Nimesil gran. for shouted. susp. 100mg/2g package 2g No. 30

Pharmacological properties

Pharmacodynamics

Nimesulide ― nimesit active pharmaceutical ingredient of medicine ― defines its belonging to a class npvp. Nimesil has the anesthetizing, anti-inflammatory and febrifugal activity which is caused by suppression by Nimesulide of effects tsog, responsible for biosynthesis of prostaglandins.

Pharmacokinetics

good absorption after introduction of per os. At oral administration at adult individuals of a dose of 100 mg of _{Nimesulide C max} in blood plasma 3–4 mg/l make; t _max — 2–3 h; AUC — 20-35 mg ch/l.

described high extent of linking with proteins of blood plasma (for 95%), good penetration into fabrics of a reproductive system of women (≈40% of content in blood plasma after single dose), the inflammation centers (40%) and synovial fluid (43%). Well overcomes GEB.

it is Actively metabolized in a liver with the participation of P450 2C9 cytochrome (thus, interaction with other HP — substrates of this enzyme is probable). The main active metabolite are 4 hydroxynimesulide. T _½ Nimesulide makes 3.2-6 h

Nimesulide through kidneys (≈50% of the entered dose) and with a stake (≈29%), in not changed look — about 1-3% Is excreted.

Indication

; dentalgiya; musculoskeletal system pathology — traumatic damage, joint dislocation, a distorziya, a tendinitis, a bursitis (therapy of a pain syndrome); osteoarthrosis (therapy of a pain syndrome); algodismenoreya.

Use

Per os, after meal.

Contents of a sachet is dissolved in a glass of water and drunk.

Adult — on 100 mg of Nimesulide (1 sachet) twice a day.

treatment Duration — elderly patients of need for dose adjustment have no ≤15 days

.

Contraindication

Hypersensitivity, oh, polyposes of a nasal cavity (recurrent) and/or adnexal bosoms of a nose, an idiosyncrasy to ask and also to others npvp; heart failure (decompensation stage); damages of upper parts of a GIT of erosive and ulcer character; a hemorrhage in a GIT (active phase); cerebrovascular or any other hemorrhages; hemophilia and/or other pathology of a system of a vascular and platelet and coagulative hemostasis; alcoholic/narcotic addiction; in the anamnesis hepatotoxic reactions (at use of Nimesulide); heavy extent of violation of homeostatic function of kidneys (kk 30 ml/min.); pathology of kidneys (the progressing course); violation of functions of a liver; Crohn's disease, ulcer colitis (aggravation phase); the hyperpotassemia (stated laboratory and clinically); aortocoronary shunting (post-operational period); the combined application with other gepatototoksichny means; period of pregnancy and/or feeding by a breast; children's age (12 years).

Side effects

Thrombocytopenia, an eozinfiliya, anemia, pathological decrease in maintenance of all uniform elements of blood, hypersensitivity (among other things — anaphylactic reactions, a Quincke's edema), a hyperpotassemia, nervousness, a dyssomnia, vertigo, a cephalalgia, encephalopathy, a hypersomnia, decrease in visual acuity, etc., tachycardia, ag, a hemorrhage, fluctuations hell, rushes of blood, short wind, oh / a spasm of unstriated muscles of a wall of bronchial tubes, diarrhea, nausea/vomiting, a konstipation, intestinal gases, gastritis, bleeding in a GIT, a GIT ulcer, perforation of an ulcer of upper parts of a GIT, an abdominalgiya, the dispepsichesky phenomena, stomatitis, a melena, fulminantny hepatitis, jaundice, a cholestasia, strengthening of activity of enzymes of a liver, dermatitis, an itch, rash on integuments, a small tortoiseshell, the increased sweating, a face edema, a polymorphic erythema, Stephens's syndromes — Johnson, a layell, urination violations, an oliguria, an ischuria, a hamaturia, violations of homeostatic function of kidneys, interstitial nephrite, hypostasis, an adynamy, a hypothermia.

Special instructions

in the absence of effect of the carried-out medicament treatment its application needs to be finished.

during therapy by medicine needs to abstain from consumption of alcoholic beverages and the combined application of HP with the proved hepatotoxicity.

At development of heavy reactions from a liver use of medicine needs to be finished immediately.

needs to take into account increase in frequency of side reactions at application of NPVP for patients at advanced age.

begin treatment With the smallest effective dose with Nimesulide of the patients having the GIT ulcer complicated by bleeding/perforation in the anamnesis (in view of increase in risk of an ultserogenez in a GIT, in particular at increase in a dose of NPVP).

to Patients with Crohn's disease or nonspecific ulcer colitis in the anamnesis of NPVP is appointed with extreme discretion.

to Patients from sharp SN, the uncontrollable AG diagnosed by an ischemic heart disease, pathology of peripheral arteries and/or vessels of a brain Nimesulide is appointed after scrupulous assessment of a condition of an organism.

with respect for precaution to patients with diseases of kidneys or SN to a type of probability of decrease in kidney functions.

Prescribing of medicine is not recommended to patients who plan pregnancy, in view of probable violations of fertility at women at use of Nimesulide.

Braking of activity of COG and, respectively, biosynthesis of prostaglandins has adverse impact on course of pregnancy and/or fetation.

Interaction

Combined application with gks increases the probability of an ultserogenez of a GIT or bleeding.

likelihood of developing bleeding in a GIT at combined use with antithrombocytic means and SIOZS Raises.

Combined application with anticoagulants (for example, warfarin) enhances effect of the last.

At the combined application with diuretics notes decrease in their action.

notes easing of hypotensive effect at the combined application with antagonists of receptors of angiotensin II and igibitor of APF.

to decrease in its clearance and, respectively, increase in content in blood and strengthening of toxic action.

as a result of suppression of activity of enzyme P450 2C9 cytochrome Nimesulide in blood can contents metaboliziruyemy this isoenzyme of HP will increase.

Combined application with fungicide, antitubercular HP, antikonvulsant and also metildopy, amoxicillin / klavulanovoy to - that, a methotrexate and Amiodaronum can cause hepatotoxic effect.

In view of strengthening of toxic action to or after application of a methotrexate.

Overdose

Is shown by slackness, a hypersomnia, nausea, vomiting, pain in epigastriums. on condition of the adequate supporting treatment the symptoms are reversible. development of bleeding in a GIT, opn, ag, respiratory insufficiency, a coma is in rare instances probable. treatment — supporting and symptomatic. specific antidote is absent. Storage conditions

Special storage conditions it is not required by

to p.