Aponil - instructions for use, dose, side effects, contraindications

Each tablet contains 100 mg of nimesulide and excipients (lactose monohydrate, microcrystalline cellulose, sodium docusate, starch, sodium glycolate, hydroxypropylcellulose, hydrogenated vegetable oil, magnesium stearate).

Description:White with a yellowish tint, round, flat tablets with a risk on one side.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID)

ATX: & nbsp

M.01.A.X Other non-steroidal anti-inflammatory drugs

M.01.A.X.17 Nimesulide

Pharmacodynamics:

The drug has anti-inflammatory, analgesic and antipyretic action.The mechanism of action consists, mainly, in the selective inhibition of COX-2. This leads to a decrease in the synthesis of prostaglandins in the focus of inflammation, as well as in the hypothalamus. The effect on the synthesis of prostaglandins in the mucous membrane of the stomach and kidneys is much less pronounced, which causes a good tolerance of nimesulide. The drug also inhibits lipid peroxidation and formation of free oxygen radicals, reduces the formation of platelet activation factor, tumor necrosis factor alpha, release of histamine, proteinases and some other mediators of inflammation.

Pharmacokinetics:After ingestion nimesulide well absorbed from the gastrointestinal tract, the maximum concentration is achieved in 1-2 (up to 2.5) h. Food reduces the absorption rate, without affecting its degree. 99% bound to plasma proteins. The volume of distribution is 0.19-0.35 l / kg. The therapeutic concentration in the blood is maintained for 6-8 hours. The half-life period is 2-3 hours. With prolonged use of cumulation is not observed. It is subject to biotransformation in the liver with the formation of an active (hydroxynimesulide - up to 25% dose) and several inactive metabolites.Excreted by the kidneys, 65-98% of the dose is excreted in the urine within 24 hours. Up to 35% of the dose is excreted with feces.

Indications:

Pain syndrome (headache, dental, menstrual, post traumatic and postoperative pain), fever of various origin (with acute respiratory viral infections, other infectious and inflammatory diseases). Inflammatory diseases of the musculoskeletal system - arthritis, osteoarthritis, tendovaginitis, bursitis, myositis.

Contraindications:Erosive-ulcerative lesions of the gastrointestinal tract (in the phase of exacerbation). Gastrointestinal bleeding. "Aspirin Asthma." Liver failure. Renal failure (with creatinine clearance <30 mL / min). Hypersensitivity to nimesulide and other NSAIDs. Pregnancy (III trimester). Lactation. Children's age (up to 12 years).

Carefully:FROM caution apply in the arterial hypertension of heart failure, type 2 diabetes mellitus.

Pregnancy and lactation:Although embryotoxic and teratogenic effects of nimesulide are not described, in pregnancy the drug can be prescribed only if the intended benefit to the mother exceeds the possible risk to the fetus.During lactation, appoint nimesulide Not recommended.

Dosing and Administration:

A single dose for adults is 50-200 mg (average 100 mg, maximum dose 400 mg per day), for children 1.5 mg / kg (not more than 100 mg, maximum dose 5 mg / kg per day). It is taken orally 2 times a day after meals, washed down with water.

Side effects:

From the digestive system: increased activity of "liver" transaminases, pain in the epigastric region, ulceration of the mucous membrane of the gastrointestinal tract, diarrhea, heartburn, nausea, vomiting (rarely).

From the central nervous system: headache, dizziness, drowsiness.

From the urinary system (rarely): hematuria, oliguria, fluid retention, edema.

On the part of the blood system: thrombocytopenia, leukopenia, anemia, agranulocytosis, prolongation of bleeding time.

Allergic reactions: skin rash, hives, anaphylactic shock.

Overdose:

Overdose of the drug is not described. There may be nausea and vomiting. For treatment recommended gastric lavage, the appointment of adsorbents, infusion therapy, osmotic diuretics and symptomatic agents.

Interaction:

Nimesulide is displaced from the connection with proteins by acetylsalicylic acid, which increases the concentration of free nimesulide in blood plasma by 2-3 times. Competition for the association with proteins is also possible with the combination of nimesulide with oral hypoglycemic agents (tolbutamide), other sulfonamides, hydantoin, digitalis preparations (digoxin), cyclosporine, methotrexate. With the simultaneous use of indirect anticoagulants, it is possible to intensify their action. When combined with lithium salts nimesulide increases their concentration in the blood plasma.

Special instructions:

Nimesulide should be used with caution and in reduced doses for chronic kidney failure and other kidney diseases, with reduced liver function, stomach ulcer or duodenal ulcer in history, systemic lupus erythematosus, chronic heart failure, use of diuretics, anticoagulants, as well as in elderly patients age. In the appointment of nimesulide in patients with intolerance to other NSAIDs, an allergy is possible.

Form release / dosage:

Tablets of 100 mg.

Packaging:For 10 tablets in a blister of a film of polyvinylchloride and aluminum foil.For 1.2, 10 blisters together with instructions for use in a pack of cardboard.

Storage conditions:In a dry, protected from light place at a temperature of up to 25 ° C. Keep away from children. Do not use after expiry date.

Shelf life:3 years.

Terms of leave from pharmacies:On prescription

Registration number:П N014987 / 01-2003

Date of registration:19.05.2008

Expiration Date:Unlimited

The owner of the registration certificate:Medocemi Co., Ltd.Medocemi Co., Ltd. Cyprus

Manufacturer: & nbsp

MEDOCHEMIE, Ltd. Cyprus

Representation: & nbspMEDOKEMI LTD. MEDOKEMI LTD. Cyprus

Information update date: & nbsp10.09.2017

Illustrated instructions

Instructions

Aponil® (Aponil®)