Dexlansoprazole
دکسلانزوپرازول
🍽️ Alimentary Tract And MetabolismProton-pump inhibitor
Market / country: 🇺🇸 USA
Dexilant (US)
🧮 Dose calculator
Erosive esophagitis (GERD) · Regimen source: FDA Dexilant · 2.1, Table 1
- • Without regard to food; swallow whole. Moderate hepatic impairment: 30 mg up to 8 weeks; severe not recommended. FDA Dexilant · 2FDA Dexilant · 2.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to any component (anaphylaxis, interstitial nephritis); rilpivirine-containing products. FDA Dexilant · 4
Warnings
- • Masking gastric malignancy; tubulointerstitial nephritis; C. difficile diarrhoea; bone fracture; lupus; vitamin B12 and magnesium deficiency with long use. FDA Dexilant · 5
Formulations
- 60 mg delayed-release capsule — capsule 🇺🇸 USA FDA Dexilant · 3
- 30 mg delayed-release capsule — capsule 🇺🇸 USA FDA Dexilant · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Dexilant · 8.1
“Risk Summary There are no studies with dexlansoprazole use in pregnant women to inform a drug-associated risk.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Dexilant · 8.2
“Risk Summary There is no information regarding the presence of dexlansoprazole in human milk, the effects on the breastfed infant, or the effects on milk production.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Dexilant · 8.4
“The safety and effectiveness of DEXILANT have been established in pediatric patients 12 years to 17 years of age for the healing of all grades of EE, the maintenance of healed EE and relief of heartburn, and treatment of heartburn associated with symptomatic non-erosive GERD.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Dexilant · 8.5
“Of the total number of patients (n=4,548) in clinical studies of DEXILANT, 11% of patients were aged 65 years and over, while 2% were 75 years and over.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)NDA022287
- DailyMed (FDA label)FDA Dexilant
- MedlinePlus (NIH)Dexlansoprazole
- WHO ATC/DDDA02BC06
- Darooyab (Iran)Dexlansoprazole
🇮🇷 Registered in Iran Darooyab · G-4911/Dexlansoprazole
Dosage forms with Iranian generic codes, per Darooyab.
- 53447 · DEXLANSOPRAZOLE 60 MG CAPSULE · کپسول دکسلانسوپرازول ۶۰ میلیگرم
- 53446 · DEXLANSOPRAZOLE 30 MG CAPSULE · کپسول دکسلانسوپرازول ۳۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Dexilant · 3FDA Dexilant · 2.1, Table 1FDA Dexilant · 2FDA Dexilant · 2.2FDA Dexilant · 4FDA Dexilant · 5FDA Dexilant · SPL approval / marketing categoryFDA Dexilant · 8.1FDA Dexilant · 8.2FDA Dexilant · 8.4FDA Dexilant · 8.5
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-4911/Dexlansoprazole
- Clinical review⚠ Unverified