Nimesubel powder for suspension for oral administration 100mg in bags №20

Name:
Nimesubel pore d/prig.susp.d/pr.vn.100mg in packages in unitary enterprise No. 20
Description:
Powder from white with a yellowish tint to light yellow color with a specific odor. The main active ingredient Nimesulide Release form Powder Dosage 100 mg Pharmacological action Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties, which acts as an inhibitor of the cyclooxygenase enzyme responsible for the synthesis of prostaglandins. Indications for use Treatment of acute pain; primary dysmenorrhea. Nimesubel can only be prescribed as a second-line therapy. The decision to prescribe Nimesubel should be based on an overall risk assessment for each patient. Method of administration and doses Before using the drug, it is necessary to prepare a suspension ready for use. To do this, 100 ml of freshly boiled and cooled to room temperature water is added to the contents of one package, intensively mixed until a homogeneous suspension is obtained. The resulting suspension is taken orally after meals 2 times a day. The prepared suspension is not subject to storage. The minimum effective dose should be administered for the shortest possible period of time in order to minimize the risk of adverse reactions. The maximum duration of taking Nimesubel should not exceed 15 days. Patients with renal insufficiency with a creatinine clearance of 30-80 ml / min, as well as elderly patients, do not need to reduce the dose. In severe renal failure (creatinine clearance less than 30 ml / min), the drug is contraindicated. Use during pregnancy and lactation is contraindicated. Like other NSAIDs known to inhibit prostaglandin synthesis, Nimesubel can cause premature closure of the ductus arteriosus, pulmonary hypertension, oliguria, oligoamnios, an increased risk of bleeding, weakness in labor and the development of peripheral edema. There have been isolated cases of renal failure in children and women taking Nimesubel in late pregnancy. Influence on the ability to drive vehicles and other potentially dangerous mechanisms No studies have been conducted on the effect of Nimesubel on the ability to drive a vehicle, however, people who report dizziness or drowsiness after using Nimesubel should refrain from driving and potentially dangerous mechanisms. Precautions Unwanted side effects can be minimized by using the lowest effective dose for the shortest duration necessary to control the symptoms of the disease. In the absence of improvement in symptoms, drug therapy should be discontinued. In elderly patients, the frequency of adverse reactions to NSAIDs is increased, especially the frequency of gastrointestinal bleeding and perforation (in some cases even fatal), as well as impaired renal, hepatic and cardiac function. Therefore, appropriate clinical observation is recommended. Liver disorders Rare cases of serious liver reactions, including very rare cases of death, have been reported associated with the use of nimesulide-containing medicinal products. Patients who experience symptoms similar to those of liver damage (eg, anorexia, nausea, vomiting, abdominal pain, fatigue, dark urine) during treatment with Nimesubel, or patients in whom laboratory tests of liver function deviate from normal values should stop drug treatment. Re-appointment of nimesulide in such patients is contraindicated. Liver damage, in most cases reversible, has been reported after short-term exposure to the drug. During treatment with Nimesubel, the patient should refrain from taking other analgesics. The concomitant use of Nimesubel and other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided. Patients treated with nimesulide and who develop flu-like or cold-like symptoms should discontinue treatment with the drug. Gastrointestinal disorders Gastrointestinal bleeding, ulcers, and ulcer perforation may be life-threatening if there is a history of such problems with any NSAID during treatment (regardless of time elapsed), with or without dangerous symptoms, or a history of serious disorders of the gastrointestinal tract. The risk of gastrointestinal bleeding, ulceration or perforation of the ulcer increases with increasing dose of NSAIDs, in patients with a history of an ulcer, especially complicated by hemorrhage or perforation, and in elderly patients. For these patients, treatment should be initiated at the lowest possible dose. For these patients, as well as patients taking concomitant low doses of aspirin or other drugs that increase the risk of gastrointestinal disease, combination therapy with protective agents (eg, misoprostol or proton pump inhibitors) should be considered. Patients with gastrointestinal toxicity, especially the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding). This is especially important in the early stages of treatment. Gastrointestinal bleeding, as well as the formation of ulcers or perforation, are noted for all NSAIDs at different stages of treatment, regardless of the presence of precursor symptoms or a history of pathology from the gastrointestinal tract. With the development of gastrointestinal bleeding or ulceration, nimesulide should be discontinued. Nimesulide should be used with caution in patients with gastrointestinal disorders, including peptic ulcer, history of gastrointestinal bleeding, ulcerative colitis, and Crohn’s disease. Patients taking concomitant medications that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents such as aspirin, should be advised to take the drug with caution. If gastrointestinal bleeding or ulcers occur in patients receiving Nimesubel, treatment with the drug should be discontinued. NSAIDs should be used with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease), as