Emanera capsules 40 mg 28 pcs
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Active ingredients
Esomeprazole
Release form
Capsules
Composition
Active ingredient: zomeprazole magnesium Concentration of active ingredient (mg): 41,290
Pharmacological effect
Antiulcer
Pharmacokinetics
Esomeprazole is the S-isomer of omeprazole and inhibits the secretion of hydrochloric acid in the stomach due to a specific and directional mechanism of action. It specifically inhibits the proton pump of parietal cells. Both isomers of omeprazole, R- and S-, have similar pharmacodynamic activity.
Indications
Gastroesophageal Reflux Disease (GERD): treatment of erosive reflux esophagitis; long-term supportive treatment after healing of erosive reflux esophagitis to prevent relapses; symptomatic treatment of GERD. Peptic ulcer and duodenal ulcer. duodenal disease associated with Helicobacter pylori, prevention of recurrence of peptic ulcers associated with Helicobacter pylori. Patients long-term nonsteroidal anti-inflammatory drugs (NSAIDs): healing of gastric ulcers associated with taking NSAIDs; prevention of gastric and duodenal ulcers associated with taking NSAIDs in patients at risk. Long-term prevention of recurrence of recurrent bleeding from peptic ulcers (after intravenous use of drugs lowering the secretion of gastric glands); Zollinger-Ellison syndrome and other conditions characterized by increased gastric secretion, including idiopathic hypersecretion.
Contraindications
Hypersensitivity to esomeprazole, substituted benzimidazoles or components of the Emaner preparation, simultaneous use with atazanavir and nelfinavir, hereditary fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency, children under 12 years old (no data on efficacy and safety) and older years - according to other indications, except gastroesophageal reflux disease (GERD). With caution: severe renal failure (experience of use is limited).
Precautionary measures
Keep out of the reach of children.
Use during pregnancy and lactation
Use of the drug Emaner during pregnancy is possible only if the expected benefit to the mother exceeds the possible risk to the fetus, insufficient data on the use of esomeprazole in pregnant women. In epidemiological studies during the use of the racemic mixture of omeprazole, no fetotoxic effects or fetal developmental disorders were detected. In studies with esomeprazole in animals, no direct or indirect negative effect on the development of the embryo or fetus was detected; there was also no direct or indirect negative effect on the course of pregnancy, childbirth and the postnatal period of the newborn. It is currently unknown whether esomeprazole is excreted in breast milk, therefore Emanera should not be used during breastfeeding.
Dosage and administration
Inside, without chewing, drinking a small amount of liquid. For patients with difficulty swallowing, empty the contents of the capsules in half a glass of non-carbonated water, stir and drink immediately or within 30 minutes. Then re-fill the glass with water by half, rinse the walls of the glass and drink. Do not mix the drug with other liquids, because This may lead to the dissolution of the pellet containment shell. Pellets should not be chewed or crushed. For patients who cannot swallow, the contents of the capsules should be dissolved in still water and injected esomeprazole through a nasogastric tube. It is necessary to check the compliance of the syringe for the injection and the probe. Instructions on the preparation and administration of the drug through a nasogastric tube are given in the subsection Injection of the drug through a nasogastric tube. Adults and adolescents over 12 years oldEERD: erosive reflux esophagitis (treatment) - 40 mg 1 time per day for 4 weeks If after the 1st course of therapy, the healing of esophagitis does not occur or symptoms persist, an additional 4-week course of treatment with esomeprazole is recommended. Long-term supportive treatment after healing of erosive reflux esophagitis to prevent recurrence - 20 mg 1 time per day. 1 time per day (for patients without esophagitis). If, after 4 weeks of therapy, it was not possible to control the symptoms, it is necessary to re-examine the patient.After the symptoms are eliminated, you can continue taking the drug Emaner on demand, i.e. take 20 mg of the drug 1 time per day if symptoms occur. Patients receiving NSAIDs at risk of developing gastric or duodenal ulcers are still treating patients on an on-demand basis. and prevention of recurrence of peptic ulcers associated with Helicobacter