Indications:

Peptic ulcer disease, H. pylori infection, Gastro-oesophageal reflux disease, Paediatric GERD

Dosage (breakdown or, not) :

Adult:

Oral Gastro-oesophageal reflux disease Adult: 20 mg daily for 4-8 wk. Maintenance: 10 or 20 mg/day. All doses to be taken once in the morning. Zollinger-Ellison syndrome Adult: Initially, 60 mg once in the morning, adjusted to max dose of 120 mg/day if needed. Daily doses >100 mg should be given in 2 divided doses. Peptic ulcer Adult: 20 mg once in the morning for 4-8 wk (duodenal ulcer) or for 6-12 wk (gastric ulcer). H.pylori infection Adult: 1-wk triple therapy: 20 mg bid combined w/ clarithromycin 500 mg bid and amoxicillin 1 g bid or combined w/ clarithromycin 250 mg bid and metronidazole 400 mg bid. Erosive oesophagitis Adult: 20 mg/day for 4-8 wk. May continue for another 8 wk if healing is incomplete. Maintenance: 10 or 20 mg/day. All doses to be taken once in the morning. Elderly: No dosage adjustment needed. Hepatic impairment: No dosage adjustment needed.

Child: 

Delayed-release capsule (sprinkles) <1 year: Safety and efficacy not established 1-11 years (<15 kg): 5 mg PO qDay 30 minutes before a meal, for up to 12 weeks; may increase to 10 mg/day if inadequate response 1-11 years (>15 kg): 10 mg PO qDay 30 minutes before a meal, for up to 12 weeks Gastroesophageal Reflux Disease Delayed-release tablet <12 years: Safety and efficacy not established >12 years: 20 mg PO qDay for up to 8 weeks

Administration:

Administer with or without meals

Interaction:

May decrease serum concentration of ketoconazole, itraconazole and clopidogrel. Increased risk of hypomagnesaemia w/ diuretics and digoxin. May increase prothrombin time and INR of warfarin. May increase plasma concentration of saquinavir and methotrexate. Decreased serum levels w/ sucralfate. Potentially Fatal: May decrease plasma concentrations and pharmacological effects of rilpivirine and atazanavir.

Contraindication:

Rabeprazole is contraindicated in patients with known hypersensitivity to Rabeprazole, other PPIs or to any component of the formulation.

Side Effects: 

1-10% Headache (2-10%),Constipation (2%),Diarrhea (2-5%),Flatulence (3%),Pain (3%),Pharyngitis (3%),Abdominal pain (4%) <1% Agitation,Agranulocytosis,Alopecia,Anemia,Angioedema,Chest pain,Delirium,Erythema,Hypokalemia,Hypomagnesemia,Hyponatremia,Jaundice,Leukocytosis,Leukopenia,Migraine,Osteoporosis related fracture,Rhabdomyolysis,Stevens-Johnson syndrome,Sudden death,Toxic epidermal necrolysis,Abnormal taste

Pregnancy: 

Risk Summary There are no available human data in pregnant women to inform drug associated risk; background risk of major birth defects and miscarriage for indicated populations are unknown; however, background risk in U.S. general population of major birth defects is 2-4% and of miscarriage is 15- 20% of clinically recognized pregnancies; no evidence of adverse developmental effects were seen in animal reproduction studies with rabeprazole administered during organogenesis at 13 and 8 times human area under plasma concentration-time curve (AUC) at recommended dose for GERD, in rats and rabbits, respectively; Changes in bone morphology were observed in offspring of rats treated with oral doses of different PPI through most of pregnancy and lactation; when maternal administration was confined to gestation only, there were no effects on bone physeal morphology in offspring at any age