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Nimid 100 mg (100 tablets)

$19.50

6852deca75ac

Description

NimidTM

the Trade name

NimidTM

Mezhdunarodnoye the unlicensed

name Nimesulide Dosage Form

of the Tablet, 100 mg

Structure

One tablet contains

active agent Nimesulide of 100 mg,

excipients: microcrystalline cellulose, sodium of a kroskarmeloz (Ac-di-sol), magnesium stearate, silicon dioxide colloidal anhydrous (Aerosil 200).

Description

of the Tablet of round shape, light yellow color, smooth on both sides

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.

17.9 36.2% through intestines and less than 0.1% in not changed look are removed in the form of metabolites of 50.5 62.5% with urine.

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.

A route of administration and doses

For intake.

The adult on 100 mg – 200 mg 2 times a day, after a meal.

The maximum single dose makes 200 mg.

The maximum daily dose makes 400 mg.

The maximum course of treatment drug – 5 days.

Side effects

often (& ge, l/100, & lt, l/10):

– diarrhea, nausea, vomiting

– increase in level of liver enzymes

sometimes (& ge, l/l, 000, & lt, l/100):

– dizziness

– hypertensia

– short wind

– a constipation, a meteorism, gastritis

– an itching, rash, the increased perspiration

– hypostases

seldom (& ge, l/10.000, & lt, l/l, 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 (& lt, l/10.000):

– 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 & lt, 30 ml/min.)

– 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:

& middot, the liver diseases, disturbance of blood clotting, arterial hypertension, cardiovascular diseases which are followed by hypostases, an ulcer of the digestive tract (DT), bleeding or perforation of a GIT, a renal failure

& middot, medicinal hepatitis heavy or moderate severity, these patients, accepting Nimesulide, have to have a control of function of a liver (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 10 tablets in blister strip packaging from a film of polyvinylchloride and aluminum foil.

On 1 planimetric packing together with the instruction for medical use in the state and Russian languages put in a pack from cardboard.

On 10 packs place in a cardboard box.

To Store storage conditions in the place protected from light at a temperature not over 250C.

To store out of children’s reach.

3 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

Additional information

Ingredient

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