Amelotex, rectal 15 mg 6 pcs

NSAID, has anti-inflammatory, antipyretic, analgesic effects. It belongs to the class of oxycams; a derivative of enolic acid.

The mechanism of action is inhibition of Pg synthesis as the result of selective suppression of COX2 enzymatic activity.

When administered in high doses, prolonged use and individual characteristics of the body COX2 selectivity decreases.

Suppresses Pg synthesis in the area of inflammation to a greater extent than in the gastric mucosa or kidneys, which is associated with relatively selective inhibition of COX2. Less often causes gastrointestinal erosive and ulcerative diseases.

Indications

Inflammatory and degenerative joint diseases (arthrosis, osteoarthritis), rheumatoid arthritis, Bechterew disease (ankylosing spondylitis).

Active ingredient

Composition

Rectal suppositories are greenish-yellow, torpedo-shaped.

1 supp.meloxicam15 mg

Supplementary substances:

Solid fat (Supposir BP) – 1628.5 mg,

Macrogoal glyceryl hydroxystearate – 16.5 mg.

3 pcs. – Contour cell packs (2) – cardboard boxes.

How to take, the dosage

Overly, with meals, in a daily dose of 7.5-15 mg. The maximum daily dose is 15 mg, in patients with severe renal impairment who are on hemodialysis – 7.5 mg.

In mild to moderate renal function impairment (CKD greater than 25 ml/min) and in liver cirrhosis in stable clinical condition, no dose adjustment is required. The initial dose in patients with increased risk of side effects is 7.5 mg/day.

Rectally – 15 mg (one suppository) once daily.

Interaction

Concomitant use may decrease the effectiveness of antihypertensive drugs (beta-adrenoblockers, ACE inhibitors, vasodilators).

Concomitant use with anticoagulants increases the risk of bleeding.

Concomitant use with diuretics increases the risk of renal failure in patients who are dehydrated.

Simultaneous use with NSAIDs increases the risk of gastrointestinal ulcers and gastrointestinal bleeding.

Simultaneous use with lithium preparations increases plasma lithium concentrations.

Concomitant use of colestyramine accelerates excretion of meloxicam.

Concomitant use with methotrexate may increase myelodepressive effects; with cyclosporine – may increase nephrotoxic effects of cyclosporine.

Special Instructions

In case of peptic ulcers or gastrointestinal bleeding, development of side effects on the skin and mucous membranes, the drug should be discontinued.

. In patients with decreased RBC and glomerular filtration (dehydration, CHF, cirrhosis, nephrotic syndrome, clinically expressed renal diseases, intake of diuretics, dehydration after major surgery) there may be clinically manifest CPN which is completely reversible after discontinuation of the drug (daily urine output and renal function should be monitored in such patients during the initial therapy). In case of steady and significant increase of transaminases and changes of other liver function parameters the drug should be discontinued and control tests should be performed.

In patients with increased risk of side effects, treatment should be started with 7.5 mg. In terminally ill CKD patients on dialysis, the dose should not exceed 7.5 mg/day.

When taking this therapy, caution should be exercised while driving and engaging in other potentially dangerous activities requiring increased concentration and rapid psychomotor reactions (if dizziness and somnolence occur).

In order to decrease the risk of gastrointestinal adverse events, the minimum effective dose should be used for the shortest possible course.

Contraindications

Gastric ulcer and duodenal ulcer in the acute phase, marked liver function disorders, renal failure (without hemodialysis), pregnancy, children and adolescents under 15 years of age, hypersensitivity to meloxicam and other NSAIDs (including salicylates).

Side effects

Digestive system disorders:dyspepsia, nausea, vomiting, abdominal pain, constipation, intestinal colic, diarrhea, esophagitis, stomatitis; rarely – erosive-ulcerative gastrointestinal lesions.

CNS side:dizziness, headache, tinnitus.

Cardiovascular system disorders:increased BP, palpitations, edema, hot flashes.

More urinary system disorders:changes in laboratory indicators of renal function.

From the hematopoietic system:anemia, leukopenia, thrombocytopenia.

Allergic reactions: bronchospasm, photosensitization, skin itching, rash, urticaria.

Similarities