Dexlansoprazole
Regulatory sources consulted
- Clinical Pharmacology Knowledge
- General Drug Information Databases
- RxNorm rxcui 816346 ↗
Approved indications
- Healing of all grades of erosive esophagitis (EE) for up to 8 weeks.
- Maintenance of healed erosive esophagitis and relief of heartburn for up to 6 months.
- Treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for 4 weeks.
Contraindications
Absolute
- Known hypersensitivity to dexlansoprazole or any component of the formulation.
- Concomitant use with rilpivirine-containing products.
Clinical warnings
- Long-term PPI therapy may be associated with an increased risk of osteoporosis-related bone fractures, especially at high doses or for over one year. — Clinical Knowledge
- Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of PPIs. Consider CDAD diagnosis in patients with persistent diarrhea. — Clinical Knowledge
- Hypomagnesemia, symptomatic and asymptomatic, has been rarely reported in patients treated with PPIs for at least three months. — Clinical Knowledge
Drug interactions
- HighRilpivirineJ05AG05
Mechanism: Increased gastric pH by dexlansoprazole significantly reduces rilpivirine absorption, which may lead to loss of virologic response and possible resistance.
Recommendation: Concomitant use is contraindicated.
Clinical Pharmacology Knowledge
- ModerateMethotrexateL01BA01
Mechanism: Concomitant use of PPIs with methotrexate (primarily at high doses) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to toxicities.
Recommendation: For patients receiving high-dose methotrexate, a temporary withdrawal of dexlansoprazole therapy may be considered.
Clinical Pharmacology Knowledge
- ModerateClopidogrelB01AC04
Mechanism: Dexlansoprazole is metabolized by CYP2C19. Although considered to have a weaker inhibitory effect than omeprazole, it could reduce the conversion of clopidogrel to its active metabolite, decreasing its antiplatelet effect.
Recommendation: The need for co-administration should be evaluated. Monitor clinical response. The clinical relevance of this interaction is debated.
Clinical Pharmacology Knowledge
Adverse events
Common (≥1%)
diarrhea · abdominal pain · nausea · headache · flatulence · upper respiratory tract infection
Rare but serious
acute interstitial nephritis · hypomagnesemia · cutaneous and systemic lupus erythematosus · severe cutaneous adverse reactions (SJS/TEN) · rhabdomyolysis
Pregnancy and lactation
FDA category: B (historical)
There are no adequate and well-controlled studies in pregnant women. Animal studies have not shown a fetal risk. Use during pregnancy only if clearly needed. It is not known whether it is excreted in human milk.