Nimid 2g (30 granules)
- $20.20
NimidTM
the Trade name
NimidTM
Mezhdunarodnoye the unlicensed
name Nimesulide Dosage Form
of the Granule of 2 g
Structure
Structure on 1 sachet package
active agent - Nimesulide of 100 mg,
excipients: tabletoza 80 (lactoses monohydrate), K-30 povidone, sodium saccharin, citric acid monohydrate, flavoring Orange DC 100 PH additive, Aerosil 200.
The description
of the Granule of light yellow color with an orange smell
Pharmacotherapeutic group
Non-steroidal anti-inflammatory drugs. Non-selective non-steroidal anti-inflammatory drugs.
The code of automatic telephone exchange M01AX17
the Pharmacological
Pharmacokinetics Nimesulide properties is well soaked up at oral administration, meal does not affect absorbing capacity of Nimesulide. Time of achievement of the maximum concentration in blood (Tmax), at intake, is 1.2 - 3.3 hours. The volume of distribution (Vd) is 0.18 - 0.39 l/kg, linking with proteins of blood plasma makes 99%. Well gets through gisto-gematichesky barriers.
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
NimidTM is non-steroidal anti-inflammatory drug, having anti-inflammatory, febrifugal and analgetic properties, is selection inhibitor of synthesis of prostaglandin owing to inhibition of enzyme of cyclooxygenase-2 (TsOG-2). Enzyme inhibits type phosphodiesterase IV owing to what formation of superoxide by activation of neutrophils without influence on phagocytal and hemotaksichesky activity decreases.
NimidTM reduces extracellular availability of the hypochlorous acid which is formed in the course of phagocytosis and also inhibits release of a histamine from basophiles and mast cells, depending on concentration, reduces formation of a factor of activation of thrombocytes.
NimidTM reduces destruction of cartilaginous tissue by suppression of synthesis of metalproteases, such as collagenase and stromelizin.
Nimesulide controls activity of enzyme of elastase in the site of inflammation that provides anti-inflammatory effect.
Indications
- treatment of acute pains
-
- treatment of primary dysmenorrhea
Nimesulide it is necessary to appoint symptomatic treatment of an osteoarthritis with a pain syndrome only as drug of the second line. The decision on therapy has to be made by Nimesulide on the basis of assessment of all risks for the specific patient.
The route of administration and doses
the Adult is recommended to take the drug in a dose 1 bag (100 mg of Nimesulide) twice a day after a meal. The maximum duration of treatment is 5 days.
Patients of advanced age: correction of a daily dose is not required.
Patients with a renal failure: for patients with easy or moderate degree of a renal failure (clearance of creatinine of 30-80 ml/min.) the dose adjustment is not required.
Contents of a portion bag are dissolved in a glass of water.
Side effects
often (≥ l/100,
- diarrhea, nausea, vomiting
- increase in level of liver enzymes
sometimes (≥ l/l, 000,
- dizziness
- hypertensia
- short wind
- a constipation, a meteorism, gastritis
- an itching, rash, the increased perspiration
- hypostases
seldom (≥ l/10.000,
- anemia, an eosinophilia
- hypersensitivity
- a hyperpotassemia
- sensation of fear, nervousness, dreadful dreams
- indistinct sight
- tachycardia
- a hemorrhage, lability of arterial blood pressure, inflows
- an erythema, dermatitis
- a dysuria, a hamaturia, an urination delay
- weakness, an asthenia
very seldom (
-thrombocytopenia, a pancytopenia, a purpura
- an anaphylaxis
- a headache, drowsiness, encephalopathy (a syndrome to Reja)
- vertigo
- a visual disturbance
- asthma, a bronchospasm
- an abdominal pain, dyspepsia, stomatitis, a tar-like chair, gastrointestinal bleeding, an ulcer and perforation of a 12-perstny gut, an ulcer and perforation of a stomach
- hepatitis, lightning hepatitis (including lethal outcomes), jaundice, a cholestasia
- urticaria, a Quincke's disease, a face edema, an erythema poliformny, Stephens-Johnson's syndrome, a toxic epidermal necrolysis
- a renal failure, an oliguria, interstitial nephrite
-
the Contraindication hypothermia
- hypersensitivity to Nimesulide or to one of drug excipients
- the giperergichesky reactions taking place in the past (for example a bronchospasm, rhinitis, a small tortoiseshell) in connection with intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs
- existence in the anamnesis of hepatotoxic reactions to Nimesulide
- the accompanying intake of other substances with potential hepatotoxicity
- alcoholism, drug addiction
- ulcer of stomach or duodenum in an aggravation phase, existence in the anamnesis of an ulcer, perforation or bleeding in digestive tract
- existence in the anamnesis of cerebrovascular bleedings or other hemorrhages and also the diseases which are followed by bleeding
- heavy disturbances of a coagulant system of blood
- heavy degree of heart failure
- heavy degree of a renal failure (clearance of creatinine
- liver diseases, increase in level of liver enzymes, a liver failure
- patients with symptoms of cold or flu
- children's and teenage age up to 18 years
- pregnancy and the period of a lactation
- hereditary intolerance of fructose, glucose galactose malabsorption, insufficiency of invertase-isomaltase
Medicinal interaction
At intake of Nimesulide together with furosemide, is possible decrease in oral bioavailability of furosemide, and its action on glomerular filtration, a renal blood stream.
