Instructions for using Lornoxicam tablets and injections to relieve joint pain


Brief description of the drug

Lornoxicam is a medicine for quickly relieving pain and inflammatory processes in the body. Available in tablet form, as well as in powder form for preparing a solution for injection. Before using the drug, you need to carefully study its adverse reactions, contraindications and exact dosage.

ATX code

M01AC05

Active substance

Lornoxicam

Trade name of the drug

Lornoxicamum

Pharmacotherapeutic group

Nonsteroidal anti-inflammatory drug (NSAID)

Release form

Lyophilisate for the preparation of a solution for intravenous and intramuscular administration, 8 mg. An amount of the drug containing 8 mg of the active substance is placed in 10 ml light-protective glass bottles, sealed with rubber stoppers and rolled in aluminum caps. 5 bottles each in a blister pack made of polyvinyl chloride film and aluminum foil or without foil. 1 blister pack along with instructions for use of the drug is placed in a cardboard pack.

tablet form under the trade name Xefocam. 4 mg and 8 mg film-coated tablets, oblong, oval, white to yellowish in color, smooth on both sides (for 4 mg dosage) Film-coated tablets, oblong, oval, white to yellowish in color, embossed “L8” " on one side and smooth on the other side (for a dosage of 8 mg).


Packaging of Lornoxicam

Compound

1 bottle contains:

  • lornoxicam – 8.0 mg;
  • mannitol (mannitol) – 100.0 mg;
  • trometamol – 12.0 mg;
  • disodium edetate (disodium salt of ethylenediaminetetraacetic acid dihydrate) – 0.2 mg;
  • sodium hydroxide – up to pH 8.0-9.5.

One tablet contains:

  • lornoxicam 4 mg or 8 mg;
  • lactose monohydrate;
  • microcrystalline cellulose;
  • povidone;
  • croscarmellose sodium;
  • magnesium stearate;
  • opadry white 03F58750.*

* white opadry 03F58750: talc, polyethylene glycol, hydroxypropyl methylcellulose, titanium dioxide (E 171).

Manufacturer

Nycomed Austria (Austria)

Release form and packaging

The manufacturer of the drug is the Austrian pharmaceutical company Nycomed Austria.

Lornoxicam is a drug available in the form of:

  • tablets packed in blister packs (called Xefocam or Xefocam Rapid);
  • dry powder (lyophilisate) intended for the preparation of an injection solution. The powder is colored yellow and packaged in dark glass bottles (10 ml), closed with a rubber stopper and sealed with an aluminum cap. Five bottles are combined into one cell, which, in turn, is packed in a cardboard box. The delivery set includes a solvent.

Lornoxicam powder

Pharmacodynamics: mechanism of action and therapeutic effect

Lornoxicam is a non-steroidal anti-inflammatory drug, has a pronounced analgesic and anti-inflammatory effect, belongs to the class of oxicams.

The mechanism of action is associated with the suppression of inflammatory factors; inhibition of prostaglandin synthesis due to inhibition of COX1 and COX2, which leads to disruption of arachidonic acid metabolism and inhibition of prostaglandin synthesis both in the site of inflammation and in healthy tissues. Suppresses the exudative and proliferative phases of inflammation.

  • Lornoxicam does not affect the main indicators of the body's condition: body temperature, heart rate (HR), blood pressure (BP), electrocardiogram (ECG) data, spirometry. The analgesic effect of lornoxicam is not associated with narcotic effects.
  • The drug Lornoxicam does not have an opiate-like effect on the central nervous system (CNS) and, unlike narcotic analgesics, does not depress respiration and does not cause drug dependence.
  • Due to the presence of a local irritant effect on the gastrointestinal tract (GIT) and a systemic ulcerogenic effect associated with the suppression of prostaglandin synthesis, gastrointestinal complications are common undesirable effects during treatment with non-steroidal anti-inflammatory drugs.


Lornoxicam has an analgesic effect

Pharmacological properties

Pharmacodynamics

Lornoxicam is an NSAID belonging to the oxicam class. The mechanism of action of the drug is based on the suppression of prostaglandin production - inhibition of the enzyme cyclooxygenase (COX), leading to the elimination of inflammation. Lornoxicam does not affect vital signs of the body, such as blood pressure (BP), heart rate (HR), body temperature, electrocardiogram (ECG) data, spirometry. The analgesic effect of the active substance is not due to narcotic effects. The drug does not demonstrate opiate-like effects on the central nervous system (CNS) and, unlike narcotic analgesics, does not lead to drug dependence and does not depress breathing.

