Omeprazole oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations containing omeprazole.
Drugs List
Therapeutic Indications
Uses
Benign gastric ulcer
Duodenal ulcer
Duodenal ulcer associated with Helicobacter pylori (with other drugs)
Dyspepsia associated with hyperacidity
Gastric and/or duodenal ulcer associated with NSAIDs
Gastric ulcer associated with Helicobacter pylori (with other drugs)
Gastro-oesophageal reflux disease
Healed oesophagitis
Prevention of duodenal or benign gastric ulcer recurrence
Prophylaxis of acid aspiration
Ulcer prophylaxis during NSAID treatment in patients with previous history
Zollinger-Ellison syndrome (and other hypersecretory conditions)
Unlicensed Uses
Fat malabsorption despite pancreatic enzyme replacement in cystic fibrosis
Dosage
Adults
Reflux oesophagitis
20mg once daily for 4 weeks. If not fully healed, dosage may be continued for a further 4 weeks. In patients with severe oesophagitis, a dose of 40mg once daily for 8 weeks is recommended.
For long-term management of patients with healed reflux oesophagitis, a dose of 10mg once daily is recommended. Dose can be increased to 20mg to 40mg once daily if necessary.
Treatment of symptomatic gastro-oesophageal reflux disease
20mg once daily. Some patients may respond to a dose of 10mg once daily.
If symptoms still persist after 4 weeks treatment at a dose of 20mg once daily, further investigation is required.
Alternative sources suggest that in long term management of acid reflux disease, the dose may be increased up to 40mg once daily if symptoms return.
Duodenal ulcers
20mg once daily. Healing occurs within 2 weeks in most patients. For patients not fully healed after the initial course, healing usually occurs during a further 2 weeks treatment period. A dose of 40mg once daily is recommended in patients with poor response. Healing usually occurs within 4 weeks.
Prevention of relapse in patients with duodenal ulcer
20mg once daily (up to 40mg daily).
Benign gastric ulcers
20mg once daily. Healing occurs within 4 weeks in most patients. For patients not fully healed after the initial course, healing usually occurs during a further 4 weeks treatment period. A dose of 40mg once daily is recommended in patients with poor response. Healing usually occurs within 8 weeks.
Prevention of relapse in patients with gastric ulcer
20mg once daily increasing to 40mg once daily if necessary.
Treatment of NSAID-associated gastric and duodenal ulcers
20mg once daily for 4 weeks. If not healed, dosage may be continued for a further 4 weeks.
Prophylaxis of NSAID-associated gastric and duodenal ulcers
20mg once daily.
Eradication of Helicobacter pylori in peptic ulcer disease in combination with antibacterial agents
Omeprazole 20mg twice daily for 7 days.
In each combination regimen, if the patient is still H. pylori positive, therapy may be repeated or one of the alternative regimens can be used.
Zollinger-Ellison syndrome
Initial dose: 60mg once daily.
Maintenance: Adjust dose as necessary. Usual dose is 20mg to 120mg daily. For doses above 80mg daily, divide dose and give twice daily.
Children
Reflux oesophagitis, symptomatic treatment of heartburn and acid regurgitation in gastro-oesophageal reflux disease (GORD)
Children aged 1 month to 1 year
1mg/kg once daily.
Children aged 1 year and above with a body weight between 10kg and 20kg
10mg once daily. Dose may be increased to 20mg once daily if required.
Children aged 2 years and above with a body weight greater than 20kg
20mg once daily. Dose may be increased to 40mg once daily if required.
Treatment time for reflux oesophagitis is 4 to 8 weeks.
Symptomatic treatment of heartburn and acid regurgitation in GORD is 2 to 4 weeks. If symptoms persist after 2 to 4 weeks, the patient should be investigated further.
Treatment of duodenal ulcer caused by Helicobacter pylori in combination with antibacterial agents
Children aged 4 years and above
Bodyweight 15kg to 31kg: 10mg twice daily for 1 week.
Bodyweight 31kg to 40kg: 20mg twice daily for 1 week.
Bodyweight over 40kg: 20mg twice daily for 1 week.
The following unlicensed alternative dosing regimen may be suitable:
Children aged 12 to 18 years
40mg once daily.
Children aged 1 to 12 years
1mg/kg to 2mg/kg (up to 40mg) once daily.
Acid-related dyspepsia (unlicensed), treatment of duodenal and benign gastric ulcers including those complicating NSAID therapy Zollinger-Ellison syndrome (unlicensed), fat malabsorption despite pancreatic enzyme replacement therapy in cystic fibrosis (unlicensed)
Children aged 2 to 18 years with a bodyweight over 20kg
20 mg once daily increased if necessary to 40mg once daily (in severe ulcerating reflux oesophagitis, maximum 12 weeks at higher dose).
Children aged 2 to 18 years with a bodyweight between 10kg and 20kg
10 mg once daily increased if necessary to 20mg once daily (in severe ulcerating reflux oesophagitis, maximum 12 weeks at higher dose).
Children 1 month to 2 years
700 micrograms/kg once daily, increased if necessary to 3 mg/kg (up to 20 mg) once daily.
Neonates
Gastro-oesophageal reflux disease (unlicensed), acid-related dyspepsia (unlicensed), treatment of duodenal and benign gastric ulcers including those complicating NSAID therapy (unlicensed), Zollinger-Ellison syndrome, fat malabsorption despite pancreatic enzyme replacement therapy in cystic fibrosis (unlicensed).
