Lornoxicam-Trivium, lyophilizate 8 mg 5 pcs

Pharmacotherapeutic group: Non-steroidal anti-inflammatory drug (NSAID).

ATX code: M01AC05

Indications

Short-term treatment of mild to moderate acute pain.

Symptomatic treatment of pain and inflammation associated with osteoarthritis.

Symptomatic
therapy of pain and inflammation due to rheumatoid arthritis.

Pharmacological effect

Pharmacotherapeutic group: Non-steroidal anti-inflammatory drug (NSAID).

ATX code: M01AC05

Special instructions

With caution

For the following disorders, the drug Lornoxicam – TRIVIUM®
should be prescribed only after a careful assessment of the expected benefits of therapy and the possible risks:

– Impaired renal function: mild (serum creatinine 150-300 µmol/l) and moderate (serum creatinine 300-700 µmol/l), since the maintenance of renal blood flow depends on the level of renal prostaglandins. Taking Lornoxicam – TRIVIUM® should be discontinued if renal function deteriorates during treatment.

– Monitoring of renal function should be carried out in patients who have undergone major surgery, patients with heart failure receiving diuretics, and in the case of the use of drugs with proven or suspected nephrotoxicity.

– Coagulation disorders: Close clinical observation and evaluation of laboratory parameters, such as activated partial thrombin time (aPTT), are recommended.

– Impaired liver function (liver cirrhosis): regular clinical observation and assessment of laboratory parameters should be carried out, since when treated with lornoxicam at a daily dose of 12-16 mg, drug accumulation is possible.

– Long-term treatment (more than 3 months): regular assessment of laboratory blood parameters (hemoglobin), kidney function (creatinine) and liver enzymes is recommended.

– Patients over 65 years of age: monitoring of liver and kidney function is recommended. Use with caution in elderly people in the postoperative period.

– Concomitant use with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.

– Adverse effects can be minimized by using the lowest effective dose of the drug for the shortest period of time sufficient to control symptoms.

– Gastrointestinal bleeding, ulcer, perforation, which have previously been noted with the use of all NSAIDs at any stage of treatment and can be fatal. Presence of Helicobacter pylori.

– History of gastrointestinal toxicity, particularly in old age.

– While taking medications such as oral glucocorticosteroids (for example, prednisolone), anticoagulants (for example, warfarin), selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine, paroxetine, sertraline) and antiplatelet drugs (for example, acetylsalicylic acid, clopidogrel).

– With the simultaneous use of NSAIDs and heparin during spinal and epidural anesthesia, the risk of developing hematoma increases.

– History of gastrointestinal pathology (ulcerative colitis, Crohn’s disease), as the patient’s condition may worsen.

– History of arterial hypertension and/or heart failure, as fluid retention and the development of edema were noted when using NSAIDs.

– In the presence of peripheral arterial diseases or cerebrovascular diseases, the presence of risk factors for the development of cardiovascular diseases, such as arterial hypertension, hyperlipidemia, diabetes mellitus, smoking, Lornoxicam – TRIVIUM® should be prescribed only after a thorough assessment of the expected benefits of therapy and the possible risks.

– Lornoxicam – TRIVIUM®, like other NSAIDs, may increase the risk of arterial thromboembolic complications (for example, myocardial infarction or stroke).

– The drug should be prescribed with caution to patients with active bronchial asthma or a history of asthma, since it is known that NSAIDs can provoke bronchospasm in such patients.

– In very rare cases, severe skin reactions that can be fatal can occur, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis.

– The use of the drug Lornoxicam – TRIVIUM®, like any drug that suppresses the synthesis of prostaglandins, can impair the ability to fertilize, therefore it is not recommended for use by women wishing to become pregnant.

– Patients with systemic lupus erythematosus (SLE) and mixed connective tissue diseases may be at increased risk of aseptic meningitis.

– Lornoxicam inhibits platelet aggregation and prolongs bleeding time, so it should be prescribed with caution if there is an increased tendency to bleeding.

– Concomitant use of NSAIDs and tacrolimus may lead to an increased risk of nephrotoxicity due to inhibition of prostacyclin synthesis in the kidneys.

– It is recommended to avoid the use of lornoxicam for infections caused by varicella zoster virus.

The drug should not be used simultaneously with other NSAIDs.

The risk of gastrointestinal bleeding, ulceration, or perforation increases with increasing doses of NSAIDs in patients with a history of gastric ulcer, especially if it is accompanied by complications such as bleeding or perforation in the elderly. Such patients should begin treatment with the lowest possible dose of the drug. In such patients, as well as in patients who require concomitant use of low-dose acetylsalicylic acid or other drugs that may increase the risk of adverse gastrointestinal events, concomitant administration of drugs that have a protective effect (for example, misoprostol or proton pump inhibitors) is indicated.

