Adult: In patients who are unable to take oral formulations: 30 mg bid via IV infusion, or slow IV inj over 2 minutes. Switch to oral formulation once the patient can take oral medications.
Oral Eradication of H. pylori associated with peptic ulcer disease
Adult: As triple therapy: 30 mg bid for 7-14 days in combination with clarithromycin and with either amoxicillin or metronidazole. As dual therapy: 30 mg tid for 14 days in combination with amoxicillin. Combination therapy consideration should be given to official local guidance regarding bacterial resistance, duration of treatment and appropriate use of antibacterial agents. Elderly: Dose reduction may be necessary.
Oral Acid-related dyspepsia
Adult: 15-30 mg once daily for 2-4 weeks depending on the severity and persistence of symptoms.
Oral Gastro-oesophageal reflux disease
Adult: For short-term treatment of symptomatic GERD: 15 mg or 30 mg once daily for 4 weeks, may be adjusted according to response. Child: For short-term treatment of symptomatic GERD: 1-11 years ≤30 kg: 15 mg once daily for up to 12 weeks; >30 kg: 30 mg once daily for up to 12 weeks. For short-term treatment of symptomatic non-erosive GERD: 12-17 years 15 mg once daily for up to 8 weeks. Treatment and dosage recommendations may vary among individual products and between countries (refer to specific product guidelines). Elderly: Dose reduction may be necessary.
Oral Benign gastric ulcer
Adult: 30 mg once daily for 4-8 weeks. Elderly: Dose reduction may be necessary.
Oral Prophylaxis of NSAID-induced ulcers
Adult: In at-risk patients (e.g. history of gastric or duodenal ulcer) who require prolonged NSAID treatment: 15-30 mg once daily. Elderly: Dose reduction may be necessary.
Oral Erosive oesophagitis
Adult: For short-term treatment: 30 mg once daily for up to 8 weeks. Maintenance therapy following healing of cases (to reduce recurrence): 15 mg once daily. Treatment and dosage recommendations may vary among individual products and between countries (refer to specific product guidelines). Child: For short-term treatment: 1-11 years ≤30 kg: 15 mg once daily for up to 12 weeks; >30 kg: 30 mg once daily for up to 12 weeks; 12-17 years 30 mg once daily for up to 8 weeks. Treatment and dosage recommendations may vary among individual products and between countries (refer to specific product guidelines).
Oral NSAID-associated ulceration
Adult: In patients requiring continued NSAID treatment: 30 mg once daily for 4-8 weeks. Elderly: Dose reduction may be necessary.
Oral Reflux oesophagitis
Adult: Treatment: 30 mg once daily for 4-8 weeks. Prophylaxis: 15 mg once daily, may be increased up to 30 mg once daily if necessary. Elderly: Dose reduction may be necessary.
Oral Duodenal ulcer
Adult: 30 mg once daily for 2-4 weeks. Alternatively, 15 mg once daily for 4 weeks. Maintenance therapy (prevention of ulcer relapse): 15 mg once daily. Dosage recommendations may vary among individual products and between countries (refer to specific product guidelines). Elderly: Dose reduction may be necessary.
Oral Zollinger-Ellison syndrome
Adult: Initially, 60 mg once daily, may be adjusted according to response. Doses of up to 90 mg bid have been used. Daily doses of >120 mg should be given in 2 divided doses. Elderly: Dose reduction may be necessary.
Special Patient Group
Lansoprazole, a 1st generation proton pump inhibitor (PPI), is extensively metabolised in the liver primarily by CYP2C19 isoenzyme and to a lesser extent by CYP3A4 isoenzyme into inactive metabolites.
CYP2C19 genotypes have been linked to PPI exposure, in which a lower exposure is associated with treatment failure while higher exposure is associated with improved efficacy. Higher PPI exposure and long-term use have also been associated with adverse effects.
The allele frequency of CYP2C19*2 (c.681G > A; rs4244285), the most common CYP2C19 non-functional allele, is approx 60% in Oceanians, approx 25-30% in Asians, and approx 15% in Europeans and Africans. The increased functional allele CYP2C19*17 (c.-806C > T; rs12248560) is most common in African, European, and Near Eastern populations, with approx 20% allele frequency.
The Royal Dutch Pharmacists Association - Pharmacogenetics Working Group (DPWG) Guideline for lansoprazole and CYP2C19 as of November 2018:
Phenotype
Description
Recommendation
CYP2C19 ultrarapid metaboliser
Patients may have reduced lansoprazole plasma concentrations resulting in lower lansoprazole effectiveness.
For Helicobacter pylori eradication therapy: Use a 4-fold higher dose and advise patients to inform the doctor if dyspepsia symptoms persist. For other indications: Be alert for reduced effectiveness and use a 4-fold higher dose if necessary. Advise patients to report persisting symptoms of dyspepsia.
The DPWG guideline recommends to consider CYP2C19 genotyping on an individual basis before initiating lansoprazole.
Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2C19 and PPIs as of August 2020:
Dosing recommendations for lansoprazole based on CYP2C19 phenotype:
Phenotype
Genotype
Implications
Therapeutic Recommendations
CYP2C19 ultrarapid metaboliser
Individuals carrying 2 increased functional alleles e.g. *17/*17
Decreased lansoprazole plasma concentrations as compared with CYP2C19 normal metabolisers and are at increased risk of therapeutic failure.
Increase starting daily dose by 100%. Daily dose may be given in divided doses. Monitor for efficacy.
CYP2C19 rapid metaboliser
Individuals
carrying 1 normal functional allele and 1 increased functional
allele
e.g. *1/*17
Decreased lansoprazole plasma concentrations as compared with CYP2C19 normal metabolisers and are at increased risk of therapeutic failure.
Initiate standard starting daily dose. Consider increasing the dose by 50-100% for the therapy of H. pylori infection and erosive esophagitis. Daily dose may be given in divided doses. Monitor for efficacy.
CYP2C19 normal metaboliser
Individuals carrying 2 normal functional alleles e.g. *1/*1
Normal lansoprazole metabolism but may be at increased risk of therapeutic failure as compared with CYP2C19 intermediate and poor metabolisers.
Initiate standard starting daily dose. Consider increasing the dose by 50-100% for the therapy of H. pylori infection and erosive esophagitis. Daily dose may be given in divided doses. Monitor for efficacy.
CYP2C19 intermediate metaboliser
Individuals carrying 1 normal functional allele and 1 non-functional allele, or 1 increased functional allele and 1 non-functional allele e.g. *1/*2, *1/*3, *2/*17, *3/*17
Increased lansoprazole plasma concentration as compared with CYP2C19 normal metabolisers and are at increased chance of efficacy and potential toxicity.
Initiate standard starting daily dose. For chronic therapy (>12 weeks) and once efficacy is achieved, consider a 50% reduction in daily dose. Monitor for continued efficacy.
CYP2C19 poor metaboliser
Individuals carrying 2 non-functional alleles e.g. *2/*2, *3/*3, *2/*3
Increased lansoprazole plasma concentration as compared with CYP2C19 normal metabolisers and are at increased chance of efficacy and potential toxicity.
Initiate standard starting daily dose. For chronic therapy (>12 weeks) and once efficacy is achieved, consider a 50% reduction in daily dose. Monitor for continued efficacy.
Hepatic Impairment
Oral:
Moderate to severe: Reduce daily dose by 50%.
Administration
Should be taken on an empty stomach.
Reconstitution
Slow IV inj: Reconstitute vial labelled as 30 mg with up to 20 mL 0.9% NaCl solution or 5% dextrose in water (D5W). IV infusion: Reconstitute a 30 mg vial with 5-10 mL 0.9% NaCl solution or D5W then shake the vial gently. Further dilute the reconstituted solution with 100 mL of 0.9% NaCl solution or D5W.
Contraindications
Concomitant use with rilpivirine and atazanavir.
Special Precautions
Patients with reduced body stores or risk factors for reduced vitamin B12 absorption; those at risk of osteoporosis. May mask symptoms of gastric malignancy. CYP2C19 ultrarapid, rapid, normal, intermediate, and poor metabolisers. Renal and moderate to severe hepatic impairment. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant:Clostridium difficile-associated diarrhoea, gastrointestinal infections (e.g. Salmonella, Campylobacter), cutaneous lupus erythematosus (CLE), subacute CLE, SLE, severe cutaneous adverse reactions (e.g. acute generalised exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, toxic epidermal necrolysis); osteoporosis-related bone fractures of the hip, spine, or wrist (long-term use or high doses); fundic gland polyps (prolonged use), acute tubulointerstitial nephritis, vitamin B12 deficiency (long-term use). Rarely, hypomagnesaemia (prolonged use), which may lead to hypocalcaemia and hypokalaemia. Blood and lymphatic system disorders: Leucopenia, eosinophilia, thrombocytopenia. Ear and labyrinth disorders: Rarely, vertigo. Eye disorders: Rarely, visual disturbances. Gastrointestinal disorders: Vomiting, nausea, diarrhoea, abdominal pain, constipation, flatulence, dry mouth or throat. General disorders and administration site conditions: Fatigue. Hepatobiliary disorders: Rarely, cholestatic jaundice, hepatitis. Investigations: Increased liver enzymes. Musculoskeletal and connective tissue disorders: Arthralgia, myalgia. Nervous system disorders: Headache, dizziness. Rarely, somnolence. Respiratory, thoracic and mediastinal disorders: Rarely, interstitial pneumonia. Skin and subcutaneous tissue disorders: Urticaria, pruritus, rash.
This drug may cause dizziness, vertigo, visual disturbances or somnolence; if affected, do not drive or operate machinery.
Monitoring Parameters
Rule out the presence of gastric malignancy prior to initiation of treatment. Monitor CBC, liver and renal function, serum gastrin levels, and gastric acid output (in patients with Zollinger-Ellison syndrome); serum Mg and Ca levels at baseline and periodically thereafter. Observe for signs and symptoms of vitamin B12 deficiency, bone loss or fractures, and C. difficile-associated diarrhoea. Assess for the effectiveness of ulcer symptom relief.
