Adult: For healing of all grades of erosive oesophagitis: 60 mg once daily for up to 8 weeks. As maintenance of healed cases and relief of heartburn: 30 mg once daily for up to 6 months. Treatment duration may vary among individual products and between countries (refer to specific product guidelines). Child: For healing of all grades of erosive oesophagitis: ≥12 years Same as adult dose. As maintenance of healed cases and relief of heartburn: ≥12 years 30 mg once daily for up to 4 months. Treatment duration may vary among individual products and between countries (refer to specific product guidelines).
Oral Gastro-oesophageal reflux disease
Adult: For the treatment of heartburn associated with symptomatic non-erosive GERD: 30 mg once daily for 4 weeks. Child: For the treatment of heartburn associated with symptomatic non-erosive GERD: ≥12 years Same as adult dose.
What are the brands available for Dexlansoprazole in Hong Kong?
Dexlansoprazole, a 2nd generation proton pump inhibitor (PPI) and the R-enantiomer of lansoprazole, is extensively metabolised in the liver mainly by CYP2C19, among other enzymes.
CYP2C19 genotypes have been linked to PPI exposure, in which lower exposure is associated with treatment failure while higher exposure is associated with improved efficacy. Higher exposure and long-term use of PPIs 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.
Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline as of August 2020:
Phenotype and Genotype
Implications
Recommendations
CYP2C19 ultrarapid metaboliser
Individuals carrying 2 increased functional alleles e.g. *17/*17
Decreased dexlansoprazole 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 dexlansoprazole 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 treatment of erosive oesophagitis. 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 dexlansoprazole 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 treatment of erosive oesophagitis. 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 dexlansoprazole 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 dexlansoprazole 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
Moderate (Child-Pugh class B): 30 mg once daily. Severe (Child-Pugh class C): Not recommended. Dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Administration
Dexlansoprazole May be taken with or without food. Swallow whole. May open cap & administer dispersed pellets w/o dissolving/chewing orally. Take immediately.
Contraindications
Concomitant use with rilpivirine-containing products.
Special Precautions
Patient with risk factors for hypomagnesaemia (e.g. hypoparathyroidism); risk of osteoporosis-related bone fractures. Symptomatic response to the treatment does not preclude the presence of gastric malignancy. CYP2C19 ultrarapid, rapid, normal, intermediate and poor metabolisers. Moderate to severe hepatic impairment. Children. Pregnancy and lactation.
Adverse Reactions
Significant:Clostridioides difficile-associated diarrhoea (CDAD); gastrointestinal infections (Salmonella, Campylobacter); subacute cutaneous lupus erythematosus (SCLE), 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, vitamin B12 deficiency (prolonged use); acute tubulointerstitial nephritis. Rarely, hypomagnesaemia (prolonged use). Ear and labyrinth disorders: Ear pain, tinnitus, vertigo. Gastrointestinal disorders: Diarrhoea, abdominal pain, nausea, vomiting, flatulence. Investigations: Increased ALT and AST, increased or decreased bilirubin. Musculoskeletal and connective tissue disorders: Arthralgia, muscle cramps, myalgia. Psychiatric disorders: Insomnia. Respiratory, thoracic and mediastinal disorders: URTI, nasopharyngitis. Skin and subcutaneous tissue disorders: Erythema, pruritus, rash, skin lesions, urticaria.
Monitor serum Ca and Mg levels. Assess for signs and symptoms of CDAD.
Overdosage
Symptoms: Hypertension, hot flushes, contusion, oropharyngeal pain and weight loss. Management: Symptomatic and supportive treatment.
Drug Interactions
May decrease serum concentration of rilpivirine, atazanavir and nelfinavir. May increase serum concentration of saquinavir, tacrolimus and digoxin. Increased INR and prothrombin time with warfarin. May diminish the therapeutic effect of clopidogrel. May increase and prolong the serum levels of methotrexate. May reduce absorption of medicines that depend on gastric pH for absorption (e.g. ketoconazole, itraconazole, dasatinib, erlotinib, Fe salts). May increase serum concentration with CYP2C19 inhibitors. May decrease serum concentration with strong CYP2C19 or 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 false-positive result in the diagnostic test for neuroendocrine tumours.
Action
Description: Mechanism of Action: Dexlansoprazole, an R-isomer of lansoprazole, is a proton pump inhibitor. It blocks the final step in gastric acid production by inhibition of (H+, K+)-adenosine triphosphatase (ATPase) enzyme system at the secretory surface of the gastric parietal cells, thereby reducing gastric acid secretion. Pharmacokinetics: Absorption: Time to peak plasma concentration: 1-2 hours (initial peak); 4-5 hours (second peak). Distribution: Volume of distribution: 40 L (symptomatic GERD). Plasma protein binding: 96-99%. Metabolism: Extensively metabolised in the liver via hydroxylation by CYP2C19 and via oxidation by CYP3A4, followed by reduction to sulfate, glucuronide and glutathione conjugates. Excretion: Via urine (approx 51% as metabolites); faeces (approx 48%). Elimination half-life: Approx 1-2 hours.
Chemical Structure
Dexlansoprazole Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 9578005, Dexlansoprazole. https://pubchem.ncbi.nlm.nih.gov/compound/Dexlansoprazole. Accessed May 27, 2025.
A02BC06 - dexlansoprazole ; 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 08/05/2025Annotation of FDA Label for Dexlansoprazole and CYP2C19. Pharmacogenomics Knowledgebase (PharmGKB). https://www.pharmgkb.org. Accessed 08/05/2025.Annotation of Swissmedic Label for Dexlansoprazole and CYP2C19. Pharmacogenomics Knowledgebase (PharmGKB). https://www.pharmgkb.org. Accessed 08/05/2025.Brayfield A, Cadart C (eds). Dexlansoprazole. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/05/2025.Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2C19 and Proton Pump Inhibitor Dosing. Clinical Pharmacogenetics Implementation Consortium (CPIC). https://cpicpgx.org. Accessed 08/05/2025.CYP2C19 - Dexlansoprazole. UpToDate Lexidrug, Pharmacogenomics Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 08/05/2025.Dexilant Capsule, Delayed Release (Takeda Pharmaceuticals America, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 08/05/2025.Dexilant Delayed-release Capsules 30 mg and 60 mg (Takeda Malaysia Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 08/05/2025.Dexlansoprazole Capsule, Delayed Release Pellets (Mylan Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 08/05/2025.Dexlansoprazole. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 08/05/2025.Dexlansoprazole. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 08/05/2025.
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