Drugs List

Therapeutic Indications

Uses

Benign gastric and duodenal ulceration
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
Zollinger-Ellison syndrome (and other hypersecretory conditions)

Unlicensed Uses

Fat malabsorption despite pancreatic enzyme replacement in cystic fibrosis
Severe peptic ulcer bleeding

Administration

For intravenous administration only.

Infusion should be administered over 20 to 30 minutes.

Contraindications

Neonates under 1 month
Long QT syndrome
Torsade de pointes

Precautions and Warnings

Children 1 month to 18 years
Family history of long QT syndrome
Breastfeeding
Electrolyte imbalance
Hepatic impairment
History of torsade de pointes

Advise patient dizziness may affect ability to drive or operate machinery
Advise visual disturbances 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
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
Consider discontinuing if subacute cutaneous lupus erythematosus occurs
Increased risk of GI infection due to decreased gastric acidity
May reduce absorption of vitamin B12
Advise patient not to take St John's wort concurrently
Advise patient to avoid sun exposure if subacute lupus erythematosus occurs

Prolonged use (greater than 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 omeprazole.

Prolonged use (greater than 1 year) of PPIs has been associated with an increased risk of hip, wrist and spine fracture, predominantly in the elderly or in the presence of other recognised risk factors.

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 may be used 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 for reflux oesophagitis in pregnancy (Schaefer, 2007) 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 (Briggs, 2011).

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

Omeprazole should be used with caution in breastfeeding.

Omeprazole is excreted in breast milk but limited information suggests that is not likely to cause any adverse effects in breastfed infants when therapeutic doses are used.

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 pain
Aggression
Agitation
Agranulocytosis
Alopecia
Anaphylactic shock
Angioedema
Arthralgia
Blurred vision
Bronchospasm
Candidiasis (gastro-intestinal)
Confusion
Constipation
Depression
Dermatitis
Diarrhoea
Dizziness
Dry mouth
Encephalopathy
Erythema multiforme
Fever
Flatulence
Gynaecomastia
Hallucinations
Headache
Hepatic failure
Hepatitis
Hypersensitivity reactions
Hypomagnesaemia
Hyponatraemia
Increased risk of fractures
Increased sweating
Increases in hepatic enzymes
Insomnia
Interstitial nephritis
Jaundice
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

Presentation

Powder for solution for infusion containing omeprazole (as omeprazole sodium)

Drugs List

Therapeutic Indications

Uses

Benign gastric and duodenal ulceration
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
Zollinger-Ellison syndrome (and other hypersecretory conditions)

Unlicensed Uses

Fat malabsorption despite pancreatic enzyme replacement in cystic fibrosis
Severe peptic ulcer bleeding

Dosage

Adults

Children

Patients with Hepatic Impairment

Administration

For intravenous administration only.

Infusion should be administered over 20 to 30 minutes.

Contraindications

Neonates under 1 month
Long QT syndrome
Torsade de pointes

Precautions and Warnings

Children 1 month to 18 years
Family history of long QT syndrome
Breastfeeding
Electrolyte imbalance
Hepatic impairment
History of torsade de pointes

Advise patient dizziness may affect ability to drive or operate machinery
Advise visual disturbances 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
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
Consider discontinuing if subacute cutaneous lupus erythematosus occurs
Increased risk of GI infection due to decreased gastric acidity
May reduce absorption of vitamin B12
Advise patient not to take St John's wort concurrently
Advise patient to avoid sun exposure if subacute lupus erythematosus occurs

Prolonged use (greater than 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 omeprazole.

Prolonged use (greater than 1 year) of PPIs has been associated with an increased risk of hip, wrist and spine fracture, predominantly in the elderly or in the presence of other recognised risk factors.

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 may be used 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 for reflux oesophagitis in pregnancy (Schaefer, 2007) 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 (Briggs, 2011).

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

Omeprazole should be used with caution in breastfeeding.

Omeprazole is excreted in breast milk but limited information suggests that is not likely to cause any adverse effects in breastfed infants when therapeutic doses are used.

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

Counselling

Advise patient to seek medical advice if symptoms of hypomagnesaemia occur (e.g. muscle twitches, tremors, vomiting, tiredness, loss of appetite) while taking omeprazole.

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
Erythema multiforme
Fever
Flatulence
Gynaecomastia
Hallucinations
Headache
Hepatic failure
Hepatitis
Hypersensitivity reactions
Hypomagnesaemia
Hyponatraemia
Increased risk of fractures
Increased sweating
Increases in hepatic enzymes
Insomnia
Interstitial nephritis
Jaundice
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

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 2016

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Summary of Product Characteristics: Omeprazole 40mg Powder for Solution for Infusion. Sandoz Limited. Revised January 2016.

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: 18 February 2016

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: 18 February 2016

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 15 September 2017

UK Drugs in Lactation Advisory Service.
Available at: https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Last accessed: 18 February 2016

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
Omeprazole Last revised: 10 March 2015
Last accessed: 18 February 2016