pylori. The combined eradication therapy of Helicobacter pylori includes Emanera - at a dose of 20 mg, amoxicillin - at a dose of 1 g and clarithromycin - at a dose of 500 mg. All drugs are taken 2 times a day for 7–14 days. Patients who take NSAIDs for a long time: healing of a stomach ulcer associated with taking NSAIDs - 20 or 40 mg 1 time per day for 4–8 weeks; prevention of gastric and duodenal ulcers, associated with taking NSAIDs in patients at risk - Emanera 20 or 40 mg 1 per day. Long-term prophylaxis of recurrence of repeated bleeding from peptic ulcers (after i / p drugs reducing the secretion of gastric glands) - Emanera 40 mg 1 time day within 4 weeks after the started in / in p ofilaktiki repeated krovotecheniy.Sindrom Zollinger-Ellison syndrome and other conditions characterized by increased gastric secretions, including idiopathic hypersecretion - the initial dose of the drug Emaner 40 mg 2 times a day. The dose of the drug and the duration of treatment are selected individually depending on the clinical picture of the disease. The disease in most patients is controlled by taking the drug in a dose of 80 to 160 mg / day. If necessary, the use of the drug Emanera over 80 mg / day, the daily dose is divided into 2 doses. Renal dysfunction. Patients with impaired renal function do not need to change the dose. Experience with the use of esomeprazole in patients with severe renal insufficiency is limited; therefore, caution should be exercised in prescribing such patients. Liver function impairmentPatients with mild or moderate hepatic impairment do not need to change the dose. With severe liver failure, the maximum dailyThe dose should not exceed 20 mg. Elderly patients Elderly patients dose adjustment is not required. Administration of the drug through a nasogastric tube When prescribing the drug through a nasogastric tube, you must: Open the capsule and empty its contents into a special syringe. Add 25 ml of drinking water to the syringe and draw approximately 5 ml of air. For some probes, it may be necessary to dilute the drug in 50 ml of drinking water in order to prevent the pellets contained in the capsule from clogging the probe. After adding water, immediately shake the syringe to obtain a suspension. Make sure that the tip is not clogged (pressing the plunger a little while holding the syringe in the position of the tip up). Insert the tip of the syringe into the probe, continuing to keep it pointing up. Shake the syringe and turn it upside down. Immediately introduce 5–10 ml of the dissolved drug into the probe. After the introduction of the solution, return the syringe to its previous position and shake (the syringe should be kept tip up to avoid clogging the tip). Again, lower the syringe tip down and inject 5-10 ml of solution into the probe. Repeat the procedure until the syringe is empty. If there is a residual portion of the drug in the form of sediment in the syringe: fill the syringe with 25 ml of water and 5 ml of air and repeat the procedures described in paragraphs 5 and 6. For some probes, 50 ml of drinking water.
Side effects
From the nervous system: often - headache; infrequently - insomnia, dizziness, paresthesias, drowsiness; rarely - depression, agitation, confusion; very rarely - hallucinations, aggressive behavior. On the part of the respiratory system: rarely - bronchospasm. On the part of the digestive system: often - abdominal pain, constipation, diarrhea, flatulence, nausea, vomiting; infrequently - dryness of the oral mucosa, increased activity of liver enzymes; rarely - stomatitis, gastrointestinal candidiasis, hepatitis (with or without jaundice); very rarely - liver failure, hepatic encephalopathy in patients with liver diseases in history. From the urinary system: very rarely - interstitial nephritis. From the reproductive system: very rarely - gynecomastia. From the musculoskeletal system: rarely - arthralgia,myalgia; very rarely - muscle weakness. On the skin side: infrequently - dermatitis, skin rash, pruritus, urticaria; rarely - alopecia, photosensitivity; very rarely - erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. For the blood-forming organs: rarely - leukopenia, thrombocytopenia; very rarely - agranulocytosis, pancytopenia. For the senses: infrequently - blurred vision; rarely - change in taste. Allergic reactions: rarely - hypersensitivity reactions (for example, fever, angioedema, anaphylactic reaction / anaphylactic shock). Laboratory data: rarely - hyponatremia. Other: infrequently - peripheral edema; rarely - sweating; very rarely - weakness (malaise).
