Etodin Fort pills p/o 400mg №14×2

Name:
This is one Fort tabl. p / captive ob. 400mg No. 14×2 Main active ingredient Etodolac Release form tablets Composition 1 film-coated tablet contains: etodolac 400 mg in the form of etodolac DS (98%), excipients: anhydrous lactose, cellulose. . microcrystalline pH102, croscarmellose sodium, aerosil 200, magnesium stearate, polyvinylpyrrolidone K30, opadra pink (hydroxypropyl methylcellulose (5 cp) – methocel E5-LV, titanium dioxide (E171), methocel E5 / iron oxide red (T’ 172). macrogol (polyethylene glycol)
Description:
Pale pink film-coated oval tablet scored on one side and engraved “NOBEL” on the other Dosage 400mg Indications For the reduction of acute pain or long-term symptomatic treatment of osteoarthritis and rheumatoid arthritis Acute pain syndrome of various origins Needed take the lowest effective dose for the shortest period of time. taking NSAIDs – severe cardiac, hepatic or renal failure insufficiency – Etodin Fort is contraindicated to reduce pain in the perioperative period in case of coronary artery bypass grafting (CABG) – hypersensitivity to the components of the drug – it is not recommended to prescribe the drug to patients who have developed bronchial asthma, rhinitis, urticaria in the treatment of aspirin or other non-steroidal anti-inflammatory drugs in history – pregnancy and lactation Dosage and administration Acute pain Adults: The recommended daily dose of Etodin Fort is 400-800 mg. The maximum daily dose is 1000 mg. The drug is prescribed 2 times a day: 1 tablet in the morning and in the evening after meals. Doses of etodolac greater than 1000 mg per day have not been adequately evaluated in well-controlled clinical trials. The lowest effective dose should be taken for the shortest period of time. Osteoarthritis and rheumatoid arthritis In rheumatic diseases, the course of treatment depends on the effectiveness of therapy and the nature of the disease. The recommended starting dose is 400 mg 1-2 times a day. Doses of etodolac greater than 1000 mg per day have not been adequately evaluated in well-controlled clinical trials. In chronic diseases, the therapeutic effect develops after 1-2 weeks of taking etodolac. After achieving the desired effect, the dose of the drug should be reviewed and adjusted as necessary. Doses for children have not been established. In patients with impaired liver and/or kidney function, etodolac should be administered with caution. Elderly patients are more likely to develop a decrease in renal function, therefore, in these patients, Etodin Fort should be prescribed with caution and monitor renal function. Features of the use of the drug in pediatric, geriatric, obstetric and gynecological practice Etodin Fort is not recommended for the treatment of children and adolescents under 18 years of age, because. efficacy and safety of use in patients of this age group have not been proven. alopecia, cutaneous vasculitis with purpura, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme. From the senses: blurred vision, photophobia, transient visual disturbances, conjunctivitis, tinnitus, deafness, change in taste. From the genitourinary system: dysuria, frequent urination, impaired water and electrolyte balance, increased urea levels, papillary necrosis of the kidneys, oliguria / polyuria. proteinuria, cystitis, hematuria, leukocyturia, nephrolithiasis, interstitial nephritis, renal failure, metrorrhagia. From the cardiovascular system: arterial hypertension, flushing, palpitations, fainting, vasculitis (including necrotizing and allergic), tachycardia, arrhythmia, heart failure, myocardial infarction, stroke. On the part of the blood system: bruising, thrombocytopenia, increased bleeding time, leukopenia, neutropenia, agranulocytosis, anemia (including hemolytic), aplastic anemia, pancytopenia, agranulocytosis, lymphadenopathy: Metabolic disorders: edema, increased creatinine, hyperglycemia in patients with or absence of diabetes mellitus, change in body weight, hypernatremia, hyperkalemia. From the respiratory system: bronchospasm, infiltration of the pulmonary system with eosinophilia, bronchitis, shortness of breath, pharyngitis, rhinitis, sinusitis, respiratory depression, pneumonia. Other: fatigue, epistaxis, chills and fever, infections, sepsis. Hypersensitivity reactions: allergic reactions, anaphylactoid / anaphylactic reactions (including anaphylactic shock), angioedema. Overdose In case of an overdose of etodolac, side effects may increase: