Rabeprazole


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Peptic ulcer 20 mg once daily for 4-8 weeks (duodenal ulcer) or for 6-12 weeks (gastric ulcer). Gastro-oesophageal reflux disease Usual dose: 20 mg once daily for 4-8 weeks. Maintenance: 10 or 20 mg daily depending on the response. In patients with symptomatic disease without oesophagitis: 10 or 20 mg once daily for 4 weeks. Once symptoms have resolved, 10 mg once daily as needed. Erosive oesophagitis 20 mg daily for 4-8 weeks. Maintenance: 10 or 20 mg daily depending on patient response. Zollinger-Ellison syndrome 60 mg daily, may titrate up to 100 mg daily as single dose or up to 120 mg daily in 2 divided doses if necessary. Eradication of H. pylori associated with peptic ulcer disease In combination with clarithromycin 500 mg bid and amoxicillin 1g bid: 20 mg bid for 7 days.
Dosage Details
Oral
Erosive oesophagitis
Adult: 20 mg once daily for 4-8 weeks. Maintenance: 10 or 20 mg once daily depending on patient response.

Oral
Gastro-oesophageal reflux disease
Adult: Usual dose: 20 mg once daily for 4-8 weeks. Maintenance: 10 or 20 mg daily depending on the response. In patients with symptomatic disease without oesophagitis: 10 or 20 mg once daily for 4 weeks. Once symptoms have resolved, 10 mg once daily as needed.
Child: 1-11 years <15 kg: 5 mg once daily, may increase up to 10 mg once daily if necessary, for up to 12 weeks. ≥15 kg: 10 mg once daily for up to 12 weeks. ≥12 years 20 mg once daily for up to 8 weeks.

Oral
Peptic ulcer
Adult: 20 mg once daily for 4-8 weeks (duodenal ulcer) or for 6-12 weeks (gastric ulcer).

Oral
Eradication of H. pylori associated with peptic ulcer disease
Adult: In combination with clarithromycin 500 mg bid and amoxicillin 1 g bid: 20 mg bid for 7 days.

Oral
Zollinger-Ellison syndrome
Adult: 60 mg once daily, may titrate up to 100 mg daily as single dose or up to 120 mg daily in 2 divided doses if necessary.
Special Patient Group
Pharmacogenomics:

CYP2C19 is one of the major enzymes in the metabolism of rabeprazole. CYP2C19 exhibits a known genetic polymorphism due to its deficiency in certain populations (3-5% of Caucasians, 17-20% of Asians) which may result in slower metabolism. These sub-populations are referred as poor metabolisers.

In a clinical study evaluating rabeprazole sodium delayed-release tablets in Japanese adult patients that was categorised by CYP2C19 genotype (n=6 per genotype category) showed that gastric acid suppression was higher in poor metabolisers as compared to extensive metabolisers. This could be due to higher rabeprazole plasma levels in poor metabolisers.
Administration
Delayed-Release: May be taken with or without food.
Contraindications
Concomitant use with rilpivirine.
Special Precautions
Patients at risk of osteoporosis, reduced body stores or with risk factors for vitamin B12 malabsorption, PPI-induced autoimmune disease. Severe hepatic impairment. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: New-onset or exacerbation of subacute cutaneous and systemic lupus erythematosus, osteoporosis-related bone fractures, fundic gland polyps, acute interstitial nephritis, Clostridium difficile-associated diarrhoea (hospitalised patients). Rarely, hypomagnesaemia, vitamin B12 deficiency.
Gastrointestinal disorders: Diarrhoea, vomiting, nausea, abdominal pain, constipation, flatulence.
General disorders and admin site conditions: Back pain, asthenia, influenza-like illness.
Hepatobiliary disorders: Hepatic encephalopathy, hepatitis.
Infections and infestations: Infection (e.g. Salmonella, Campylobacter).
Investigations: Increased liver enzymes.
Nervous system disorders: Headache, dizziness.
Psychiatric disorders: Insomnia.
Respiratory, thoracic and mediastinal disorders: Cough, pharyngitis, rhinitis.
Patient Counseling Information
This drug may cause somnolence, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor magnesium levels prior to initiation of therapy and periodically thereafter on long-term treatments or in patients taking digoxin, diuretics or other drugs that cause hypomagnesaemia.
Drug Interactions
May decrease serum concentration of ketoconazole, itraconazole, atazanavir, nelfinavir. Increased INR and prothrombin time with concomitant use of warfarin. Increased serum concentrations of methotrexate, tacrolimus, saquinavir.
Potentially Fatal: Decreased serum concentrations and reduced antiviral effect of rilpivirine.
Lab Interference
May lead to false-positive results in the diagnosis of neuroendocrine tumour and urine screening tests for tetrahydrocannabinol. May suggest false result of gastrinoma in secretin stimulation test.
Action
Description: Rabeprazole is a proton pump inhibitor that suppresses the gastric acid secretion by inhibiting H+/K+ ATPase at the secretory surface of the gastric parietal cell.
Onset: Within 1 hour.
Duration: 24 hours.
Pharmacokinetics:
Absorption: Well absorbed from the gastrointestinal tract. Food delays absorption. Bioavailability: Approx 52% (tablet). Time to peak plasma concentration: 2-5 hours; range: 1-6.5 hours (capsule).
Distribution: Plasma protein binding: 96.3%.
Metabolism: Mainly metabolised via non-enzymatic reduction and to a lesser extent via CYP3A and CYP2C19 isoenzymes.
Excretion: Mainly via urine (90% as thioether carboxylic acid metabolites); faeces. Elimination half-life: 1-2 hours; increased by 1.6 times in CYP2C19 slow metabolisers.
Chemical Structure

Click on icon to see table/diagram/image
Storage
Store below 30°C. Protect from moisture.
ATC Classification
A02BC04 - rabeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Disclaimer: This information is independently developed by MIMS based on Rabeprazole from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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