Description
Product form
Tablets
Packaging
In a package of 14pcs. 20mg each
Pharmacological action
Anti-ulcer drug from the group of proton pump inhibitors H + / K + ATPase), it is 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 the content of basal and stimulated secretion, regardless of the nature of the stimulus. It has high lipophilicity, easily penetrates into the parietal cells of the stomach and concentrates in them, exerting a cytoprotective effect and increasing the secretion of bicarbonate.
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, the duration of action is 48 hours. After the reception, secretory activity is normalized within 2-3 days.
In the first 2-8 weeks of therapy, the concentration of gastrin in the blood serum increases and returns to baseline levels within 1-2 weeks after withdrawal. Does not affect the central nervous system (CNS), cardiovascular and respiratory systems. Against the background of taking rabeprazole, no stable changes were found in the morphological structure of enterochromaphine-like cells, in the degree of gastritis, in the frequency of atrophic gastritis, intestinal metaplasia, or the spread of Helicobacter pylori infection.
Effect on the concentration of gastrin in plasma. At the beginning of rabeprazole therapy, the concentration of gastrin in the blood plasma increases, which is a reflection of the inhibitory effect on the secretion of hydrochloric acid. The concentration of gastrin returns to its initial level, usually within 1-2 weeks after discontinuation of treatment.
Indications
Peptic ulcer of the duodenum (duodenal ulcer) peptic ulcer of the stomach gastroesophageal reflux disease (GERD) non-ulcer dyspepsia for eradication Helicobacter pulori (N. rulori) (in combination with appropriate antibacterial therapeutic agents) Zollinger-Ellison syndrome chronic gastritis in the acute stage.
Contraindications
Contraindications to patients with hypersensitivity to rabeprazole sodium, substituted benzimidazoles, or any other ingredient in this drug. A contraceptive package is also for pregnant women and mothers who breastfeed children under 14 years of age.
Use during pregnancy and lactation
There are no data on the safety of rabeprazole in pregnant women, therefore Rabelok is contraindicated in women during pregnancy.
Unknown whether rabeprazole sodium is excreted in breast milk. Studies in mothers who are breastfeeding have not been conducted. Rabeprazole sodium should not be prescribed to women who are breastfeeding.
Children
Rabelok is not recommended for children, since there is no experience with the drug in this group of patients.
Composition
1 tab. contains rabeprazole sodium – 20 mg
Excipients: mannitol – 89 mg, magnesium oxide – 80 mg, hypromellose – 5 mg, microcrystalline cellulose – 20 mg, starch – 20 mg, carmellose – 20 mg, talc – 3 mg, magnesium stearate – 6 mg, colloidal silicon dioxide – 3 mg.
Shell composition: hypromellose – 9.5 mg, propylene glycol – 1.5 mg.
Composition of enteric coat: methacrylic acid-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, yellow iron dye – 0.783 mg, talc – 5.63 mg, titanium dioxide – 1.210 mg.
Dosage and administration of
For peptic ulcer of duodenum, peptic ulcer and GERD are prescribed 20 mg once a day (if necessary, 40 mg twice a day for 20 mg in the morning and evening). The duration of treatment for peptic ulcer of duodenum is 2 to 4 weeks, for gastric ulcer – 2 to 8 weeks, and for GERD – 4 to 8 weeks, maintenance therapy for GERD is 10 mg or 20 mg once a day for up to 12 months.
In non-ulcer dyspepsia, 40 mg is prescribed once a day, or 20 mg twice a day for 2 to 3 weeks.
To eradicate N. Rulori, it is necessary to refer to the complex therapy regimens with appropriate antibiotics (amoxicillin, clarithromycin, tetracycline), metronidazole, furazolidone and bismuth preparations.
Rabelok 20 mg twice a day + clarithromycin 500 mg twice a day + amoxicillin 1 g twice a day for 7 days.
Rabelok 20 mg twice a day + clarithromycin 500 mg twice a day + metronidazole 400 mg twice a day for 7 days.
The optimal scheme of destruction of N. Rulori is recommended by the doctor.
With Zollinger-Ellison syndrome, the initial dose of the drug is 20-60 mg per day, if necessary, the dose is increased to 120 mg per day (daily dose of 80 mg or more should be divided into two doses), the course of treatment is 2-8 weeks.
In chronic gastritis in the acute stage, 40 mg are prescribed per day (1 tablet twice, or two tablets once a day) for 2 to 4 weeks.
Tablets cannot be chewed or crushed, but must be swallowed whole.
Side effects
Rabelok generally well tolerated. Adverse effects were mild / moderate and reversible. The most common side effects were headache, diarrhea, and nausea. Adverse reactions, which were noted more than once, are indicated below by organ class systems and frequency. Frequency is defined as: often (> 1/100, <1/10), infrequently (> 1/1000, <1/100) and rarely (> 1/10000, <1/1000), very rarely (<1/10000 ) Infections: often – infections. Disorders of the blood and lymphatic system: rarely – neutropenia, leukopenia, thrombocytopenia, leukocytosis. Immune system disorders: rarely, acute systemic allergic reactions (eg, facial edema, arterial hypotension, and dyspnea). Metabolism and Nutrition Disorders: Rarely – Anorexia. Mental disorders: often – insomnia is infrequent – nervousness is rare – depression is unknown – confusion. Nervous system disorders: often – headache, dizziness infrequently – drowsiness. Disorders of the organ of vision: rarely – visual disturbances (blurred vision, bifurcation). Respiratory, thoracic and mediastinal disorders: often – cough, pharyngitis, rhinitis infrequently – bronchitis, sinusitis. Gastrointestinal disorders: often – diarrhea, vomiting, nausea, abdominal pain, constipation, bloating infrequently – dyspepsia, dry mouth, belching rarely – gastritis, stomatitis, taste disorder. Disorders of the liver and biliary tract: rarely – hepatitis, jaundice, hepatitis encephalopathy. Changes in the skin and subcutaneous tissues: infrequently – rash, erythema multiforme rarely – itching, increased sweating, bullous reactions, the appearance of blisters on the skin is very rare – toxic epidermal necrolysis, Stevens-Johnson syndrome. Musculoskeletal disorders, disorders of the connective tissue: often – nonspecific pain / back pain infrequently – myalgia, leg cramps, arthralgia. Kidney and urinary tract disorders: infrequently – urinary tract infections rarely – interstitial nephritis. General disorders: often – weakness, flu-like state infrequently – chest pain, chills, fever. Laboratory indicators: infrequently – growth of liver enzymes is rare – increase in body weight is unknown – hyponatremia. Other: very rarely – gynecomastia. Drug interaction Not described Overdose The experience of intentional or accidental overdose is limited. The maximum dose did not exceed 60 mg twice daily or 160 mg once daily. The effects were generally minimal, consistent with the known profile of adverse events and were reversible without additional medical intervention. The specific antidote is unknown. Rabeprazole sodium binds widely to plasma proteins and is therefore not excreted during dialysis. As with any overdose, symptomatic treatment requires general supportive measures. Storage conditions Store below 25 ° C in a dry, dark place and out of reach of children. Expiration date and 2 years Conditions of release from drugstores Prescription of pptrofp252516 Terms and conditions of vocational Dosage PMA Possible product names Plate worktop coated with solution-sol. 20 mg 14 pcs.
