Naiz, 100 mg 2 g 9 pcs.

Interaction

Glucocorticosteroids: increase risk of gastrointestinal ulceration or bleeding.

Antiplatelet agents and selective serotonin reuptake inhibitors: increase the risk of gastrointestinal bleeding.

Anticoagulants: NSAIDs may increase the effect of anticoagulants such as warfarin.

Because of the increased risk of bleeding, this combination is not recommended and is contraindicated in patients with severe coagulation disorders.

If combination therapy still cannot be avoided, careful monitoring of blood clotting parameters is necessary.

Diuretics: NSAIDs may decrease the effect of diuretics. In healthy volunteers, nimesulide temporarily reduces sodium excretion under the effect of furosemide, to a lesser extent – potassium excretion, and reduces the diuretic effect itself.

The co-administration of nimesulide and furosemide results in a decrease (approximately 20%) in the area under the concentration-time curve (AUC) and a decrease in the cumulative excretion of furosemide without changing the renal clearance of furosemide.

The co-administration of furosemide and nimesulide requires caution in patients with impaired renal or cardiac function.

ACE inhibitors and angiotensin-II receptor antagonists: NSAIDs may decrease the effect of hypotensive drugs.

. In patients with mild to moderate renal insufficiency (creatinine clearance 30-80 ml/min) when ACE inhibitors, angiotensin II receptor antagonists or substances that inhibit cyclooxygenase system (NSAIDs, antiaggregants) are prescribed together, further deterioration of renal function and acute renal failure may occur, which is usually reversible.

These interactions should be considered in patients taking nimesulide in combination with ACE inhibitors or angiotensin-II receptor antagonists. Therefore, co-administration of these drugs should be prescribed with caution, especially for elderly patients.

Patients should receive adequate fluids, and renal function should be closely monitored after initiation of coadministration.

There is evidence that NSAIDs decrease lithium clearance, which leads to increased plasma lithium concentrations and toxicity.

When nimesulide is prescribed to patients receiving therapy with lithium drugs, plasma lithium concentrations should be monitored regularly.

Clinically significant interactions with glibenclamide, theophylline, digoxin, cimetidine and antacids (e.g., aluminum and magnesium hydroxide combination) have not been observed.

Nimesulide inhibits the activity of CYP2C9 isoenzyme. When concomitant use of drugs metabolized with nimesulide, plasma concentrations of these drugs may increase.

In concomitant use with antiepileptic drugs (valproic acid), antifungal drugs (ketoconazole), anti-tuberculosis drugs (isoniazid), amiodarone, methotrexate, methyldopa, amoxicillin in combination with clavulanic acid an additive hepatotoxic effect is possible.

Because of the high degree of binding of nimesulide to plasma proteins, patients simultaneously taking sulfonamides should be under medical supervision and be examined at short intervals.

When nimesulide is prescribed less than 24 hours before or after methotrexate, caution is required,

because in these cases the plasma concentration of methotrexate and therefore the toxic effects of this drug may increase.

In connection with action on renal prostaglandins, inhibitors of prostaglandin synthetases, such as nimesulide, may increase nephrotoxicity of cyclosporines.

In vitro studies have shown that nimesulide is displaced from binding sites by tolbutamide, salicylic acid.

While these interactions have been determined in plasma, these effects were not observed during clinical use of the drug.

Special Instructions

Unwanted side effects can be minimized by using the drug in the lowest effective dose with the shortest duration of use necessary to relieve pain syndrome.

Contraindications

• Hypersensitivity to nimesulide or other components of the drug.
• Hyperergic reactions in history (bronchospasm, rhinitis, urticaria),
• related to the use of acetylsalicylic acid or other NSAIDs, including nimesulide.
• Complete or incomplete combination of bronchial asthma, recurrent nasal or paranasal sinus polyposis with intolerance to acetylsalicylic acid and other NSAIDs (including history);
• Hepatotoxic reactions to nimesulide in anamnesis.
• Simultaneous use with other drugs with potential hepatotoxicity (e.g., other NSAIDs).
• Chronic inflammatory bowel disease (Crohn’s disease, ulcerative colitis) in the acute phase.
• Period after coronary artery bypass surgery.
• Fever syndrome in colds and acute respiratory viral infections.
• Suspicion of acute surgical pathology.
• Gastric or duodenal ulcer in the acute phase; gastrointestinal erosive and ulcerative lesions; perforations or gastrointestinal bleeding in the history.
• A history of cerebrovascular bleeding or other conditions associated with increased bleeding.
• Severe clotting disorders.
• Severe heart failure.
• Severe renal failure (creatinine clearance <30 ml/min), confirmed hyperkalemia.
• Hepatic failure or any active liver disease.
• Alcoholism, drug addiction.
• Hereditary fructose intolerance, sucrose-isomaltase deficiency and glucose-galactose malabsorption syndrome.
• Pregnancy and breastfeeding.
• Children under 12 years of age.

With caution:
Arterial hypertension, diabetes mellitus, compensated heart failure, coronary heart disease,
cerebrovascular disease, dyslipidemia/hyperlipidemia, peripheral artery disease,
hemorrhagic diathesis, smoking, creatinine clearance 30-60 ml/min.
history of gastrointestinal ulcers; history of infection caused by Helicobacter pylori; elderly age;
long previous use of NSAIDs; severe somatic diseases.
Concurrent use 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).

Side effects

The incidence of adverse reactions is determined according to World Health Organization recommendations:
very frequently (≥ 1/10), frequently (≥ 1/100 to < 1/10), infrequently (≥ 1/1,000 to < 1/100), rarely (≥ 1/10,000 to < 1/1,000), very rarely (< 10,000),