Emaner capsules 40mg, No. 28
Expiration Date: 05/2027
Russian Pharmacy name:
Эманера капсулы 40мг, №28
gastroesophageal reflux disease (GERD):
- treatment of erosive reflux esophagitis;
- long-term supportive treatment after healing of erosive reflux esophagitis in order to prevent relapse;
- symptomatic treatment of GERD;
peptic ulcer of the stomach and duodenum;
as part of a combination antibiotic therapy for the eradication of Helicobacter pylori:
- duodenal ulcer associated with Helicobacter pylori;
- prevention of recurrence of peptic ulcers associated with Helicobacter pylori;
patients taking NSAIDs for a long time:
- healing of stomach ulcers associated with the intake of NSAIDs;
- prevention of gastric and duodenal ulcers associated with the intake of NSAIDs in patients at risk;
long-term prevention of recurrence of repeated bleeding from peptic ulcers (after intravenous use of drugs that lower the secretion of gastric glands);
Zollinger-Ellison syndrome and other conditions characterized by increased gastric secretion, incl. idiopathic hypersecretion.
Inside, without chewing, with a small amount of liquid.
For patients with difficulty swallowing, pour the contents of the capsules into half a glass of still water, stir and drink immediately or within 30 minutes. Then fill the glass halfway with water again, rinse the sides of the glass and drink.
Do not mix the drug with other liquids, because this can lead to dissolution of the pellet protective shell. Pellets should not be chewed or crushed.
For patients who cannot swallow on their own, the contents of the capsules should be dissolved in still water and esomeprazole should be administered through a nasogastric tube. It is necessary to check the conformity of the syringe for the injection of the drug and the probe. Instructions for preparing and administering the drug through a nasogastric tube are given in the subsection УAdministration of the drug through a nasogastric tubeФ.
Adults and adolescents over 12 years of age
GERD:
- Erosive reflux esophagitis (treatment): 40 mg once a day for 4 weeks. If after the first course of therapy, esophagitis does not heal or symptoms persist, an additional 4-week course of esomeprazole is recommended.
- Long-term supportive treatment after healing of erosive reflux esophagitis to prevent relapse: 20 mg once a day.
- Symptomatic treatment of GERD: 20 mg once a day - for patients without esophagitis. If after 4 weeks of therapy it was not possible to achieve control of symptoms, it is necessary to re-examine the patient. After elimination of the symptoms, you can continue taking the drug Emaner on demand, i.e. take 20 mg of the drug once a day if symptoms occur. On-demand treatment is not recommended for patients taking NSAIDs who are at risk of developing gastric or duodenal ulcers.
Adult patients
Peptic ulcer and duodenal ulcer
As part of combined antibiotic therapy for the eradication of Helicobacter pylori:
- Duodenal ulcer associated with Helicobacter pylori and prevention of recurrence of peptic ulcers associated with Helicobacter pylori (the combined eradication therapy for Helicobacter pylori includes: Emanera 20 mg, amoxicillin 1 g and clarithromycin 500 mg). All drugs are taken 2 times a day for 7-14 days.
Patients taking NSAIDs for a long time:
- Healing of stomach ulcers associated with taking NSAIDs: 20 mg or 40 mg once a day for 4-8 weeks.
- Prevention of gastric and duodenal ulcers associated with taking NSAIDs in patients at risk: Emanera drug 20 mg or 40 mg 1 time per day.
Long-term prevention of recurrence of repeated bleeding from peptic ulcers (after intravenous administration of drugs that lower the secretion of gastric glands): Emanera drug 40 mg 1 time per day for 4 weeks after started IV prevention of repeated bleeding.
Zollinger-Ellison syndrome and other conditions characterized by increased gastric secretion, incl. idiopathic hypersecretion: the initial dose of Emaner is 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 at a dose of 80 to 160 mg / day. If it is necessary to use the drug Emaner more than 80 mg / day, the daily dose is divided into two doses.
