The instruction for use
of medicine for experts
of NIMEZTM
the Trade name
NimezTM
Mezhdunarodnoye the unlicensed
name Nimesulide Dosage Form
of the Tablet, 100 mg
Structure
One tablet contains
active agent – Nimesulide, 100 mg,
excipients: calcium double-base phosphate, starch, microcrystalline cellulose (Avitsel rn 101), starch sodium glycollate, water purified, the colloidal silicon dioxide, talc purified, magnesium stearate.
Description
Light yellow round biconvex tablets
Pharmacotherapeutic group
Anti-inflammatory and antirheumatic drugs. Other non-steroidal anti-inflammatory drugs
the ATC M 01AX17 Code
the Pharmacological
Pharmacokinetics Nimesulide properties is well soaked up at oral administration, meal does not affect absorbing capacity of Nimesulide. Tmax makes 1.2 - 3.3 hours at intake. Vd makes 0.18 - 0.39 l/kg, linking with proteins of plasma makes 99%. Well gets through gisto-gematichesky bayeryer.
Nimesulide is actively metabolized in a liver with education 4 hydroxynimesulides. Elimination half-life makes 1.8 - 5.25 hours. The general clearance - from 31.02 to 106.16 ml/h/kg.
It is removed in the form of metabolites – 50.5 - 62.5% with urine, 17.9 - 36.2% through intestines and less than 0.1% in not changed look.
The pharmacodynamics
Nimesulide is non-steroidal anti-inflammatory drug, having effective anti-inflammatory, febrifugal and analgetic properties. Chemically Nimesulide differs from other non-steroidal anti-inflammatory drugs in existence in its structure of functional group of a sulfonanilid. Nimesulide is selection inhibitor of synthesis of prostaglandin owing to cyclooxygenase-2 enzyme inhibition. Enzyme inhibits type phosphodiesterase IV owing to what formation of superoxide by activation of neutrophils without influence on phagocytal and hemotaksichesky activity decreases.
Nimesulide reduces extracellular availability of the hypochlorous acid which is formed in the course of phagocytosis.
Nimesulide also inhibits release of a histamine from basophiles and mast cells, depending on concentration, reduces formation of a factor of activation of thrombocytes.
Nimesulide reduces destruction of cartilaginous tissue by suppression of synthesis of metalproteases, such as collagenase and stromelizin.
Drug controls activity of enzyme of elastase in the site of inflammation that provides anti-inflammatory effect.
Indications
- the fever, pain, a headache, a general malaise connected with cold
and flu
- a toothache
- pain in injuries
- the pseudorheumatism, osteortrit
- myalgias, a tendinitis, a bursitis
- painful periods
the Route of administration and doses
the Adult: 100 mg - 200 mg 2 times a day.
The maximum single dose – 200 mg.
The maximum daily dose – 400 mg.
In a liver failure the extent of removal of Nimesulide considerably falls therefore at such patients the dosage is reduced by 4-5 times.
Side effects
- the sleep disorder, hyperexcitability, dizziness, a headache,
drowsiness
- heartburn, pains in epigastriums, nausea, diarrhea, vomiting, is rare – gastro
intestinal bleedings and stomatitises
- purple skin rashes, a Werlhof's disease
- skin rash, an itching, an erythema, rush of blood
- perspiration
- a gynecomastia
- an acute renal failure
- an acute hepatitis
of the Contraindication
- hypersensitivity to Nimesulide and other components
of drug,
- exacerbation of a round ulcer of a stomach
- a moderate and heavy liver failure
- rhinitis, urticaria, asthma or allergic reaction to aspirin or other
anti-inflammatory drugs
- pregnancy and the period of a lactation
- children's and teenage age up to 18 years
Medicinal interaction
Nimesulide can reduce oral bioavailability of furosemide, therefore, reduces efficiency of effect of furosemide on glomerular filtration, a renal blood stream.
Sharply theophylline level in plasma after intake of Nimesulide against the background of continuous treatment by theophylline decreases.
At combined use with warfarin it is necessary to control blood clotting.
At combined use of NPVS with beta blockers there were cases of increase in pressure, it is necessary to control arterial blood pressure.
The special
instructions Apply with care at:
· Hepatic pathology, disturbance of coagulability, hypertensive and warm states followed by stagnation of liquid, hypostasis, gastrointestinal ulcers, bleeding or perforation, renal failure.
· Moderate or heavy medicinal hepatitis. Therefore the patients accepting Nimesulide have to be examined on jaundice symptoms. If necessary, to investigate the plasma AST/ALT level. It is necessary to stop administration of drug at the first signs of hepatotoxicity
of Feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Considering side effects of medicine it is necessary to be careful when driving or potentially dangerous mechanisms
Overdose
Symptoms: hypoglycemia, fall of temperature of a body.
Treatment: gastric lavage, symptomatic therapy.
Form of release
of the Tablet, 100 mg
Primary packing: 10 tablets in a strip.
Secondary packing: 1 strip with the instruction for use in cardboard packing.
To Store storage conditions in the dry place at the room temperature not higher than + 250C
to Protect from direct sunshine
to Store out of children's reach!
Not to apply an expiration date of 5 years after an expiration date.
