Esomeprazole
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Parenteral formulations of Esomeprazole
Drugs List
Therapeutic Indications
Uses
Gastroesophageal reflux disease with oesophagitis: acute treatment
Gastroesophageal reflux disease with severe reflux: acute treatment
Prophylaxis of recurrent haemorrhage in bleeding peptic ulcers
Treatment of benign gastric or duodenal ulcer - NSAID associated
Ulcer prophylaxis during NSAID treatment
Dosage
Adults
Gastric antisecretory treatment
Reflux oesophagitis
40mg (5ml of the reconstituted solution) once daily, given either as an intravenous injection over a period of at least 3 minutes, or as an intravenous infusion over a period of 10 to 30 minutes.
Symptomatic treatment of reflux disease
20mg (2.5ml or half of the reconstituted solution) once daily, given either as an intravenous injection over a period of at least 3 minutes, or as an intravenous infusion over a period of 10 to 30 minutes.
Treatment of gastric ulcers associated with NSAID therapy
20mg once daily as an intravenous injection over 3 minutes or an infusion over 10 to 30 minutes
Patients requiring continued NSAID therapy
For ulcer prophylaxis, 20mg should be given once daily as an intravenous injection over 3 minutes or as an infusion over 10 to 30 minutes.
Prevention of rebleeding of gastric and duodenal ulcers
80mg should be administered as a bolus infusion over 30 minutes followed by a continuous intravenous infusion of 8mg/hour given over 3 days (71.5 hours).
Oral acid-suppression therapy should follow the parenteral treatment period (40mg once daily for 4 weeks).
Children
Children 12 to 18 years
Reflux oesophagitis
40mg (5ml of the reconstituted solution) once daily, given either as an intravenous injection over a period of at least 3 minutes, or as an intravenous infusion over a period of 10 to 30 minutes.
Symptomatic treatment of reflux disease
20mg (2.5ml or half of the reconstituted solution) once daily, given either as an intravenous injection over a period of at least 3 minutes, or as an intravenous infusion over a period of 10 to 30 minutes.
Children under 12 years
Reflux oesophagitis
Children under 20kg of weight: 10mg (1.25ml of the reconstituted solution) once daily, given either as an intravenous injection over a period of at least 3 minutes, or as an intravenous infusion over a period of 10 to 30 minutes.
Children 20kg of weight or more: 10mg or 20mg once a day (1.25ml or 2.5ml of the reconstituted solution) once daily, given either as an intravenous injection over a period of at least 3 minutes, or as an intravenous infusion over a period of 10 to 30 minutes.
Symptomatic treatment of reflux disease
10mg once daily (1.25ml of the reconstituted solution) once daily, given either as an intravenous injection over a period of at least 3 minutes, or as an intravenous infusion over a period of 10 to 30 minutes.
Patients with Hepatic Impairment
Patients with severe hepatic impairment should not receive more than 20mg esomeprazole daily in GORD. For patients with severe hepatic impairment who have bleeding ulcers an initial 80mg bolus dose followed by a continuous intravenous infusion dose of 4mg/hour for 71.5 hours is probably sufficient.
Additional Dosage Information
When administering a 20mg dose only half the reconstituted solution should be used. Any unused solution should be discarded.
Contraindications
Children under 1 year
Long QT syndrome
Torsade de pointes
Precautions and Warnings
Family history of long QT syndrome
Breastfeeding
Electrolyte imbalance
History of torsade de pointes
Pregnancy
Severe hepatic impairment
Severe renal impairment
Correct electrolyte disorders before treatment
Advise patient dizziness may affect ability to drive or operate machinery
Exclude malignancy, if alarm symptoms develop and gastric ulcer suspected
Exclude malignancy, if alarm symptoms develop in presence of gastric ulcer
Discard any unused portion
Patient should be converted to oral therapy as soon as possible
Measure magnesium levels before and periodically during prolonged treatment
Ensure adequate vitamin D & calcium in patients at risk of osteoporosis
Monitor ECG in patients at risk of QT prolongation
Monitor serum electrolytes
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
Consider dose reduction in severe hepatic impairment
Not licensed for all indications in all age groups
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 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 esomeprazole.
Pregnancy and Lactation
Pregnancy
Use Esomeprazole with caution during pregnancy.
The manufacturer advises caution if Esomeprazole is caused during pregnancy. Available reports indicate no risk of teratogenic or developmental effects.
Lactation
Use Esomeprazole with caution during lactation.
The manufacturer advises caution if ibuprofen is used when breastfeeding.
Whilst available data indicates Esomeprazole is present in human breast milk, the quantity is not considered to be sufficient to cause adverse effects in the breastfed infants.
Side Effects
Abdominal pain
Aggression
Agitation
Agranulocytosis
Alopecia
Anaphylactic shock
Angioedema
Arthralgia
Blurred vision
Bronchospasm
Candidiasis (gastro-intestinal)
Confusion
Constipation
Depression
Dermatitis
Diarrhoea
Dizziness
Dry mouth
Encephalopathy in patients with pre-existing severe hepatic disease
Erythema multiforme
Fever
Flatulence
Gynaecomastia
Hallucinations
Headache
Hepatic failure
Hepatitis with or without jaundice
Hypersensitivity reactions
Hypomagnesaemia
Hyponatraemia
Increased risk of fractures
Increased sweating
Increases in hepatic enzymes
Injection site reactions
Insomnia
Interstitial nephritis
Leukopenia
Malaise
Muscle weakness
Myalgia
Nausea
Pancytopenia
Paraesthesia
Peripheral oedema
Photosensitivity
Pruritus
Rash
Somnolence
Stevens-Johnson syndrome
Stomatitis
Subacute cutaneous lupus erythematosus
Taste disturbances
Thrombocytopenia
Toxic epidermal necrolysis
Urticaria
Vertigo
Visual impairment (irreversible)
Vomiting
Effects on Laboratory Tests
Esomeprazole may increase Chromogranin A (CgA) levels and may therefore interfere with investigations for neuroendocrine tumours. To avoid this, stop esomeprazole treatment temporarily for at least five days, before CgA measurements.
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: April 2021
Reference Sources
MHRA Drug Safety Update April 2012. Proton pump inhibitors in long-term use: reports of hypomagnesaemia.
Available at: https://www.mhra.gov.uk
Last accessed: 01 April 2021
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: 01 April 2021
Summary of Product Characteristics: Esomeprazole 40mg powder for solution for injection/infusion. Ranbaxy (UK) Limited a Sun Pharmaceutical Company. August 2018
Summary of Product Characteristics: Nexium I.V. 40mg Powder for solution for injection/infusion. AstraZeneca UK Ltd. May 2017
Summary of Product Characteristics: Esomeprazole 40mg powder for solution for injection/infusion. Bowmed Ibisqus Limited. April 2017
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://www.ncbi.nlm.nih.gov/books/NBK501922/
Esomeprazole - Last revised: 17 March 2021
Last accessed: 01 April 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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