Nimesil granules for suspension for oral administration 100mg/2g in bags No. 30

Name:
Nimesil gran d / pr.susp d / oral administration 100mg / 2g in pack. in pack. No. 30
Description:
Granules for the preparation of a suspension for oral administration in the form of a light yellow granular powder with an orange smell. The main active ingredient Nimesulide Release form Granules for suspension for oral administration in the form of a light yellow granular powder with an orange smell. 1 pack (2 g) nimesulide 100 mg Excipients: ketomacrogol 1000, sucrose, maltodextrin, anhydrous citric acid, orange flavor. 2 g – laminated paper bags (9) – packs of cardboard. 2 g – paper bags laminated (15) – packs of cardboard. 2 g – paper bags laminated (30) – packs of cardboard. Special instructionsUndesirable side effects can be minimized by using the minimum effective dose of the drug in the shortest possible course. Nimesil should be used with caution in patients with a history of gastrointestinal diseases (ulcerative colitis, Crohn’s disease), since exacerbation of these diseases is possible. The risk of gastrointestinal bleeding, ulceration or perforation of the ulcer increases with increasing dose of NSAIDs in patients with a history of ulcers, especially complicated by bleeding or perforation, as well as in elderly patients, so treatment should be started with the lowest possible dose. Patients receiving drugs that reduce blood clotting or inhibit platelet aggregation also increase the risk of gastrointestinal bleeding. In the event of gastrointestinal bleeding or ulcers in patients taking Nimesil, treatment with the drug should be discontinued. Since Nimesil is partially excreted by the kidneys, its dosage for patients with impaired renal function should be reduced, depending on the level of urination. There is evidence of the occurrence of rare cases of reactions from the liver. If there are signs of liver damage (skin itching, yellowing of the skin, nausea, vomiting, abdominal pain, dark urine, increased activity of “liver” transaminases), you should stop taking the drug and consult your doctor. Despite the rarity of visual impairment in patients taking nimesulide simultaneously with other NSAIDs, treatment should be stopped immediately. If any visual disturbance occurs, the patient should be examined by an ophthalmologist. The drug can cause fluid retention in the tissues, so patients with high blood pressure and cardiac disorders should use Nimesil with extreme caution. In patients with renal or heart failure, Nimesil should be used with caution, as renal function may deteriorate. If the condition worsens, treatment with Nimesil should be discontinued. Clinical studies and epidemiological data suggest that NSAIDs, especially at high doses and with long-term use, may lead to a small risk of myocardial infarction or stroke. There are not enough data to exclude the risk of such events when using nimesulide. The composition of the drug includes sucrose, this should be taken into account for patients with diabetes mellitus (0.15-0.18 XE per 100 mg of the drug) and people on a low-calorie diet. Nimesil is not recommended for patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltose deficiency. If there are signs of a “cold” or an acute respiratory viral infection during treatment with Nimesil, the drug should be discontinued. Nimesil should not be used simultaneously with other NSAIDs. Nimesulide can change the properties of platelets, so care must be taken when using the drug in people with hemorrhagic diathesis, but the drug does not replace the preventive effect of acetylsalicylic acid in cardiovascular diseases. Elderly patients are particularly susceptible to adverse reactions to NSAIDs, including the occurrence of life-threatening gastrointestinal bleeding and perforations, deterioration of kidney, liver and heart function. When taking the drug Nimesil for this category of patients, proper clinical monitoring is necessary. Like other NSAIDs that inhibit prostaglandin synthesis, nimesulide may adversely affect pregnancy and/or fetal development and may lead to premature closure of the ductus arteriosus, hypertension in the pulmonary artery system, impaired renal function, which may progress to renal failure. with oligodyramnia, to an increased risk of bleeding, a decrease in uterine contractility, the occurrence of peripheral edema. In this regard, nimesulide is contraindicated during pregnancy and lactation. The use of the drug Nimesil can adversely affect female fertility and is not recommended for women planning a