Nimesulide is a selective inhibitor of COX-2; nonsteroidal anti-inflammatory agent (NSAIDs).
Release form and composition
Dosage form - tablets: cylindrical, biconvex, light yellow color (10, 20 or 30 each in a blister pack, 1, 2, 3, 4, 5, 6, 8 or 10 packs in a carton box; 30 pieces in blisters, 10 packs in a carton box, 15 packs in blister packs, 1, 2, 3, 4, 5 or 6 packs in a carton box, 10, 20, 30, 40, 50 or 100 pieces in plastic cans, 1 can each in a cardboard box, 1000 each in plastic bags, 1 package in a plastic container).
Active ingredient - nimesulide: in 1 tablet - 100 mg.
Auxiliary components: povidone, sodium carboxymethyl starch, lactose monohydrate, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, water.
Indications for use
- Post-traumatic and postoperative pain;
- Arthritis of various etiologies;
- Rheumatoid arthritis.
Nimesulide is intended for symptomatic therapy, to relieve pain and reduce inflammation at the time of its use, it does not affect the progression of the underlying disease.
- Bleeding, including cerebrovascular;
- Active gastrointestinal bleeding;
- Erosive and ulcerative lesions of the gastric mucosa and duodenum;
- Exacerbation of inflammatory bowel disease (Crohn's disease or ulcerative colitis);
- Decompensated chronic heart failure;
- The period after coronary artery bypass surgery;
- Any active or progressive liver disease, liver failure;
- Blood coagulation disorders, incl. hemophilia;
- Confirmed hyperkalemia;
- Severe chronic renal failure (creatinine clearance <30 ml / minute);
- Alcoholism or drug addiction;
- A complete or incomplete combination of asthma and recurrent nasal polyposis / paranasal sinuses with intolerance to acetylsalicylic acid or other NSAIDs (including a history of);
- The simultaneous appointment of other hepatotoxic drugs;
- Hepatotoxic reactions with the use of nimesulide in history;
- Children's age up to 12 years;
- Hypersensitivity to the drug.
- Chronic heart failure;
- Cerebrovascular diseases;
- Coronary heart disease;
- Peripheral artery diseases;
- Dyslipidemia and hyperlipidemia;
- Creatinine clearance <30-60 ml / minute;
- The presence of Helicobacter pylori infection;
- Ulcer lesion of the gastrointestinal tract in history;
- Severe somatic diseases;
- Elderly age;
- The simultaneous use of the following drugs: anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid and clopidogrel), oral glucocorticosteroids, selective serotonin reuptake inhibitors (including paroxetine, citalopram, sertralin, fluoxetine).
Dosing and Administration
Nimesulide should be taken orally, preferably after a meal.
Adults are prescribed on 100-200 mg 2 times a day, for children - depending on weight, 1.5 mg / kg 2-3 times a day, but not more than 5 mg / kg / day.
For patients with chronic renal failure, the daily dose should not exceed 100 mg.
To minimize the risk of side effects, it is recommended to use the minimum effective dose for as short a period as possible. The maximum duration of receiving Nimesulide is 15 days.
- Central nervous system: nightmares, nervousness, headache, feeling of fear, dizziness, drowsiness, encephalopathy (Reye's syndrome);
- Digestive system: abdominal pain, gastritis, stomatitis, flatulence, tarry stools, constipation, gastrointestinal bleeding, nausea, vomiting, diarrhea, ulcer and / or perforation of the stomach or duodenum;
- Hematopoietic system: purpura, pancytopenia, prolongation of bleeding time, eosinophilia, anemia, thrombocytopenia;
- Liver and biliary systems: jaundice, increased liver transaminases, cholestasis, hepatitis, including fulminant;
- Respiratory system: dyspnea, bronchospasm, exacerbation of bronchial asthma;
- Cardiovascular system: hemorrhages, tachycardia, hot flashes, arterial hypertension;
- Urinary system: hyperkalemia, urinary retention, renal failure, hematuria, oliguria, dysuria, interstitial nephritis, edema;
- Sense organs: blurred vision;
- Skin: increased sweating, itching, skin rash, swelling of the face, angioedema, dermatitis, erythema, urticaria, erythema multiforme, toxic epidermal necrolysis;
- Other: hypothermia, general weakness.
It is necessary to stop taking Nimesulide in case of fever or flu-like symptoms; increased levels of liver transaminases or the appearance of signs that indicate liver damage, such as nausea, abdominal pain, vomiting, anorexia, dark urine, fatigue (such patients are not recommended to prescribe the drug in the future); the appearance of gastrointestinal bleeding or ulceration; impaired renal function.
If necessary, the use of Nimesulide more than 2 weeks in a row should monitor liver function indicators.
The binding of nimesulide is reduced in patients with renal insufficiency, accompanied by hyperbilirubinemia or hypoalguminemia, and in patients with cirrhosis of the liver.
Nimesulide may have a negative effect on female fertility, therefore it is not recommended for women who are planning a pregnancy.
If during the use of the drug adverse effects occur on the part of the senses and / or the central nervous system, one should refrain from driving and performing types of work that require quick reactions and concentration.
Older people are more likely to have side effects, including abnormal liver function, liver and heart, perforation, gastrointestinal bleeding. For this reason, continuous clinical monitoring is recommended.
Nimesulide can compete in the binding of plasma proteins with salicylic acid, fenofibrate, tolbutamide. In his presence, the free fractions of methotrexate can significantly increase.
The drug can reduce the bioavailability of furosemide, enhance the effect of cyclosporine on the kidneys. Contributes to the increase in the concentration of lithium in blood plasma
In the case of simultaneous use of serotonin reuptake inhibitors, glucocorticosteroids increases the risk of gastrointestinal bleeding.
Nimesulide is not recommended to appoint simultaneously with diuretics, which have a damaging effect on renal hemodynamics.
Terms and conditions of storage
Store at a temperature up to 25 ºС in a dark place, dry and out of reach of children.
Shelf life - 3 years.