RABEMAC Tablet

In patients with known hypersensitivity to rabeprazole, substituted benzimidazoles or to any component of the formulation.

The most common adverse event was headache, diarrhoea and nausea. Other adverse events were rhinitis, abdominal pain, asthenia, flatulence, pharyngitis, vomiting, non-specific back pain, dizziness, flu syndrome, infections, cough, constipation and insomnia. Further less frequent adverse events were rash, myalgia, chest pain, dry mouth, dyspepsia, nervousness, somnolence, bronchitis, sinusitis, chills, leg cramps, urinary tract infections, arthralgia and fever.

Increased hepatic enzymes have been observed in 2% of patients.

Treatment should be stopped immediately at the recurrence of skin lesions.

See the package insert about the details below:

CYP450 drug metabolizing enzyme system (warfarin, theophylline, diazepam, cyclosporine)

ketoconazole

antacids

Pregnancy (Pregnancy Category B)

Animal studies revealed no evidence of impaired fertility or harm to the fetus due to rabeprazole. There are, however no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known if unmetabolized rabeprazole is excreted in human breast milk and hence should be used with caution in nursing mothers.

Symptomatic response to therapy with rabeprazole sodium dose not precludes the presence of gastric or esophageal malignancy, therefore the possibility of malignancy should be excluded prior to commencing treatment with Rabeprazole.

Caution should be exercised when treatment with rabeprazole is first initiated in patients with severe hepatic dysfunction.

Rabeprazole sodium belongs to a class of antisecretory compounds (substituted benzimidazole proton-pump inhibitors) that do not exhibit anticholinergic or histamine H2-receptor antagonist properties, but suppress gastric acid secretary by inhibiting the gastric H+,K+ ATPase at the secretary surface of the gastric parietal cell. Rabeprazole blocks the final step of gastric acid secretion. In gastric parietal cells, rabeprazole is protonated, accumulates, and is transformed to an active sulfonamide.