Ksefokam lyophilized powder for injection vial 8mg N5
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Active ingredients
Lornoxicam
Release form
Lyophilisate
Composition
Tablets, film coated, composition (1 tab.): Active substance: lornoxicam - 8 mg adjuvants: magnesium stearate - 2 mg; Povidone K25 - 5 mg; croscarmellose sodium - 10 mg; cellulose - 85 mg; lactose monohydrate - 90 mg-sheath film: macrogol 6000 - 0.8 mg; titanium dioxide E171 - 1.6 mg; talc - 3.2 mg; hypromellose - 5.6 mg
Pharmacological effect
anti-inflammatory, analgesic, inhibiting COX
Pharmacokinetics
Lornoxicam is rapidly and almost completely absorbed from the gastrointestinal tract after oral administration. At the same time, Cmax in plasma is reached in approximately 1–2 hours. Eating reduces Cmax by 30% and increases Tmax to 2.3 hours. The absolute bioavailability of lornoxicam is 90–100%. Lornoxicam is present in plasma mainly in unchanged form and to a lesser extent in the form of a hydroxylated metabolite that does not possess pharmacological activity. The binding of lornoxicam with plasma proteins (mainly with the albumin fraction) is 99% and does not depend on its concentration. T1 / 2 averages 4 hours and does not depend on the concentration of the drug. Lornoxicam is completely metabolized in the liver. CYP2C9 isoenzyme is involved in metabolism. Approximately 1/3 of the metabolites excreted by the kidneys and 2/3 with bile. In elderly people, as well as in patients with renal or hepatic insufficiency, no significant changes in the pharmacokinetics of lornoxicam were found.
Indications
short-term treatment of pain syndrome of various origins, symptomatic therapy of rheumatic diseases (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, articular syndrome with exacerbation of gout, rheumatic soft tissue damage).
Contraindications
known hypersensitivity / allergy to lornoxic or one of the components of the drug, complete or incomplete combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs (including a history), hemorrhagic diathesis or blood clotting disorders, as well as patients undergoing surgery with a risk of bleeding or incomplete hemostasis, the period after coronary artery bypass surgery, erosive-ulcerative changes of the gastric mucosa or and the duodenum,active gastrointestinal bleeding; cerebrovascular or other bleeding, recurrent gastric ulcer or repeated gastrointestinal bleeding, gastrointestinal bleeding associated with taking NSAIDs, in history, inflammatory bowel disease (Crohn's disease, ulcerative colitis) in exacerbation phase, decompensated heart failure; or active liver disease, severe renal failure (serum creatinine level of more than 300 mcmol / l), progressive kidney disease, confirm Determined hyperkalemia, hypovolemia or dehydration, pregnancy, breastfeeding period, children age. With care: erosive-ulcerative lesions and bleeding from the gastrointestinal tract (in history); moderate renal failure; conditions after surgery; age over 65; body weight less than 50 kg; coronary heart disease; chronic heart failure; cerebrovascular diseases; dyslipidemia / hyperlipidemia; diabetes; peripheral arterial disease; smoking; Cl creatinine less than 60 ml / min; ulcerative lesions of the gastrointestinal tract in history; the presence of Helicobacter pylori infection; prolonged use of NSAIDs; alcoholism; severe somatic diseases; simultaneous administration of oral GCS (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel), SSRIs (including citalopram, fluoxetine, paroxetine, sertraline).
Dosage and administration
Inside, before eating, with a glass of water. In severe pain syndrome: the recommended dose - 8-16 mg / day, divided into 2-3 doses; the maximum daily dose is 16 mg. For inflammatory and degenerative rheumatic diseases: the recommended initial dose is 12 mg; The standard dose is 8–16 mg / day, depending on the patient’s condition. The duration of therapy depends on the nature and course of the disease. In diseases of the gastrointestinal tract, patients with impaired renal or liver function are recommended for elderly people (over 65) to use the minimum effective dose of the drug the shortest possible short course. The maximum daily dose is 12 mg divided overnight into 3 doses of 4 mg.
Side effects
Interaction with ranitidine and antacid preparations was not detected. Simultaneous use of the drug Ksefokam and: - Cimetidine - increases the plasma concentration of lornoxicam; - anticoagulants or platelet aggregation inhibitors - prolonged bleeding time is possible (increased risk of bleeding, MHO control is necessary); ACE inhibitors - can reduce their hypotensive effect; - diuretics - reduces the diuretic effect and hypotensive effect; - digoxin - reduces the renal clearance of digoxin; - quinolone a Tibacterials - increases the risk of convulsive syndrome; - other NSAIDs or GCS - increases the risk of gastrointestinal bleeding; - methotrexate - increases the concentration of methotrexate in serum; - SSRIs (eg citalopram, fluoxetine, paroxetine, sertraline) - increases the risk of gastrointestinal bleeding - lithium salts - can cause an increase in peak plasma lithium concentrations and thereby increase the known side effects of lithium; - cyclosporine - an increase in cyclosporine nephrotoxicity; - sul derivatives phonylurea - the hypoglycemic effect of the latter may increase; - alcohol, corticotropin, potassium preparations - the risk of side effects from the gastrointestinal tract increases; - cefamandol, cefoperazone, cefotetan, valproic acid - the risk of bleeding increases.
Overdose
On the part of the gastrointestinal tract and liver: dyspepsia, abdominal pain, dry mouth, stomatitis, nausea, vomiting, heartburn, diarrhea, esophagitis, gastritis, erosive and ulcerative lesions of the mucous membrane of the stomach and intestines, including with perforation and bleeding, constipation, flatulence, melena, abnormal liver function, elevated liver transaminases. On the nervous system: headache, dizziness, drowsiness, sleep disorders, depression, agitation, tremor, aseptic meningitis, paresthesias. On the skin side and subcutaneous fat: edematous syndrome, ecchymosis, skin rash, pruritus, urticaria, alopecia, Stevens-Johnson syndrome, Lyell's syndrome, angioedema. From the urinary system: dysuria, reduced GFR, interstitial nephritis, glomerulonephritis, papillary necrosis, nephrotic syndrome, peripheral edema,acute renal failure. For the sensory organs: tinnitus, blurred vision. For the CAS: development or aggravation of heart failure, tachycardia, increased blood pressure. . For respiratory organs: pharyngitis, rhinitis, dyspnea, cough, bronchospasm. Others: anorexia, increased sweating, weight change, arthralgia, myalgia.
Interaction with other drugs
Precautionary measures
special instructions
Symptoms: may increase the side effects of the drug Ksefokam described above. Treatment: symptomatic. Taking activated carbon immediately after taking the drug Ksefokam can help reduce the absorption of this drug. For the prevention of damage to the gastrointestinal tract mucosa, it is possible to prescribe anti-ulcer drugs.