Esomeprazole oral formulations
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of esomeprazole
Drugs List
Therapeutic Indications
Uses
Eradication of Helicobacter pylori (with other drugs)
Gastric and/or duodenal ulcer associated with NSAIDs
Healing of duodenal ulcer associated with Helicobacter pylori
Management and prevention of relapse in reflux oesophagitis
Prevention of relapse of Helicobacter pylori associated peptic ulcers
Prophylaxis of recurrent haemorrhage in bleeding peptic ulcers
Symptomatic treatment of gastro-oesophageal reflux disease
Treatment of erosive reflux oesophagitis
Ulcer prophylaxis during NSAID treatment
Zollinger-Ellison syndrome (and other hypersecretory conditions)
Dosage
Adults
Gastro-oesophageal reflux disease (GORD)
Adults and children 12 years and over
Treatment of erosive reflux oesophagitis:
40 mg once daily for 4 weeks. An additional 4 weeks treatment is recommended for patients in whom oesophagitis has not healed or who have persistent symptoms.
Long term management of patients with healed oesophagitis to prevent relapse:
20 mg once daily.
Symptomatic treatment of gastro oesophageal reflux disease (in patients without oesophagitis):
20 mg once daily for 4 weeks, then 20 mg once daily when required.
Helicobacter pylori eradication (in combination with appropriate antibiotics)
Adults over the age of 18 years
Healing of Helicobacter pylori associated duodenal ulcer and prevention of relapse of peptic ulcers in patients with Helicobacter pylori associated ulcer disease:
20 mg esomeprazole with 1 gram amoxicillin and 500 mg clarithromycin, all twice daily for 7 days.
Patients requiring continued NSAID therapy
Adults over the age of 18 years
The usual dose is 20 mg once daily for the treatment of gastric ulcers associated with NSAID therapy. Duration of treatment is 4 to 8 weeks.
For ulcer prophylaxis in at risk patients, the dose is 20 mg once daily. An on-demand regimen for symptom control is not recommended in NSAID treated patients at risk of developing gastric and duodenal ulcers.
Treatment of Zollinger Ellison Syndrome
Adults over the age of 18 years
Initially 40 mg twice daily. The dosage should then be individually adjusted and treatment continues as long as clinically indicated.
The majority of patients can be controlled on doses between 80 mg and 160 mg esomeprazole daily. With doses above 80 mg daily, the dose should be divided and given twice daily.
Prolonged treatment after IV induced prevention of rebleeding of peptic ulcers
Adults over the age of 18 years
40 mg once daily for 4 weeks after IV induced prevention of rebleeding of peptic ulcers.
Children
Children under 12 years with bodyweight of equal or greater than 10 kg
Esomeprazole gastro-resistant tablets and capsules are unlicensed in children under 12 years.
Treatment of endoscopically proven erosive reflux oesophagitis
Weight equal or greater than 10 kg - less than 20 kg: 10 mg once daily for 8 weeks.
Weight equal or greater than 20 kg: 10 mg or 20 mg once daily for 8 weeks.
Symptomatic treatment of gastro-oesophageal reflux disease
10 mg once daily for up to 8 weeks.
Doses over 1 mg/kg/day have not been studied.
Children 4 to 12 years
Treatment of duodenal ulcer caused by Helicobacter pylori
Weight less than 30 kg: 10 mg esomeprazole with amoxicillin 25 mg/kg body weight and clarithromycin 7.5 mg/kg body weight, all twice daily for 7 days
Weight 30 to 40 kg: 20 mg esomeprazole with amoxicillin 750 mg and clarithromycin 7.5 mg/kg body weight, all twice daily for 7 days.
Weight greater than 40 kg: 20 mg esomeprazole with amoxicillin 1 g and clarithromycin 500 mg, all twice daily for 7 days.
Children 12 to 18 years
Gastro-oesophageal reflux disease (GORD)
See Dosage; Adult
Treatment of duodenal ulcer caused by Helicobacter pylori
Weight 30 to 40 kg: 20 mg esomeprazole with amoxicillin 750 mg and clarithromycin 7.5 mg/kg body weight, all twice daily for 7 days.
Weight greater than 40 kg: 20 mg esomeprazole with amoxicillin 1 g and clarithromycin 500 mg, all twice daily for 7 days.
