Aponil (nimesulide) tablets 100 mg. №20

active ingredient : nimesulide;

1 tablet contains nimesulide 100 mg;

excipients : sodium docusate; hydroxypropyl cellulose; lactose monohydrate, sodium starch (type A); Cellulose microcrystalline vegetable oil hydrogenated magnesium stearate.

Pills.

Basic physical and chemical properties: light yellow flat round tablets with a diameter of approximately 10.5 mm with a line on one side.

Non-steroidal anti-inflammatory drugs. ATX code M01A X17.

Nimesulide is an NSAID of the methanesulfonanilide group, which has anti-inflammatory, analgesic and antipyretic effects. The therapeutic effect of nimesulide is due to the fact that it interacts with the arachidonic acid cascade. Nimesulide selectively inhibits COX II (cyclooxygenase II) and inhibits the synthesis of prostaglandins in the focus of inflammation.

Nimesulide inhibits the release of the enzyme myeloperoxidase, and also inhibits the formation of free oxygen radicals, without affecting the processes of phagocytosis and chemotaxis, inhibits the formation of tumor necrosis factor and other inflammatory mediators.

After oral administration, nimesulide is rapidly absorbed from the gastrointestinal tract. The maximum plasma concentration is reached after 2-3 hours. Up to 97.5% of nimesulide binds to plasma proteins.

The drug is actively metabolized in the liver with the participation of CYP2C9, the cytochrome P450 enzyme. The main metabolic product is hydroxynimesulide, a pharmacologically active substance. The half-life is from 3.2 to 6 hours. Nimesulide is excreted from the body in the urine – about 50% of the dose taken. About 29% of the dose taken is excreted in the feces in a metabolized form. Only 1-3% is excreted unchanged from the body. The pharmacokinetic profile in the elderly does not change.

• Treatment of acute pain. Treatment of primary dysmenorrhea.
• Nimesulide should only be used as a second line drug.
• The decision to prescribe nimesulide should be made on the basis of an assessment of all risks for a particular patient.

• Hypersensitivity to nimesulide or to any component of the drug. Hyperergic reactions that have occurred in the past (bronchospasm, rhinitis, urticaria) in connection with the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
• Hepatotoxic reactions to nimesulide that have occurred in the past.
• Concomitant use of other substances with potential hepatotoxicity.
• Alcoholism and drug addiction.
• Suspicion of acute surgical pathology.
• History of gastrointestinal bleeding or perforation associated with previous use of non-steroidal anti-inflammatory drugs (NSAIDs).
• An ulcer of the stomach or duodenum in the acute phase, a history of ulcers, perforation or bleeding in the digestive tract.
• A history of cerebrovascular bleeding or other hemorrhages, as well as diseases accompanied by bleeding.
• Severe bleeding disorders.
• Severe heart failure.
• Severe renal dysfunction (creatinine clearance <30 ml/min).
• Impaired liver function.
• Fever and/or flu-like symptoms in a patient.
• Age up to 12 years.
• Third trimester of pregnancy and lactation.