pregnancy. When planning pregnancy, consultation with your doctor is necessary. There is evidence of the occurrence in rare cases of skin reactions (such as exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) to nimesulide as well as to other NSAIDs. At the first sign of a skin rash, mucosal lesions or other signs of an allergic reaction, Nimesil should be discontinued. The effect of the drug on the ability to drive vehicles and control mechanisms. The effect of Nimesil on the ability to drive vehicles and control mechanisms has not been studied, therefore, during the period of treatment with Nimesil, care should be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions. Pharmacological action Non-steroidal anti-inflammatory drug from the class of sulfonamides. It has anti-inflammatory, analgesic and antipyretic effects. Nimesulide acts as an inhibitor of the cyclooxygenase enzyme responsible for the synthesis of prostaglandins and inhibits mainly cyclooxygenase-2. Pharmacokinetics After oral administration, the drug is well absorbed from the gastrointestinal tract, reaching Cmax in blood plasma after 2-3 hours. Plasma protein binding is 97.5%. T1 / 2 is 3.2-6 hours. Easily penetrates through histohematic barriers. It is metabolized in the liver by cytochrome P450 (CYP) 2C9 isoenzyme. The main metabolite is the pharmacologically active parahydroxy derivative of nimesulide, hydroxynimesulide. Hydroxynimesulide is excreted in the bile in a metabolized form (found exclusively in the form of glucuronate – about 29%). Nimesulide is excreted from the body, mainly by the kidneys (about 50% of the dose taken). The pharmacokinetic profile of nimesulide in the elderly does not change when prescribing single and multiple / repeated doses. According to an experimental study conducted with the participation of patients with mild to moderate renal insufficiency (CC 30-80 ml / min) and healthy volunteers, Cmax of nimesulide and its metabolite in the plasma of patients did not exceed the concentration of nimesulide in healthy volunteers. AUC and T1 / 2 in patients with renal insufficiency were higher by 50%, but within the pharmacokinetic values. With repeated administration of the drug, cumulation is not observed. Indications for use – treatment of acute pain (pain in the back, lower back; pain in the musculoskeletal system, including injuries, sprains and dislocations of the joints, tendinitis, bursitis; toothache); – symptomatic treatment of osteoarthritis with pain syndrome; – algomenorrhea. The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use. Dosage and administration Nimesil is taken orally, 1 sachet (100 mg of nimesulide) 2 times / day. The drug is recommended to be taken after meals. The contents of the sachet are poured into a glass and dissolved in about 100 ml of water. The prepared solution cannot be stored. Nimesil is used only for the treatment of patients older than 12 years. Adolescents (aged 12 to 18 years): based on the pharmacokinetic profile and pharmacodynamic characteristics of nimesulide, there is no need for dose adjustment in adolescents. Patients with impaired renal function: based on pharmacokinetic data, there is no need to adjust the dose in patients with mild to moderate renal insufficiency (CC 30-80 ml / min). Elderly patients: in the treatment of elderly patients, the need to adjust the daily dose is determined by the doctor based on the possibility of interaction with other drugs. The maximum duration of treatment with nimesulide is 15 days. To reduce the risk of unwanted side effects, the minimum effective dose should be used for the shortest possible course. Use during pregnancy and lactation Like other drugs of the NSAID class that inhibit the synthesis of prostaglandins, nimesulide can adversely affect the course of pregnancy and / or the development of the embryo and can lead to premature closure of the arterial duct, hypertension in the pulmonary artery system, impaired renal function, which can turn into renal failure with oligodyramnia, an increased risk of bleeding, a decrease in uterine contractility, and the occurrence of peripheral edema. In this regard, the drug is contraindicated during pregnancy and during breastfeeding. Precautions Use for impaired renal function In patients with renal insufficiency, the drug Nimesil should be used with caution, since deterioration in renal function is possible. If the condition worsens, treatment with Nimesil should be discontinued. The drug is contraindicated in severe renal failure (CC < 30 ml / min). In patients with mild to moderate renal