- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Gastro-resistant tablets containing 10mg of rabeprazole sodium each containing 9.42mg rabeprazole.
Gastro-resistant tablets containing 20mg of rabeprazole sodium each containing 18.85mg rabeprazole.
Treatment of active duodenal and benign gastric ulcers
Treatment of symptomatic erosive or ulcerative gastro-oesophageal reflux disease (GORD)
Long-term management of gastro-oesophageal reflux disease (GORD maintenance)
Symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease (symptomatic GORD)
Eradication of Helicobacter pylori in combination with appropriate antibacterial therapeutic regimens in patients with peptic ulcer disease
Active duodenal ulcer and active benign gastric ulcer:
The recommended oral dose for both active duodenal ulcer and active benign gastric ulcer is 20mg once daily in the morning.
Most patients with active duodenal ulcer heal within four weeks. However a few patients may require an additional four weeks of therapy to achieve healing. Most patients with active benign gastric ulcer heal within six weeks. However again a few patients may require an additional six weeks of therapy to achieve healing.
Erosive or ulcerative gastro-oesophageal reflux disease (GORD):
The recommended oral dose for this condition is one 20mg tablet to be taken once daily for four to eight weeks. For long-term management, a maintenance dose of 10mg or 20mg once daily can be used depending upon patient response.
Symptomatic treatment of moderate to very severe gastro-oesophageal reflux disease (symptomatic GORD) : The recommended oral dose is 10mg once daily in patients without oesophagitis. If symptom control has not been achieved during 4 weeks, the patient should be further investigated. Once symptoms have resolved subsequent symptom control can be achieved using an on-demand regimen taking 10mg once daily when needed.
Eradication of Helicobacter pylori :
Patients with Helicobacter pylori infection should be treated with eradication therapy. The following combination given for 7 days is recommended:
Rabeprazole 20mg twice daily plus clarithromycin 500mg twice daily and amoxicillin 1g twice daily.
The recommended adult starting dose is 60mg once a day. The dose may be titrated upwards to 120mg/day based on individual patient needs. Single daily doses up to 100mg/day may be given. 120mg dose may require divided doses, that is 60mg twice daily. Treatment should continue for as long as clinically indicated.
As adult dosage.
Rabeprazole is not recommended for use in children, as there is no experience of its use in this group.
Patients with Renal Impairment
No dosage adjustment is necessary for patients with renal impairment.
Patients with Hepatic Impairment
No dosage adjustment is necessary for patients with mild to moderate hepatic impairment.
There are no clinical data on the use of rabeprazole sodium in patients with severe hepatic dysfunction so the prescriber is advised to exercise caution when initiating treatment in such patients.
For oral administration.
For indications requiring once daily treatment, the tablets should be swallowed whole in the morning before eating; although neither the time of day nor food intake was shown to have any effect on rabeprazole sodium activity, this regimen will facilitate treatment compliance.
The tablets should not be crushed or chewed, but should be swallowed whole.
Pregnancy - (see 'Pregnancy' section)
Breast feeding - (see 'Lactation' section)
Children under 18 years
Precautions and Warnings
Risk of cross-hypersensitivity reactions with other proton pump inhibitors (PPIs).
Symptomatic response to therapy with rabeprazole sodium does not preclude the presence of gastric or oesophageal malignancy. The possibility of malignancy should be excluded before commencing treatment with rabeprazole sodium.
Prolonged use (>1 year) of PPIs has been associated with hypomagnesaemia. Measure magnesium levels before and periodically during prolonged treatment. Patient should seek medical advice if symptoms of hypomagnesaemia occur (e.g. muscle twitches, tremors, vomiting, tiredness, loss of appetite) while taking rabeprazole.
Low serum magnesium and/or low serum potassium may result in torsades de pointes (TdP) arrhythmia and should be used with caution in Long QT Syndrome.
Prolonged use (>1 year) of PPIs has been associated with an increased risk of fracture. Ensure patients have an adequate intake of vitamin D and calcium.
Patients on long-term treatment (particularly those treated for more than 1 year) should be kept under regular surveillance.
Initiate treatment cautiously in patients with severe hepatic impairment as there is no clinical data on the use of rabeprazole sodium in these patients.
Hepatic enzyme abnormalities have been seen in clinical trials and reported since market authorisation. In most cases it was uncomplicated and resolved upon discontinuation.
Some reports of blood dyscrasias (thrombocytopenia and neutropenia) have been reported but in most cases it was uncomplicated and resolved upon discontinuation.
