Lansoprazole
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of Lansoprazole
Drugs List
Therapeutic Indications
Uses
Benign gastric ulcer
Duodenal ulcer - treatment and maintenance
Dyspepsia associated with hyperacidity
Eradication of Helicobacter pylori (with other drugs)
Gastro-oesophageal reflux disease
Treatment of benign gastric or duodenal ulcer - NSAID associated
Ulcer prophylaxis during NSAID treatment
Zollinger-Ellison syndrome (and other hypersecretory conditions)
Unlicensed Uses
Fat malabsorption despite pancreatic enzyme replacement in cystic fibrosis
Dosage
Adults
Duodenal ulcer
30mg once daily for two weeks. Most patients will be healed after two weeks. For those patients not fully healed, a further two weeks treatment can be given.
Benign gastric ulcer
30mg once daily for four weeks. If the ulcer is not fully healed treatment may continued for another four weeks.
Treatment of NSAID-associated benign gastric and duodenal ulcers and relief of symptoms
30mg once daily for four weeks. Most patients will be healed after four weeks. For those patients not fully healed, a further four weeks treatment can be given.
Prophylaxis of NSAID-associated benign gastric ulcers, duodenal ulcers and symptoms in patients at risk
15mg or 30mg once daily.
Gastro-oesophageal reflux disease
30mg once daily for four weeks, then a further four weeks in patients not fully healed.
Prophylaxis of reflux oesophagitis
15mg once daily, increased to 30mg if necessary.
Symptomatic gastro-oesophageal reflux disease
Intermittent courses, as required, of 15mg to 30mg once daily for two to four weeks depending on the severity and persistence of symptoms. Patients who do not respond after four weeks, or who relapse shortly afterwards, should be investigated.
Eradication of Helicobacter pylori
The following combinations have been shown to be effective when given for seven days:
Lansoprazole 30mg twice daily plus clarithromycin 250mg to 500mg twice daily and amoxicillin 1g twice daily.
or
Lansoprazole 30mg twice daily plus clarithromycin 250mg twice daily and metronidazole 400mg to 500mg twice daily.
or
Lansoprazole 30mg twice daily plus amoxicillin 1g twice daily and metronidazole 400mg to 500mg twice daily.
The best eradication results are obtained when clarithromycin is combined with either metronidazole or amoxicillin. Eradication of H. pylori has been shown to result in the healing of duodenal ulcers without the need for continued anti-ulcer therapy.
For optimal prevention of symptom recurrence in patients with ulcer-like dyspepsia, eradication of H.pylori should be followed by continued lansoprazole treatment.
Six months after successful eradication the risk of re-infection is low, so the relapse is unlikely.
Zollinger-Ellison syndrome and other hypersecretory conditions
Initial dose 60mg daily, to be adjusted individually. For patients who require 120mg or more per day, the dose should be divided and administered twice daily. Daily doses up to 180mg have been used.
Elderly
The clearance of lansoprazole is decreased in the elderly and as such a 30mg daily dose should not be exceeded.
Children
Acid related dyspepsia; Benign gastric ulcer; Duodenal ulcer; Fat malabsorption despite pancreatic enzyme replacement therapy in cystic fibrosis; Gastro-oesophageal reflux disease; NSAID associated duodenal or gastric ulcer(unlicensed)
Children weighing 30kg and above
15mg to 30mg once daily in the morning.
Children weighing under 30kg
0.5mg/kg to 1mg/kg (up to 15mg per dose) once daily in the morning.
Patients with Hepatic Impairment
For patients with moderate or severe liver disease, the recommended daily dose should be reduced by half.
Contraindications
Long QT syndrome
Pregnancy
Torsade de pointes
Precautions and Warnings
Children under 18 years
Elderly
Family history of long QT syndrome
Breastfeeding
Electrolyte imbalance
Galactosaemia
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
History of torsade de pointes
Lactose intolerance
Moderate hepatic impairment
Phenylketonuria
Correct electrolyte disorders before treatment
Reduce dose in patients with moderate hepatic impairment
Some formulations contain aspartame - caution in phenylketonuria
Advise ability to drive/operate machinery may be affected by side effects
Exclude gastric cancer before commencing treatment
May reduce absorption of antiretroviral HIV drugs
Some formulations contain lactose
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 patients on long term therapy (over 1 year)
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
Discontinue if severe and persistent diarrhoea develops
Advise patient not to take St John's wort concurrently
Advise patient to avoid sun exposure if subacute lupus erythematosus occurs
Before using lansoprazole with antibiotics for the eradication of the H. pylori , prescribers should refer to the full prescribing information for the respective antibiotics.