As a result of the existing systemic ulcerogenic effect and local irritant effect on the mucous membrane of the gastrointestinal tract (GIT), associated with inhibition of prostaglandin production, NSAID therapy often leads to gastrointestinal complications.

Pharmacokinetics

With intramuscular administration in the blood plasma, the maximum concentration (Cmax) of lornoxicam is observed on average 0.4 hours after injection. Absolute bioavailability, calculated from the area under the concentration-time curve (AUC), after intramuscular administration is 97%.

Lornoxicam is detected in blood plasma unchanged and in the form of a hydroxylated metabolite. The active substance binds to plasma proteins by approximately 99%, regardless of its concentration.

The drug is metabolized primarily in the liver, mainly through the process of hydroxylation to inactive 5-hydroxylornoxicam. Biotransformation of the active substance is carried out with the participation of the CYP2C9 isoenzyme. Due to genetic polymorphism affecting this enzyme, slow and rapid metabolism of lornoxicam is possible, as a result of which a significant increase in plasma drug levels may occur in individuals with slow metabolism. The hydroxylated metabolite does not exhibit pharmacological activity.

Lornoxicam is completely metabolized: approximately ⅔ of the drug is excreted by the liver, and ⅓ in the form of an inactive derivative by the kidneys. The half-life (T½) can vary from 3 to 4 hours.

No significant changes in the kinetics of lornoxicam were found in patients with renal impairment.

In patients with chronic liver diseases, after 7 days of using the drug at a daily dose of 12–16 mg, its cumulation was detected.

In patients over 65 years of age, the clearance of lornoxicam is reduced by 30–40%.

Pharmacokinetics of Lornoxicam

  • Suction

The maximum concentration (Cmax) of lornoxicam in blood plasma after intramuscular (IM) administration is reached after approximately 0.4 hours.

Absolute bioavailability (calculated by AUC - area under the concentration-time curve) after intramuscular administration is 97%.

  • Distribution

Lornoxicam is found in blood plasma unchanged and as a hydroxylated metabolite. The degree of binding of lornoxicam to plasma proteins is about 99% and does not depend on concentration.

  • Biotransformation

Lornoxicam is extensively metabolized in the liver, mainly through hydroxylation to inactive 5-hydroxylornoxicam. Biotransformation of lornoxicam is carried out through the CYP2C9 isoenzyme.

Due to polymorphisms in the gene encoding this enzyme, there are slow and rapid metabolizers of the drug, which can lead to a significant increase in plasma levels of lornoxicam in slow metabolizers.

The hydroxylated metabolite has no pharmacological activity. Lornoxicam is completely metabolized: approximately 2/3 of the drug is excreted by the liver, and 1/3 by the kidneys in the form of an inactive metabolite.

  • Removal

The half-life (T1/2) of lornoxicam averages 3 to 4 hours.

In elderly people (over 65 years of age), drug clearance is reduced by 30-40%.

In patients with impaired liver or kidney function, no significant changes in the kinetics of lornoxicam are observed, with the exception of accumulation in patients with chronic liver disease after 7 days of treatment at a daily dose of 12 mg or 16 mg.

Compound

The composition of the powder contained in one bottle includes:

  • the main active ingredient is lornoxicam in an amount of 8 mg;
  • excipients: trometamol, mannitol, sodium hydroxide, disodium edetate.

If we talk about tablet form, then one tablet may contain 8 or 16 mg of the main substance. Auxiliary components – lactose, magnesium stearate, cellulose, hypromellose, croscarmellose sodium, polyvidone K25, talc, titanium dioxide.

Indications for use

  • rheumatoid arthritis;
  • osteoarthritis;
  • ankylosing spondylitis;
  • articular syndrome during exacerbation of gout;
  • bursitis;
  • tenosynovitis;
  • moderate and severe pain syndrome (including arthralgia, myalgia, neuralgia, lumbago, sciatica, migraine, toothache and headache, algodismenorrhea, pain from injuries, burns;
  • febrile syndrome (for colds and infectious diseases).


Rheumatoid arthritis is one of the indications for the use of Lornoxicam

Nosological classification (ICD-10)

  • M06.9 Rheumatoid arthritis, unspecified
  • M10 Gout
  • M13.9 Arthritis, unspecified
  • M15-M19 Arthrosis
  • M25.5 Joint pain
  • M54.3 Sciatica
  • R52.1 Persistent, intractable pain
  • R52.2 Other persistent pain

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;
  • period after coronary artery bypass surgery;
  • 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 ulcer perforation 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).


