Rabelock, 20 mg 14 pcs.

An antiulcer agent from the group of H+/K+ATPase proton pump inhibitors), metabolized in the parietal cells of the stomach to active sulfonamide derivatives, which inactivate the sulfhydryl groups of H+/K+-ATPase.

Blocks the final stage of hydrochloric acid secretion, reducing basal and stimulated secretion, regardless of the nature of the irritant. It has high lipophilicity, easily penetrates into the parietal cells of the stomach and concentrates in them, having cytoprotective effect and increasing the secretion of hydrocarbonate.

The antisecretory effect after oral administration of 20 mg occurs within 1 hour and reaches a maximum after 2-4 hours; inhibition of basal and food-stimulated acid secretion 23 hours after the first dose is 62 and 82% respectively, duration of action is 48 hours. After the end of the intake, secretory activity normalizes within 2-3 days.

In the first 2-8 weeks of therapy, gastrin concentration in serum increases and returns to baseline levels within 1-2 weeks after withdrawal. It does not affect the central nervous system (CNS), cardiovascular and respiratory systems. No sustained changes in the morphological structure of enterochromaffin-like cells, in the severity of gastritis, in the frequency of atrophic gastritis, intestinal metaplasia or the spread of Helicobacter pylori infection were found during rabeprazole administration.

The effect on plasma gastrin concentration. At the beginning of therapy with rabeprazole, plasma gastrin concentration increases, which is a reflection of the inhibitory effect on hydrochloric acid secretion. Gastrin concentration usually returns to initial level within 1-2 weeks after discontinuation of treatment.

Indications

Gastric and duodenal ulcers in the acute phase;

Gastric and duodenal ulcer associated with Helicobacter pylori (in combination with antibiotics); gastroesophageal reflux.

Active ingredient

Composition

1 tablet contains rabeprazole sodium – 20 mg

Excipients:

mannitol – 89 mg,

magnesium oxide – 80 mg,

p> hypromellose – 5 mg,

microcrystalline cellulose – 20 mg,

starch – 20 mg,

carmellose – 20 mg,

talc – 3 mg,

magnesium stearate – 6 mg,

colloidal silica – 3 mg.

Shell composition:

Hypromellose – 9.5 mg, propylene glycol – 1.5 mg.

Composition of the enteric coating:

Methacrylic acid and ethyl acrylate copolymer (type C) (1:1) – 13.95 mg, polysorbate 80 – 0.209 mg, dibutyl phthalate – 2.090 mg, sodium hydroxide – 0.119 mg, iron oxide yellow dye – 0.783 mg, talc – 5.63 mg, titanium dioxide – 1.210 mg.

How to take, the dosage

It is taken orally. A single dose is 10-20 mg. Frequency and duration of use depend on the indication and the treatment regimen.

Interaction

Concomitant use with digoxin may increase (mild to moderate) plasma concentrations of digoxin.

Concomitant use with ketoconazole decreases its bioavailability.

Special Instructions

Before starting therapy, malignant neoplasms of the stomach should be excluded, since the use of rabeprazole may mask symptoms and delay correct diagnosis.

Patients with hepatic or renal impairment do not require dose adjustment, but in patients with severe hepatic impairment rabeprazole is recommended with caution.

In concomitant use with rabeprazole, the doses of ketoconazole and digoxin should be adjusted.

In experimental studies carcinogenic effects of rabeprazole were not established, but in the study of mutagenicity there were mixed results. Tests on lymphoma cells in mice were positive, while the in vivo micronucleus test and in vivo and in vitro DNA repair test were negative.

Contraindications

Pregnancy, lactation (breastfeeding), hypersensitivity to rabeprazole sodium or substituted benzimidazoles.

Side effects

The digestive system: diarrhea, nausea, abdominal pain, vomiting, flatulence, constipation; rarely – dry mouth, dyspepsia, belching; in single cases – anorexia, gastritis, stomatitis, increased activity of liver transaminases.

CNS and peripheral nervous system disorders: headache, asthenia, dizziness, insomnia; rarely – nervousness, somnolence; in single cases – depression, visual and taste disorders.

Respiratory system: possible – rhinitis, pharyngitis, cough; rarely – sinusitis, bronchitis.

Allergic reactions: rare – skin rash; in isolated cases – itching.

Others: back pain, flu-like syndrome; rarely – myalgia, chest pain, chills, cramps of the calf muscles, urinary tract infection, arthralgia, fever; in single cases – weight gain, increased sweating, leukocytosis.

Overdose

The reports of overdose are minimal. Rabeprazole has been reported at a dose of 60 mg twice daily and 160 mg once daily. Side effects were minimal and did not require medical intervention.

Treatment.A specific antidote is not known. Rabeprazole binds well to plasma proteins and is therefore poorly excreted by dialysis.

In case of overdose, symptomatic treatment is necessary.

Similarities