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Indication & Dosage
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Oral
Gastro-oesophageal reflux
disease
Adult:
For erosive oesophagitis: 20 mg once daily in the morning for 4-8 wk. Maintenance: 10-20 mg once daily according to response. For
non-erosive oesophagitis: 10 mg once daily for 4 wk, upon symptom resolution, may continue with 10 mg once daily when necessary.
Oral
Hypersecretory conditions
Adult:
Initially, 60 mg daily adjusted according to response. Max dose: 120 mg daily.
Oral
Active
peptic ulcer
disease
Adult:
20 mg daily given for 4-8 wk for duodenal ulcer and 6-12 wk
for gastric ulcer.
Oral
H.pylori
infection
Adult:
As a combination with two antibacterials: 20 mg bid combined with clarithromycin 500 mg bid and either amoxicillin 1 g bid or metronidazole
400 mg bid. To be taken for a wk.
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Overdosage
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May result in drowsiness, headache and tachycardia.
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Contraindications
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Hypersensitivity.
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Special Precautions
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Severe hepatic impairment, gastric malignancy. May increase the risk of GI infections due to acid suppressive effects. Pregnancy.
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Adverse Drug Reactions
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Headache, diarrhoea, rash, infection and flu-like syndrome. Dizziness, fatigue, constipation, nausea and vomiting.
Potentially Fatal:
Anaphylaxis, agranulocytosis.
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Drug Interactions
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May reduce absorption of ketoconazole and itraconazole. May prolong the elimination of diazepam, phenytoin and warfarin.
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Food Interaction
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Delayed absorption with high-fat meals.
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Pregnancy Category (US FDA)
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Category B
: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or
animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled
studies in women in the 1sttrimester (and there is no evidence of a risk in later trimesters).
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Mechanism of Action
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Rabeprazole is a PPI that suppresses gastric acid secretion by inhibiting the gastric H+/K+ ATPase at the secretory
surface of the gastric parietal cell.
Onset:
1 hr.
Duration:
24 hr.
Absorption:
Oral bioavailability: about 52% and peak plasma concentrations are reached about 3.5 hr after oral admin.
Distribution:
Protein-binding: 97%.
Metabolism:
Extensively metabolised in the liver by cytochrome P450 isoenzymes.
Excretion:
Metabolites are mainly excreted in the urine (90%). Half-life: about 1 hr.
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Storage
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Oral:
Store at 15-30°C.
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CIMS Class
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Antacids, Antireflux Agents & Antiulcerants
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