Drug Interactions
May decrease the plasma concentrations of rilpivirine, atazanavir and nelfinavir. Increased INR and prothrombin time with warfarin. May elevate and prolong the serum levels of methotrexate which may result in toxicities. May increase the exposure of tacrolimus, particularly in transplant patients who are CYP2C19 intermediate or poor metabolisers. May increase plasma concentrations of digoxin. May decrease the plasma levels of theophylline. May diminish the therapeutic effect of clopidogrel. May reduce absorption of agents that depend on gastric pH for absorption (e.g. Fe salts, erlotinib, dasatinib, ketoconazole, itraconazole). May increase risk of hypomagnesaemia with diuretics. Sucralfate and antacids may reduce the bioavailability of lansoprazole. Increased plasma concentration with CYP2C19 inhibitor (e.g. fluvoxamine). Lansoprazole plasma concentration may be markedly reduced by CYP2C19 and CYP3A4 inducers (e.g. rifampicin).
Food Interaction
Decreased plasma concentrations with St. John's wort.
Lab Interference
May increase the serum chromogranin A (CgA) levels which may cause a false-positive result in the diagnostic test for neuroendocrine tumours. May cause false-positive result for secretin stimulation test and urine screening test for tetrahydrocannabinol.
Action
Description: Lansoprazole is a substituted benzimidazole gastric antisecretory agent and is also known as a proton pump inhibitor (PPI). It blocks the final step in gastric acid production by inhibition of H+/K+-adenosine triphosphatase (ATPase) enzyme system present at the secretory surface of the gastric parietal cells, thereby suppressing gastric acid secretion. Onset: Gastric acid suppression: 1-3 hours. Duration: Gastric acid suppression: >24 hours. Pharmacokinetics: Absorption: Rapidly absorbed from the gastrointestinal tract. Food delays absorption and reduces bioavailability by approx 50-70%. Bioavailability: >80%. Time to peak plasma concentration: Approx 1.5-2 hours. Distribution: Volume of distribution: 15.7 ± 1.9 L. Plasma protein binding: 97%. Metabolism: Extensively metabolised in the liver primarily by CYP2C19 isoenzyme to inactive 5-hydroxyl-lansoprazole, and by CYP3A4 isoenzyme to inactive lansoprazole sulfone. Excretion: Mainly via faeces (67%); urine (33%; 14-25% as metabolites, <1% as unchanged drug). Elimination half-life: Approx 1-2 hours.
Chemical Structure
Lansoprazole Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 3883, Lansoprazole. https://pubchem.ncbi.nlm.nih.gov/compound/3883. Accessed July 26, 2022.
Storage
Store between 15-30°C. Protect from light and moisture.
A02BC03 - lansoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
References
Lima JJ, Thomas CD, Barbino J et al. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2C19 and Proton Pump Inhibitor Dosing. Clinical Pharmacology & Therapeutics. 2020;0(0):1-7. doi:10.1002/cpt.2015. Accessed 002/06/2022Annotation of CPIC Guideline for Lansoprazole and CYP2C19. Pharmacogenomics Knowledgebase (PharmGKB). https://www.pharmgkb.org. Accessed 02/06/2022.Annotation of DPWG Guideline for Lansoprazole and CYP2C19. Pharmacogenomics Knowledgebase (PharmGKB). https://www.pharmgkb.org. Accessed 02/06/2022.Annotation of FDA Label for Lansoprazole and CYP2C19. Pharmacogenomics Knowledgebase (PharmGKB). https://www.pharmgkb.org. Accessed 02/06/2022.Anon. CYP2C19 - Lansoprazole (Pharmacogenomics). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/06/2022.Anon. Lansoprazole. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 02/06/2022.Anon. Lansoprazole. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/06/2022.Buckingham R (ed). Lansoprazole. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/06/2022.Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2C19 and Proton Pump Inhibitor Dosing. Clinical Pharmacogenetics Implementation Consortium. https://cpicpgx.org. Accessed 02/06/2022.Joint Formulary Committee. Lansoprazole. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/06/2022.Lanpro Gastro-resistant Capsules (Healol Pharmaceuticals Sdn Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 21/06/2022.Lansoprazole 15 mg Gastro-resistant Capsules (Bristol Laboratories Limited). MHRA. https://products.mhra.gov.uk. Accessed 02/06/2022.Prevacid Delayed-release Capsules and Prevacid Solutab Delayed-release Orally Disintegrating Tablets (Takeda Pharmaceuticals America, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 02/06/2022.Prevacid Fast Disintegrating Tablets (Takeda Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 02/06/2022.Prevacid IV (Takeda [Thailand] Ltd.). MIMS Thailand. http://www.mims.com/thailand. Accessed 21/06/2022.Prevacid IV (Takeda Healthcare Philippines, Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 21/06/2022.Zoton FasTab 15 mg Oro-dispersible Tablets (Pfizer Limited). MHRA. https://products.mhra.gov.uk. Accessed 02/06/2022.
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