Nimesulide-Teva 100mg tab 20 pc

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Nimesulide-Teva 100mg tab 20 pc

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Description

Composition
Active substance:
Nimesulide 100.0 mg
Excipients:
1.5 mg docusate sodium, giproloza 0.8 mg lactose monohydrate 153.7 mg sodium carboxymethyl starch 35.0 mg Microcrystalline cellulose 100.0 mg Magnesium stearate 1.0 mg Hydrogenated vegetable oil 8.0 mg.
Description:
round biconvex tablets of a light yellow color with Valium on one party.
Product form:
Tablets of 100 mg.
10 tablets in blister PVC / aluminum foil. 2 blister together with instructions for use in a cardboard box.
Contraindications
– Known hypersensitivity to nimesulide or any of its constituent excipients.
– a history of hypersensitivity reactions in response to receiving NSAIDs (e.g., bronchoconstriction, rhinitis, urticaria, full or partial combination of asthma, recurrent nasal polyposis or paranasal sinuses and intolerance to acetylsalicylic acid and other NSAIDs).
– Gastrointestinal bleeding or perforation of the intestinal wall in the history associated with the previous treatment NSAIDs, erosive-ulcerous lesion of gastric mucosa and duodenal ulcers (two or more confirmed ulceration episodes and / or bleeding), inflammatory bowel disease (Crohn’s disease, ulcerative colitis ) in the acute phase.
– Cerebrovascular bleeding, bleeding disorders, bleeding accompanied by a history of hemophilia.
– decompensated heart failure.
– Liver failure or liver disease at any stage of exacerbation, hepatotoxic reactions using nimesulide history, concomitant use of other potentially hepatotoxic substances.
– renal failure (creatinine clearance less than 30 mL / min), progressive renal disease, confirmed hyperkalemia.
– postoperative period after coronary artery bypass grafting.
– Related colds with heat.
– Congenital lactose intolerance, malabsorption of glucose-galactose, lactase deficiency.
– Children up to age 12 years.
– The third trimester of pregnancy and during breastfeeding.
Precautions – Heavy somatic diseases: coronary artery disease, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes, peripheral arterial obliterative disease, mild and moderate renal impairment (creatinine clearance of 30-80 ml / min), history data about the development of ulcerative lesions of the gastrointestinal intestinal tract, the presence of infection Helicobacter pylori.
– Smoking, advanced age, long-term use of NSAIDs, alcoholism, simultaneous anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), oral corticosteroids, selective serotonin reuptake inhibitors (incl . citalopram, fluoxetine, paroxetine and sertraline).
Dosage
100 mg
Indications
Acute pain: algomenorrhea, postoperative and post-traumatic pain, arthralgia, myalgia, tooth and headache, tendonitis, bursitis.
Symptomatic treatment of osteoarthritis accompanied with pain (preparation intended for symptomatic therapy, reduce pain and inflammation at the time of use, does not affect the progression of the disease; nimesulide should be used only as second-line therapy).
Interaction with other drugs
Pharmacodynamic interactions. Nimesulide drug combination-Teva with other NSAIDs, including aspirin in anti-inflammatory doses (> 1 g once or> 3 g per day) are not advised.
NSAIDs increase the anticoagulant effect of warfarin. Patients on warfarin and antiplatelet agents (including clopidogrel and aspirin) in patients receiving nimesulide have an increased risk of bleeding.
Prostaglandin synthesis inhibitors (NSAIDs, including nimesulide), cyclosporin nephrotoxicity may increase.
While the use of corticosteroids and selective serotonin reuptake inhibitors increase the risk of bleeding from the gastrointestinal tract.
NSAIDs can reduce the effectiveness of diuretics or other antihypertensives. In patients with early renal impairment (e.g., in dehydrated patients or elderly patients with impaired renal function) concomitant administration of angiotensin converting enzyme inhibitors (ACE) inhibitors or angiotensin II antagonists with COX inhibitors may lead to increased manifestations of renal insufficiency (usually reversible). This combination should be administered with caution, especially in elderly patients. Patients should receive the necessary amount of liquid also should consider the need to monitor renal function.
In healthy subjects, nimesulide briefly reduces the severity of natriuretic action of furosemide (to a lesser extent – kaliyureticheskogo).
