PROMTO Tablet

Rabeprazole sodium is contraindicated:

- In patients with known hypersensitivity to rabeprazole or other substituted benzimidazoles or any component of this product.

- In pregnancy and during breast-feeding.

Rabeprazole sodium is not recommended for children, as there is no experience of its use in this group.

Rabeprazole sodium Is usually very well tolerated. However, following are the adverse events reported during therapy with rabeprazole sodium.

Common: Headache, diarrhoea and nausea. Other adverse events were rhinitis, abdominal pain, asthenia, flatulence, pharyngitis, vomiting, non-specific pain/back pain, dizziness, flu-like syndrome, Infection, cough, constipation and insomnia.

Less frequent: Rash, myalgia, chest pain, dry mouth, dyspepsia, nervousness, somnolence, bronchitis, sinusitis, chills, eructation, leg cramps, urinary tract infection, arthralgia and fever.

Rare: Anorexia, gastritis, weight gain, depression, pruritus, vision or taste disturbances, stomatitis, sweating and leucocytosis, thrombocytopenia, neutropenia and leukopenia.

Drug Interactions:

Rabeprazole sodium produces a profound and long-lasting inhibition of gastric acid secretion. An interaction with compounds 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 rabeprazole.

- The possibility of malignancy should be excluded prior to commencing treatment with rabeprazole as symptomatic response to therapy with rabeprazole sodium does not preclude the presence of gastric or esophageal malignancy. Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance.

- Rabeprazole sodium should be used with caution in patients with severe hepatic dysfunction.

Rabeprazole sodium belongs to a new class of antisecretory compounds (substituted benzimidazole proton-pump inhibitor) that do not exhibit anticholinergic or histamine H2-receptor antagonist properties, but suppress gastric acid secretion by inhibiting the gastric H+/K+ ATPase at the parietal cell. The effect is dose related and leads to the inhibition of both basal and stimulated acid secretion irrespective to the stimulus.