Dexlansoprazole Dosing and Treatment Duration for GERD
For patients 12 years and older with GERD, use dexlansoprazole 60 mg once daily for up to 8 weeks to heal erosive esophagitis, then 30 mg once daily for maintenance therapy (up to 6 months in adults, 16 weeks in adolescents 12-17 years), or 30 mg once daily for 4 weeks for symptomatic non-erosive GERD. 1
Dosing by Indication
Healing of Erosive Esophagitis
- 60 mg once daily for up to 8 weeks in patients ≥12 years of age 1
- This dosage achieved complete healing in ≥92% of patients with all grades of erosive esophagitis and was noninferior to lansoprazole 30 mg once daily 2
- Pharmacokinetic studies confirm similar exposure in adolescents (12-17 years) compared to adults, supporting this dosing 3
Maintenance of Healed Erosive Esophagitis
- 30 mg once daily for patients ≥12 years of age 1
- Duration: up to 6 months in adults; up to 16 weeks in adolescents 12-17 years 1
- This regimen was significantly more effective than placebo in maintaining healing at 6 months (73-81% sustained remission) 2, 4
- The 30 mg maintenance dose provides persistent symptom control with fewer days experiencing reflux symptoms compared to other PPIs 5
Symptomatic Non-Erosive GERD
- 30 mg once daily for 4 weeks in patients ≥12 years of age 1
- This dosage significantly increased the proportion of 24-hour heartburn-free days compared to placebo 2, 4
- Asian population data shows median 26.9% of days without 24-hour heartburn/regurgitation symptoms and 59.3% without nighttime symptoms 6
Administration Guidelines
Timing and Food
- Take without regard to food 1
- Unlike most PPIs that require dosing 30-60 minutes before meals 7, dexlansoprazole's dual delayed-release formulation allows flexible timing 4
- The dual delayed-release system provides prolonged mean residence time (5.56-6.43 hours vs 2.83-3.23 hours for lansoprazole) 4
For Patients with Swallowing Difficulties
- Capsules can be opened and administered with applesauce, via oral syringe with water, or through NG tube (≥16 French) 1
- Do not chew granules; swallow immediately after mixing 1
Special Populations
Hepatic Impairment
- Moderate impairment (Child-Pugh Class B): Reduce to 30 mg once daily for up to 8 weeks when treating erosive esophagitis 1
- Severe impairment (Child-Pugh Class C): Not recommended 1
Pediatric Considerations
- No pediatric indication for children <12 years 7, 1
- For adolescents 12-17 years, use adult dosing but limit maintenance therapy to 16 weeks rather than 6 months 1
Clinical Context and Positioning
When to Consider Dexlansoprazole
- Inadequate response to standard once-daily PPIs: Dexlansoprazole's extended-release formulation may be switched to when standard PPIs fail 7
- The 2022 AGA guidelines specifically mention dexlansoprazole as a more effective acid suppressive agent option alongside PPIs less metabolized through CYP2C19 7
- Comparative data shows fewer days with reflux symptoms over 24 weeks versus esomeprazole (37.3 vs 53.9 days; P=0.008) 5
Long-Term Management Strategy
- Initial 4-8 week trial: Assess response and titrate to lowest effective dose 7
- Continuous daily dosing is required for patients with healed erosive esophagitis; on-demand therapy results in high recurrence rates of erosive disease 7
- For non-erosive GERD, on-demand therapy may be reasonable after initial healing 7
- Patients on chronic PPI therapy should have appropriateness evaluated within 12 months, potentially with endoscopy and pH monitoring off PPI 7
Safety Profile
- Well tolerated with low incidence of treatment-related adverse events (5.7-6.7%) 6
- Common adverse events include headaches, diarrhea, constipation, and nausea in up to 14% of patients 7
- All adverse events in adolescent studies were mild severity 3
- General PPI safety concerns apply, though routine bone density studies, calcium supplementation, or H. pylori screening are not recommended based on PPI use alone 7