700micrograms/kg once daily, increased if necessary after 7 to 14 days to 1.4mg/kg; some neonates may require up to 2.8mg/kg once daily.
Patients with Hepatic Impairment
The bioavailability and half-life can increase in patients with impaired hepatic function. The dose requires adjustment with a maximum dose of 20mg daily.
Combination therapy with clarithromycin should be used with caution in patients with hepatic impairment because plasma concentrations of omeprazole and clarithromycin are increased during concomitant administration.
Contraindications
Long QT syndrome
Torsade de pointes
Precautions and Warnings
Children under 1 year
Family history of long QT syndrome
Restricted potassium intake
Breastfeeding
Electrolyte imbalance
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
Hereditary fructose intolerance
History of torsade de pointes
Lactose intolerance
Correct electrolyte disorders before treatment
Potassium content of oral suspension may be significant
Exclude gastric cancer before commencing treatment
Exclude malignancy, if alarm symptoms develop and gastric ulcer suspected
Not all available brands are licensed for all indications
Some formulations contain glucose
Some formulations contain hydroxybenzoate
Some formulations contain lactose
Some formulations contain maltitol
Some formulations contain propylene glycol
Some formulations contain sucrose
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 interfere with certain laboratory measurements
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. 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 omeprazole.
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.
Regularly review treatment in patients on long term maintenance treatment.
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
Omeprazole is considered safe for use in pregnancy.
Animal studies do not indicate direct or indirect harmful effects with respect to reproduction. Results from epidemiological studies have not revealed any evidence of adverse events of omeprazole on pregnancy or on the health of the foetus/newborn child. Schaefer concludes that omeprazole is the drug of choice in pregnancy for this group of medications and Briggs states that if omeprazole is required or if inadvertent exposure does occur early in gestation, the known risk to the embryo/foetus appears to be low.
Lactation
Use omeprazole with caution during breastfeeding.
The manufacturer advises that omeprazole is excreted in breast milk but is not likely to influence the child when therapeutic doses are used.
Counselling
Advise patient not to take St John's wort concurrently.
Advise patient to seek medical advice if symptoms of hypomagnesaemia occur (e.g. muscle twitches, tremors, vomiting, tiredness, loss of appetite) while taking omeprazole.
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:
Break and disperse the contents of the capsule or dispersible tablet in half a glass of water (non-carbonated) or mix with fruit juice or apple sauce. Advise the patient that the dispersion should be taken within 30 minutes, always stirred just before drinking and rinsed down with half a glass of water. Milk or carbonated water should not be used.
Side Effects
Abdominal pain
Aggression
Agitation
Agranulocytosis
Alopecia
Anaphylactic shock
Angioedema
Arthralgia
Blurred vision
Bronchospasm
Candidiasis
Confusion
Constipation
Depression
Dermatitis
Diarrhoea
Dizziness
Dry mouth
Encephalopathy
Erythema multiforme
Faintness
Fatigue
Fever
Flatulence
Fundic gland polyps (benign)
Gynaecomastia
Hallucinations
Headache
Hepatic failure
Hepatitis
Hypersensitivity reactions
Hypocalcaemia
Hypokalaemia
Hypomagnesaemia
Hyponatraemia
Impotence
Increased risk of fractures
Increased sweating
Increases in hepatic enzymes
Insomnia
Interstitial nephritis
Jaundice
Leukopenia
Light-headedness
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 omeprazole may increase Chromogranine A (CgA) levels and may interfere with investigations for neuroendocrine tumours. To avoid this, stop Omeprazole treatment temporarily for at least 5 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: February 2019
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Losec MUPS Tablets 10mg. AstraZeneca UK Limited. Revised May 2017.
Summary of Product Characteristics: Losec MUPS Tablets 20mg. AstraZeneca UK Limited. Revised May 2017.
Summary of Product Characteristics: Losec MUPS Tablets 40mg. AstraZeneca UK Limited. Revised May 2017.
Summary of Product Characteristics: Losec Capsules 10mg. AstraZeneca UK Ltd. Revised May 2017.
Summary of Product Characteristics: Losec Capsules 20mg. AstraZeneca UK Ltd. Revised May 2017.
Summary of Product Characteristics: Losec Capsules 40mg. AstraZeneca UK Ltd. Revised May 2017.
Summary of Product Characteristics: Mepradec 10mg gastro-resistant capsules. Dexcel-Pharma Ltd. Revised February 2017.
Summary of Product Characteristics: Mepradec 20mg gastro-resistant capsules. Dexcel-Pharma Ltd. Revised February 2017.
Summary of Product Characteristics: Mezzopram 10mg Dispersible Gastro-resistant Tablets. Sandoz Ltd. Revised March 2018.
Summary of Product Characteristics: Mezzopram 20mg Dispersible Gastro-resistant Tablets. Sandoz Ltd. Revised March 2018.
Summary of Product Characteristics: Mezzopram 40mg Dispersible Gastro-resistant Tablets. Sandoz Ltd. Revised March 2018.
Summary of Product Characteristics: Omeprazole 2mg/ml Powder for Oral Suspension. Rosemont Pharmaceuticals Limited. Revised October 2019.
Summary of Product Characteristics: Omeprazole 4mg/ml Powder for Oral Suspension. Rosemont Pharmaceuticals Limited. Revised October 2019.
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: 22 February 2019
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: 22 February 2019
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 19 March 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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