In case of renal failure, the use of Lornoxicam is limited

Use with caution

For the following disorders, Lornoxicam 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. Lornoxicam 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 monitoring 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.
  • Undesirable 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 were previously 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 corticosteroids (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 disease or cerebrovascular disease, the presence of risk factors for the development of cardiovascular diseases, such as arterial hypertension, hyperlipidemia, diabetes mellitus, smoking, Lornoxicam should be prescribed only after a thorough assessment of the expected benefits of therapy and the possible risks.
  • Lornoxicam, like other NSAIDs, may increase the risk of arterial thromboembolic events (eg, 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 Lornoxicam, like any drug that inhibits the synthesis of prostaglandins, may 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 bleed.
  • 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 varicella-zoster virus infections.

If you have one of the listed diseases, be sure to consult your doctor before taking the drug.


Before using Lornoxicam, you should consult your doctor.

For impaired renal function

The use of the drug is contraindicated in patients with severe renal failure (with a serum creatinine level of more than 700 µmol/l), progressive kidney disease, confirmed hyperkalemia.

Patients with mild (with serum creatinine 150–300 µmol/l) and moderate (with serum creatinine 300–700 µmol/l) functional impairment of the kidneys should be treated with the drug with caution and, if necessary, adjust the dose, since it is especially important to maintain renal blood flow The level of renal prostaglandins is important. Treatment with Lornoxicam should be discontinued if deterioration in renal function is detected.

Treatment regimen and dosage regimen

The method of administration and dosage regimen of a particular drug depend on its release form and other factors. The optimal dosage regimen is determined by the doctor. The compliance of the dosage form of a particular drug with the indications for use and dosage regimen should be strictly observed.

Pills

When taken orally - 4 mg 2-3 times/day or 8 mg 2 times/day. Maximum daily doses:

  • in the absence of relative contraindications - 16 mg;
  • for concomitant diseases of the gastrointestinal tract, impaired renal or liver function, elderly patients (over 65 years old), with a body weight of less than 50 kg, as well as after extensive surgery - 12 mg in 3 doses.

Lyophilisate

IV or IM initial dose is 8-16 mg. If the analgesic effect at a dose of 8 mg is insufficient, another 8 mg can be reintroduced. The daily dose should not exceed 16 mg.

Solution for injection is prepared by dissolving the contents of one vial (8 mg of lornoxicam) with water for injection (2 ml). After preparing the solution, the needle is replaced.

The solution prepared in this way is administered intravenously or intramuscularly for postoperative pain and intramuscularly for an acute attack of lumbago/ischialgia. Intramuscular injections are made with a long needle.

The duration of intravenous administration of the solution should be at least 15 seconds, intramuscular - at least 5 seconds.

The minimum effective dose should be used for the shortest possible course.

Instructions for use

The tablet form of the drug is prescribed exclusively for oral administration in the indicated dosage. The standard therapeutic course lasts no longer than 10 days, provided there are no negative reactions. It is recommended to take no more than 3 times a day at a dosage of 4 mg.

In severe conditions, treatment with 8 mg tablets up to 3 times a day for 7 days is allowed. As a rule, this time is enough to eliminate acute symptoms and improve the patient's condition. Further, it is allowed to take 8 mg daily as maintenance therapy, but not longer than 10 days in a row.

Injections are made only in a hospital setting, since independent use often provokes the formation of a painful lump in the injection area. The classic scheme involves a daily injection using 1 bottle of powder and 10-20 ml of 0.9% saline solution. Such proportions are used for intravenous administration, which is carried out slowly.

If the drug is administered intramuscularly, 4-5 ml of water for injection or saline is sufficient. It is important to shake the bottle well before putting the medicine into the syringe and wait until the powder is completely dissolved. This process is quite lengthy, since the substance is difficult to dissolve.

The powder turns the water bright yellow, and the finished liquid has several bubbles. This is not air, and it is almost impossible to get rid of them. The bubbles resemble yellow flakes. It is also worth administering the medicine intramuscularly slowly.

In some cases, the powder is used for drip infusion, dissolving it in a 0.9% sodium chloride bottle, the volume of which is 200 ml. As a rule, this requires 2 ampoules of the drug. Similar procedures are prescribed to patients with severe pain.

The course of therapeutic action is 7-10 days, taking into account the patient’s condition and concomitant pathologies. It is usually not recommended to use additional analgesics during this period.

Overdose

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

However, if the maximum daily dose is exceeded, the following symptoms may occur: 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.

If an overdose is suspected, 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.