Nimesulide reduces efficiency of antihypertensive drugs.
At patients with a renal failure, at the combined use of Nimesulide and APF inhibitors, antagonists of angiotensin II, drugs suppressing the system of cyclooxygenase the developing of an acute renal failure, as a rule, reversible is possible.
After intake of Nimesulide, against the background of continuous treatment by theophylline,
theophylline level in blood plasma sharply decreases.
At combined use of Nimesulide with warfarin or other similar anticoagulants, acetylsalicylic acid, action of the last amplifies.
At combined use of NPVS with beta blockers perhaps increases in arterial blood pressure.
Nimesulide can reduce clearance of lithium that leads to increase in level of lithium in blood plasma and its toxicity.
At simultaneous use with cyclosporine the increase in nephrotoxicity of the last is possible.
It is necessary to appoint the special instructions Nimesulide only as drug of the second line. The decision on therapy has to be made by Nimesulide on the basis of assessment of all risks for the specific patient.
At joint use of Nimesulide elderly people need to be careful with the furosemide, antihypertensive drugs, APF inhibitors, drugs suppressing cyclooxygenase, especially. At use of these combinations, consumption of enough liquid, and also control of function of kidneys is necessary.
At combined use of NPVS with beta blockers it is necessary to control arterial blood pressure.
When prescribing Nimesulide the control of level of lithium in blood plasma is necessary for the patients receiving therapy by lithium drugs.
When prescribing Nimesulide less than in 24 hours prior to or less than in 24 hours after reception of a methotrexate, it is required to be careful as methotrexate level in blood plasma and, respectively, its toxic effects can amplify.
At fervescence and emergence of grippopodobny symptoms in the patients applying Nimesulide, administration of drug should be cancelled.
At emergence of symptoms of damage of a liver, during treatment by Nimesulide (anorexia, nausea, vomiting, an abdominal pain, fatigue, dark color of urine), or a deviation from normal values of laboratory indicators of function of a liver, it is necessary to stop administration of drug.
Repeated prescribing of Nimesulide in this case is contraindicated.
During treatment by Nimesulide it is necessary to abstain from intake of other analgetics. It is necessary to avoid the accompanying use of Nimesulide and other NPVP, including, selection inhibitors of cyclooxygenase-2.
To apply with care at:
· liver diseases, disturbance of blood clotting, arterial hypertension, cardiovascular diseases which are followed by hypostases, ulcer of the digestive tract (DT), bleeding or perforation of a GIT, renal failure
· medicinal hepatitis or moderate severity, at these patients, accepting Nimesulide, control of function of a liver has to be heavy (if necessary, to investigate the blood plasma AST/ALT level).
It is necessary to stop administration of drug at the first signs of hepatotoxicity.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Considering side effects of drug, 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.
A release form
On 2 g of drug place in a sachet - bags.
On 30 sachets - bags together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
Storage conditions
In the place protected from light at a temperature not above 25 °C.
To store out of children's reach.