Regular monitoring is recommended. If signs of liver damage appear (itching, yellowing of the skin, nausea, vomiting, abdominal pain, dark urine, increased levels of “liver transaminases”), you should stop taking the drug and consult your doctor.

The drug can change the properties of platelets, but does not replace the preventive effect of acetylsalicylic acid in cardiovascular diseases.

Impact on the ability to drive vehicles and machinery

Patients who experience dizziness and/or drowsiness during treatment with lornoxicam should refrain from driving or operating machinery.

Active ingredient

Lornoxicam

Composition

One bottle of lyophilisate contains:

Active ingredient:

lornoxicam – 8.0 mg

Excipients:

mannitol – 100.0 mg, trometamol – 12.0 mg, disodium edetate – 0.2 mg.

One ampoule with solvent contains:

Water for injections – 2 ml.

Pregnancy

Due to the lack of data on the use of the drug Lornoxicam – TRIVIUM® during pregnancy and lactation, the drug should not be used.

Inhibition of prostaglandin synthesis may have adverse effects on pregnancy and/or fetal development.

The use of prostaglandin synthesis inhibitors in early pregnancy increases the risk of miscarriage or the development of heart disease. The risk is considered to be proportional to the dose and duration of treatment.

The administration of prostaglandin synthesis inhibitors 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 the development of pulmonary hypertension), as well as impaired renal function and, consequently, a decrease in amniotic fluid. Late use may cause prolongation of bleeding time in the mother and fetus, as well as suppression of uterine contractility, which may delay or prolong labor.

Contraindications

– hypersensitivity to lornoxicam or any of the excipients;

– complete or incomplete combination of bronchial asthma, recurrent nasal polyposis or paranasal sinuses, rhinitis, angioedema, urticaria and intolerance to acetylsalicylic acid and other NSAIDs (including a history);

– thrombocytopenia;

– hemorrhagic diathesis or bleeding disorders, as well as those who have undergone operations associated with the risk of bleeding or incomplete hemostasis;

– the period after coronary artery bypass grafting;

– decompensated heart failure;

– erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding; cerebrovascular or other bleeding;

– a history of gastrointestinal bleeding or perforation of an ulcer associated with taking NSAIDs;

– active peptic ulcer or history of recurrent peptic ulcer;

– inflammatory bowel diseases (Crohn’s disease, ulcerative colitis) in the acute phase;

– severe liver failure;

– severe renal failure (serum creatinine level more than 700 µmol/l), progressive kidney disease, confirmed hyperkalemia;

– pregnancy and breastfeeding;

– patients under the age of 18 years (due to insufficient clinical experience).

Side Effects

In each particular category, side effects are grouped by system-organ class and presented in descending order of frequency: very often (≥ 1/10); often (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000), unknown (cannot be estimated based on available data).

Infectious and parasitic diseases

Rarely: pharyngitis.

Blood and lymphatic system disorders

Rarely: anemia, thrombocytopenia, leukopenia, increased bleeding time.

Very rare: ecchymosis. NSAIDs have been reported to cause potentially severe hematological disorders, such as neutropenia, agranulocytosis, aplastic anemia and hemolytic anemia (class-specific effects).

Immune system disorders

Rarely: hypersensitivity, anaphylactoid and anaphylactic reactions.

Metabolic and nutritional disorders

Uncommon: anorexia, weight change.

Mental disorders

Uncommon: sleep disturbance, depression.

Rarely: confusion, nervousness, agitation.

Nervous system disorders

Often: short-term headaches of low intensity, dizziness.

Rarely: somnolence, paresthesia, taste disturbance, tremor, migraine.

Very rare: aseptic meningitis in patients with SLE and mixed connective tissue diseases.

Visual disorders

Uncommon: conjunctivitis.

Rarely: visual disturbances.

Hearing and labyrinth disorders

Uncommon: dizziness, tinnitus.

Heart disorders

Uncommon: palpitations, tachycardia, edema, heart failure.

Vascular disorders

Uncommon: flushing of the face, swelling.

Rarely: arterial hypertension, bleeding, hematoma.

Respiratory, thoracic and mediastinal disorders

Uncommon: rhinitis.

Rarely: dyspnea, cough, bronchospasm.

Gastrointestinal disorders

Common: nausea, abdominal pain, dyspepsia, diarrhea, vomiting.