An overdose of Lornoxicam may cause digestive disorders.

For liver dysfunction

Treatment with the drug is contraindicated in patients with severe liver failure.

Patients with mild to moderate liver dysfunction (including cirrhosis) require clinical monitoring and regular evaluation of laboratory tests during therapy. For moderate liver dysfunction, a dose change may be required. Adverse effects can be minimized by using the lowest effective dose for the shortest period required to control symptoms.

Side effects

Undesirable disorders from systems and organs when taking Lornoxicam (classified as follows: very often - ≥ 1/10, often - ≥ 1/100 and < 1/10, infrequently - ≥ 1/1000 and < 1/100, rarely - ≥ 1/10,000 and <1/1000, extremely rarely - <1/10,000, including isolated cases):

  • infectious and parasitic diseases: rarely – pharyngitis;
  • blood and lymphatic system: rarely - increased bleeding time, thrombocytopenia, anemia, leukopenia; extremely rarely - ecchymosis; there are reports that NSAIDs can lead to the development of potentially severe hematological disorders, such as agranulocytosis, neutropenia, aplastic anemia, hemolytic anemia (class-specific effects);
  • immune system: rarely - hypersensitivity reactions, anaphylactic and anaphylactoid reactions;
  • metabolism and nutritional disorders: infrequently – weight change, anorexia;
  • nervous system: often – short-term headaches of low intensity, dizziness; rarely - taste disturbance, paresthesia, tremor, somnolence, migraine; extremely rarely - aseptic meningitis in patients with mixed connective tissue lesions and SLE;
  • mental disorders: infrequently – sleep disturbance, depression; rarely – anxiety, nervousness, confusion;
  • organ of vision: infrequently – conjunctivitis; rarely - visual disturbances;
  • organ of hearing and labyrinthine disorders: infrequently – tinnitus, dizziness;
  • cardiovascular system: infrequently - flushing, palpitations, edema, tachycardia, heart failure; rarely – hematoma, bleeding, arterial hypertension;
  • respiratory system, chest and mediastinal organs: infrequently – rhinitis; rarely – cough, dyspnea, bronchospasm;
  • digestive tract: often - abdominal pain, nausea, dyspepsia, vomiting, diarrhea; uncommon – pain in the epigastric region, dry mouth, belching, flatulence, constipation, ulcerations in the oral cavity, gastritis, duodenal ulcer, gastric ulcer; rarely - stomatitis, glossitis, aphthous stomatitis, hematemesis, melena, esophagitis, dysphagia, gastroesophageal reflux, gastrointestinal bleeding, perforated peptic ulcer;
  • liver and biliary tract: infrequently - an increase in liver function tests, aspartate aminotransferase (AST) or alanine aminotransferase (ALT); rarely - liver dysfunction; extremely rarely - damage to hepatocytes; hepatotoxicity may cause liver failure, hepatitis, jaundice and cholestasis;
  • skin and subcutaneous tissues: uncommon - sweating, itching, rash, urticaria, alopecia, erythematous rash, Quincke's edema; rarely – dermatitis, purpura, eczema; extremely rarely - edema, Stevens-Johnson syndrome, bullous reactions, toxic epidermal necrolysis (sometimes fatal);
  • musculoskeletal and connective tissue: uncommon – arthralgia; rarely – muscle spasms, bone pain, myalgia;
  • kidneys and urinary tract: rarely - urinary disorders, nocturia, increased creatinine and urea levels in the blood; extremely rarely - in the presence of impaired renal function, against which renal prostaglandins are required to maintain renal blood flow, lornoxicam can cause acute renal failure (various forms of nephrotoxicity, including nephritis and nephrotic syndrome, are a class-specific effect of NSAIDs);
  • general disorders and disorders at the injection site: infrequently - facial swelling, malaise; rarely - asthenia.

If any of the above adverse reactions worsen, or other disturbances occur, you should consult a doctor.


Sleep disturbances may occur as side effects from taking Lornoxicam.

Lornoxicam tablets 8 mg No. 10 in Kyzylorda

Instructions for medical use of the drug Lornoxicam Viva Pharm
Trade name Lornoxicam Viva Pharm

International nonproprietary name Lornoxicam

Dosage form Film-coated tablets, 4 mg and 8 mg

Composition One film-coated tablet contains the active substance - lornoxicam 4 mg or 8 mg, excipients: magnesium stearate, povidone, croscarmellose sodium, microcrystalline cellulose, lactose monohydrate, shell composition: Opadry white OY-S-28924 (hypromellose, titanium dioxide (E171), polyethylene glycol/macrogol).

