Short-term treatment in healing & symptomatic relief of duodenal ulcers & erosive or ulcerative Gastroesophageal Reflux Disease (GERD). Maintaining healing & reducing relapse rates of heartburn symptoms in patients with GERD. Treatment of daytime & nighttime heartburn & other symptoms associated with GERD. Longterm treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome. In combination with Amoxicillin & Clarithromycin to eradicate Helicobacter pylori.
Rabeprazole suppresses gastric acid secretion by inhibiting the gastric H+/K+-ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, Rabeprazole has been characterized as a gastric proton-pump inhibitor.
Can be taken with or without food. Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD): 20 mg to be taken once daily for 4 to 8 weeks. For those patients who have not healed after 8 weeks of treatment, an additional 8 week course may be considered. Maintenance of Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD Maintenance): The recommended adult oral dose is 20 mg once daily. Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD): The recommended adult oral dose is 20 mg once daily for 4 weeks. If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered. Healing of Duodenal Ulcers: The recommended adult oral dose is 20 mg once daily after the morning meal for a period up to four weeks. Most patients with Duodenal Ulcer heal within four weeks. A few patients may require additional therapy to achieve healing. Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence: Rabeprazole Sodium 20 mg Twice Daily for 7 Days Amoxicillin 1000 mg Twice Daily for 7 Days Clarithromycin 500 mg Twice Daily for 7 Days. All three medications should be taken twice daily with the morning & evening meals. It is important that patients comply with the full 7-day regimen. Treatment of Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome: The dosage of Rabeprazole Sodium in patients with pathologic hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once a day. Doses should be adjusted to individual patient needs & should continue for as long as clinically indicated. Some patients may require divided doses. Doses up to 100 mg QD & 60 mg BID have been administered. Some patients with Zollinger-Ellision syndrome have been treated continuously with Rabeprazole Sodium for up to one year.
Respite produces a profound and long-lasting inhibition of gastric acid secretion. An interaction with a compound whose absorption is pH dependent may occur. Co-administration of rabeprazole sodium with ketoconazole or itraconazole may result in a significant decrease in antifungal plasma levels. Therefore individual patients may need to be monitored to determine if a dosage adjustment is necessary when ketoconazole or itraconazole are taken concomitantly with Respite. No interaction with liquid antacids was observed. The absorption of atazanavir is pH-dependent. Therefore PPIs, including rabeprazole, should not be co-administered with atazanavir.
Rabeprazole Sodium is contraindicated in patient with known hypersensitivity to Rabeprazole or to any component in the product. Administration of Rabeprazole Sodium to patients with mild to moderate liver impairment resulted in increased exposure & decreased elimination. Caution should be exercised in patients with severe hepatic impairment.
Headache, diarrhoea, rash, infection & flu-like syndrome. Dizziness, fatigue, constipation, nausea & vomiting. Anaphylaxis, agranulocytosis.
Rabeprazole is USFDA Pregnancy Category C. No data is available on administration of Rabeprazole to pregnant women. However this drug should be used during pregnancy, only if clearly needed. There are no data on the excretion of Rabeprazole into the breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.
The maximum established exposure has not exceeded 60 mg twice daily, or 160 mg once daily. Effects are generally minimal, representative of the known adverse event profile and reversible without further medical intervention. No specific antidote is known. Rabeprazole is extensively protein bound and is, therefore, not dialysable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilised.
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
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