Pharmacokinetic interactions. Concomitant administration of nimesulide and furosemide results in a decrease (about 20%) AUC, without affecting its renal clearance.
NSAIDs reduce clearance of lithium, resulting in the increase of its concentration in plasma and toxicity.
Nimesulide inhibit CYP2C9. Plasma concentrations of drugs that are substrates of this enzyme may be increased with concomitant use of the drug Nimesulide-Teva.
Caution is needed when assigning nimesulide in less than 24 hours before or after treatment with methotrexate (MTX concentration in blood plasma can be increased, which will increase its toxicity).
Studies in vitro have shown the possibility of displacement of nimesulide connection with blood plasma proteins furosemide, fenofibrate, tolbutamide, salicylic and valproic acid (clinical significance of this fact has not).
Overdose
Symptoms: lethargy, drowsiness, nausea, vomiting, gastrointestinal bleeding, high blood pressure, acute renal failure, respiratory depression.
Treatment: symptomatic and supportive therapy. No specific antidote. During the first 4 hours after the overdose -, induce vomiting, expedient reception activated carbon (1 g / kg body weight). Carrying out forced diuresis and hemodialysis ineffective
pharmachologic effect
Pharmacological group:
nonsteroidal anti-inflammatory drug (NSAID)
Pharmacodynamics:
Nimesulide is among non-steroidal anti-inflammatory drugs (NSAIDs), anti-inflammatory, analgesic, antipyretic, and antiplatelet action. In contrast, indomethacin, largely inhibits cyclooxygenase-2 (COX-2), rather than COX-1 (potentially less likely to cause side effects associated with inhibition of prostaglandin synthesis in healthy tissue, inhibiting their synthesis advantageously in inflammation).
Pharmacokinetics:
Nimesulide is well absorbed upon ingestion (food intake reduces the rate of absorption, without affecting its degree). After a single dose of 100 mg of nimesulide maximum concentration (Cmax) in the blood plasma of adult reaches 3-4 mg / l and observed after 2-3 hours. Communication with plasma proteins – 95%, with erythrocytes – 2%, with lipoproteins – 1%, with alpha 1-acid glycoproteins – 1%.
Increasing the dose does not affect the degree of binding.
The area under the curve “concentration-time» (AUC) is 20-35 mg h / L.
Statistically significant differences between these parameters after a single dose and purpose for 7 days at a dose of 100 mg 2 times a day is not found.
The volume of distribution – 0,19-0,35 l / kg. Gistogematicalkie easily penetrates the barriers (in the tissues of the female genital organs after a single dose of nimesulide concentration is about 40% of plasma concentration), including in the acidic environment of the inflammatory focus and synovial fluid (40% and 43%, respectively, of the plasma concentration).
It is metabolized in the liver with monooxygenases, including Cytochrome P450 (CYP) 2C9. The major metabolite – 4-soluble hydroxynimesulide (25%), similar to that nimesulide has pharmacological activity.
Nimesulide appears mainly in urine (about 50% of the dose). The half-life (T1 / 2) Nimesulide – 6.3 hours, 4-hydroxynimesulide – 3-5 hours. 4-hydroxynimesulide excreted by the kidneys (65%) and in bile (35%) undergoes enterohepatic recycling.
Only 1-3% of nimesulide is excreted unchanged. Approximately 29% of the dose is excreted as a metabolite in the feces.
The pharmacokinetic profile of nimesulide in the elderly after single and repeated administration of the drug does not change.
In patients with mild to moderate impaired renal function – creatinine clearance (CC) 30-80 ml / min, Cmax nimesulide and its main metabolite in plasma levels do not exceed those of healthy volunteers. Repeated reception of nimesulide is not accompanied by his cumulation.
Pregnancy and breast-feeding
Use of the drug Nimesulide-Teva is contraindicated in the third trimester of pregnancy.
Like other NSAIDs, Nimesulide drug-Teva is not recommended in women trying to conceive.