Description Tablets are round in shape with a biconvex surface, coated in white or almost white, with a score on one side (for a dosage of 4 mg). Round tablets with a biconvex surface, white or almost white coated (for a dosage of 8 mg).

Pharmacotherapeutic group Musculoskeletal system. Anti-inflammatory and antirheumatic drugs. Anti-inflammatory and antirheumatic drugs, non-steroidal. Oxycams. Lornoxicam. ATX code M01AC05

Pharmacological properties Pharmacokinetics Lornoxicam is rapidly and almost completely absorbed from the gastrointestinal tract (GIT) after oral administration. In this case, the maximum concentration in plasma (Cmax) is reached after approximately 1 - 2 hours. Eating reduces the maximum concentration (Cmax) by 30% and increases the time to reach the maximum concentration (Tmax) to 2.3 hours. The absolute bioavailability of lornoxicam is 90–100%. Lornoxicam is present in plasma unchanged and also in the form of a hydroxylated metabolite, which has no pharmacological activity. The degree of binding to plasma proteins is 99% and does not depend on concentration. The half-life averages 4 hours and is independent of drug concentration. Lornoxicam is completely metabolized in the liver. The isoenzyme CYP2C29 is involved in metabolism. Approximately 2/3 is excreted through the liver and 1/3 through the kidneys as an inactive compound. Excreted in breast milk. In elderly people and in patients with impaired liver and kidney function, no significant changes in the pharmacokinetics of lornoxicam were found. Pharmacodynamics Lornoxicam is a non-steroidal anti-inflammatory drug (NSAID) with an analgesic effect. The mechanism of action of lornoxicam is based on inhibition of prostaglandin synthesis due to a balanced inhibition of the activity of cyclooxygenase-1 and cyclooxygenase-2 isoenzymes. In addition, lornoxicam inhibits the release of oxygen radicals from activated leukocytes. Lornoxicam does not have an opiate-like effect on the central nervous system and therefore does not depress respiration, nor does it cause constipation or a miotic effect. There is also no reason to assume that patients may develop drug dependence on lornoxicam. Lornoxicam does not affect vital signs (eg, body temperature, respiratory rate, heart rate, blood pressure, ECG, spirometry).

Indications for use  short-term treatment of pain of various origins  symptomatic treatment of pain and inflammation in osteoarthritis  symptomatic treatment of pain and inflammation in rheumatoid arthritis

Method of administration and dosage: Orally, for moderate and severe pain, a dose of 8–16 mg 2–3 times a day is recommended. The maximum daily dose is 16 mg. For inflammatory and degenerative rheumatic diseases, the recommended initial dose is 12 mg/day. The average dose is 8 – 16 mg/day, depending on the patient’s condition; frequency of administration – 2 times/day; the maximum daily dose is 16 mg. Lornoxicam Viva Pharm tablets are taken orally before meals with a glass of water. For gastrointestinal diseases, in patients with kidney or liver disorders, the maximum daily dose is 12 mg 2 – 3 times a day. There is no special dose modification in elderly patients (over 65 years of age). To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used for the shortest possible short course.

