Index of drugs

Short-term treatment of mild to moderate acute pain.

1 tabl powl. contains 8 mg of lornoxicam.

A non-steroidal anti-inflammatory drug with analgesic activity from the oxicam group. It works by inhibiting the synthesis of prostaglandins (inhibition of cyclooxygenase activity) leading to a reduction in the sensitivity of peripheral nociceptors and a reduction in the severity of the inflammatory response. It is also possible to operate at the central nociceptors level, independent of the anti-inflammatory effect. Quickly and almost completely absorbed from the gastrointestinal tract, C_max occurs after approx. 30 min, bioavailability is 90-100%. It binds 99% of plasma proteins. It is extensively metabolised in the liver (mainly mediated by CYP2C9) to inactive 5-hydroxylornoxicam. In people with low CYP2C9 metabolism, there may be a significant increase in the concentration of the parent substance in the blood. It is excreted in faeces (50%) and urine (42%), mainly in the form of 5-hydroxylornoxicam. Medium T_0,5 in the elimination phase it is 3-4 hours.

Hypersensitivity to lornoxicam or to any of the excipients. Hypersensitivity (bronchial asthma, rhinitis, angioneurotic edema or urticaria) to other NSAIDs, including acetylsalicylic acid. Thrombocytopenia. Severe heart failure. Bleeding from the gastrointestinal tract, bleeding from cerebral vessels or other hemorrhagic complications. Perforation or gastrointestinal bleeding associated with NSAID therapy in the past. Active or recurrent peptic ulcer disease and / or duodenal ulceration, bleeding (at least 2-fold diagnosis of ulceration or bleeding). Severe liver dysfunction. Severe renal impairment (blood creatinine> 700 μmol / l). Third trimester of pregnancy.

The risk of bleeding, ulceration or perforation of the gastrointestinal tract increases with high doses of NSAIDs, in the elderly, in people with a history of peptic ulcer and / or duodenal ulceration, especially if it was complicated by bleeding or perforation, and in patients receiving concurrent other medicines that may increase the risk of stomach ulcers and / or duodenum or bleeding (such as oral corticosteroids, anticoagulants, selective serotonin reuptake inhibitors - SSRIs or antiplatelet agents, including low dose acetylsalicylic acid) - in these the patient groups require close medical supervision and special care, use the lowest effective dose of lornoxicam and consider combination therapy with gastroprotective drugs (eg misoprostol or proton pump inhibitors). Monitoring of clinical symptoms at regular intervals is recommended. The concomitant use of lornoxicam with other NSAIDs, including selective COX-2 inhibitors, is not recommended. Taking the medicine in the lowest effective dose and for the shortest time necessary to alleviate the symptoms reduces the risk of side effects. Particularly cautiously used in patients with mild renal impairment (creatinine blood level 150-300 μmol / l) to moderate (creatinine blood concentration 300-700 μmol / l), due to dependence of renal blood flow on prostaglandins; with bleeding disorders or bleeding tendency (control of clinical symptoms and laboratory tests, e.g. APTT); with liver dysfunction (risk of increased blood levels of the drug during treatment with doses of 12-16 mg / day, regularly monitor clinical symptoms and laboratory test results); at the age of> 65 years, especially in the postoperative period (monitor renal and hepatic function; in addition, these patients have an increased risk of adverse reactions, particularly bleeding and perforation of the gastrointestinal tract that may lead to death); with diseases of the gastrointestinal tract such as ulcerative colitis, Crohn's disease (risk of exacerbation of the course of the disease); with bronchial asthma currently or in history (risk of bronchospasm); with systemic lupus erythematosus or mixed connective tissue disease (risk of steroid inflammation of the meninges); with a history of hypertension or mild to moderate congestive heart failure (risk of fluid retention and edema).The results of clinical and epidemiological studies indicate that some NSAIDs (especially used for a long time in high doses) may slightly increase the risk of arterial blockages (eg, myocardial infarction or cerebrovascular accident); limited clinical data available do not allow to exclude such a risk when using lornoxicam. Treatment with lornoxicam can only be started after a careful analysis of the indications in patients with uncontrolled hypertension, congestive heart failure, stable ischemic heart disease, peripheral and / or cerebral vascular disease. Consideration should also be given to indications for long-term treatment, in patients with a risk factor for cardiovascular disease (e.g. hypertension, hyperlipidemia, diabetes, and smoking). Monitoring of renal function is indicated in patients who have undergone extensive surgery and have been diagnosed with heart failure treated with diuretics or with medicines with a presumed or confirmed kidney injury. In patients treated for a long time (> 3 months) morphology (hemoglobin), renal function (creatinine) and liver enzymes should be monitored regularly. The use of lornoxicam should be discontinued if abnormal liver function tests of the liver, kidneys or other indicators persist in laboratory tests; if there is a gastrointestinal haemorrhage or ulcer; and also after the first signs of hypersensitivity, such as skin rash, mucosal changes. Avoid using lornoxicam in the case of chickenpox (a risk of severe complications of skin and soft tissue infections). The use of lornoxicam in children and adolescents <18 years is not recommended (no data on safety and efficacy).

