Digoxin: reduces renal clearance of digoxin. Storage Conditions and Shelf Life Store at 15-25 °C. Keep out of reach of children. Shelf life Tablets 4mg: glass bottle and blister - 5 years. Tablets 8mg: glass bottle - 5 years and blister 5 years. Do not use after the expiry date. Dispensing from Pharmacy Available by prescription only.