these diseases may worsen. In patients with renal or heart failure, Nimesubel should be used with caution as the drug may impair renal function. If the condition worsens, treatment should be discontinued. Skin reactions Very rare cases of severe skin reactions to NSAIDs have been reported, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, some of which can be fatal. Patients appear to be most at risk of developing skin reactions during the initial period of therapy. Nimesubel should be discontinued at the first sign of skin rash, mucosal lesions and other signs of hypersensitivity. Renal disorders It is necessary to prescribe the drug with caution in patients with impaired renal or cardiac function, since the use of nimesulide may lead to deterioration of renal function. In case of deterioration, treatment should be interrupted. Influence on fertility: The use of nimesulide can reduce female fertility, so it is not recommended to prescribe it to women planning a pregnancy. In women who have problems conceiving or who are being examined for infertility, the possibility of discontinuing nimesulide should be considered. Disorders of the cardiovascular and cerebrovascular systems Patients with arterial hypertension and / or mild / moderate acute heart failure in history, as well as patients with the occurrence of fluid retention in the body and edema, as a reaction to the use of NSAID therapy, require appropriate monitoring and consultation doctor. Clinical studies and epidemiological data suggest that some NSAIDs, especially at high doses and with long-term use, may lead to a small risk of arterial thrombotic events (eg, myocardial infarction or stroke). There are not enough data to exclude the risk of such events when using nimesulide. In patients with uncontrolled arterial hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease, nimesulide should be prescribed after a thorough evaluation of the condition. An equally thorough assessment of the condition should be performed before starting long-term treatment in patients with risk factors for the development of cardiovascular disease (for example, arterial hypertension, hyperlipidemia, diabetes mellitus, smoking). Since nimesulide can affect platelet function, it should be used with caution in patients with hemorrhagic diathesis. However, Nimesubel does not replace acetylsalicylic acid in the prevention of cardiovascular disease. Interaction with other drugs Pharmacodynamic interactions Other NSAIDs The combined use of drugs containing nimesulide and other NSAIDs, including acetylsalicylic acid in anti-inflammatory doses (? 1 g once or ? 3 g as a total daily dose), is not recommended. Corticosteroids: Increase the risk of gastrointestinal ulcers or bleeding. Anticoagulants: NSAIDs may increase the effect of anticoagulants such as warfarin or acetylsalicylic acid. Due to the increased risk of bleeding, this combination is not recommended and is contraindicated in patients with severe coagulation disorders. If combination therapy still cannot be avoided, careful monitoring of blood coagulation parameters should be carried out. Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): Increase the risk of gastrointestinal bleeding. Diuretics, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin type 2 receptor antagonists (AIIA) NSAIDs may reduce the effectiveness of diuretics and other antihypertensive drugs. In some patients with impaired renal function (for example, in patients with dehydration or in elderly patients), the co-administration of ACE inhibitors or angiotensin II antagonists, as well as substances that suppress the cyclooxygenase system, can cause a further decrease in kidney function up to acute renal failure, which is usually reversible. This interaction should be taken into account in patients taking Nimesubel together with ACE inhibitors or AIIA. Therefore, when prescribing this combination of drugs, care should be taken, especially in elderly patients. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of combination therapy and periodically thereafter. Pharmacokinetic interactions: effects of nimesulide on the pharmacokinetics of other drugs Furosemide In healthy volunteers, nimesulide temporarily reduced the effect of furosemide on sodium excretion, to a lesser extent on potassium excretion, and reduced the diuretic response. 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 furosemide. The co-administration of furosemide and drugs containing nimesulide requires caution in patients with impaired renal or cardiac function. Lithium There is evidence that NSAIDs reduce the clearance of lithium, resulting in increased plasma lithium levels and lithium toxicity. When prescribing Nimesubel to patients receiving lithium therapy, frequent monitoring of plasma lithium levels should be carried out. In vivo studies have been conducted to identify possible pharmacokinetic interactions with glibenclamide, theophylline, warfarin, digoxin, cimetidine, and antacids (eg, a combination of aluminum and magnesium hydroxide). No clinically significant interactions were observed. Nimesulide inhibits the activity of the CYP2C9 enzyme. When taking drugs that are substrates of this enzyme with Nimesubel, the concentration of these drugs in plasma may increase. When prescribing nimesulide less than 24 hours before or less than 24 hours after taking methotrexate, care must be taken, since in such cases the plasma level of methotrexate and, accordingly, the toxic effects of this drug may increase. When prescribing nimesulide less than 24 hours before or less than 24 hours after taking methotrexate, care must be taken, 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. Pharmacokinetic