Overdose
To date, cases of overdose of the drug Emaner not described. Ingestion of esomeprazole at a dose of 280 mg was accompanied by general weakness and symptoms of the gastrointestinal tract. A single intake of 80 mg of esomeprazole was not accompanied by any symptoms. A specific antidote does not exist. Esomeprazole is actively associated with plasma proteins, so hemodialysis is ineffective. Treatment: in case of overdose, symptomatic therapy should be carried out.
Interaction with other drugs
Effect of esomeprazole on the pharmacokinetics of other drugs Drugs, the absorption of which depends on the pH level. Reduced secretion of hydrochloric acid in the stomach during treatment with esomeprazole and other proton pump inhibitors may lead to changes in the absorption of drugs, the absorption of which depends on the acidity of the medium. Like antacids and other drugs that reduce the acidity of gastric juice, the use of esomeprazole may reduce the absorption of ketoconazole, itraconazole and erlotinib, and increase the absorption of drugs such as digoxin. Simultaneous administration of omeprazole at a dose of 20 mg once a day and digoxin increases bioavailability digoxin. 10% (digoxin bioavailability increased by up to 30% in 2 out of 10 patients). It is known that omeprazole interacts with some antiretroviral drugs. The mechanism and clinical significance of these interactions are not always known. Reducing the acidity of gastric juice during therapy with omeprazole may affect the absorption of antiretroviral drugs.Interaction at the level of an isoenzyme CYP2C19 is also possible. During therapy with omeprazole, a decrease in the serum concentration of certain antiretroviral drugs (atazanavir and nelfinavir) has been observed. Therefore, simultaneous use is not recommended. The simultaneous use of omeprazole (40 mg once daily) with atazanavir 300 mg / ritonavir 100 mg in healthy volunteers is accompanied by a marked decrease in the exposure to atazanavir (AUC, Cmax and Cmin in plasma decreased by about 75%). An increase in the dose of atazanavir to 400 mg did not compensate for the effects of omeprazole on the bioavailability of atazanavir. not recommended. CYP2C19 metabolized drugs. Esomeprazole inhibits CYP2C19, the main isoenzyme of the metabolism of esomeprazole. Thus, with simultaneous use of esomeprazole with drugs whose metabolism involves the CYP2C19 isoenzyme, such as diazepam, citalopram, imipramine, clomipramine, phenytoin, etc., the plasma concentration of these drugs may increase and, accordingly, their dose reduction may be required .It is especially necessary to take into account when prescribing the drug Emaner in the mode of necessity. So, with simultaneous use with 30 mg of esomeprazole, diazepam clearance (CYP2C19 isoenzyme substrate) is reduced by 45%. Simultaneous use of esomeprazole at a dose of 40 mg leads to an increase in plasma phenytoin concentration in epilepsy by 13%. It is recommended to monitor plasma phenytoin concentrations in plasma. of blood at the beginning of therapy with esomeprazole and when it is canceled. When using omeprazole at a dose of 40 mg, the Cmax and AUC of voriconazole (CYP2C19 isoenzyme substrate) increases by 15 and 41%, respectively. The coagulation time is simultaneous Receiving warfarin and esomeprazole 40mg remains within acceptable limits. However, several cases of a clinically significant increase in the INR index have been reported. It is recommended to control INR at the beginning and at the end of simultaneous use of esomeprazole and warfarin or othercoumarin derivatives. The use of omeprazole at a dose of 40 mg resulted in an increase in Cmax and AUC of cilostazol by 18 and 26%, respectively; for one of the active metabolites of Cilostazol, the increase was 29 and 69%, respectively. Simultaneous use of esomeprazole in a dose of 40 mg with cisapride leads to an increase in the values of pharmacokinetic parameters of cisapride in healthy volunteers: AUC - by 32% and T1 / 2 - by 31%, but