Dexlansoprazole

What it is and how it works

Mechanism of Action Dexlansoprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the (H + , K + )-ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, dexlansoprazole has been characterized as a gastric proton-pump inhibitor, in that it blocks the final step of acid production.

Mechanism class: Proton Pump Inhibitors

Indications

Dexlansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: • Healing of all grades of erosive esophagitis (EE). • Maintenance of healed EE and relief of heartburn. • Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). Healing of Erosive Esophagitis Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (EE) for up to eight weeks. Maintenance of Healed Erosive Esophagitis and Relief of Heartburn Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older to maintain healing of EE and relief of heartburn for up to six months in adults and 16 weeks in patients 12 to 17 years of age. Treatment of Symptomatic Non-Erosive Gastroesophageal Reflux Disease Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.

Dosage and administration (summary)

Recommended dosage in patients 12 years of age and older: • See full prescribing information for complete dosing information for dexlansoprazole delayed-release capsules by indication and age group and dosage adjustment in patients with hepatic impairment. ( 2.1 , 2.2 ) Administration Instructions : • Take without regard to food. • Swallow whole; do not chew. • See full prescribing information for alternative administration options. Recommended Dosage in Patients 12 Years of Age and Older Table 1.

Contraindications

• Dexlansoprazole delayed-release capsules are contraindicated in patients with known hypersensitivity to any component of the formulation . Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis and urticaria . • PPIs, including dexlansoprazole delayed-release capsules, are contraindicated with rilpivirine-containing products . • Patients with known hypersensitivity to any component of the formulation.

Warnings and precautions

• Gastric Malignancy: In adults, symptomatic response with dexlansoprazole does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. • Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients. • Clostridium difficile -Associated Diarrhea: PPI therapy may be associated with increased risk. • Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine.

Pregnancy

Pregnancy Risk Summary There are no studies with dexlansoprazole use in pregnant women to inform a drug-associated risk. Dexlansoprazole is the R-enantiomer of lansoprazole, and published observational studies of lansoprazole use during pregnancy did not demonstrate an association of adverse pregnancy-related outcomes with lansoprazole ( see Data )…

Storage and supply

Dexlansoprazole delayed-release capsules 30 mg, are lite green opaque cap and reddish brown opaque body size ‘3’ cellulose capsule shell, imprinted with ‘A361’ on cap in black ink and filled with white to grey colored pellets.

Source: Dexlansoprazole (Dexlansoprazole) — US FDA prescribing information, 2025-11-19, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.