Rabeprazole is indicated for the treatment of:

• Active duodenal ulcer
• Active benign gastric ulcer
• Symptomatic erosive or ulcerative gastro-esophageal reflux disease (GERD)
• Long-term management (maintenance) of gastro-esophageal reflux disease (GERD)
• Symptomatic treatment of moderate to severe gastro-esophageal reflux disease
• Zollinger–Ellison syndrome
• In combination with appropriate antibacterial regimens for the eradication of Helicobacter pylori in patients with peptic ulcer disease

Rabeprazole suppresses gastric acid secretion by inhibiting the H⁺/K⁺-ATPase enzyme located on the secretory surface of gastric parietal cells. This enzyme functions as the acid (proton) pump, and therefore rabeprazole is classified as a proton pump inhibitor that blocks the final step of acid production.

Active Duodenal Ulcer and Active Benign Gastric Ulcer: The recommended oral dose for both bioactive duodenal ulcer and active benign gastric ulcer is 20 mg to be taken once daily in the morning. Most patients with active duodenal ulcer heal within four weeks. However, a few patients may require an additional four weeks of therapy to achieve healing. Most patients with active benign gastric ulcer heal within six weeks. However, again a few patients may require an additional six weeks of therapy to achieve healing.

Erosive or Ulcerative Gastro-Esophageal Reflux Disease (GERD): The recommended oral dose for this condition is 20 mg to be taken once daily for four to eight weeks.

Gastro-Esophageal Reflux Disease Long-term Management (GERD Maintenance): For long-term management, a maintenance dose of rabeprazole sodium 20 mg or 10 mg once daily can be used depending upon patient response.

Symptomatic treatment of moderate to very severe Gastro-Esophageal Reflux Disease (symptomatic GERD): 10 mg once daily in patients without oesophagitis. If symptom control has not been achieved during four weeks, the patient should be further investigated. Once symptoms have resolved, subsequent symptom control can be achieved using an on-demand regimen taking 10 mg once daily when needed.

Treatment of GERD in pediatric patients 1 to 11 years of age (Less than 15 kg): 5 mg once daily for 12 weeks with the option to increase to 10 mg if inadequate response.

Treatment of GERD in pediatric patients 1 to 11 years of age (15 kg or more): 10 mg once daily for 12 weeks.

Zollinger-Ellison Syndrome: The recommended adult starting dose is 60 mg once a day. The dose may be titrated upwards to 120 mg/day based on individual patient needs. Single daily doses up to 100 mg/day may be given. 120 mg dose may require divided doses, 60 mg twice daily. Treatment should continue for as long as clinically indicated.

Eradication of H. pylori: Patients with H. pylori infection should be treated with eradication therapy. The following combination given for 7 days is recommended. Rabeprazole sodium 20 mg twice daily, clarithromycin 500 mg twice daily and amoxicillin 1g twice daily.

For indications requiring once-daily treatment Rabeprazole tablets should be taken in the morning, before eating; and although neither the time of day nor food intake was shown to have any effect on rabeprazole sodium activity, this regimen will facilitate treatment compliance. Patients should be cautioned that the Rabeprazole tablets should not be chewed or crushed, but should be swallowed whole.

Rabeprazole produces a strong and long-lasting reduction in gastric acid secretion. This may affect the absorption of drugs whose bioavailability depends on gastric pH. Co-administration of rabeprazole sodium with ketoconazole or itraconazole may significantly reduce their plasma concentrations. Therefore, patients may require monitoring and dose adjustment when these antifungal agents are used together with rabeprazole. No interaction has been observed with liquid antacids. The absorption of atazanavir is also pH-dependent; therefore, proton pump inhibitors (PPIs), including rabeprazole, should not be co-administered with atazanavir.

Rabeprazole is contraindicated in patients with known hypersensitivity to the active substance or any of its excipients. It is also contraindicated during pregnancy and breastfeeding.

Rabeprazole is generally well tolerated in both short-term and long-term use. However, it may sometimes cause: headache, diarrhoea, abdominal pain, vomiting, constipation, dry mouth, altered appetite, muscle pain, drowsiness, and dizziness.

US FDA pregnancy category: C. Animal studies have shown no evidence of impaired fertility or fetal harm due to rabeprazole. However, there are no adequate and well-controlled studies in pregnant women. Rabeprazole is likely excreted in human breast milk. Therefore, a decision should be made either to discontinue breastfeeding or to discontinue the drug, considering the importance of therapy for the mother.

• A symptomatic response to rabeprazole therapy does not exclude the presence of gastric or esophageal malignancy. Therefore, the possibility of malignancy should be ruled out before starting treatment with rabeprazole 20 mg gastro-resistant tablets.
• Patients on long-term therapy (especially beyond one year) should be regularly monitored.
• Proton pump inhibitors (PPIs), particularly with high doses and prolonged use (>1 year), may slightly increase the risk of fractures of the hip, wrist, and spine, mainly in elderly patients or those with other risk factors. Observational data suggest a 10–40% increased overall fracture risk, partly influenced by other contributing factors. Patients at risk of osteoporosis should ensure adequate intake of calcium and vitamin D.
• Cross-hypersensitivity with other PPIs or substituted benzimidazoles cannot be ruled out.
• Rabeprazole tablets should not be chewed or crushed; they must be swallowed whole.
• Post-marketing reports have described blood disorders such as thrombocytopenia and neutropenia. In most cases, where no alternative cause was identified, these conditions were mild and resolved after stopping rabeprazole.
• Liver enzyme abnormalities have been reported in clinical trials and post-marketing surveillance, and generally resolved after discontinuation when no other cause was identified.
• No significant safety issues were observed in patients with mild to moderate hepatic impairment compared with matched controls. However, due to limited data in severe hepatic impairment, caution is advised when initiating therapy in such patients.
• Co-administration of rabeprazole with atazanavir is not recommended.
• PPIs, including rabeprazole, may increase the risk of gastrointestinal infections such as Salmonella, Campylobacter, and Clostridium difficile.

Hypomagnesaemia: Severe magnesium deficiency has been reported in patients using PPIs for at least three months, often after one year. Symptoms may include fatigue, tetany, delirium, seizures, dizziness, and ventricular arrhythmias. Symptoms may develop gradually and go unnoticed. Most cases improve after magnesium supplementation and stopping the PPI. Magnesium levels should be monitored in long-term users or those taking digoxin or diuretics.

Vitamin B12 absorption: Long-term use of rabeprazole may reduce absorption of vitamin B12 due to reduced stomach acid. This should be considered in patients with low stores or risk factors for deficiency.

Subacute cutaneous lupus erythematosus (SCLE): Very rare cases have been reported with PPIs. If skin lesions occur, especially in sun-exposed areas with joint pain, medical attention should be sought and discontinuation of rabeprazole considered. Prior SCLE with PPIs may increase risk with other drugs in the same class.

Laboratory interference: Rabeprazole may increase Chromogranin A (CgA) levels, which can affect neuroendocrine tumor testing. It should be discontinued at least 5 days before testing. If levels remain elevated, testing should be repeated 14 days after stopping treatment.

Renal and hepatic impairment: No dose adjustment is required.
Pediatric use: Not recommended due to insufficient safety and efficacy data.

Exposure up to 60 mg twice daily or 160 mg once daily has been reported with generally mild, reversible effects consistent with known adverse reactions. No specific antidote exists. Rabeprazole is highly protein-bound and not dialyzable. Management should be symptomatic and supportive.

Proton Pump Inhibitor

Store below 30°C, protected from light and moisture. Keep out of reach of children.