Side effects Adverse side effects are distributed taking into account the class of organ systems and the frequency of occurrence, which was classified as follows: very often (≥1/10); often (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000); very rare (<1/10000), unknown (cannot be estimated from available data). Infectious and parasitic diseases Rare: pharyngitis Circulatory and lymphatic system disorders Rare: anemia, thrombocytopenia, leukopenia, increased bleeding time Very rare: bruising NSAIDs have been reported to cause potentially serious hematological disorders such as neutropenia, agranulocytosis, aplastic and hemolytic anemia Immune system disorders Rare: hypersensitivity, anaphylactoid reaction and anaphylaxis Metabolic and nutritional disorders Uncommon: anorexia, weight change Mental disorders Uncommon: insomnia, depression Rare: confusion, nervousness, agitation Nervous system disorders Common: mild or short-term headache, dizziness Rare : drowsiness, paresthesia, change in taste, tremor, migraine Very rare: aseptic meningitis, occurring mainly in patients with systemic lupus erythematosus or mixed connective tissue diseases Visual disorders Uncommon: conjunctivitis Rare: visual impairment Disturbances of the hearing organs and ear labyrinth Uncommon: dizziness, tinnitus Cardiac disorders Uncommon: palpitations, tachycardia, heart failure, edema Vascular disorders Uncommon: malaise, facial swelling Rare: hypertension, hot flashes, bleeding, hematomas Respiratory, thoracic and mediastinal disorders Uncommon: rhinitis Rare: shortness of breath, cough, bronchospasm Gastrointestinal tract disorders Common: abdominal pain, dyspepsia, nausea, vomiting, diarrhea Uncommon: constipation, flatulence, belching, dry mouth, gastritis, stomach ulcer, abdominal pain, duodenal ulcer, ulcers in the oral cavity Rarely: melena, vomiting with blood, stomatitis, esophagitis, gastroesophageal reflux, dysphagia, aphthous stomatitis, glossitis, erosive and ulcerative lesions of the mucous membrane of the stomach and intestines, including with perforation and bleeding Disorders of fibrous tissue of the liver Uncommon: increased levels of hepatic transaminases, impaired liver function Very rare: liver failure, hepatitis, jaundice, cholestasis Disorders of the skin and subcutaneous tissue Uncommon: rash, itching, erythematous rash, urticaria and Quincke's edema, alopecia, sweating Rare: dermatitis and eczema, purpura Very rare: edema syndrome, bullous reaction, Stevens-Johnson syndrome, Lyell's syndrome Musculoskeletal and connective tissue disorders Uncommon: arthralgia Rare: bone pain, muscle spasms, myalgia Renal and urinary tract disorders Rare: nocturia, urinary disorders, increased levels of creatinine and urea nitrogen in the blood serum Very rare: acute renal failure, interstitial nephritis, nephrotic syndrome General disorders and reactions at the injection site Uncommon: malaise, facial swelling Rare: asthenia

Contraindications  hypersensitivity to lornoxicam, or to any of the components of the drug, or to other NSAIDs (including acetylsalicylic acid)  history of bronchial asthma, urticaria and rhinitis  thrombocytopenia  severe heart failure  gastrointestinal, cerebrovascular and other bleeding or suspicion of bleeding, blood clotting disorder - peptic ulcer of the stomach and duodenum in the acute phase, a history of bleeding from the gastrointestinal tract associated with taking NSAIDs - severe liver failure - severe renal failure (serum creatinine level > 700 µmol/l) - children and adolescents age under 18 years – pregnancy and lactation – persons with hereditary fructose intolerance, deficiency of the enzyme Lapp-lactase, glucose-6-phosphate dehydrogenase, glucose-galactose malabsorption

Drug interactions With the simultaneous use of the drug Lornoxicam Viva Pharm and: cimetidine, the concentration of lornoxicam in the blood plasma increases; no interactions with ranitidine and antacid drugs were detected; - anticoagulants or platelet aggregation inhibitors - may increase bleeding time and increase the risk of bleeding (monitoring of the international normalized INR ratio is necessary);  β-blockers and ACE inhibitors can reduce their hypotensive effect;  diuretics – the diuretic effect and hypotensive effect are reduced  digoxin – reduces the renal clearance of digoxin; - quinolone antibiotics increase the risk of developing convulsive syndrome; - other non-steroidal anti-inflammatory drugs and glucocorticoids - increases the risk of gastrointestinal bleeding;  methotrexate increases the concentration of methotrexate in the serum; - selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine, paroxetine, sertraline) increases the risk of gastrointestinal bleeding; - lithium salts can cause an increase in the maximum concentration of lithium in plasma and thereby increase the known side effects of lithium; - cyclosporine increases the nephrotoxicity of cyclosporine; - sulfonylurea derivatives may enhance the hypoglycemic effect of the latter;  pemetrexed – may reduce the clearance of pemetrexed; - alcohol, corticotropin, potassium supplements may increase the risk of side effects from the gastrointestinal tract; - cefamandole, cefoperazone, cefotetan, valproic acid increases the risk of bleeding. Special instructions Renal failure In patients with impaired renal function (serum creatinine level 150 - 300 µmol/l), with heart failure, with impaired liver function and other conditions that cause a decrease in circulating blood volume and renal blood flow, carry out constant clinical monitoring, control of function kidneys (for example, by serum creatinine level) and liver. Long-term treatment (more than 3 months) It is recommended to regularly assess blood status (hemoglobin), kidney function (creatinine) and liver enzymes. With long-term use of the drug Lornoxicam Viva Pharm, it is necessary to monitor the peripheral blood picture, as well as indicators of liver and kidney function. History of gastrointestinal ulcers and bleeding Clinical observation is recommended. For peptic ulcers of the stomach and duodenal ulcers, therapy with Lornoxicam Viva Pharm should be carried out while taking proton pump inhibitors (pantoprazole). Should not be used concomitantly with other NSAIDs. Patients with a history of hypertension and/or heart failure should be careful when taking the drug long-term. 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. Like other oxicams, lornoxicam inhibits platelet aggregation and may therefore prolong bleeding time. When using this drug, it is necessary to carefully monitor the condition of patients with disorders of the blood coagulation system, patients with an increased tendency to bleeding. The use of the drug may adversely affect female fertility and is not recommended for women planning pregnancy. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms You should refrain from driving vehicles and other mechanisms that require increased attention due to the likelihood of dizziness and drowsiness.

