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Pharmacological properties

Affida Fort - an NSAID drug with analgesic and antipyretic properties, acts as an inhibitor of the enzyme synthesis of prostaglandins tsog.

Pharmacokinetics Nimesulide is well absorbed after oral administration. After taking the drug at a dose of 100 mg Cmax plasma nimesulide - 3-4 mg / l - is reached in adults in 2-3 hours. AUC is 20–35 mg / l / h. There was no statistically significant difference between these indicators and similar indicators when using 100 mg of nimesulide 2 times a day for 7 days.

Binding to blood plasma proteins - up to 97.5%.

Nimesulide is significantly metabolized in the liver in various ways, including the cytochrome P450 (CYP) 2C9 isoenzymes. Therefore, there is a likelihood of its interaction with concomitantly taken drugs that are also metabolized by CYP 2C9. The main metabolite, the parahydroxy derivative of nimesulide, also has pharmacological activity. The time before the appearance of this metabolite in the blood is short (about 0.8 hours), however, its formation constant is small and significantly lower than the absorption constant of nimesulide.

Hydroxinimesulide is almost completely conjugated and is the only metabolite found in blood plasma. Its t½ is 3.2-6 hours

Nimesulide is excreted mainly in urine (about 50% of the dose taken).

Only 1-3% is excreted unchanged. Hydroxinimesulide, the main metabolite, is detected in urine only in the form of a glucuronide conjugate. About 29% of the dose after metabolism is excreted in the feces.

The kinetic profile of nimesulide did not change when taking a single or repeated dose in elderly patients.

As shown by an experimental study, in patients with moderate and initial renal failure (creatinine clearance - 30–80 ml / min) Cmax nimesulide and its main metabolite in blood plasma are not higher than in healthy volunteers. AUC and T½ were 50% higher, but remained within the kinetic values ​​observed in healthy volunteers.

Repeated reception does not cause accumulation.

Indications

Treatment for acute pain. symptomatic treatment for osteoarthritis with pain. primary dysmenorrhea.

Application

Affida Fort is prescribed after a thorough assessment of the risk / benefit ratio. used in the minimum effective dose for the least time to reduce side effects. the maximum duration of treatment is 15 days.

Adults and the elderly: 1 single-dose packet containing 100 mg of nimesulide, 2 times a day (daily dose - 200 mg).

Children over 12 years of age: Dose adjustment not required.

Patients with impaired renal function: for patients with mild or moderate degree of renal failure (creatinine clearance - 30-80 ml / min) dose adjustment is not required. In severe renal failure (creatinine clearance of 30 ml / min), the use of the drug is contraindicated.

The contents of single-dose packets are poured into a glass, dissolved in water and taken orally after a meal.

Contraindications

Hypersensitivity to the active substance or to any component of the drug. hypersensitivity reaction (bronchospasm, rhinitis, urticaria) with the use of acetylsalicylic acid or other NSAIDs in history. hepatotoxic reactions to the use of the drug in history. an active form of a stomach or duodenal ulcer, a history of relapse of the ulcer or gastrointestinal bleeding, cerebrovascular bleeding or other diseases accompanied by bleeding. severe bleeding disorder. severe heart failure. severe renal failure (creatinine clearance 30 ml / min). liver failure. fever and flu-like symptoms. alcoholism and drug addiction.

Side effects

The following side effects are based on data from controlled clinical trials - marked with "*" (about 7800 patients), the rest are based on data from post-marketing observation. the frequency of side effects was determined as follows: very often (1/10); often (1/100, 1/10); infrequently (1/1000, 1/100); rarely (1/10 000, 1/1000); very rarely (1/10 000), including isolated cases.

From the circulatory and lymphatic systems Rarely Anemia *, eosinophilia *
Rarely Thrombocytopenia, pancytopenia, purpura
From the immune system Rarely Hypersensitivity Reactions *
Rarely Anaphylaxis
Metabolic and nutritional disorders Rarely Hyperkalemia *
Mental disorders Rarely Sensation of anxiety *, nervousness *, nightmares *
Disorders of the nervous system Infrequently Dizziness*
Rarely Headache, drowsiness, encephalopathy (Reye syndrome)
Violations of the organ of vision Rarely Visual Impairment *
Rarely Visual impairment
Disorders of the organ of hearing and the vestibular apparatus Rarely Dizziness
Heart disorders Rarely Tachycardia*
Vascular disorders Infrequently AH *
Rarely Bleeding *, fluctuations in blood pressure *, flushing of the face *
Respiratory system disorders Infrequently Dispnea *
Rarely BA, bronchospasm
Digestive disorders Often Diarrhea *, nausea *, vomiting *
Infrequently Constipation * flatulence *, gastritis *
Rarely Abdominal pain, dyspepsia, stomatitis, melena, gastrointestinal bleeding, ulcer and perforation of the duodenum, ulcer and perforation of the stomach
Hepatobiliary disorders Rarely Hepatitis, including fatal fulminant hepatitis, jaundice, cholestasis
On the part of the skin and subcutaneous tissue Infrequently Itching *, rash *, excessive sweating *
Rarely Erythema *, dermatitis *
Rarely Urticaria, angioedema, facial edema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis
Impaired renal function and urinary system Rarely Dysuria *, hematuria *, urinary retention *
Rarely Renal failure, oliguria, interstitial nephritis
General violations Infrequently Edema *
Rarely General malaise *, asthenia *
Rarely Hypothermia
Laboratory indicators Often Increased liver enzymes *

special instructions

To reduce the risk of side effects, it is necessary to use the drug in a minimally effective dose with the shortest duration of use. if the patients condition does not improve, treatment should be discontinued.

There are separate reports of cases of serious reactions from the liver, in isolated cases with a fatal outcome (see ADVERSE EFFECTS). If patients using nimesulide develop symptoms that indicate liver damage (for example, anorexia, nausea, vomiting, abdominal pain, fatigue, dark urine), or altered indicators of liver function, the drug should be discontinued. Such patients are further prohibited from prescribing nimesulide. After a short-term use of the drug, in most cases, liver damage is reversible.

During treatment with nimesulide, it is recommended to avoid the simultaneous use of drugs that have a hepatotoxic effect, and the use of alcohol due to the increased risk of developing liver reactions.

Patients should be advised to refrain from using other painkillers in the treatment of Affida Fort. The simultaneous use of various NSAIDs is not recommended.

Gastrointestinal bleeding or ulcer / perforation may occur at any time during treatment with the drug. In this case, there are not always concomitant warning symptoms, as well as the presence of a history of previous gastrointestinal diseases.If gastrointestinal bleeding or ulcers occur, the drug should be discontinued.

With caution, the drug should be prescribed to patients with gastrointestinal disorders, including those who have a history of peptic ulcer, ulcerative colitis, or Crohns disease.

With caution, the drug should be prescribed to patients with a kidney

Tags: Nimesulide