Increased risk of gastrointestinal infections such as Salmonella, Campylobacter or Clostridium difficile due to decreased gastric acidity.
Rebound acid hypersecretion and protracted dyspepsia may occur after stopping prolonged treatment with a PPI.
Very infrequent cases of subacute cutaneous lupus erythematosus (SCLE) have been reported in patients taking PPIs. Drug-induced SCLE can occur weeks, months or even years after exposure to the drug. The MHRA have issued the following advice if a patient treated with a PPI develops lesions - especially in sun-exposed areas of the skin - and it is accompanied by arthralgia:
- advise them to avoid exposing the skin to sunlight
- consider SCLE as a possible diagnosis
- consider stopping use of the PPI unless it is imperative for a serious acid-related condition; a patient who develops SCLE with a particular PPI may be at risk of the same reaction with another
- in most cases, symptoms resolve on PPI withdrawal; topical or systemic steroids might be necessary for treatment of SCLE only if there are no signs of remission after a few weeks or months
Pregnancy and Lactation
Rabeprazole is contraindicated in pregnancy.
At the time of writing, there is no published experience concerning exposed pregnancies and their outcomes. Reproduction studies performed in rats and rabbits have revealed no evidence of impaired fertility or harm to the foetus due to rabeprazole, although low foeto-placental transfer occurs in rats. It is not known if rabeprazole crosses the placenta in humans although its molecular weight is low enough that passage should be expected. Schaefer concludes that inadvertent exposure to rabeprazole at any stage in pregnancy is not considered an indication for termination of pregnancy, although a detailed foetal ultrasonography during the second trimester can be considered. If a PPI is needed, omeprazole is the drug of choice.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password at ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( https://www.TOXBASEbackup.org/ ).
Licensed in pregnancy? - No, contraindicated.
Recommended for use in pregnancy? - No
Drug of choice for use in pregnancy - Omeprazole.
Known human teratogen? - Unknown
Animal data - Suggests low risk
Crosses placenta? - Unknown but should be expected due to low molecular weight.
Rabeprazole is contraindicated in lactation.
At the time of writing, there is no published experience concerning the use of rabeprazole during breastfeeding. It is not known whether rabeprazole is excreted into human breast milk however its molecular weight is low enough that passage should be expected. Rabeprazole is excreted in rat mammary secretions. Omeprazole or Pantoprazole are the preferred PPIs for use during breast feeding.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Drug excreted in breast milk? - Unknown but should be expected due to low molecular weight.
Considered suitable or recommended by manufacturer? - No.
preferred drug for use during breast feeding - Omeprazole or Pantoprazole.
UK Drugs in Lactation Advisory Service Classification - Category B.
Effects on Ability to Drive and Operate Machinery
Based on the pharmacodynamic properties and the adverse events profile, it is unlikely that rabeprazole would impair the ability to drive or operate machinery. If, however, alertness is impaired due to somnolence, it is recommended that driving and operating machinery is avoided.
Advise patients that the tablets must be swallowed whole and not crushed or chewed.
Advise patients that if alertness is impaired due to somnolence, they should not drive or operate machinery.
Advise patient to seek medical advice if symptoms of hypomagnesaemia occur (e.g. muscle twitches, tremors, vomiting, tiredness, loss of appetite) while taking rabeprazole.
Advise patient to avoid sun exposure if subacute cutaneous lupus erythematosus occurs.
Toxic epidermal necrolysis
Non specific pain/back pain
Urinary tract infections
Increases in hepatic enzymes
Increased risk of fractures - long term use
Subacute cutaneous lupus erythematosus
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( https://www.TOXBASEbackup.org/ ).
Shelf Life and Storage
Do not store above 25 degrees C
Do not refrigerate
Last Full Review Date: November 2011
British National Formulary, 62nd Edition (2011) Pharmaceutical Press, London.
Available at: https://www.crediblemeds.org/
Last accessed: 21 October, 2014
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 8th edition (2008) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
MHRA Drug Safety Update April 2012. Proton pump inhibitors in long-term use: increased risk of fracture.
Available at: https://www.mhra.gov.uk
Last accessed: 20 September 2015
MHRA Drug Safety Update September 2015. Proton pump inhibitors: very low risk of subacute cutaneous lupus erythematosus.
Available at: https://www.mhra.gov.uk
Last accessed: 20 September 2015
Summary of Product Characteristics: Pariet 10mg & 20mg tablets. Eisai Ltd. Revised November 2010.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Rabeprazole. Last revised: December 27, 2007
Last accessed: November 24, 2011
Already a member? Log in
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.