rabeprazole sodium: clinical use

Prescribing considerations

• Exclude gastric or oesophageal malignancy where clinically indicated; symptom improvement does not exclude it.
• Review the ongoing indication during long-term treatment and exercise caution when initiating treatment in severe hepatic dysfunction.
• Consider gastrointestinal infection, fracture risk, vitamin B12 deficiency and hypomagnesaemia during prolonged treatment.
• Rabeprazole may interfere with chromogranin A testing for neuroendocrine tumours.
• It is not recommended for children in the selected product information because clinical experience is lacking.

Contraindications and cautions

• Hypersensitivity to rabeprazole, relevant substituted benzimidazoles or product excipients.
• The selected generic product information contraindicates pregnancy; Pariet instead uses a benefit–uncertainty assessment.
• The selected products advise against use during breastfeeding.
• Avoid concomitant atazanavir.

Monitoring

• Review symptoms and continuing need during long-term therapy.
• Consider magnesium before and during prolonged therapy, particularly with digoxin or medicines that can lower magnesium.
• Assess vitamin B12 where body stores are low, risk factors exist or compatible symptoms develop.
• Investigate suspected tubulointerstitial nephritis promptly and discontinue rabeprazole if suspected.
• Consider hepatic, haematological or bone-health assessment when symptoms or individual risk factors warrant it.

Clinical pharmacology

Rabeprazole is an acid-labile substituted benzimidazole supplied in a gastro-resistant formulation. After absorption it concentrates in parietal-cell canaliculi, is converted to an active sulphenamide and inhibits gastric H+/K+-ATPase. It is highly protein-bound and is metabolised mainly through non-enzymatic pathways and hepatic CYP2C19/CYP3A4 pathways.

Formulation and product differences

• Both selected products are gastro-resistant tablets that must be swallowed whole.
• Tablet appearance, excipient composition, packaging and storage conditions differ between manufacturers; check the specific pack when allergy, intolerance or storage is relevant.
• No suitable licensed rabeprazole formulation is identified for adults unable to swallow whole tablets.

Gastro-resistant tablet

Route: Oral

Strengths: 10 mg, 20 mg

Tablet

Route: Oral

Strengths: 10 mg, 20 mg