drowsiness, nausea, vomiting, epigastric pain, ulceration and bleeding of the gastrointestinal tract, increased blood pressure, acute renal failure, respiratory depression. In case of an overdose, anaphylactoid reactions are possible. Treatment: you should stop taking the drug. There is no specific antidote. Recommended gastric lavage, cleansing enema or the appointment of laxatives, activated charcoal, detoxification therapy. It is necessary to ensure monitoring of the activity of the respiratory and cardiovascular systems, control of hemostasis. Forced diuresis, hemodialysis, hemoperfusion are ineffective due to the binding of etodolac to blood proteins. Interaction with other drugs Since etodolac is highly bound to plasma proteins, when used simultaneously with other drugs that also bind to plasma proteins, dose adjustment of the drugs is necessary. Other analgesics, including cyclooxygenase-2 selective inhibitor: the simultaneous use of two or more NSAIDs (including aspirin) should be avoided, as this may increase the risk of adverse effects on the body. Antihypertensive drugs: reduces the antihypertensive effect. Diuretics: diuretic effect decreases. Diuretics may increase the risk of nephrotoxicity. Cardiac glycosides: Etodolac may decrease GFR and increase plasma glycoside levels. Lithium: Etodolac increases the concentration of lithium in the blood, therefore, when it is used simultaneously with lithium salts, it is necessary to control the concentration of lithium in the blood. Methotrexate: Etodolac enhances the haematological toxicity of methotrexate. Cyclosporine: Increased risk of nephrotoxicity. Anticoagulants: Etodolac may increase the effect of anticoagulants such as warfarin. To avoid bleeding, it is necessary to control prothrombin time and INN. Since Etodin Fort is largely bound to plasma proteins, it can displace bilirubin from albumin. Tacrolshus: Increased risk of nephrotoxicity. Zidovudine: Increased risk of haematological toxicity. Mifepristone: Etodolac should not be used within 8 to 12 days of taking mifepristone as it may reduce the effect of this drug. Corticosteroids: Increased risk of gastrointestinal ulceration. Quinolone antibiotics: Increases the risk of seizures. Precautions Cardiac disorders The use of selective COX-2 inhibitors and non-selective non-steroidal anti-inflammatory drugs (NSAIDs) increases the risk of cardiovascular thrombotic complications (myocardial infarction and stroke), which can be fatal. All NSAIDs, both selective and non-selective, have this risk. To reduce side reactions, the possibility of using a minimum period of time. Cardiac paci symptoms. There is no evidence of a vascular system with the simultaneous use of acetylsalicylic acid. Simultaneous administration of acetylsalicylic acid increases the risk of severe adverse reactions from the digestive tract. The use of selective COX-2 NSAIDs for the treatment of pain in the first 10-14 days of coronary bypass surgery increases the risk of myocardial infarction. Arterial hypertension Taking NSAIDs, including etodolac, may lead to an increase in blood pressure or worsening of pre-existing hypertension, which may contribute to adverse reactions from the cardiovascular system. Patients who take thiazide and loop diuretics concomitantly with etodolac may experience a decrease in the effect of the latter. While taking NSAIDs, blood pressure should be monitored. Chronic heart failure and edema. Patients taking NSAIDs experience fluid retention and edema. Etodolac should be used with caution in patients with fluid retention or heart failure. Effects on the digestive tract NSAIDs, including etodolac, can cause severe gastrointestinal side effects including inflammation, bleeding, ulcers or perforations of the stomach and intestines, which can be fatal. NSAIDs should be used with caution in patients with a history of peptic ulcer or gastrointestinal bleeding. Other risk factors that increase the risk of gastrointestinal bleeding include: simultaneous oral administration of corticosteroids, anticoagulants, long-term use of NSAIDs, smoking, alcohol intake, older age, severe general condition. Most spontaneous reports were recorded in elderly and debilitated patients. To reduce the potential risk of adverse reactions from the digestive tract, use the lowest effective dose for the shortest period of time. Physicians and patients should be aware of the symptoms of gastrointestinal bleeding and ulcers in the treatment of NSAIDs, if adverse reactions are suspected, the