Rabeprazole 20 mg – [14 capsules]

Rabeprazole belongs to the class of antisecretory agents, benzimidazole derivatives. Suppresses gastric juice secretion by specifically inhibiting the H+

/K+-ATPase on the secretory surface of gastric parietal cells. Blocks the final stage of hydrochloric acid secretion, reducing basal and stimulated secretion, regardless of the nature of the stimulus.

Having high lipophilicity, it easily penetrates into the parietal cells of the stomach, concentrates in them, having cytoprotective effect and increasing the secretion of hydrocarbonate. The antisecretory effect after oral administration of 20 mg of rabeprazole, occurs within 1 hour and reaches a maximum after 2-4 hours; inhibition

basal and food-stimulated acid secretion 23 hours after the first dose is 62 and 82%, respectively, and lasts up to

48 hours. When discontinued, secretory activity is restored within 1-2 days.

During the first 2-8 weeks of therapy with rabeprazole, plasma gastrin concentrations increase, (which is a reflection of the inhibitory

influence on hydrochloric acid secretion) and returns to initial levels 1-2 weeks after its cessation.

Rabeprazole has no anticholinergic properties and has no effect on the central nervous system (CNS), cardiovascular and respiratory systems.

Against the background of taking rabeprazole stable changes in the morphological structure of enterochromaffin-like cells, in the degree of severity

gastritis, in the frequency of atrophic gastritis, intestinal metaplasia or the spread of Helicobacter pylori infection were not found.

-Gastric ulcer in the stage of exacerbation and anastomosis ulcer;

– Duodenal ulcer in the acute stage;

– Erosive and ulcerative gastroesophageal reflux disease

(GERD) – adults and children from 12 years of age or reflux esophagitis;

– Maintenance therapy for gastroesophageal reflux disease;

– Non-erosive gastroesophageal reflux disease;

– Zollinger-Ellison syndrome and other conditions characterized by

pathological hypersecretion;

– In combination with appropriate antibacterial therapy for

Helicobacter pylori eradication in patients with peptic ulcer disease.

– Hypersensitivity to rabeprazole, substituted benzimidazoles or to excipients of the drug;

– Sucrose/isomaltase deficiency, fructose intolerance, glucose-galactose deficiency;

– pregnancy;

– Breast-feeding period;

– children under 18 years of age, except for GERD (children under 12 years of age).

• Rabeprazole capsules should be swallowed whole. It has been established that neither time of day nor food intake affect the activity of rabeprazole.
• In acute gastric ulcers and anastomosis ulcers, it is recommended to take orally 10 mg or 20 mg once a day.
• Usually cure occurs after 6 weeks of therapy, but in some cases the duration of treatment may be extended for another 6 weeks.
• In duodenal ulcer in acute stage it is recommended to take orally 20 mg once a day. In some
• In some cases the therapeutic effect comes when taking 10 mg once a day. The duration of treatment is from 2 to 4 weeks. If necessary
• The treatment duration may be increased by 4 weeks. In treatment of erosive gastroesophageal reflux disease (GERD) or
• reflux esophagitis, it is recommended to take orally 10 mg or 20 mg once daily. The duration of treatment is 4 to 8 weeks. If necessary.
• If necessary, the duration of treatment may be prolonged for additional 8 weeks.
• In maintenance therapy of gastroesophageal reflux disease (GERD), it is recommended to take orally 10 mg or 20 mg once a day.
• The duration of treatment depends on the patient’s condition. In non-erosive gastroesophageal reflux disease (NERD) without
• esophagitis, 10 mg or 20 mg once daily is recommended orally. If symptoms persist after four weeks of treatment, a
• further evaluation of the patient. Once symptoms have resolved, and to prevent a recurrence, an oral dosage of 10 mg or 20 mg daily should be taken.
• the drug orally at a dose of 10 mg once daily on demand. For treatment of Zollinger-Ellison syndrome and other conditions characterized by pathological hypersecretion, the dose is adjusted individually. The initial dose is 60 mg per day, then the dose is increased and the drug is prescribed at a dose of up to 100 mg per day at a single dose or 60 mg twice a day. For some patients, fractional dosing is preferable. Treatment should be continued as
• as clinically necessary. In some patients with Zollinger-Ellison syndrome, the duration of treatment with rabeprazole was up to one year.
• For eradication of Helicobacter pylori it is recommended to take orally 20 mg 2 times a day according to a certain scheme with an appropriate combination of
• antibiotics. The duration of treatment is 7 days. Patients with renal and hepatic impairment Do not need dose adjustment in patients with renal impairment. In patients with hepatic insufficiency of mild to moderate degree of severity the concentration of rabeprazole in blood is usually higher than in healthy
• volunteers. Caution should be exercised when prescribing Rabeprazole in patients with severe hepatic insufficiency.
• Elderly patients No dose adjustment is required. Children Safety and efficacy of rabeprazole 20 mg for short-term (up to 8
• The safety and efficacy of rabeprazole 20 mg for short-term (up to 8 weeks) treatment of GERD in children 12 years of age and older has been confirmed by extrapolating the results of adequate and well controlled
• studies that support the efficacy of rabeprazole for adults and safety and pharmacokinetic studies for pediatric patients
• age. The recommended dose for children aged 12 years and older is 20 mg once daily for up to 8 weeks.
• Safety and efficacy of rabeprazole for GERD treatment in children under 12 years old has not been established. Safety and efficacy
• rabeprazole for use for other indications has not been established for pediatric patients.