Pantoprazole oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Gastro-resistant tablet containing pantoprazole sodium sesquihydrate.
Drugs List
Therapeutic Indications
Uses
Benign gastric and duodenal ulceration
Eradication of Helicobacter pylori (with other drugs)
Gastro-oesophageal reflux disease
Management and prevention of relapse in reflux oesophagitis
Prevention of NSAID-associated duodenal ulcer
Zollinger-Ellison syndrome (and other hypersecretory conditions)
Dosage
Adults
P product
Short-term treatment of reflux symptoms
20mg once a day until relief of symptoms has occurred.
It may be necessary to take the tablets for 2 to 3 consecutive days to achieve improvement. Once relief has been achieved the tablets should be discontinued.
Treatment should not exceed 4 weeks without consulting a doctor.
POM products
Gastro-oesophageal reflux disease
20mg to 80mg daily.
Symptom relief is normally achieved within 2 to 4 weeks, and a 4 week treatment period is usually required for healing of associated oesophagitis. If this is not sufficient, healing will usually be achieved within a further 4 weeks.
When symptom relief has been achieved, recurring symptoms may be controlled by on-demand dosage of 20mg once a day when required. A switch to continuous therapy may be considered where symptoms cannot be controlled by on-demand treatment.
Long-term management and prevention of relapse in reflux oesophagitis
Maintenance dose: 20mg once a day, increasing to 40mg once a day if a relapse occurs. After healing, the dose can be reduced again to 20mg once a day.
Prevention of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment.
20mg once a day.
For symptomatic improvement and healing of duodenal ulcer
40mg to 80mg once a day.
Duodenal ulcers generally heal within 2 weeks. If a 2 week treatment period is insufficient, healing will be achieved in almost all cases within a further 2 weeks.
For symptomatic improvement and healing of gastric ulcer
40mg to 80mg once daily.
Gastric ulcers generally heal within 4 weeks. If this is not sufficient, healing will usually be achieved within a further 4 weeks.
For symptomatic improvement and healing of Zollinger-Ellison syndrome, and other pathological hypersecretory conditions
Initial dose: 80mg once a day.
Maintenance dose: Titrate up or down as required based on measurements of gastric acid secretion. Doses exceeding 80mg daily, should be divided and the total daily dose administered twice daily.
A temporary increase in dose above 160mg daily is possible but should not be administered for longer than required for adequate acid secretion control.
Treatment duration is not limited and may be continued according to the clinical need of the individual patient.
Eradication of Helicobacter pylori, in combination with two antibiotics in patients with duodenal ulcer or gastritis.
40mg twice a day. The first tablet should be taken before breakfast and the second taken 1 hour before the evening meal.
Combination therapy should be implemented for 7 days and can be prolonged for a further 7 days to a total duration of up to two weeks. If to ensure the healing of the ulcers, further treatment with pantoprazole is indicated and the dose recommendations for duodenal and gastric ulcers should be considered.
In the case of combination therapy for the eradication of Helicobacter pylori, refer to the full prescribing information for each drug concerned.
Adolescents
Not all brands are licensed for use in children under 18 years and for all indications.
Gastro-oesophageal reflux disease
20mg to 80mg daily.
Symptom relief is normally achieved within 2 to 4 weeks, and a 4 week treatment period is usually required for healing of associated oesophagitis. If this is not sufficient, healing will usually be achieved within a further 4 weeks.
When symptom relief has been achieved, recurring symptoms may be controlled by on-demand dosage of 20mg once a day when required. A switch to continuous therapy may be considered where symptoms cannot be controlled by on-demand treatment.
Long-term management and prevention of relapse in reflux oesophagitis
Maintenance dose: 20mg once a day, increasing to 40mg once a day if a relapse occurs. After healing, the dose can be reduced again to 20mg once a day.
Patients with Hepatic Impairment
A daily dose of 20mg should not be exceeded in patients with severe hepatic impairment.
Additional Dosage Information
The safety of using pantoprazole for long-term use is generally well established. Long term administration of pantoprazole is well tolerated and has a good safety profile similar to that observed with short term treatment. Except for patients with Zollinger-Ellison syndrome and other pathological hypersecretory conditions, treatment with pantoprazole should not exceed 8 weeks.
In a few cases, there may be benefits in extending the duration of treatment beyond 8 weeks to ensure healing.
In most patients, freedom from symptoms is achieved rapidly.