Increased risk of gastrointestinal infection such as Salmonella or Campylobacter due to decreased gastric acidity.
Prolong use of acid-suppressing medications may cause hypochlorhydria, which may lead to malabsorption of cyanocobalamin (Vitamin B12).
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 lansoprazole.
Restrict treatment for the prevention of peptic ulceration of patients in need of continuous NSAID treatment to high risk patients.
In patients with gastro-duodenal ulcers, the possibility of Helicobacter pylori infection should be determined.
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.
Pregnancy and Lactation
Pregnancy
Lansoprazole is contraindicated during pregnancy.
The manufacturer does not recommended using lansoprazole during pregnancy.
Available reports indicate no risk of teratogenic or developmental effects.
Lactation
Use Lansoprazole with caution during breastfeeding.
The manufacturer advises caution if ibuprofen is used when breastfeeding.
Animal data reports significant levels of Lansoprazole in the breast milk however presence in human breast milk is unknown.
Counselling
The patient should be advised not to take ingestion tablets at the same time of the day as this medicine.
Advise patient to avoid taking St John's wort concurrently.
Advise patients that if they experience dizziness, vertigo, visual disturbance, or somnolence, they should not drive or operate machinery.
Advise patient to seek medical advice if symptoms of hypomagnesaemia occur (e.g. muscle twitches, tremors, vomiting, tiredness, loss of appetite) while taking lansoprazole.
Advise patient to avoid sun exposure if subacute cutaneous lupus erythematosus occurs.
Side Effects
Abdominal pain
Agranulocytosis
Altered liver function tests
Anaemia
Anaphylaxis
Angioedema
Anorexia
Arthralgia
Bruising
Candidiasis (mouth or throat)
Colitis
Confusion
Constipation
Depression
Diarrhoea
Dizziness
Dry mouth
Dry throat
Eosinophilia
Erythema multiforme
Fatigue
Fever
Flatulence
Glossitis
Gynaecomastia
Hair loss
Hallucinations
Headache
Hepatitis
Hyperhidrosis
Hypersensitivity reactions
Hypomagnesaemia
Hyponatraemia
Impotence
Increase in plasma cholesterol
Increase in plasma triglyceride concentration
Increased risk of fractures
Insomnia
Interstitial nephritis
Itching
Jaundice
Leucopenia
Myalgia
Nausea
Oedema
Pancreatitis
Pancytopenia
Paraesthesia
Petechiae
Photosensitivity
Pruritus
Purpura
Rash
Restlessness
Somnolence
Sore throat
Stevens-Johnson syndrome
Stomatitis
Subacute cutaneous lupus erythematosus
Taste disturbances
Thrombocytopenia
Toxic epidermal necrolysis
Tremor
Urticaria
Vertigo
Visual disturbances
Vomiting
Effects on Laboratory Tests
Lansoprazole may increase Chromogranin A (CgA) levels and may therefore interfere with investigations for neuroendocrine tumours. To avoid this, stop Lansoprazole 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 ).
Last Updated: 27 January 2020
This data has been compiled using standard reference sources. Copyright, First DataBank Europe Ltd.
Further Information
Last Full Review Date: April 2021
Reference Sources
Summary of Product Characteristics: Zoton FasTab 15mg. Pfizer Limited. Revised February 2021.
Summary of Product Characteristics: Zoton FasTab 30mg. Pfizer Limited. Revised February 2021.
Summary of Product Characteristics: Lansoprazole 15mg Orodispersable Tablets. Mylan. Revised February 2018.
Summary of Product Characteristics: Lansoprazole 30mg Orodispersable Tablets. Mylan. Revised February 2018.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 March 2021
MHRA Drug Safety Update December 2014. Proton pump inhibitors in long-term use: reports of hypomagnesaemia.
Available at: https://www.mhra.gov.uk
Last accessed: 22 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: 22 March 2021
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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