Overdose Symptoms: nausea and vomiting, cerebral symptoms (dizziness, ataxia, turning into coma and convulsions). Possible changes in liver and kidney function, blood clotting disorders. Treatment: you should stop taking the medication, treatment is symptomatic. Due to its short half-life, lornoxicam is quickly eliminated from the body. Lornoxicam is not dialyzable. To date, no specific antidote is known. Taking activated charcoal immediately after taking lornoxicam may reduce the absorption of this drug. To eliminate gastrointestinal disorders caused by lornoxicam, a prostaglandin analogue or ranitidine can be used.

Release form and packaging 6 or 10 tablets are placed in a blister pack made of polyvinyl chloride film and printed aluminum foil. 1 (6 tablets or 10 tablets) or 3 (10 tablets) blister packs together with instructions for medical use in the state and Russian languages ​​are placed in a cardboard box.

Storage conditions Store at a temperature not exceeding 25°C. Keep out of the reach of children!

Do not use after the expiration date.

Conditions for dispensing from pharmacies By prescription

, The Republic of Kazakhstan

Registration certificate holder VIVA PHARM LLP, Republic of Kazakhstan...

Interaction with other drugs

Simultaneous use of the drug Lornoxicam and:

  • cimetidine – increases the concentration of lornoxicam in the blood 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 beta 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 seizures;
  • 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 (for example, 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 cytochrome P450 isoenzyme CYP2C9: lornoxicam (like other NSAIDs metabolized by the cytochrome P450 isoenzyme CYP2C9) - 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.


You should check with your doctor about the compatibility of Lornoxicam with other drugs.

special instructions

Use with caution in cases of erosive and ulcerative lesions and bleeding from the gastrointestinal tract (history), moderate renal failure, conditions after surgery, in elderly patients (over 65 years), in patients weighing less than 50 kg.

Lornoxicam should be used only after a careful assessment of the expected benefits of therapy and the possible risks in the following cases:

  • slight degree of renal dysfunction (serum creatinine level 150-300 µmol/l);
  • heart failure and other conditions accompanied by a decrease in blood volume and renal blood flow;
  • liver dysfunction;
  • arterial hypertension and conditions accompanied by fluid retention and edema;
  • patients who have undergone major surgery.

In patients with impaired renal function, regular monitoring of renal function is necessary during treatment.

Elderly patients, as well as patients with arterial hypertension, are advised to control blood pressure when using lornoxicam.

For peptic ulcers of the stomach and duodenal ulcers, therapy should be carried out while taking histamine H2 receptor blockers or omeprazole.

With long-term use, it is necessary to periodically monitor the peripheral blood picture, as well as liver and kidney function indicators.

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 patients who require concomitant use of low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal adverse events, concomitant use 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.


Patients with hypertension should monitor their blood pressure while taking Lornoxicam.

Use during pregnancy and breastfeeding

Due to the lack of data on the use of the drug Lornoxicam 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.

The use of lornoxicam may adversely affect female fertility and is not recommended for women planning pregnancy.

Use in childhood

The drug is not intended for use in persons under 18 years of age due to insufficient data on its effectiveness and safety in this category of patients.

Use in old age

There is no need to specifically titrate the dose for persons over 65 years of age if they do not have impaired renal and/or liver function.

Patients in this age category are advised to monitor liver and kidney activity during therapy and use the drug with extreme caution after surgery. It should be taken into account that in elderly patients side effects from the gastrointestinal tract are more difficult to tolerate than in younger patients.

For impaired renal function

The use of the drug is contraindicated in patients with severe renal failure (with a serum creatinine level of more than 700 µmol/l), progressive kidney disease, confirmed hyperkalemia.

Patients with mild (with serum creatinine 150–300 µmol/l) and moderate (with serum creatinine 300–700 µmol/l) functional impairment of the kidneys should be treated with the drug with caution and, if necessary, adjust the dose, since it is especially important to maintain renal blood flow The level of renal prostaglandins is important. Treatment with Lornoxicam should be discontinued if deterioration in renal function is detected.

