ARTROZAN AMPOULES 6MG/ML 2.5ML

Mechanism of action

Meloxicam - NSAIDs with anti-inflammatory, antipyretic and analgesic effects. It belongs to the class of oxycams, is a derivative of enolic acid.

The mechanism of action is associated with inhibition of the synthesis of prostaglandins as a result of selective inhibition of the enzymatic activity of cyclooxygenase of the second type (COX-2), which is involved in the biosynthesis of prostaglandins in the area of ​​inflammation. When administered in high doses, long-term use and the individual characteristics of the body, selectivity for COX-2 decreases. To a lesser extent, it acts on cyclo-oxygenase of the first type (COX-1), which participates in the synthesis of prostaglandins that protect the gastrointestinal mucosa and are involved in the regulation of blood flow in the kidneys. Due to the indicated selectivity of suppression of COX-2 activity, the drug less frequently causes erosive-ulcerative lesions of the gastrointestinal tract.

Indications and usage

Symptomatic treatment of inflammatory and degenerative diseases of the musculo-articular system, accompanied by pain, including:

• Osteoarthritis.
• Rheumatoid arthritis.
• Ankylosing spondylitis (ankylosing spondylitis).
• Osteochondrosis.

Contraindications

• Hypersensitivity to meloxicam or auxiliary components of the drug.
• Decompensated heart failure.
• Early postoperative period after coronary artery bypass surgery.
• A complete or incomplete combination of asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to Acetylsalicylic acid or other NSAIDs.
• Exacerbation of gastric ulcer and duodenal ulcer; active Gastrointestinal bleeding.
• Inflammatory bowel disease (ulcerative colitis, Crohn's disease in the acute stage).
• Cerebrovascular bleeding or other bleeding.
• Hemophilia and other bleeding disorders.
• Severe liver failure or active liver disease.
• Chronic renal failure (in patients not undergoing hemodialysis (creatinine clearance less than 30 ml / min)).
• Progressive kidney disease, incl. confirmed hyperkalemia.
• Children's age up to 18 years.
• Pregnancy.
• Breastfeeding period.

Carefully: in elderly patients and in the presence of the following conditions in the history: coronary heart disease, congestive heart failure, cerebrovascular diseases, diseases of the peripheral arteries, dyslipidemia / hyperlipidemia, diabetes mellitus, chronic renal failure (creatinine clearance 30-60 ml / min); ulcerative lesions of the gastrointestinal tract, the presence of Helicobacter pylori infection, smoking, severe somatic diseases.With long-term use of NSAIDs, alcohol abuse, concomitant therapy with anticoagulants (for example, warfarin), antiplatelet agents (for example, acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (for example, prednisolone), selective serotonin reuptake inhibitors (for example, citalopram, and ceramopram, for example, citalopram, and syltopram. a) the drug should be taken with caution. To reduce the risk of adverse gastrointestinal development, a minimum effective dose of a short course should be used.

Pregnancy and Breastfeeding

Contraindicated in pregnancy and lactation.

Special notes

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

Caution should be exercised when using the drug in patients with a history of gastric ulcer and duodenal ulcer, and patients undergoing anticoagulant therapy. These patients have an increased risk of erosive and ulcerative diseases of the gastrointestinal tract.

Care should be taken to control daily diuresis and kidney function when using the drug in the elderly and patients with reduced BCC and reduced glomerular filtration (dehydration, chronic heart failure, cirrhosis of the liver, nephrotic syndrome, clinically significant kidney disease, diuretic administration, dehydration after major surgery ).

If there are signs of liver damage (itching, yellowing of the skin, nausea, vomiting, abdominal pain, dark urine, persistent and significant increase in transaminase levels and other liver function indicators), take the drug and contact your doctor.

After two weeks of use of the drug, control of the activity of “liver” enzymes is necessary.

Patients with a slight or moderate decrease in renal function (CC> 30 ml / min) do not require dose adjustment.

Patients taking both diuretics and meloxicam should take a sufficient amount of fluid.

If allergic reactions (itching, skin rash, urticaria, photosensitivity) occur in the course of treatment, it is necessary to consult a doctor to decide on stopping the drug.

Meloxicam, like other NSAIDs, can mask the symptoms of infectious diseases.