Do not administer lornoxicam in the first and second trimesters of pregnancy, unless it is absolutely necessary (the risk of miscarriages and the occurrence of congenital heart defects in the fetus, the increase in risk is affected by the increase in the dose and duration of treatment). Use in the third trimester of pregnancy is contraindicated (in the fetus the drug may cause pulmonary hypertension with premature closure of the ductus arteriosus and renal dysfunction, in the mother and newborn can prolong the bleeding time, in the mother can inhibit the contractility of the uterus resulting in prolonged delivery). Do not use during breastfeeding (no data on the transfer of the drug to breast milk). The use of lornoxicam may impair female fertility - in the case of women who have difficulty conceiving or who have been tested for infertility, end of lornoxicam should be considered; not recommended for women who plan to become pregnant.

The most commonly reported adverse reactions are gastrointestinal ulceration, perforation or bleeding, which can sometimes be fatal, especially in the elderly. Common: mild, transient headaches, dizziness, nausea, abdominal pain, indigestion, diarrhea, vomiting. Uncommon: anorexia, weight change, insomnia, depression, conjunctivitis, labyrinthine dizziness, tinnitus, palpitations, tachycardia, edema, heart failure, flushing, nasal inflammation, constipation, bloating, flipping gastric or gas content, dry mouth, gastritis, gastric ulcer, epigastric pain, duodenal ulcer, ulceration of the oral mucosa, increased liver enzymes, rash, pruritus, hyperhidrosis, erythematous rash, urticaria, edema vasomotor, baldness, joint pain, malaise, facial swelling. Rarely: pharyngitis, anemia, thrombocytopenia, leukopenia, prolonged bleeding, hypersensitivity, allergic reactions, anaphylaxis, confusion, agitation, drowsiness, paresthesia, dysgeusia, tremor, migraine, visual disturbances, hypertension, hot flushes, haemorrhage, hematoma, shortness of breath, cough, bronchospasm, tarry stools, bloody vomiting, oral mucositis, esophagitis, gastroesophageal reflux, difficulty in swallowing, aphthous stomatitis, tongue inflammation, perforation of peptic ulcer, hemorrhage from the digestive tract, dermatitis, eczema, purpura, bone pain,cramps and muscle pain, urination disorders, urination at night, increased urea nitrogen and creatinine concentration in the blood, weakness. Very rare: ecchymosis, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia, idiopathic meningitis in patients with systemic lupus erythematosus and mixed connective tissue disease, hepatotoxicity (manifested, for example, by liver dysfunction, hepatitis, jaundice and cholestasis ), bladder and edema reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, acceleration of acute renal failure in patients who are dependent on prostaglandins to maintain renal blood flow. Nephrotoxicity has been reported, including nephritis and nephrotic syndrome characteristic of NSAIDs. Some NSAIDs (especially long-term and high-dose doses) may increase the risk of arterial blockages (e.g., cardiac arrest or cerebrovascular accident). Exceptionally, severe, complicated infection of the skin and soft tissues may occur when suffering from chickenpox. There may also be an exacerbation of the course of colitis and Crohn's disease.

Orally. Acute pain: 8-16 mg (in doses of 8 mg); on the first day of treatment, an initial dose of 16 mg is given, and then after 8 hours an additional 8 mg can be given; after the first day of treatment, the maximum recommended dose is 16 mg / day.Special groups of patients. No dose adjustment is required in patients> 65 years of age with normal liver and kidney function. In patients with impaired liver or kidney function, it is recommended to reduce the frequency of administration to once daily administration.Way of giving. The tablets should be taken with water. When a rapid onset of action is required (regression of pain), the drug should not be taken with food, because it delays the absorption of the drug.