patient’s condition should be assessed, the drug should be discontinued and appropriate measures should be taken. Effects on the kidneys Long-term use of NSAIDs can lead to the development of papillary necrosis and other kidney damage. Renal prostaglandins play a compensatory role in maintaining renal perfusion. Patients treated with NSAIDs may experience a dose-dependent decrease in prostaglandin formation, which contributes to the development of renal failure. Risk factors for the development of these reactions include: impaired renal and / or liver function, heart failure, taking diuretics and ACE inhibitors, advanced age. Discontinuation of NSAIDs usually leads to the restoration of the previous state. There is no information on the use of etodolac in patients with progressive renal insufficiency, so it is not recommended to use etodolac in this category of patients. Renal function should be evaluated before starting treatment with etodolac. Anaphylactoid reactions As with other NSAIDs, patients taking etodolac may experience anaphylactoid reactions without a history of them. Etodolac should not be given to patients with the aspirin triad (polypous rhinosinusitis, bronchospasm attacks, intolerance). NSAIDs, including etodolac, can cause severe skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, sometimes fatal. These severe reactions may occur without warning Patients should be informed of the symptoms of severe skin manifestations If skin rashes or any other manifestation of hypersensitivity reactions occur, the drug should be discontinued Other precautions should be discontinued gradually.Effects on the liver When taking etodolac.an increase in the level of liver enzymes.Laboratory changes may progress, remain unchanged or decrease after cessation of therapy.Significant increase non-ALT, ACT (about 3 times or more) – was observed in 15% of patients during clinical trials of NSAIDs. Rare cases of severe liver reactions have been reported, including fatal jaundice and fulminant hepatitis, hepatic necrosis, liver failure, sometimes fatal. With the development of clinical symptoms of impaired renal function, systemic manifestations (eosinophilia, skin rashes) are possible, in which case the use of etodolac should be discontinued. Influence on the blood. Sometimes when using NSAIDs, including etodolac. anemia develops. This may be due to fluid retention, as a result of gastrointestinal bleeding, impaired erythropoiesis. In patients with long-term use of NSAIDs, including etodolac, hemoglobin and hematocrit levels should be monitored. NSAIDs inhibit platelet aggregation and, in some patients, prolong bleeding time. Compared to acetylsalicylic acid, the effect on platelets is much less or less lasting. In patients taking etodolac, it is necessary to monitor the level of platelets, since coagulation disorders are possible, especially in patients taking anticoagulants. Bronchial asthma Patients with bronchial asthma may develop bronchospasm. The use of acetylsalicylic acid in aspirin asthma causes severe bronchospasm. Due to the possibility of a cross-reaction, the drug should not be used in patients with a history of asthma, rhinitis, and urticaria during treatment with other NSAIDs. The drug contains lactose, so it should not be used in hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose. Like other non-steroidal anti-inflammatory drugs, etodolac can inhibit platelet function, especially in patients taking anticoagulants. In this case, patients should be under medical supervision. In case of bleeding, treatment is stopped. In patients with heart failure, chronic liver or kidney failure, liver cirrhosis, as well as in elderly patients, kidney and liver function should be monitored (at least once a month). Patients with SLE and systemic connective tissue disease have an increased risk of noninfectious meningitis. Influence on the ability to drive vehicles, work with dangerous devices and mechanisms: The patient should be warned that taking Etodin Fort may cause the development of dizziness, general weakness of visual impairment. While taking the drug, care must be taken when driving vehicles or operating other mechanisms. In the event of the development of these reactions, it is necessary to refrain from driving vehicles and working with moving mechanisms. Storage conditions Store at a temperature not exceeding 25 ° C in the original packaging to protect from light. Keep out of the reach of children. Buy Etodin Fort tablets p/o 400mg No. 14×2