Impaired renal function. Patients with impaired renal function do not need to change the dose. Experience with esomeprazole in patients with severe renal impairment is limited; in this regard, caution should be exercised when prescribing the drug to such patients.
Liver dysfunction. Patients with mild to moderate hepatic impairment do not need to change the dose. In severe hepatic impairment, the maximum daily dose should not exceed 20 mg.
Elderly patients. Elderly patients do not need dose adjustment.
Administration of the drug through a nasogastric tube
When prescribing the drug through a nasogastric tube, it is necessary:
1. Open the capsule and pour the contents of the capsule into a special syringe. Add 25 ml of drinking water and about 5 ml of air to the syringe. 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.
2. After adding water, immediately shake the syringe until a suspension is obtained.
3. Make sure the tip is not clogged (by pushing the plunger slightly while holding the syringe tip up).
4. Insert the tip of the syringe into the probe while continuing to keep it pointing up.
5. Shake the syringe and turn it upside down. Immediately inject 5-10 ml of the dissolved drug into the tube. After injecting the solution, return the syringe to its original position and shake it (the syringe must be held with the tip up to avoid clogging of the tip).
6. Lower the syringe again with the tip down and inject another 5-10 ml of solution into the probe. Repeat the procedure until the syringe is empty.
7. In case of residual part 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 points 5 and 6. For some probes, 50 ml of drinking water may be required for this purpose.
(contains an average of 14.5% water (weight loss on drying)
Enteric capsules | 1 caps. |
pellet core: | |
active substance: | |
esomeprazole magnesium | 20.645 mg |
41.29 mg | |
(equivalent to esomeprazole - 20 or 40 mg) | |
excipients: sugar crumbs (contains sucrose and starch molasses) - 35.58 / 71.16 mg; povidone K30 - 7.5 / 15 mg; sodium lauryl sulfate - 0.9 / 1.8 mg | |
pellet shell: Opadry II white 85F28751 (polyvinyl alcohol - 9.376 / 18.752 mg; titanium dioxide (E171) - 5.86 / 11.72 mg; macrogol 3000 - 4.735 / 9.47 mg; talc - 3.469 / 6.938 mg) - 23 .44 / 46.88 mg; magnesium hydroxycarbonate (heavy magnesium carbonate) - 3/6 mg; methacrylic acid and ethyl acrylate copolymer (1: 1); dispersion 30% * - 127.49 / 254.98 mg; talc - 11.925 / 23.85 mg; macrogol 6000 - 3.825 / 7.65 mg; titanium dioxide (E171) - 3.825 / 7.65 mg; polysorbate 80 - 1.72 / 3.44 mg | |
empty gelatin capsules | |
body: iron dye red oxide (E172) - 0.014 / 0.114 mg; titanium dioxide (E171) - 0.406 / 0.458 mg; gelatin ** - 28.38 / 45.028 mg | |
cap: iron dye red oxide (E172) - 0.01 / 0.076 mg; titanium dioxide (E171) - 0.271 / 0.305 mg; gelatin ** - 18.92 / 30.019 mg | |
* Eudragit L30D dispersion contains, in addition to methacrylic acid, ethyl acrylate copolymer and water, also sodium lauryl sulfate (0.7% based on the solid in the dispersion) and polysorbate 80 (2.3% based on the solid in the dispersion) as emulsifiers | |
** contains on average 14.5% water (weight loss on drying) |
hypersensitivity to esomeprazole, substituted benzimidazoles or drug components;
simultaneous reception with atazanavir and nelfinavir (see 'Interaction');
hereditary fructose intolerance;
syndrome of glucose-galactose malabsorption or sucrase-isomaltase deficiency;
children under 12 years of age (no data on efficacy and safety) and over 12 years - for other indications, except for gastroesophageal reflux disease (GERD).
Precautions: severe renal impairment (experience with limited use).
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