Prescription status
According to the prescription
Plethico Pharmaceuticals Ltd/Pletkhiko Pharmasyyutikalz Ltd Adres Producer of location:
A.B. the Road, Mangliya - 453,771, Indore (L. S.), India
the Legal address:
37/37A, Indastrial Isteyt, Polograund, Indore (L. S.), 452,015, India
of medicine for experts
of NIMEZTM
the Trade name
NimezTM
Mezhdunarodnoye the unlicensed
name Nimesulide Dosage Form
of the Tablet, 100 mg
Structure
One tablet contains
active agent – Nimesulide, 100 mg,
excipients: calcium double-base phosphate, starch, microcrystalline cellulose (Avitsel rn 101), starch sodium glycollate, water purified, the colloidal silicon dioxide, talc purified, magnesium stearate.
Description
Light yellow round biconvex tablets
Pharmacotherapeutic group
Anti-inflammatory and antirheumatic drugs. Other non-steroidal anti-inflammatory drugs
the ATC M 01AX17 Code
the Pharmacological
Pharmacokinetics Nimesulide properties is well soaked up at oral administration, meal does not affect absorbing capacity of Nimesulide. Tmax makes 1.2 - 3.3 hours at intake. Vd makes 0.18 - 0.39 l/kg, linking with proteins of plasma makes 99%. Well gets through gisto-gematichesky bayeryer.
Nimesulide is actively metabolized in a liver with education 4 hydroxynimesulides. Elimination half-life makes 1.8 - 5.25 hours. The general clearance - from 31.02 to 106.16 ml/h/kg.
It is removed in the form of metabolites – 50.5 - 62.5% with urine, 17.9 - 36.2% through intestines and less than 0.1% in not changed look.
The pharmacodynamics
Nimesulide is non-steroidal anti-inflammatory drug, having effective anti-inflammatory, febrifugal and analgetic properties. Chemically Nimesulide differs from other non-steroidal anti-inflammatory drugs in existence in its structure of functional group of a sulfonanilid. Nimesulide is selection inhibitor of synthesis of prostaglandin owing to cyclooxygenase-2 enzyme inhibition. Enzyme inhibits type phosphodiesterase IV owing to what formation of superoxide by activation of neutrophils without influence on phagocytal and hemotaksichesky activity decreases.
Nimesulide reduces extracellular availability of the hypochlorous acid which is formed in the course of phagocytosis.
Nimesulide also inhibits release of a histamine from basophiles and mast cells, depending on concentration, reduces formation of a factor of activation of thrombocytes.
Nimesulide reduces destruction of cartilaginous tissue by suppression of synthesis of metalproteases, such as collagenase and stromelizin.
Drug controls activity of enzyme of elastase in the site of inflammation that provides anti-inflammatory effect.
Indications
- the fever, pain, a headache, a general malaise connected with cold
and flu
- a toothache
- pain in injuries
- the pseudorheumatism, osteortrit
- myalgias, a tendinitis, a bursitis
- painful periods
the Route of administration and doses
the Adult: 100 mg - 200 mg 2 times a day.
The maximum single dose – 200 mg.
The maximum daily dose – 400 mg.
In a liver failure the extent of removal of Nimesulide considerably falls therefore at such patients the dosage is reduced by 4-5 times.
Side effects
- the sleep disorder, hyperexcitability, dizziness, a headache,
drowsiness
- heartburn, pains in epigastriums, nausea, diarrhea, vomiting, is rare – gastro
intestinal bleedings and stomatitises
- purple skin rashes, a Werlhof's disease
- skin rash, an itching, an erythema, rush of blood
- perspiration
- a gynecomastia
- an acute renal failure
- an acute hepatitis
of the Contraindication
- hypersensitivity to Nimesulide and other components
of drug,
- exacerbation of a round ulcer of a stomach
- a moderate and heavy liver failure
- rhinitis, urticaria, asthma or allergic reaction to aspirin or other
anti-inflammatory drugs
- pregnancy and the period of a lactation
- children's and teenage age up to 18 years
Medicinal interaction
Nimesulide can reduce oral bioavailability of furosemide, therefore, reduces efficiency of effect of furosemide on glomerular filtration, a renal blood stream.
Sharply theophylline level in plasma after intake of Nimesulide against the background of continuous treatment by theophylline decreases.
At combined use with warfarin it is necessary to control blood clotting.
At combined use of NPVS with beta blockers there were cases of increase in pressure, it is necessary to control arterial blood pressure.
The special
instructions Apply with care at:
· Hepatic pathology, disturbance of coagulability, hypertensive and warm states followed by stagnation of liquid, hypostasis, gastrointestinal ulcers, bleeding or perforation, renal failure.
· Moderate or heavy medicinal hepatitis. Therefore the patients accepting Nimesulide have to be examined on jaundice symptoms. If necessary, to investigate the plasma AST/ALT level. It is necessary to stop administration of drug at the first signs of hepatotoxicity
of Feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Considering side effects of medicine it is necessary to be careful when driving or potentially dangerous mechanisms
Overdose
Symptoms: hypoglycemia, fall of temperature of a body.
Treatment: gastric lavage, symptomatic therapy.
Form of release
of the Tablet, 100 mg
Primary packing: 10 tablets in a strip.
Secondary packing: 1 strip with the instruction for use in cardboard packing.
To Store storage conditions in the dry place at the room temperature not higher than + 250C
to Protect from direct sunshine
to Store out of children's reach!
Not to apply an expiration date of 5 years after an expiration date.
Prescription status
According to the prescription
Plethico Pharmaceuticals Ltd/Pletkhiko Pharmasyyutikalz Ltd Adres Producer of location:
A.B. the Road, Mangliya - 453,771, Indore (L. S.), India
the Legal address:
37/37A, Indastrial Isteyt, Polograund, Indore (L. S.), 452,015, India
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