Inhibition of prostaglandin synthesis may have an adverse effect on pregnancy and / or development of the embryo / fetus. The results of epidemiological studies suggest an increased risk of spontaneous abortion (miscarriage in the early stages) and the development of heart disease, as well as the development of gastroschisis (malformation representing a cleft of the anterior abdominal wall in the umbilical region, at which the falling out of the abdominal cavity) on the back the use of NSAIDs in the first trimester of pregnancy. The risk of teratogenicity and embryotoxicity increases with increasing dose and duration of treatment.
If the preparation takes Nimesulide-Teva woman who is trying to become pregnant, or during the first and second trimester of pregnancy, the dose and duration of treatment should be as small as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may affect:
fetus:
– cardiopulmonary toxicity (with premature closure of the ductus arteriosus botallova with pulmonary hypertension);
– renal dysfunction, which may progress to renal failure;
mother and newborn:
– prolongation of bleeding time (even at low doses);
– reducing uterine contractions (lengthening of the delay and the birth).
No data on the allocation of nimesulide in breast milk, the drug Nimesulide Teva is contraindicated during breast-feeding.
Conditions of supply of pharmacies
On prescription.
side effects
The evidence suggests that long-term use of all NSAIDs (particularly at high doses) may potentially be accompanied by an increased risk of arterial thrombosis (including myocardial infarction manifested or ischemic stroke) clinical and epidemiological studies.
Against the background of the use of NSAIDs may develop edema syndrome, hypertension, heart failure worsening trends. Very rarely reported occurrence of serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
Most often, there are a variety of gastrointestinal disorders (especially in predisposed and elderly persons): peptic ulcer, perforation of the wall of the gastrointestinal tract, the development of a potentially severe gastrointestinal bleeding, nausea, vomiting, bloody vomiting, flatulence, abdominal pain, diarrhea, constipation, melena, stomatitis, ulcerative colitis, gastritis symptoms rarely occur.
The following adverse events in patients receiving nimesulide have been identified in the controlled clinical trials (marked with “*”), as well as marketing observations submitted by the frequency, classified according to the recommendations of the World Health Organization: very often (at least 10%); frequently (10.1%); infrequently (0.1-1%); rarely (0.01-0.1%); very rare (less than 0.01%, including some cases).
Allergic reactions: seldom – hypersensitivity *; very rare – anaphylaxis.
Violations of water-electrolyte balance: rarely – hyperkalemia.
Mental disorders: rare – anxiety, fear *, anxiety *, “nightmarish” dream *.
Disorders of the nervous system and sensory organs: rarely – dizziness *; rarely – blurred vision *; very rarely – visual impairment.
Violations of the cardiovascular system: seldom – hypertension *; rarely – tachycardia *, blood pressure lability *, “tides” of blood to the face. *
Violations of the respiratory system: rarely – dyspnea *; very rarely – bronchospasm.
Violations of the digestive system: often – diarrhea *, nausea *, vomiting *;
rarely – constipation *, flatulence * * gastritis; very rare – abdominal pain, dyspepsia, stomatitis, melena, gastrointestinal bleeding, ulcers and perforation of the duodenum and / or stomach.
Violations of the liver and biliary tract: often – increased activity of “liver” enzymes *; very rarely – hepatitis, including fulminant course, jaundice,
cholestasis.
Violations of the skin and subcutaneous tissue disorders: uncommon – pruritus *, rash *, sweating *; rare – Erythema * Dermatitis *; very rarely – urticaria,
angioneurotic edema, facial edema, erythema multiforme, StivensaDzhonsona syndrome, toxic epidermal necrolysis.
Violations by the kidneys and urinary tract: rarely – dysuria *, haematuria *, urinary retention *; very rarely – renal failure, oliguria, interstitial nephritis.
System Disorders: Infrequent – edema syndrome *; rarely – discomfort *, asthenia *; very rarely – hypothermia.
Blood disorders: rarely – anemia *, eosinophilia *; very rarely – thrombocytopenia, pancytopenia, purpura.
special instructions
Every 2 weeks should monitor liver function. When the liver disease symptoms (itching, jaundice, nausea, vomiting, abdominal pain, dark urine, increased activity of “liver” transaminases) should stop treatment immediately.
Given the possibility of visual impairment in patients taking NSAIDs, if you notice such symptoms, treatment should be immediately discontinued and an ophthalmologic examination performed.
The drug can cause fluid retention, and therefore patients with high blood pressure or signs of congestive heart failure nimesulide should be used with caution.
