Meloxicam, tablets 7.5 mg 20 pcs

Meloxicam is a non-steroidal anti-inflammatory drug with analgesic, anti-inflammatory and antipyretic effects. Anti-inflammatory effect is associated with inhibition of enzymatic activity of cyclooxygenase-2 (COX-2), involved in the biosynthesis of prostaglandins in the area of inflammation. To a lesser extent, meloxicam acts on cyclooxygenase-1 (COX-1), involved in the synthesis of prostaglandin, which protects the mucosa of the gastrointestinal tract and is involved in the regulation of blood flow in the kidneys.

Indications

– symptomatic treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis (Behterev disease) and other inflammatory and degenerative diseases accompanied by pain syndrome.

Active ingredient

Composition

Tablets light yellow to yellow, flat cylindrical shape, beveled, with a ridge on one side; marbling and slight staining are possible.

1 tablet meloxicam 15 mg

Auxiliary substances: lactose, microcrystalline cellulose, sodium citrate dihydrate, povidone (polyvinylpyrrolidone), sodium carboxymethyl starch (primogel), colloidal silicon dioxide (aerosil), calcium stearate.

How to take, the dosage

The drug is taken orally with meals once a day.

The recommended dosing regimen:

Rheumatoid arthritis: 15 mg/day. After achieving therapeutic effect, the dose may be reduced to 7.5 mg/day.

Osteoarthritis: 7.5 mg/day. If necessary, the dose can be increased to 15 mg/day.

Ankylosing spondylitis: 15 mg/day. The maximum daily dose should not exceed 15 mg.

In patients at increased risk of side effects, and in patients with significant renal insufficiency who are on hemodialysis, the dose should not exceed 7.5 mg/day.

Interaction

Concomitant use with other NSAIDs (as well as with acetylsalicylic acid) increases the risk of erosive ulcerative lesions and bleeding of the gastrointestinal tract.

Concomitant use with hypotensive drugs may decrease the effectiveness of the latter.

Simultaneous use with lithium preparations may lead to cumulation of lithium and increase its toxic effects (it is recommended to control the lithium concentration in the blood).

In concomitant use with methotrexate there is an increased side effect of the latter on the hematopoietic system (risk of anemia and leukopenia, periodic control of total blood count is indicated).

Concomitant use with diuretics and with cyclosporine increases the risk of renal failure.

Concomitant use with intrauterine contraceptives may decrease the effectiveness of the latter.

In concomitant use with anticoagulants (heparin, ticlopidine, warfarin), as well as with thrombolytic drugs (streptokinase, fibrinolysin) the risk of bleeding increases (periodic control of blood clotting is necessary).

In concomitant use with colestiramine, as a result of binding meloxicam, its excretion through the gastrointestinal tract is increased.

Special Instructions

Caution should be exercised when using the drug in patients with a history of peptic ulcer or duodenal ulcer, as well as in patients on anticoagulant therapy. These patients have an increased risk of gastrointestinal erosive-ulcer disease.

We should use the drug with caution and monitor renal function parameters in elderly patients, patients with chronic heart failure with signs of insufficient circulation, patients with cirrhosis of the liver, as well as in patients with hypovolemia as a result of surgical interventions.

In patients with renal insufficiency if creatinine clearance is more than 25 ml/min does not require dosing regimen adjustment. In patients on dialysis, the drug dosage should not exceed 7.5 mg/day.

Patients taking diuretics and meloxicam concomitantly should take sufficient fluids.

If allergic reactions (itching, skin rash, urticaria, photosensitization) occurred during the treatment it is necessary to stop the drug and consult a physician.

Influence on driving and operating machinery

The use of the drug may cause undesirable effects in the form of headache and dizziness, drowsiness. It is necessary to refrain from driving vehicles and operating machines and mechanisms requiring concentration.

Contraindications

– anamnestic evidence of an attack of bronchoobstruction, rhinitis, urticaria after taking acetylsalicylic acid or other NSAIDs (complete or incomplete acetylsalicylic acid intolerance syndrome – rhinosinusitis, urticaria, nasal mucosal polyps, asthma (bronchial));

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

– inflammatory bowel diseases (nonspecific ulcerative colitis, Crohn’s disease);

– cerebrovascular bleeding or other bleeding;

– in the period after coronary artery bypass grafting;

– decompensated heart failure;

– Severe hepatic impairment or active liver disease;

– Severe renal impairment in non-dialysis patients (creatinine clearance less than 30 mL/min), advanced renal disease including

– pregnancy;

– breastfeeding;

– children under 15 years of age;

– hypersensitivity to any component of the drug.

With cautiousness:

IBS, cerebrovascular disease, chronic heart failure, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral artery disease, smoking, creatinine clearance less than 60 ml/min.

Anamnestic evidence of peptic ulcer disease, presence of Helicobacter pylori infections, older age, long-term use of NSAIDs, frequent alcohol use, severe somatic diseases, concomitant therapy with the following drugs:

– anticoagulants (e.g., warfarin);

– antiaggregants (e.g., acetylsalicylic acid, clopidogrel);

– Oral glucocorticosteroids (e.g., prednisolone);

– Selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, paroxetine, sertraline).

In order to reduce the risk of gastrointestinal adverse events, the lowest effective dose should be used for the shortest possible course

Side effects

Digestive system disorders: more than 1% – dyspepsia, including nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea; 0.1-1% – transient increase in liver transaminase activity, hyperbilirubinemia, belching, esophagitis, gastroduodenal ulcer, GI bleeding (including hidden), stomatitis; less than 0.1% – GI perforation, colitis, hepatitis, gastritis.

Hematopoietic organs: more than 1% – anemia; 0.1-1% – blood count changes, including leukopenia, thrombocytopenia.

Skin disorders: more than 1% – itching, skin rash; 0.1-1% – urticaria; less than 0.1% – photosensitization, bullous rash, erythema multiforme, including Stevens-Johnson syndrome, toxic epidermal necrolysis.

In the respiratory system: less than 0.1% – bronchospasm.

Nervous system disorders: more than 1% – dizziness, headache; 0.1-1% – vertigo, tinnitus, drowsiness; less than 0.1% – confusion, disorientation, emotional lability.

Cardiovascular system: more than 1% – peripheral edema; 0.1-1% – increase in BP, palpitations, blood rushes to the skin of the face.

On the urinary system: 0.1-1% – hypercreatininemia and/or increased serum urea; less than 0.1% – acute renal failure; association with meloxicam administration is not established – interstitial nephritis, albuminuria, hematuria.

Sensory organs: less than 0.1% – conjunctivitis, visual impairment, including blurred vision.

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

Overdose

Symptoms:consciousness disorder, nausea, vomiting, epigastric pain, GI bleeding, acute renal failure, liver failure, respiratory arrest, asystole.

Treatment:There is no specific antidote; in overdose of the drug, gastric lavage, administration of activated charcoal (within the next hour), and symptomatic therapy should be performed. Colestiramine accelerates excretion of the drug from the body. Forced diuresis, urine alkalinization, hemodialysis are ineffective due to high binding of the drug to blood proteins.

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