Uncommon: constipation, flatulence, belching, dry mouth, gastritis, gastric ulcer, epigastric pain, duodenal ulcer, oral ulceration.

Rarely: 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, alanine aminotransferase (ALT) or aspartate aminotransferase (AST).

Rarely: liver dysfunction.

Very rare: damage to hepatocytes. Hepatotoxicity, which can lead to liver failure, hepatitis, jaundice and cholestasis.

Skin and subcutaneous tissue disorders

Uncommon: rash, itching, sweating, erythematous rash, urticaria, Quincke’s edema, alopecia.

Rarely: dermatitis and eczema, purpura.

Very rare: edema, bullous reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Musculoskeletal and connective tissue disorders

Uncommon: arthralgia.

Rarely: bone pain, muscle spasms, myalgia.

Renal and urinary tract disorders

Rarely: nocturia, urinary disorders, increased levels of urea and creatinine in the blood.

Very rare: In patients with pre-existing renal impairment who require renal prostaglandins to maintain renal blood flow, lornoxicam may precipitate acute renal failure. Nephrotoxicity in various forms, including nephritis and nephrotic syndrome, is a class-specific effect of NSAIDs.

General and administration site disorders

Uncommon: malaise, facial swelling.

Rarely: asthenia.

Interaction

Simultaneous use of the drug Lornoxicam – TRIVIUM®
And:

• cimetidine – increases the concentration of lornoxicam in plasma. No interactions with ranitidine and antacid drugs have been identified;

• anticoagulants or platelet aggregation inhibitors – possible increase in bleeding time (increased risk of bleeding, international normalized ratio (INR) monitoring is required);

• phenprocoumon – reduces the effectiveness of treatment with phenprocoumon;

• heparin – NSAIDs increase the risk of developing spinal/epidural hematoma when used simultaneously with heparin during spinal or epidural anesthesia;

• beta-blockers – reduces the antihypertensive effectiveness of angiotensin II receptor blockers;

• diuretics – reduces the diuretic effect and hypotensive effect of loop thiazide and potassium-sparing diuretics;

• digoxin – reduces the renal clearance of digoxin;

• quinolone antibiotics – increases the risk of developing convulsive syndrome;

• antiplatelet agents – increases the risk of gastrointestinal bleeding;

• other NSAIDs or glucocorticoids – increases the risk of gastrointestinal ulceration or bleeding;

• methotrexate – increases the serum concentration of methotrexate. This may lead to increased toxicity. If it is necessary to prescribe these drugs simultaneously, close monitoring of the patient is required;

• selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, paroxetine, sertraline) – increases the risk of gastrointestinal bleeding;

• lithium salts – NSAIDs inhibit the renal clearance of lithium ions, so serum lithium concentrations may exceed the toxicity limit. Therefore, constant monitoring of the level of lithium ions in the serum is necessary, especially during the initial stage of treatment, when changing the dose and stopping treatment;

• cyclosporine – increases the nephrotoxicity of cyclosporine;

• sulfonylurea derivatives – may enhance the hypoglycemic effect of the latter;

• cefamandole, cefoperazone, cefotetan, valproic acid – increases the risk of bleeding;

• substances that are inducers and inhibitors of the CYP2C9 cytochrome P450 isoenzyme: lornoxicam (like other NSAIDs metabolized by the CYP2C9 cytochrome P450 isoenzyme) – interacts with its inducers and inhibitors;

• tacrolimus – increases the risk of nephrotoxic effect due to inhibition of prostacyclin synthesis in the kidneys;

• pemetrexed – NSAIDs may reduce the renal clearance of pemetrexed, which leads to increased nephrotoxicity and gastrointestinal toxicity of the drug, as well as inhibition of hematopoiesis.

Overdose

Currently, there are no data on overdose that would allow us to assess its consequences or suggest specific treatment.

In case of an overdose of the drug Lornoxicam – TRIVIUM®, the following symptoms may be observed: nausea and vomiting, cerebral symptoms (dizziness, visual disturbances, ataxia leading to coma, and convulsions). Changes in liver and kidney function and blood clotting disorders are possible.

In case of overdose or suspected overdose, drug therapy should be stopped immediately. Due to its short half-life, lornoxicam is rapidly eliminated from the body. Dialysis is ineffective.

To date, the existence of a specific antidote is not known. Prostaglandin analogues or ranitidine may be used to treat gastrointestinal disorders.

Storage conditions

In a place protected from light at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life

3 years (for lyophilisate);

3 years (for solvent).

The prepared solution must be used within 24 hours.

Not
use after expiration date.

Manufacturer

Armavir biofactory FKP, Russia