Patients with Hepatic Impairment
For patients 12 years and over with severe hepatic impairment, a maximum dose of 20 mg esomeprazole should not be exceeded. For children aged 1 to 11 years with severe hepatic impairment, a maximum dose of 10 mg esomeprazole should not be exceeded.
Contraindications
Children under 1 year
Children weighing less than 10kg
Hereditary fructose intolerance
Long QT syndrome
Torsade de pointes
Precautions and Warnings
Children aged 1 to 12 years
Family history of long QT syndrome
Breastfeeding
Electrolyte imbalance
Glucose-galactose malabsorption syndrome
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
Not all available brands are licensed for all age groups
Not all available brands are licensed for all indications
Preparation contains sucrose
Some formulations contain glucose
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
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
Advise patient not to take St John's wort concurrently
Advise patient to avoid sun exposure if subacute lupus erythematosus occurs
Patients on on-demand treatment should contact doctor if symptoms change
The concomitant administration of Esomeprazole is contraindicated with Nelfinavir.
Close clinical monitoring is required, if the Esomeprazole is co-administrated with the Atazanavir 400mg + Ritonavir 100mg and should not exceed the 20mg of Esomeprazole.
The co-administration of Esomeprazole is contraindicated with CYP3A4 inhibitors like Clarithromycin, Cisapride, etc...
Pregnancy and Lactation
Pregnancy
Use Esomeprazole with caution during pregnancy.
The manufacturer advises caution if Esomeprazole is used during pregnancy. Available reports indicate no risk of teratogenic or developmental effects.
Lactation
Use Esomeprazole with caution during breastfeeding.
The manufacturer does not recommended breastfeeding whilst taking Esomeprazole. Available data indicates Esomeprazole is not present in human breast milk and there is insufficient information on the effects in newborns or infants.
Counselling
Advise patient to seek medical advice if symptoms of hypomagnesaemia occur (e.g. muscle twitches, tremors, vomiting, tiredness, loss of appetite) while taking esomeprazole. Advise patient to avoid sun exposure if subacute cutaneous lupus erythematosus occurs. The tablets/capsules should be swallowed whole with liquid, and should not be chewed or crushed. For patients who have difficulty in swallowing: Tablets and capsules Disperse the tablet/pellets from the capsule in half a glass of non-carbonated water. No other liquids should be used as the enteric coat may be dissolved. Stir until the tablets/pellets disintegrate and drink immediately or within 30 minutes. Rinse the glass with half a glass of water and drink. The pellets must not be chewed or crushed. For patients that cannot swallow, the tablets/pellets from the capsules can be dispersed in non-carbonated water and administered through a gastric tube. The appropriateness of the selected syringe and tube should be considered prior to administration. Granules For a 10 mg dose empty the contents of a 10 mg sachet into a glass containing 15 ml of water. For a 20 mg dose empty the contents of two 10mg sachets into a glass containing 30ml of water. Do not use carbonated water. The contents should be stirred until the granulate has been dispersed. Leave for a few minutes to thicken, then stir again and drink the liquid within 30 minutes. Rinse the glass with 15 ml water and drink to ensure all the granules are obtained. For patients that cannot swallow, the suspension may be administered through a gastric tube
Side Effects
Abdominal pain
Aggression
Agitation
Agranulocytosis
Alopecia
Anaphylactic shock
Anaphylaxis
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
Insomnia
Interstitial nephritis
Leukopenia
Malaise
Microscopic colitis
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
Vomiting
Effects on Laboratory Tests
Treatment with esomeprazole may increased 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: 24 March 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: 24 March 2021
Summary of Product Characteristics: Emozul 20mg gastro-resistant capsules, hard. Consilient Health Limited. Revised May 2017
Summary of Product Characteristics: Emozul 40mg gastro-resistant capsules, hard. Consilient Health Limited. Revised May 2017
Summary of Product Characteristics: Nexium 20mg Tablets. Astra Zeneca UK Limited. Revised January 2021
Summary of Product Characteristics: Nexium 40mg Tablets. Astra Zeneca UK Limited. Revised January 2021
Summary of Product Characteristics: Nexium 10mg gastro-resistant granules for oral suspension, sachet. Astra Zeneca UK Limited. Revised June 2020
Summary of Product Characteristics: Ventra 20 mg gastro-resistant capsules, hard. Ethypharm UK Ltd. Revised March 2017
Summary of Product Characteristics: Ventra 40 mg gastro-resistant capsules, hard. Ethylpharm UK Ltd. Revised March 2017
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