For liver dysfunction

Treatment with the drug is contraindicated in patients with severe liver failure.

Patients with mild to moderate liver dysfunction (including cirrhosis) require clinical monitoring and regular evaluation of laboratory tests during therapy. For moderate liver dysfunction, a dose change may be required. Adverse effects can be minimized by using the lowest effective dose for the shortest period required to control symptoms.

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.


If taking Lornoxicam causes drowsiness, it is better to avoid driving.

Use during pregnancy and lactation

There are no data regarding the safety of using lornoxicam injections by pregnant and lactating women, therefore treatment with the drug during pregnancy and lactation is contraindicated. Suppression of prostaglandin synthesis may have a negative effect on pregnancy and/or fetal development.

In early pregnancy, therapy with prostaglandin synthesis inhibitors increases the risk of miscarriage or the development of heart disease. The threat is assumed to be proportional to the dose and duration of use. Prescribing these medications in the third trimester of pregnancy can cause a toxic effect on the heart and lungs of the fetus (premature closure of the ductus arteriosus and the occurrence of pulmonary hypertension), as well as the appearance of renal dysfunction and, as a consequence, oligohydramnios.

The administration of lornoxicam at the end of pregnancy can provoke an increase in the duration of bleeding in the mother and fetus, as well as a weakening of the contractile activity of the uterus, and thereby delay or prolong the labor process.

Lornoxicam's analogs

If Lornoxicam is not suitable for pain relief for the patient, then the doctor may prescribe a direct analogue of the drug. Here is a complete list of similar drugs:

  • Revmoxicam;
  • Xefocam;
  • Mirlox;
  • Mesipol;
  • Movalis;
  • Melbek;
  • Lem;
  • Movasin;
  • Piroxicam.

Before using any analogue, be sure to read its instructions for use. If you know the exact dosage and rules of use, then the new medicine will not harm the body.

Reviews of Lornoxicam

Reviews about Lornoxicam from specialists and patients are usually positive . They indicate the effectiveness of this drug.

Patient reviews

I was prescribed Lornoxicam injections to relieve arthritis pain. After 3 injections, all inflammation went away and my condition immediately improved. To maintain the effect of the drug, I started taking Lornoxicam tablets, 2 pieces a day. The doctor determined a course of treatment for me and regularly performed diagnostic procedures to monitor the effect of the medicine. During the entire treatment period, the drug did not cause side effects or any allergic reactions.

Alena, 54 years old

I always have Lornoxicam tablets in my medicine cabinet for quick pain relief. Recently, when I came from the dentist, the drug helped me a lot. The toothache was simply unbearable and radiated strongly to my head. 20 minutes after taking the medicine, the attack began to subside. I took another pill before bed and completely forgot about the pain.

Ivan, 42 years old

I was recently diagnosed with osteochondrosis in the cervical area. Recently, this disease has caused radicular syndrome, which was accompanied by terrible pain, inflammation and stiffness in the neck. I was prescribed daily injections of Lornoxicam. The doctor administered injections at the hospital and monitored my health. The first injection caused me side effects such as headache and body heat. The doctor reduced the dosage, and the negative reactions immediately went away. Lornoxicam quickly relieved swelling and inflammation and helped me cope with an attack of pain.

Alina, 56 years old

At home, you always have a package of Lornoxicam in your medicine cabinet, as you may need it any day. So, after visiting the dentist, this was the only medicine that saved me. The pain was simply unbearable with strong shooting pains. The medicine began to act in about 20-25 minutes, and after taking the second tablet I generally slept peacefully until the morning. I did not observe any side effects.

Valery 44 years old

My right shoulder hurt badly, I couldn’t even move my arm normally. It is impossible to sleep or lie down - constant nagging pain. The doctor made a diagnosis after an ultrasound - a hernia in the cervical spine. I tried different painkillers, but they all worked. Nothing took the pain away completely. A friend advised me to try Lornoxicam. I took a larger dosage, just in case. After I drank it for the first time, I felt that the pain went away within half an hour. Everything is fine. The only side effects are minor problems with stool.

Veronica 52 years old

I am a gymnast and I know first-hand about injuries, sprains and other joys of professional sports. During my career I have tried a lot of painkillers, from expensive to cheap. On the recommendation of a specialist, I recently tried Lornoxicam. It is, of course, not cheap, but most importantly it helps relieve pain perfectly. It suited me. There were no side effects, at least not yet.

Larisa 25 years old

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