2 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
the Producer Kusum Heltker Pvt. Ltd., India
to Develop
the Trade name
NimidTM
Mezhdunarodnoye the unlicensed
name Nimesulide Dosage Form
of the Granule of 2 g
Structure
Structure on 1 sachet package
active agent - Nimesulide of 100 mg,
excipients: tabletoza 80 (lactoses monohydrate), K-30 povidone, sodium saccharin, citric acid monohydrate, flavoring Orange DC 100 PH additive, Aerosil 200.
The description
of the Granule of light yellow color with an orange smell
Pharmacotherapeutic group
Non-steroidal anti-inflammatory drugs. Non-selective non-steroidal anti-inflammatory drugs.
The code of automatic telephone exchange M01AX17
the Pharmacological
Pharmacokinetics Nimesulide properties is well soaked up at oral administration, meal does not affect absorbing capacity of Nimesulide. Time of achievement of the maximum concentration in blood (Tmax), at intake, is 1.2 - 3.3 hours. The volume of distribution (Vd) is 0.18 - 0.39 l/kg, linking with proteins of blood plasma makes 99%. Well gets through gisto-gematichesky barriers.
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
NimidTM is non-steroidal anti-inflammatory drug, having anti-inflammatory, febrifugal and analgetic properties, is selection inhibitor of synthesis of prostaglandin owing to inhibition of enzyme of cyclooxygenase-2 (TsOG-2). Enzyme inhibits type phosphodiesterase IV owing to what formation of superoxide by activation of neutrophils without influence on phagocytal and hemotaksichesky activity decreases.
NimidTM reduces extracellular availability of the hypochlorous acid which is formed in the course of phagocytosis and also inhibits release of a histamine from basophiles and mast cells, depending on concentration, reduces formation of a factor of activation of thrombocytes.
NimidTM reduces destruction of cartilaginous tissue by suppression of synthesis of metalproteases, such as collagenase and stromelizin.
Nimesulide controls activity of enzyme of elastase in the site of inflammation that provides anti-inflammatory effect.
Indications
- treatment of acute pains
-
- treatment of primary dysmenorrhea
Nimesulide it is necessary to appoint symptomatic treatment of an osteoarthritis with a pain syndrome only as drug of the second line. The decision on therapy has to be made by Nimesulide on the basis of assessment of all risks for the specific patient.
The route of administration and doses
the Adult is recommended to take the drug in a dose 1 bag (100 mg of Nimesulide) twice a day after a meal. The maximum duration of treatment is 5 days.
Patients of advanced age: correction of a daily dose is not required.
Patients with a renal failure: for patients with easy or moderate degree of a renal failure (clearance of creatinine of 30-80 ml/min.) the dose adjustment is not required.
Contents of a portion bag are dissolved in a glass of water.
Side effects
often (≥ l/100,
- diarrhea, nausea, vomiting
- increase in level of liver enzymes
sometimes (≥ l/l, 000,
- dizziness
- hypertensia
- short wind
- a constipation, a meteorism, gastritis
- an itching, rash, the increased perspiration
- hypostases
seldom (≥ l/10.000,
- anemia, an eosinophilia
- hypersensitivity
- a hyperpotassemia
- sensation of fear, nervousness, dreadful dreams
- indistinct sight
- tachycardia
- a hemorrhage, lability of arterial blood pressure, inflows
- an erythema, dermatitis
- a dysuria, a hamaturia, an urination delay
- weakness, an asthenia
very seldom (
-thrombocytopenia, a pancytopenia, a purpura
- an anaphylaxis
- a headache, drowsiness, encephalopathy (a syndrome to Reja)
- vertigo
- a visual disturbance
- asthma, a bronchospasm
- an abdominal pain, dyspepsia, stomatitis, a tar-like chair, gastrointestinal bleeding, an ulcer and perforation of a 12-perstny gut, an ulcer and perforation of a stomach
- hepatitis, lightning hepatitis (including lethal outcomes), jaundice, a cholestasia
- urticaria, a Quincke's disease, a face edema, an erythema poliformny, Stephens-Johnson's syndrome, a toxic epidermal necrolysis
- a renal failure, an oliguria, interstitial nephrite
-
the Contraindication hypothermia
- hypersensitivity to Nimesulide or to one of drug excipients
- the giperergichesky reactions taking place in the past (for example a bronchospasm, rhinitis, a small tortoiseshell) in connection with intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs
- existence in the anamnesis of hepatotoxic reactions to Nimesulide
- the accompanying intake of other substances with potential hepatotoxicity
- alcoholism, drug addiction
- ulcer of stomach or duodenum in an aggravation phase, existence in the anamnesis of an ulcer, perforation or bleeding in digestive tract
- existence in the anamnesis of cerebrovascular bleedings or other hemorrhages and also the diseases which are followed by bleeding
- heavy disturbances of a coagulant system of blood
- heavy degree of heart failure
- heavy degree of a renal failure (clearance of creatinine
- liver diseases, increase in level of liver enzymes, a liver failure
- patients with symptoms of cold or flu
- children's and teenage age up to 18 years
- pregnancy and the period of a lactation
- hereditary intolerance of fructose, glucose galactose malabsorption, insufficiency of invertase-isomaltase
Medicinal interaction
At intake of Nimesulide together with furosemide, is possible decrease in oral bioavailability of furosemide, and its action on glomerular filtration, a renal blood stream.
