Nimesulid-Vishfa

General characteristics. Structure:

Active ingredient: 5 ml of suspension oral contain Nimesulide 50 mg.
Excipients: sugar confectionery, ksantovy gum, polysorbate 60, Natrium benzoicum (E211), sodium citrate, citric acid, Apricot of MA/1 137 fragrance (contains propylene glycol), the water purified.

Main physical and chemical properties: Suspension of yellow color with a characteristic smell and sweet taste. At storage stratification which is eliminated when stirring is possible.

Pharmacological properties:

Pharmacodynamics. Drug has the protivospalitelny, anesthetizing and febrifugal action. Nimesulide is a selection inhibitor of cyclooxygenase-2 (TsOG-2) which inhibits formation of superoksidanion from the stimulating polymorphonuclear leukocytes, inhibits a factor of activation of synthesis of thrombocytes, interferes with an induktirovaniye bradikinin-tsitokininom of hyperalgesias of nerves (inhibiting releases of a factor of a necrosis of tumors of TNF-), is an acceptor of hypochlorous acid, blocks release of a histamine from mast cells, inhibits activity of proteases (elastase, a collagenase), umeshat processes of dehydration of a matrix of a cartilage at the expense of inhibition of synthesis of metalproteases, phosphodiesterase to type IV inhibits.

Pharmacokinetics. At oral administration quickly it is also practical completely it is soaked up. The maximum concentration in plasma a shelter of 3,5 mg/l is reached throughout 2 is frequent after a priyom, then — decreases for the next 12 hours. Nearly 99% contact proteins of a blood plasma. It is extensively metabolized, 70% of metabolites are removed with urine, about 20% — with a stake. In not changed view with urine about 1-3% of drug are removed. Pharmacological activity of drug is connected with action of the main metabolite 4 hydroxynimesulides which maximum concentration in a blood plasma are reached in 2,5–5,3 hours after a priyom of 50-200 mg of Nimesulide. A Nimesulide elimination half-life — 1,56–4,95 hour, and its main metabolite — 2,89-4,78.

Indications to use:

Treatment of an acute pain. A symptomatic treatment of an osteoarthrosis with a pain syndrome. Primary dysmenorrhea.

Route of administration and doses:

Nimesulide is appointed after careful assessment of a ratio risk/advantage.

Apply minimum effective dose throughout the shortest time to easing of side effects.

The maximum duration of a course of treatment Nimesulide — 15 days.
Suspension is accepted after food. Before the use suspension needs to be shaken up.
To adults and children after 12 years appoint 10 ml (100 mg) of suspension 2 times a day. At primary dysmenorrhea — on 5-10ml (50–100 mg) twice a day.

The course of treatment depends on a clinical situation, but has to be the shortest.

Features of use:

It is necessary to apply minimum effective dose to decrease in risk of development of side effects with the most minimum duration of use. If the condition of the patient does not improve, treatment needs to be stopped.

There are separate messages on cases of serious reactions from a liver, in isolated cases — from the death. At emergence in patients that is applied by Nimesulid-Vishfa, symptoms that point to damage of a liver (for example, anorexia, nausea, vomiting, an abdominal pain, feeling of fatigue, urine of dark color), or the changed indicators of functional hepatic trials, drug should be cancelled. Such patients and in an effect are forbidden to appoint Nimesulid-Vishfa. After short-term use of drug the return damage of a liver was in most cases observed. During treatment of Nimesulidom-Vishfa it is recommended to avoid simultaneous use of drugs that have a hepatotoxic action, and применть alcohol because of the increased risk of development of hepatic reactions. It is necessary to recommend to patients to refrain from use of other anesthetics during treatment of Nimesulidom-Vishfa. Simultaneous use of different non-steroidal anti-inflammatory drugs is not recommended.

 In case of fervescence or emergence of grippopodobny symptoms in patients who apply Nimesulide use of drug should be cancelled.

Gastrointestinal bleeding or ulcer/perforation can develop  during treatment by drug at any time. At the same time the accompanying warning symptoms, and also existence in the anamnesis of the previous gastrointestinal diseases are not always present. When developing gastrointestinal bleeding or ulcer drug should be cancelled.

With care it is necessary to appoint Nimesulid-Vishfa the patient to gastrointestinal disturbances, including those who have in the anamnesis of a peptichny ulcer, ulcer colitis or disease Krone.

With care it is necessary to appoint drug sick with a renal failure or heart failure as its use can lead to deterioration in function of kidneys. In case of deterioration in function of kidneys drug should be cancelled.

In patients of old age often there are renal failures, heart and a liver. Therefore regular clinical control a condition of the patient is recommended.

As Nimesulid-Vishfa can influence function of thrombocytes, it is necessary to appoint him with care the patient to hemorrhagic diathesis. At the same time Nimesulid-Vishfa should not appoint instead of acetylsalicylic acid for prevention in cardiology.

Use of Nimesulida-Vishfa can break female fertility and  it is not recommended to apply to women who plan to become pregnant. To women, it is difficult to them to become pregnant or if they are on inspection concerning infertility, it is not recommended to appoint Nimesulid-Vishfa.

Influence on ability to direct the car or to work with difficult mechanisms. Due to the possible drowsiness it is necessary to limit driving by motor transport and work with potential and dangerous mechanisms.