insufficiency (CC 30-80 ml / min), there is no need to adjust the dose. Use in children The drug is contraindicated in children under 12 years of age. Adolescents (aged 12 to 18 years): based on the pharmacokinetic profile and pharmacodynamic characteristics of nimesulide, there is no need for dose adjustment in adolescents. Use in elderly patients The drug is prescribed with caution to elderly patients. Elderly patients are particularly susceptible to adverse reactions to NSAIDs, including the occurrence of life-threatening gastrointestinal bleeding and perforations, deterioration of kidney, liver and heart function. When taking the drug Nimesil for this category of patients, proper clinical monitoring is necessary. In the treatment of elderly patients, the need to adjust the daily dose is determined by the doctor based on the possibility of interaction with other drugs. Interaction with other drugs Pharmacodynamic interactions: When used together with glucocorticosteroids, the risk of gastrointestinal ulcers or bleeding increases. When combined with antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine, the risk of gastrointestinal bleeding increases. NSAIDs may increase the effect of anticoagulants such as warfarin. Due to the increased risk of bleeding, this combination is not recommended and contraindicated in patients with severe coagulation disorders. If combination therapy still cannot be avoided, careful monitoring of blood coagulation parameters should be carried out. Diuretics: NSAIDs can reduce the effect of diuretics. In healthy volunteers, nimesulide temporarily reduces sodium excretion under the action of furosemide, to a lesser extent, potassium excretion, and reduces the actual diuretic effect. Co-administration of nimesulide and furosemide leads to a decrease (approximately 20%) in the area under the concentration-time curve (AUC) and a decrease in the cumulative excretion of furosemide without changing the renal clearance of furomeside. The co-administration of furosemide and nimesulide requires caution in patients with impaired renal and cardiac function. ACE inhibitors and angiotensin II receptor antagonists: NSAIDs may reduce the effect of antihypertensive drugs. In patients with mild to moderate renal insufficiency (CC 30-80 ml / min), with the joint appointment of ACE inhibitors, angiotensin II receptor antagonists or substances that suppress the cyclooxygenase system (NSAIDs, antiplatelet agents), further deterioration of kidney function and the occurrence of acute renal failure are possible. which is usually reversible. These interactions should be considered in patients taking Nimesil in combination with ACE inhibitors or angiotensin II receptor antagonists. Therefore, the combined use of these drugs should be prescribed with caution, especially for elderly patients. Patients should be adequately hydrated and renal function should be closely monitored after initiation of concomitant therapy. Pharmacokinetic interactions with other drugs: There is evidence that NSAIDs reduce the clearance of lithium, which leads to an increase in the concentration of lithium in the blood plasma and its toxicity. When prescribing nimesulide to patients receiving lithium therapy, regular monitoring of plasma lithium concentrations should be carried out. Clinically significant interactions with glibenclamide, theophylline, digoxin, cimetidine and antacids (for example, a combination of aluminum and magnesium hydroxides) were not observed. Nimesulide inhibits the activity of the CYP2C9 isoenzyme. While taking drugs that are substrates of this enzyme with nimesulide, the concentration of these drugs in plasma may increase. When prescribing nimesulide less than 24 hours before or after taking methotrexate, caution is required, since in such cases the plasma level of methotrexate and, accordingly, the toxic effects of this drug may increase. In connection with the action on renal prostaglandins, prostaglandin synthetase inhibitors, such as nimesulide, may increase the nephrotoxicity of cyclosporins. Interaction of other drugs with nimesulide: In vitro studies have shown that nimesulide is displaced from the binding sites by tolbutamide, salicylic acid and valproic acid. Despite the fact that these interactions were determined in blood plasma, these effects were not observed during the clinical use of the drug. Contraindications - a history of hyperergic reactions, for example, bronchospasm, rhinitis, urticaria associated with taking acetylsalicylic acid or other NSAIDs, incl. nimesulide; - hepatotoxic reactions to nimesulide