Nimesulide reduces efficiency of antihypertensive drugs.
At patients with a renal failure, at the combined use of Nimesulide and APF inhibitors, antagonists of angiotensin II, drugs suppressing the system of cyclooxygenase the developing of an acute renal failure, as a rule, reversible is possible.
After intake of Nimesulide, against the background of continuous treatment by theophylline,
theophylline level in blood plasma sharply decreases.
At combined use of Nimesulide with warfarin or other similar anticoagulants, acetylsalicylic acid, action of the last amplifies.
At combined use of NPVS with beta blockers perhaps increases in arterial blood pressure.
Nimesulide can reduce clearance of lithium that leads to increase in level of lithium in blood plasma and its toxicity.
At simultaneous use with cyclosporine the increase in nephrotoxicity of the last is possible.
It is necessary to appoint the special instructions Nimesulide only as drug of the second line. The decision on therapy has to be made by Nimesulide on the basis of assessment of all risks for the specific patient.
At joint use of Nimesulide elderly people need to be careful with the furosemide, antihypertensive drugs, APF inhibitors, drugs suppressing cyclooxygenase, especially. At use of these combinations, consumption of enough liquid, and also control of function of kidneys is necessary.
At combined use of NPVS with beta blockers it is necessary to control arterial blood pressure.
When prescribing Nimesulide the control of level of lithium in blood plasma is necessary for the patients receiving therapy by lithium drugs.
When prescribing Nimesulide less than in 24 hours prior to or less than in 24 hours after reception of a methotrexate, it is required to be careful as methotrexate level in blood plasma and, respectively, its toxic effects can amplify.
At fervescence and emergence of grippopodobny symptoms in the patients applying Nimesulide, administration of drug should be cancelled.
At emergence of symptoms of damage of a liver, during treatment by Nimesulide (anorexia, nausea, vomiting, an abdominal pain, fatigue, dark color of urine), or a deviation from normal values of laboratory indicators of function of a liver, it is necessary to stop administration of drug.
Repeated prescribing of Nimesulide in this case is contraindicated.
During treatment by Nimesulide it is necessary to abstain from intake of other analgetics. It is necessary to avoid the accompanying use of Nimesulide and other NPVP, including, selection inhibitors of cyclooxygenase-2.
To apply with care at:
· liver diseases, disturbance of blood clotting, arterial hypertension, cardiovascular diseases which are followed by hypostases, ulcer of the digestive tract (DT), bleeding or perforation of a GIT, renal failure
· medicinal hepatitis or moderate severity, at these patients, accepting Nimesulide, control of function of a liver has to be heavy (if necessary, to investigate the blood plasma AST/ALT level).
It is necessary to stop administration of drug at the first signs of hepatotoxicity.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Considering side effects of drug, 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.
A release form
On 2 g of drug place in a sachet - bags.
On 30 sachets - bags together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
Storage conditions
In the place protected from light at a temperature not above 25 °C.
To store out of children's reach.
2 years
not to apply a period of storage after an expiration date.
Prescription status
According to the prescription
the Producer Kusum Heltker Pvt. Ltd., India
to Develop
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