Side effects:

The side effects given below are based on data of the controlled clinical trials and data of post-marketing observation. Frequency of side reactions was defined so: frequent (1/10); widespread (1/100, 1/10); not widespread ( 1/1 000 1/100); rare  (1/10 000, 1/1 000); to soul rare (1/10 000), including isolated cases.

Diseases	Manifestations	Symptoms
Disturbances of system of blood	Rare	Anemia, eosinophilia
	Very rare	Thrombocytopenia, pancytopenia, purpura
Disturbances of immune system	Rare	Hypersensitivity reactions
	Very rare	Anaphylaxis
Disturbance of metabolism and food	Rare	Hyperpotassemia
Mental disturbances	Rare	Feelings of alarm, nervousness, koshmayena dreams
Disturbances of a nervous system	Not widespread	dizzinesses
	Very rare	Headache, drowsiness, encephalopathy (syndrome to Reja)
Vision disorders	Rare	Disturbances of a chekost of sight
	Very rare	Vision disorders
Hearing disorder and vestibular mechanism	Very rare	Dizzinesses
Serdechne of disturbance	Rare	Tachycardia
Vascular disorders	Not widespread	Arterial hypertension
	Rare	Bleeding, jumps of arterial pressure, rushes of blood to the person
Breath disturbances	Not widespread	Dispnoye
	Very rare	Asthma, bronchospasm
Gastrointestinal disturbances	Widespread	Diarrhea, nausea, vomiting
	Not widespread	Lock, meteorism, gastritis
	Very rare	Abdominal pain, dyspepsia, stomatitis, melena, gastrointestinal bleeding, ulcer and perforation of a 12-perstny gut, ulcer and perforation of a stomach
Gepatobilirny disturbances	Very rare	Гепатитв that number rapid hepatitis with the lethal end, a zheltushnitsa, a cholestasia
Disturbances of skin and hypodermic fabrics	Not widespread	Itch, rash, strengthening of a potovydeleniye
	Rare	Erythema, dermatitis
	Very rare	Urticaria, gionevrotichesky hypostasis, face edema, multiformny erythema, Stephens-Johnson's syndrome, toxic epidermal necrolysis
Renal failure and uric system	Rare	Dysuria, hamaturia, urination delay
	Very rare	Renal failure, oliguria, intersticial nephrite
General disturbances	Not widespread	Hypostases
	Rare	Febricula, adynamy
	Very rare	Hypothermia
Лабораторні pokaznik	Widespread	Increase in level of liver enzymes.

Interaction with other medicines:

At simultaneous use with drugs that contact proteins, there is a probability of substitution by Nimesulide - Vishfa of other drugs due to manifestation of its ability to communicate widely proteins of a blood plasma. Nimesulid-Vishfa can displace salicylic acid, a methotrexate, furosemide from places of binding, can also displace from places of linkng at simultaneous use with phenobarbital, salicylic acid, valiproyevy acid, tolbutaminy. Nimesulid-Vishfa can cause euzymatic induction of theophylline at simultaneous use.

Nimesulid-Vishfa at reception on an empty stomach does not influence portability of glucose at patients who accept drugs for treatment of diabetes.

With care to apply along with digoxin, lithium drugs, cyclosporine.

Contraindications:

Hypersensitivity to active ingredient or to any component of drug. Hypersensitivity reactions (a bronchospasm, rhinitis, urticaria) at use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs in the anamnesis. Hepatotoxic reactions to use of drug in the anamnesis. Simultaneous use with potentially hepatotoxic means. Alcoholism, drug addiction. An active form of a peptic ulcer of a stomach or duodenum, existence of a recurrence of a peptic ulcer or gastrointestinal bleeding in the anamnesis, cerebrovascular or bleeding that accompanies other diseases. Heavy disturbance of a blood coagulation. Heavy heart failure. A heavy renal failure (the clearance of creatine is more than 30 ml/min.). Liver failure. The increased body temperature and grippopodobny symptoms. Children up to 12 years. Third trimester of pregnancy and period of feeding by a breast.

Overdose:

Symptoms of acute overdose by nonsteroid drugs are usually limited to a lethargy, drowsiness, nausea, vomiting, we are ill in gastric area. These symptoms the, usually, return when performing the corresponding supporting treatment. Gastrointestinal bleeding can be observed. Less often arterial hypertension, an acute renal failure, respiratory depressions and a coma can be observed. Anaphylactoid reactions were observed at use of therapeutic doses of non-steroidal anti-inflammatory drugs and can be observed at overdose.

After overdose by nonsteroid drugs patients have to receive the symptomatic and supporting treatment. The specific antidote does not exist. Information on removal of Nimesulide by means of a hemodialysis is absent, but based on high extent of its linkng with proteins of plasma (to 97,5%), it is possible to assume that dialysis at overdose will not be effective. The patient for 4 hours after use of a high dose of Nimesulide, it is recommended to cause vomiting and/or to apply absorbent carbon (60-100mg to adults) and/or a purgative of osmotic type.

Necessary careful control of function of kidneys and liver.

Use during pregnancy or feeding by a breast. Use during pregnancy or feeding by a breast is contraindicated.

Children. It is applied at children aged 12 years are more senior.

Storage conditions:

To store at     a temperature from 15 °C to 25 °C in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

On 55 ml in a bottle or bank with a measured glass in a cardboard pack.