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Drugs List
Therapeutic Indications
Dosage
Administration
Contraindications
Precautions and Warnings
Pregnancy and Lactation
Side Effects
Monograph

Dosage

Adults
Elderly
Children
Patients with Renal Impairment
Patients with Hepatic Impairment

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.

Zollinger-Ellison Syndrome
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.

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

Pregnancy

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.

Lactation

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.

Presentation

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.

Drugs List

PARIET 10mg enteric coated tablets

PARIET 20mg enteric coated tablets

rabeprazole 10mg gastro-resistant tablets

rabeprazole 20mg gastro-resistant tablets

Therapeutic Indications

Uses

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

Zollinger-Ellison syndrome

Dosage

Adults

Elderly

As adult dosage.

Children

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.

Administration

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.

Contraindications

Pregnancy - (see 'Pregnancy' section)

Breast feeding - (see 'Lactation' section)

Children under 18 years