Treatment of active duodenal ulcer. Treatment of active mild stomach ulcer. Symptomatic treatment of gastroesophageal reflux disease with erosions or ulcers. Long-term treatment of gastroesophageal reflux disease. Symptomatic treatment of moderate to very severe gastroesophageal reflux disease. Zollinger-Ellison syndrome. eradicationHelicobacter pylori in patients with peptic ulcer in combination with appropriate antibacterial treatment regimens.
Composition:
1 tabl enterally contains 10 mg or 20 rabeprazole sodium.
Action:
Proton pump inhibitor (H+/ K+ATP-ases) in the parietal cells of the stomach. It inhibits the secretion of both hydrochloric acid, both basic and stimulated (regardless of the stimulus). Rabeprazole is not stable in an acidic environment and is therefore administered orally in the form of gastro-resistant tablets (with a coating resistant to hydrochloric acid). Absorption of rabeprazole begins only after passing the tablets through the stomach. Rabeprazole is rapidly absorbed and achieves Cmax about 3.5 h after administration. The bioavailability of the oral dose is approximately 52%, which is largely due to the pre-systemic metabolism of the drug. Rabeprazole is approximately 97% bound to plasma proteins. It is metabolized in the liver via the cytochrome P450 isoenzyme system: CYP2C19 and CYP3A4. It is excreted in the urine as metabolites (90% of the dose); partly with faeces.
Contraindications:
Hypersensitivity to rabeprazole, substituted benzimidazoles (risk of hypersensitivity reactions) or to any of the excipients. Pregnancy and breastfeeding.
Precautions:
Before starting treatment, the cancerous background of the disease should be excluded, because treatment with rabeprazole may relieve the symptoms of cancer and delay its diagnosis. Patients taking rabeprazole for a long time (especially those treated for more than a year) should remain under regular medical supervision. Especially cautiously use in patients with severe hepatic impairment (no clinical data). Treatment with rabeprazole may increase the risk of food-borne infections, such as bacteriaSalmonella, Campylobacter andClostridium difficile. Patients treated with proton pump inhibitors (IPP) for at least 3 months (in most cases for a year) have experienced severe hypomagnesaemia; in patients who are envisaged for long-term treatment or who are taking proton pump inhibitors concomitantly with Digoxin or hypomagnesaemic agents (eg diuretics), Magnesium determination should be considered before initiation of rabeprazole treatment and periodically during treatment. Proton pump inhibitors can increase the overall risk of fractures by 10-40%; Patients at risk of osteoporosis should receive care in accordance with current clinical guidelines, and provide adequate amounts of vitamin D and calcium. Do not use this medicine with atazanavir. The use of rabeprazole in children is not recommended (no clinical experience).
Pregnancy and lactation:
Rabeprazole is contraindicated in pregnancy (no data on safety of use) and breastfeeding (it is excreted in animal milk).
Side effects:
Common: infection, insomnia, headache, dizziness, cough, pharyngitis, rhinitis, diarrhea, vomiting, nausea, abdominal pain, constipation, flatulence, non-specific pain, back pain, weakness, flu-like symptoms. Uncommon: nervousness, drowsiness, bronchitis, sinusitis, dyspepsia, dryness of the oral mucosa, bouncing back with stomach or gas content, rash, erythema, muscle pain, leg cramps, joint pain, hip fracture, carpal bones or spine , urinary tract infection, chest pain, chills, fever, increased liver enzymes. Rare: neutropenia, leukopenia, thrombocytopenia, leukocytosis, hypersensitivity reactions, anorexia, depression, visual disturbances, gastritis, oral mucositis, taste disorders, hepatitis, jaundice, hepatic encephalopathy, pruritus, hyperhidrosis, bullous reactions,interstitial nephritis, weight gain. Very rare: erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome. Frequency unknown: hyponatremia; hypomagnesemia, confusion, peripheral edema, gynecomastia.
Dosage:
Orally. Adults. Active duodenal ulcer: 20 mg once daily (in the morning) for 4-8 weeks. Active, mild stomach ulcer: 20 mg once daily (in the morning) for 6-12 weeks. Gastroesophageal reflux disease with erosions or ulcers: 20 mg once per daily for 4-8 weeks. Long-term treatment of gastroesophageal reflux disease: 20 mg or 10 mg once a day, depending on the response to treatment as a maintenance dose. Symptomatic treatment of moderate to severe GERD: 10 mg once daily in patients who have excluded oesophagitis; if symptoms do not disappear within 4 weeks, further tests should be performed; after the symptoms have resolved, you can still control their relapse, using an ad hoc dose of 10 mg once a day, as necessary. Zollinger-Ellison syndrome: initially 60 mg once a day; the dose can be increased up to 120 mg daily, depending on the individual needs of the patient; a single daily dose of up to 100 mg, a dose of 120 mg may need to be administered in 2 divided doses; treatment should continue as clinically indicated. eradicationH. pylori: 20 mg twice daily + Clarithromycin 500 mg twice daily + Amoxicillin 1 g 2 times daily, all medicines administered for 7 days.Special groups of patients. In patients with impaired renal or hepatic function and in the elderly, no dosage adjustment is necessary.Way of giving. For indications that require taking the medicine once a day, take it in the morning before meals. The tablets should be swallowed whole; they should not be chewed or crushed.
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