Patients should be under regular medical supervision if they take along with nimesulide preparations for which are also characteristic of ulcerogenic effect on gastrointestinal tract. Formulation should not be used simultaneously with other NSAIDs (including selective COX-2 inhibitors) and narcotic analgesics.
Nimesulide reduces platelet aggregation, however, it is not able to replace the prophylactic administration of antiplatelet drugs (acetylsalicylic acid, clopidogrel, ticlopidine) for cardiovascular diseases.
Use of the drug may adversely affect female fertility (not recommended for women planning pregnancy).
The risk of adverse effects can be reduced by the use of the lowest effective dose Nimesulide-Teva over the shortest possible period.
Patients who while taking the drug Nimesulide-Teva develops symptoms suggestive of liver injury (such as anorexia, nausea, vomiting, pain in the right upper quadrant, fatigue, dark urine), or there is increased activity of “liver” transaminases, the appointment of nimesulide should be discontinued. These patients also should not be re-appoint nimesulide.
Patients who developed symptoms accompanying colds (e.g., appeared fever), nimesulide assignment should be discontinued.
In the application of NSAIDs may develop cases of bleeding, ulceration and perforation of the stomach or intestinal walls. The risk of the development of higher when high doses of NSAIDs, while taking their patients with gastric ulcer and duodenal ulcer in the anamnesis, as well as older persons. When the need for treatment in these cases, you should review the need for concomitant use of misoprostol or proton pump inhibitors.
It should warn patients (especially with complicated history, as well as the elderly) about the need to tell your doctor about any unusual abdominal symptoms (especially arising in the early stages of treatment).
There are cases of fluid retention and development of edema syndrome in patients receiving NSAIDs, due to which patients with hypertension and / or congestive heart failure, ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease require careful observation. The same precautions should be taken when appointing nimesulide in patients with increased risk for cardiovascular disease (eg, hyperlipidemia, diabetes mellitus, and smoking).
In patients with impaired renal function need to be careful in appointing a drug Nimesulide-Teva (possible further deterioration of their functions), with a decrease in creatinine clearance, treatment should be discontinued.
Nimesulide should be used with caution in patients with hemorrhagic diathesis because it can reduce platelet aggregation.
The risk of severe skin reactions (exfoliative dermatitis, StivensaDzhonsona syndrome and toxic epidermal necrolysis) while taking NSAIDs mentioned in the beginning of treatment (most of these reactions occur within the first month of treatment).
Лечение препаратом Нимесулид-Тева следует отменять при появлении первых признаков сыпи, повреждениях слизистой или других проявлениях гиперчувствительности.
Препарат Нимесулид-Тева содержит лактозы моногидрат. Пациенты с врожденной непереносимостью лактозы, нарушением всасывания глюкозы-галактозы или недостаточностью лактазы не должны принимать этот препарат.
Effect on the ability to drive mechanisms and
Влияние препарата Нимесулид-Тева на скорость психомоторных реакций специально не изучалось. Тем не менее, пациентам, у которых после приема препарата Нимесулид-Тева наблюдается головокружение или сонливость, необходимо соблюдать осторожность при управлении транспортными средствами и занятиях другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Storage conditions
Хранить при температуре не выше 25 °С в сухом, защищенном от света месте.
Keep out of the reach of children.
Dosing and Administration
Следует назначать минимальную эффективную дозу с возможно минимально коротким курсом лечения. Максимальная продолжительность лечения нимесулидом составляет 15 дней.
Взрослые: 100 мг нимесулида 2 раза в день после еды. У пациентов с почечной недостаточностью максимальная суточная доза – 100 мг.
Пожилые лица: снижать суточную дозу нет необходимости.
Дети (младше 12 лет): препарат Нимесулид-Тева противопоказан.
Подростки (от 12 до 18 лет): коррекции дозы не требуется.
Нарушенная функция почек: коррекции дозы у пациентов с легким и умеренным нарушением функции почек (КК 30-80 мл/мин) обычно не требуется. Препарат Нимесулид-Тева противопоказан в случае тяжелого нарушения функции почек (КК
Нарушение функции печени: применение препарата Нимесулид-Тева противопоказано.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

TEVA

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