Cmax it does not change significantly. A slight lengthening of the QT interval on the ECG, which is observed with cisapride monotherapy, did not increase with the addition of esomeprazole. Some patients noted an increase in serum methotrexate concentration against the background of simultaneous use with proton pump inhibitors. When using high doses of methotrexate, the possibility of temporary withdrawal of esomeprazole should be considered. Esomeprazole does not cause clinically significant changes in the pharmacokinetics of amoxicillin and quinidine. Simultaneous short-term use of esomeprazole and naproxen or rofecoxib did not reveal any clinically significant pharmacokinetic interaction. loading dose, then 75 mg / day) with omeprazole (80 mg) simultaneously, at the same time during e 5 days. The activity of the thiol metabolite (active metabolite) of clopidogrel was reduced by 46% (1st day of therapy) and 42% (5th day of therapy), while taking clopidogrel and omeprazole at the same time. When taking clopidogrel and omeprazole at one time, the average suppression of platelet aggregation (IPA) was reduced by 47% (during 24 hours of therapy) and 30% (5th day of therapy). According to another study: omeprazole when used with clopidogrel at the same time , at different times, has no inhibitory effect on the CYP2C19 isoenzyme. In the studies, conflicting data on clinical manifestations of interaction with clopidogrel on major cardiovascular events were recorded. With simultaneous use with tacrolimus, serum concentrations of tacrolimus may increase. The effect of drugs on the pharmacokinetics of esomeprazole CYP2C19 and CYP3 isoenzymes take part in the metabolism of esomeprazole. With simultaneous use of esomeprazole with clarithromycin (500 mg 2 times a day) (CYP3A4 isoenzyme inhibitor), the AUC value of esomeprazole increases by a factor of 2. Simultaneous use of esomeprazole and the combined inhibitor of isoenzymes CYP2C19 and CYP3A4,for example, voriconazole may be accompanied by an increase in the AUC of esomeprazole by more than 2 times. Usually in such situations, no change in the dose of esomeprazole is required. In patients with severe impairment of liver function or if necessary long-term therapy should be considered for dose reduction ezomeprazola.Lekarstvennye drugs inducing isozymes CYP2C19 and CYP3A4, such as rifampicin and preparations Hypericum perforatum, while the use of esomeprazole can lead to a reduction in the plasma concentration of esomeprazole blood by accelerating the metabolism of esomeprazole.
special instructions
If anxious symptoms appear (such as significant spontaneous weight loss, repeated vomiting, dysphagia, vomiting with blood or melena), as well as suspected or detected gastric ulcers, it is necessary to exclude a malignant neoplasm, because the use of Emanera can reduce the severity of symptoms and delay diagnosis. Patients who have been taking Emanera for a long time (especially for more than a year) must be under regular medical supervision. Patients who take the drug according to Requirements should be informed about the need to go to a doctor when symptoms change. Considering fluctuations in the concentration of esomeprazole in the blood plasma when using the drug on an as-needed basis, interactions with other drugs should be taken into account (see “Interaction”). Helicobacter pylori should consider the possible interaction between the components of triple therapy. Clarithromycin is a potent inhibitor of CYP3A4, therefore, contraindications and drug interaction of clarithromycin should be considered when prescribing triple therapy to patients who are simultaneously taking drugs metabolized by CYP3A4, such as cisapride. malabsorption or deficiency of sucrase-isomaltase. The effect on the ability to drive and others is difficult mi mechanisms. The drug Emanera does not affect the control of vehicles and work with other technical devices, requiring increased concentration of attention and speed of psychomotor reactions.