in history; - concomitant (simultaneous) use of drugs with potential hepatotoxicity, for example, paracetamol or other analgesic or non-steroidal anti-inflammatory drugs; - inflammatory bowel disease (Crohn's disease, ulcerative colitis) in the acute phase; - the period after coronary artery bypass grafting; - fever in infectious and inflammatory diseases; - full or partial combination of bronchial asthma, recurrent polyposis of the nose or paranasal sinuses with intolerance to acetylsalicylic acid and other NSAIDs (including history); - peptic ulcer of the stomach and duodenum in the acute phase, the presence of an ulcer in history, perforation or bleeding in the gastrointestinal tract; - a history of cerebrovascular bleeding or other bleeding, as well as diseases accompanied by bleeding; - severe blood clotting disorders; - severe heart failure; - severe renal failure (CC < 30 ml / min), confirmed hyperkalemia; - liver failure or any active liver disease; - children's age up to 12 years; - pregnancy and breastfeeding period; - alcoholism, drug addiction; - Hypersensitivity to the components of the drug. With caution: severe forms of arterial hypertension, type 2 diabetes mellitus, heart failure, coronary heart disease, cerebrovascular disease, dyslipidemia / hyperlipidemia, peripheral arterial disease, smoking, CC < 60 ml / min, anamnestic data on the presence of gastrointestinal ulcers, infections, caused by Helicobacter pylori; elderly age; long-term prior use of NSAIDs; severe somatic diseases; concomitant therapy with the following drugs: anticoagulants (eg, warfarin), antiplatelet agents (eg, acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (eg, prednisolone), selective serotonin reuptake inhibitors (eg, citalopram, fluoxetine, sertraline). The decision to prescribe the drug Nimesil should be based on an individual risk-benefit assessment when taking the drug. Composition of mesulide 100 mg Excipients: ketomacrogol 1000, sucrose, maltodextrin, anhydrous citric acid, orange flavor. Overdose Symptoms: apathy, drowsiness, nausea, vomiting, pain in the epigastric region. With maintenance therapy for gastropathy, these symptoms are usually reversible. Gastrointestinal bleeding may occur. In rare cases, it is possible to increase blood pressure, acute renal failure, respiratory depression and coma, anaphylactoid reactions. Treatment: carry out symptomatic therapy. There is no specific antidote. If an overdose has occurred within the last 4 hours, it is necessary to induce vomiting and / or provide activated charcoal (60 to 100 g for adults) and / or an osmotic laxative. Forced diuresis, hemodialysis are ineffective due to the high connection of the drug with proteins (up to 97.5%). Control of function of kidneys and a liver is shown. Side effects On the part of the hematopoietic system: rarely - anemia, eosinophilia, hemorrhagic syndrome; very rarely - thrombocytopenia, pacitopenia, thrombocytopenic purpura. Allergic reactions: infrequently - itching, rash, excessive sweating; rarely - hypersensitivity reactions, erythema, dermatitis; very rarely - anaphylactoid reactions, urticaria, angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome). From the side of the central nervous system: infrequently - dizziness; rarely - a feeling of fear, nervousness, nightmares; very rarely - headache, drowsiness, encephalopathy (Reye's syndrome). On the part of the organ of vision: rarely - blurred vision. From the side of the cardiovascular system: infrequently - arterial hypertension, tachycardia, arterial pressure lability, hot flashes. From the respiratory system: infrequently - shortness of breath; very rarely - exacerbation of bronchial asthma, bronchospasm. From the digestive system: often - diarrhea, nausea, vomiting; infrequently - constipation, flatulence, gastritis; very rarely - abdominal pain, dyspepsia, stomatitis, tarry stools, gastrointestinal bleeding, ulcers and / or perforation of the stomach or duodenum; very rarely - hepatitis, fulminant hepatitis, jaundice, cholestasis, increased activity of liver enzymes. From the urinary system: rarely - dysuria, hematuria, urinary retention; very rarely - renal failure, oliguria, interstitial nephritis. General disorders: rarely - malaise, asthenia; very rarely - hypothermia. Other: rarely - hyperkalemia. Storage conditions Store in a dry, dark place and out of the reach of children at a temperature not exceeding 25 ° C. Buy Nimesil granules for oral suspension 100mg / 2g in bags No. 30 Price for Nimesil granules for oral suspension 100mg / 2g in bags No. 30 thirty