interactions: effects of other drugs on the pharmacokinetics of 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 known hypersensitivity to nimesulide or to one of the excipients of the drug; past hyperergic reactions (for example, bronchospasm, rhinitis, urticaria) in connection with the intake of acetylsalicylic acid or other NSAIDs; past hepatotoxic reactions to nimesulide; concomitant use of other substances with potential hepatotoxicity; alcoholism, drug addiction; previous gastrointestinal bleeding or perforation associated with previous NSAID therapy; gastric or duodenal ulcer in the acute phase, a history of ulcers, perforation or bleeding in the gastrointestinal tract; a history of cerebrovascular bleeding or other hemorrhages, as well as diseases accompanied by bleeding; severe blood clotting disorders; severe heart failure; severe renal failure; liver failure; patients with cold or flu symptoms; age up to 12 years; the appointment of the drug is contraindicated in the third trimester of pregnancy and during lactation; phenylketonuria (contains aspartame). Composition Each package contains: active substance: nimesulide – 100 mg; excipients: anhydrous citric acid, aspartame, xanthan gum, Lemon PX 1548 flavor, anhydrous colloidal silicon dioxide, maltodextrin. Overdose Symptoms of acute overdose of NSAIDs are usually limited to the following: apathy, drowsiness, nausea, vomiting and pain in the epigastric region. With maintenance therapy, 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 have been reported with therapeutic doses of NSAIDs and with an overdose of such drugs. In case of overdose of NSAIDs, treatment is symptomatic and supportive. There is no specific antidote. There are no data on the elimination of nimesulide by hemodialysis, however, given the high level of plasma protein binding (up to 97.5%), it can be concluded that dialysis is ineffective in case of an overdose of the drug. In the presence of overdose symptoms or after taking a large dose of the drug within 4 hours after ingestion, patients may be prescribed: inducing vomiting and / or taking activated charcoal (60-100 grams for adults) and / or taking an osmotic laxative. Forced diuresis, alkalinization of urine, hemodialysis or hemoperfusion may be ineffective due to the high level of drug binding to blood proteins. The functions of the kidneys and liver should be monitored. Side effectsAccording to the results of clinical studies and epidemiological data, the use of some NSAIDs, especially at high doses and for a long time, may be accompanied by a slight increase in the risk of developing pathologies caused by arterial thrombosis (for example, myocardial infarction or stroke). During treatment with NSAIDs, edema, increased blood pressure and heart failure have also been reported. With the use of NSAIDs, there is evidence of very rare cases of bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis. In the treatment of NSAIDs, the most common adverse events were those of the gastrointestinal tract. Peptic ulcer, perforation, or gastrointestinal bleeding may develop, sometimes fatal, especially in elderly patients. There are reports of nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, tarry stools, blood vomiting, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease after taking the drug. Rarely observed gastritis. The side effects listed below are based on data obtained from controlled clinical trials* (approximately 7800 patients) and from post-marketing studies. The frequency of cases is classified as follows: very often (? 1/10); often (? 1/100, < 1/10); infrequently (? 1/1000, < 1/100); rarely (? 1/10000, < 1/1000); very rarely (< 1/10000), including isolated cases. Circulatory and lymphatic system disorders: Rare - Anemia*Eosinophilia* Very rare - Thrombocytopenia, Pancytopenia, Purpura Immune system disorders: Rare - Hypersensitivity* Very rare - Anaphylaxis Metabolic and nutritional disorders: Rare - Hyperkalemia* Psychiatric disorders : Rare - Anxiety*, Nervousness*, Nightmarish dreams* Nervous system disorders: Uncommon - Dizziness* Very rare - Headache, Drowsiness, Encephalopathy (Reye's syndrome) Visual disturbances: Rare - Blurred vision* Very rare - Visual impairment Hearing and labyrinth disorders: Very rare - Vertigo Heart disease: Rare - Tachycardia* Vascular disorders: Infrequent - Arterial hypertension* Rare - Hemorrhage*, Blood pressure lability*, Hot flashes* Respiratory tract disorders : Uncommon - Shortness of breath* Very rare - Asthma, Bronchospasm Gastrointestinal disorders tract: Often - Diarrhea*, Nausea*, Vomiting* Uncommon - Constipation*, Flatulence*, Gastrointestinal bleeding, Duodenal ulcer and perforation, Gastric ulcer and perforation Very rare - Gastritis*, Abdominal pain, Dyspepsia, Stomatitis , Tarry stools Liver and biliary disorders: Common - Elevated liver enzymes Very rare - Hepatitis, Fulminant hepatitis (including death), Jaundice, Cholestasis Skin and subcutaneous tissue disorders: Uncommon - Itching*, Rash *, Excessive sweating* Rare - Erythema*, Dermatitis* Very rare - Urticaria, Angioedema, Facial edema, Erythema multiforme, Stevens-Johnson syndrome, Toxic epidermal necrolysis Renal and urinary disorders: Rare - Dysuria*, Hematuria* Very rarely - Urinary retention *, Renal failure, Oliguria, Interstitial nephritis General disorders and local reactions to the drug: Infrequently - Edema * Rarely - Malaise *, Asthenia * Very rare co - Hypothermia *frequency based on clinical trial results If you experience adverse reactions, including those not listed in this leaflet, you should consult a doctor. Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Nimesubel powder for oral suspension 100mg in bags No. 20 #20