Dexlansoprazole
DEXILANT
What it isProton pump inhibitor with dual delayed release; GERD and erosive esophagitis.
Why this oneTwo release phases give a second peak, so it can be taken without regard to meals, unlike other PPIs.
What limits itLong-term use can deplete magnesium and vitamin B12 and raise fracture risk; CYP2C19 interactions remain.
FDA-approved for
- GERD (2009)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Healing of erosive esophagitis | ≥12 yr | 60 mg QD | 60 mg QD | 60 mg QD (up to 8 weeks) |
| Maintenance of healed EE / relief of heartburn | ≥12 yr | 30 mg QD | 30 mg QD | 30 mg QD |
| Symptomatic non-erosive GERD | ≥12 yr | 30 mg QD | 30 mg QD | 30 mg QD (4 weeks) |
Renal Undefined
Hepatic Moderate impairment (Child-Pugh B): max 30 mg QD for EE healing; not recommended in severe impairment (Child-Pugh C).
Instructions
- Take without regard to food
- Swallow whole; do not chew
- May open capsule and sprinkle intact granules on applesauce (see full PI for alternatives)
Contraindications
- Concomitant use with rilpivirine-containing products
Cautions
- Symptomatic response does not preclude gastric malignancy
- Acute tubulointerstitial nephritis; discontinue if it occurs
- Clostridioides difficile-associated diarrhea
- Bone fracture risk with long-term/high-dose PPI use
- Severe cutaneous adverse reactions; cutaneous/systemic lupus erythematosus
- Vitamin B12 deficiency, hypomagnesemia with prolonged use
Adverse reactions
- Diarrhea
- Abdominal pain
- Nausea
- Upper respiratory tract infection
- Vomiting
- Flatulence
Pregnancy No human studies; animal data suggest possible adverse effects on fetal bone growth/development.
Lactation No data on presence in human milk; lansoprazole present in rat milk.
NO BOXED WARNINGS
Principal riskLong-term use: B12 deficiency, hypomagnesemia, fracture
Cost, est. cash$200–$1,200/month
Generic entry2017
Classes and tags
Clinical profile
Legacy pregnancy categoryB
Defining liabilityLong-term infection, magnesium/B12 and bone risks; selected agents have clinically important CYP interactions.
Mechanism of action: Dexlansoprazole ballicule