Contraindications
Children under 12 years
Long QT syndrome
Torsade de pointes
Precautions and Warnings
Children aged 12 to 18 years
Family history of long QT syndrome
Breastfeeding
Electrolyte imbalance
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic cirrhosis
History of torsade de pointes
Jaundice
Pregnancy
Severe hepatic impairment
Vitamin B12 deficiency
Advise ability to drive/operate machinery may be affected by side effects
Exclude gastric cancer before commencing treatment
Exclude malignancy, if alarm symptoms develop and gastric ulcer suspected
Exclude malignancy, if alarm symptoms develop in presence of gastric ulcer
Not all available brands are licensed for all age groups
Not all available brands are licensed for all indications
Some formulations contain lactose
Some formulations contain propylene glycol
Measure magnesium levels before and periodically during prolonged treatment
Consider monitoring ECG in patients at risk of QT prolongation
Ensure adequate vitamin D & calcium in patients at risk of osteoporosis
Investigate patients if no response with 4 weeks of treatment
Monitor patients on prolonged therapy
Consider discontinuing if subacute cutaneous lupus erythematosus occurs
Increased risk of GI infection due to decreased gastric acidity
May reduce absorption of vitamin B12
May affect results of some laboratory tests
Discontinue if there is a rise in liver enzymes
Advise patient not to take St John's wort concurrently
Advise patient to avoid sun exposure if subacute lupus erythematosus occurs
Prolonged use (>1 year) of proton pump inhibitors (PPIs) has been associated with hypomagnesaemia. Patient should seek medical advice if symptoms of hypomagnesaemia occur (e.g. muscle twitches, tremors, vomiting, tiredness, loss of appetite) while taking pantoprazole.
Prolonged use (>1 year) of PPIs has been associated with an increased risk of fracture.
Use of pantoprazole as a preventative of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs should be restricted to patients who require continued NSAID treatment and have an increased risk of complications (for example, more than 65 years of age, history of upper gastrointestinal bleeding, gastric ulcer or duodenal ulcer).
Advise patients to consult their doctor before taking this product if they are due to have an endoscopy or urea test.
Increased levels of Chromogranin A (CgA) may interfere with investigations for neuroendocrine tumours. Pantoprazole treatment should be stopped for at least 5 days before CgA measurements. Measurements should be repeated 14 days after stopping proton pump inhibitors, if CgA and gastrin levels have not returned to the reference range after the initial measurement.
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
Pantoprazole should be used with caution in pregnancy.
The animal and limited human data suggests that pantoprazole represents a low risk in pregnancy.
Animal reproduction studies have revealed signs of slight foetotoxicity at doses above 5mg/kg.
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 to 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 on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Pantoprazole should be used with caution in breastfeeding.
There is limited information about the safety of pantoprazole during breastfeeding in humans but excretion in breast milk has been reported.
Pantoprazole doses of 40mg daily produce low levels in milk and would not be expected to cause any adverse effects in breast fed infants (LactMed).
As with all the PPIs, pantoprazole is completely unstable in an acid milieu and when present in milk, it would be largely destroyed before absorption (Hale, 2014).
Schaefer recommends that if a PPI is indicated, omeprazole or pantoprazole should be chosen.
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
Side Effects
Abdominal distension
Allergic reaction
Anaphylactic shock
Anaphylactoid reaction
Angioedema
Arthralgia
Asthenia
Bloating
Blood dyscrasias
Blurred vision
Bronchospasm
Bullous eruption
Confusion
Constipation
Depression
Diarrhoea
Disorientation
Dizziness
Dry mouth
Elevated triglyceride levels
Erythema multiforme
Exanthema
Fatigue
Fever
Flatulence
Gamma glutamyl transferase (GGT) increased
Gynaecomastia
Hallucinations
Headache
Hepatic damage
Hepatic failure
Hyperlipidaemia
Hypomagnesaemia
Hyponatraemia
Increase in plasma cholesterol
Increase of liver transaminases
Increased risk of fractures
Interstitial nephritis
Jaundice
Leukopenia
Lyell's syndrome
Malaise
Myalgia
Nausea
Peripheral oedema
Photosensitivity
Pruritus
Rash
Rise in body temperature
Serum bilirubin increased
Sleep disturbances
Stevens-Johnson syndrome
Subacute cutaneous lupus erythematosus
Sweating
Taste disturbances
Thrombocytopenia
Upper abdominal pain
Urticaria
Visual disturbances
Vomiting
Weight changes
Overdosage
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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: March 2018
Reference Sources
CredibleMeds
Available at: https://www.crediblemeds.org/
Last accessed: 16 March, 2018
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.
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: 15 March 2018
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: 15 March 2018
Summary of Product Characteristics: Pantoloc Control 20mg gastro-resistant tablets. GlaxoSmithKline Consumer Healthcare. Revised March 2017.
Summary of Product Characteristics: Pantoprazole 20mg gastro-resistant tablets. Actavis UK Ltd. Revised May 2017.
Summary of Product Characteristics: Pantoprazole 40mg gastro-resistant tablets. Actavis UK Ltd. Revised August 2017.
Summary of Product Characteristics: Pantoprazole 20mg gastro-resistant tablets. Generics UK Ltd t/a Mylan. Revised November 2017.
Summary of Product Characteristics: Pantoprazole 40mg gastro-resistant tablets. Generics UK Ltd t/a Mylan. Revised November 2017.
Summary of Product Characteristics: Pantoprazole 20mg gastro-resistant tablets. Wockhardt UK Ltd. Revised March 2018.
Summary of Product Characteristics: Pantoprazole 40mg gastro-resistant tablets. Wockhardt UK Ltd. Revised July 2011
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
Pantoprazole. Last revised: September 5, 2017
Last accessed: March 15, 2018
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 March 2018
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.