The use of meloxicam, as well as other drugs that block the synthesis of prostaglandins, can affect fertility, so it is not recommended for use in women who are planning a pregnancy.

Do not use the drug at the same time as other NSAIDs.

Influence on ability to drive motor transport and control mechanisms

The use of the drug may cause headache, dizziness and drowsiness. In the event of these phenomena, you should abandon driving and perform other potentially hazardous activities,requiring increased concentration and speed of psychomotor reactions.

Composition

1 ml of solution contains:

Active substance: Meloxicam - 6 mg.

Excipients: glycofurfurol (glycofurol) 100 mg, Glycine 5 mg, meglumine 3.75 mg, sodium hydroxide solution 1M to pH 8.2-8.9, sodium chloride 3 mg, poloxamer 188 (lutrol F68) 50 mg, water d / and to 1 ml.

Dosage and administration

Intramuscular administration of the drug is shown in the first 2-3 days of treatment. Further treatment is continued with the use of oral forms (tablets). The recommended dose is 7.5 or 15 mg 1 time per day, depending on the intensity of pain and the severity of the inflammatory process. Since the potential risk of adverse reactions depends on the dose and the duration of treatment, the smallest effective dose should be used and the shortest possible course.

In patients with severe renal failure on hemodialysis, the dose should not exceed 7.5 mg per day.

The drug is injected through a deep intramuscular injection. The contents of the ampoules should not be mixed in the same syringe with other drugs. The drug should not be administered in / in.

Adverse reactions

Gastrointestinal: more than 1% - dyspepsia, incl. nausea, vomiting, abdominal pain, diarrhea, constipation, flatulence; 0.1-1% - transient increase in the activity of “liver” transaminases, hyperbilirubinemia, belching, esophagitis, gastric or duodenal ulcer, gastrointestinal bleeding (latent or overt), stomatitis; less than 0.1% - perforation of the digestive tract, colitis, hepatitis, gastritis.

From the side of blood-forming organs: more than 1% - anemia; 0.1-1% - leukopenia, thrombocytopenia.

From the skin: more than 1% - itching, skin rash; 0.1-1% - urticaria; less than 0.1% - photosensitization, bullous eruptions, erythema multiforme, incl. Stevens-Johnson syndrome, toxic epidermal necrolysis.

Respiratory: less than 0.1% - bronchospasm.

From the side of the central nervous system: more than 1% - dizziness, headache; 0.1-1% - tinnitus, drowsiness; less than 0.1% - emotional lability, confusion, disorientation.

Cardiovascular: more than 1% - peripheral edema; 0.1-1% - increase in blood pressure, palpitations, facial flushing.

Urogenital: 0.1-1% - hypercreatininemia, increased serum urea concentration; less than 0.1% - acute renal failure ; connection with the reception of meloxicam has not been established - interstitial nephritis, albuminuria, hematuria.

From the senses: less than 0.1% - conjunctivitis, blurred vision.

Allergic reactions: less than 0.1% - angioedema, anaphylactic, anaphylactoid reactions.

With simultaneous use with other NSAIDs (including acetylsalicylic acid) increases the risk of erosive and ulcerative lesions and gastrointestinal bleeding.

With simultaneous use with antihypertensive drugs may reduce the effectiveness of the latter.

With simultaneous use with lithium preparations, the development of lithium cumulation and an increase in its toxic action is possible (it is recommended to control the concentration of lithium in the blood).

With simultaneous use with Methotrexate, the side effect of the latter on the hematopoietic system is enhanced (the risk of anemia and leukopenia, periodic blood count is shown).

With simultaneous use with diuretics and cyclosporine increases the risk of developing renal failure.

With simultaneous use with intrauterine contraceptives may reduce the effectiveness of the latter.

With simultaneous use with anticoagulants (heparin, warfarin), thrombolytic drugs (streptokinase, fibrinolysin), and antiplatelet agents (ticlopidine, Clopidogrel, acetisalicylic acid) increases the risk of bleeding (periodic monitoring of blood clotting parameters is necessary).

With simultaneous use of Kolestiramine, the removal of meloxicam through the gastrointestinal tract is accelerated.

When used simultaneously with selective serotonin reuptake inhibitors, the risk of gastrointestinal bleeding increases.