Generic Name

dual‑delayed‑release

Mechanism

• The dual‑delayed‑release formulation delivers two distinct pharmacokinetic profiles, ensuring both early and sustained plasma levels.
• Dexlansoprazole irreversibly inhibits the gastric H⁺/K⁺ ATPase (proton pump) on parietal‑cell membranes, blocking acid secretion from the moment the pump is activated.
• Inhibition lasts for the life of the proton pump, permitting once‑daily dosing for gastric acid‑related disorders.

Pharmacokinetics

• Absorption: Variable oral bioavailability (∼15 %) with a dual‑delayed release: ~60 % released within 1 h, the remainder at 4–6 h post‑dose.
• Distribution: Highly protein‑bound (≈97 %).
• Metabolism: Primarily hepatic via CYP2C19 (35 %) and CYP3A4 (55 %); minor CYP2D6 contribution.
• Elimination: Renal and fecal pathways; half‑life 1–1.5 h in plasma, but acid‑suppression effect persists >24 h.
• Drug interactions: Low potential; minimal P‑gp inhibition; significant interactions only with strong CYP2C19 or CYP3A4 inhibitors/inducers altering exposure.

Indications

• Erosive esophagitis – 30 mg once daily (OD) for 4–8 wk, 60 mg OD for healing.
• Maintenance of healing – 30 mg OD (≤30 wk) or 60 mg OD (≤12 mo) for erosive esophagitis.
• GERD (Gastro‑Esophageal Reflux Disease) – 30 mg OD in most patients; 60 mg OD for moderate‑severe disease.
• Zollinger‑Ellison Syndrome – 60 mg bid (≤16 wk) for acid‑hypersecretion.
• H. pylori eradication – 30 mg bid (≤14 wk) in combination regimens.

Contraindications

• Contraindications: Known hypersensitivity to dexlansoprazole or any PPI component.
• Warnings
• Bone health: Long‑term use (≥12 mo) may increase fracture risk.
• Electrolyte & nutrient deficiencies: Chronic hypomagnesemia, B12 malabsorption.
• Infection risk: Small‑intestine bacterial overgrowth, Clostridioides difficile colitis.
• Drug‑drug interactions: Co‑administration with drugs requiring a protonic environment for absorption (e.g., ketoconazole, itraconazole, atazanavir) may reduce efficacy.
• Pregnancy/Lactation: Category B; limited data.

Dosing

• Administer 30 min before a meal.
• Can be taken with or without food, but consistency with dosing relative to meals improves adherence.
• CYP2C19 ultra‑rapid metabolizers may consider 60 mg bid for full acid suppression.

Monitoring

• Baseline: CBC, CMP, electrolytes (Mg²⁺, Ca²⁺), serum B12 if chronic PPI use >1 yr.
• During therapy:
• Monitor symptom resolution within 2–4 wk for erosive esophagitis/GERD.
• Repeat magnesium levels every 3–6 mo for long‑term users.
• Bone densitometry if >4 yr therapy or additional osteoporosis risk factors.
• Adverse reaction vigilance: prompt evaluation of severe abdominal pain, watery diarrhea, or new-onset dyspnea.

Clinical Pearls

• Dual‑delayed release: Designed to avoid “dose dumping” and optimize intragastric pH for up to 24 h, offering superior symptom control versus first‑generation PPIs in many patients.
• Once‑daily dosing improves adherence in outpatient GERD management.
• Rapid onset: Effective after the first dose – helpful for acute symptom rescue but not for prophylaxis of stress‑ulcers in high‑risk surgical patients (use H₂ blockers or sotaloloprin).
• Reduced drug‑drug interactions: Minimal P‑gp inhibition means fewer concerns when co‑administered with statins, methotrexate, or warfarin.
• Dose adjustments: For patients on strong CYP2C19 inhibitors (e.g., fluconazole), a 30 mg BID may be considered to counter reduced bioavailability.
• Use in H. pylori: Though once-daily dosing is typical for PPIs in eradication regimens, dexlansoprazole can be safely given BID with 30 mg each dose, matching other PPIs and not compromising treatment efficacy.

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