DEXILANT 60/MG CAP 28/CAP

Indications

Approved Uses

Healing of all grades of erosive esophagitis (EE), Maintenance of healed erosive esophagitis and relief of heartburn, Treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD).

Off-Label Uses

Off-label: H. pylori eradication as part of combination therapy; Zollinger-Ellison syndrome/other hypersecretory states; prevention/treatment of NSAID-associated ulcers; stress-ulcer prophylaxis in selected high-risk hospitalized/ICU patients (institution-dependent).

Dosage & Administration

Dosing by Condition

[Indication: Healing of Erosive Esophagitis
Dose: 60 mg once daily for up to 8 weeks, Indication: Maintenance of Healed Erosive Esophagitis
Dose: 30 mg once daily for up to 6 months, Indication: Symptomatic Non-Erosive GERD
Dose: 30 mg once daily for 4 weeks]

Initial Dose

60 mg once daily for healing of erosive esophagitis; 30 mg once daily for symptomatic GERD.

Maintenance Dose

30 mg once daily for maintenance of healed erosive esophagitis.

Maximum Dose

60 mg once daily

Children's Dosage

Not approved for children under 12 years. Adolescents 12-17 years: 30 mg once daily for symptomatic non-erosive GERD for 4 weeks (approved in the US); consult local prescribing information for Saudi Arabia authorization.

Dose Adjustment Notes

Hepatic impairment: no adjustment for mild (Child-Pugh A); for moderate (Child-Pugh B) the maximum recommended dose is 30 mg once daily (avoid 60 mg); severe (Child-Pugh C): use is not recommended/avoid due to lack of data. Renal impairment: no dose adjustment.

How to Take

Swallow capsule whole with water. Do not crush, chew, or split the capsule. Alternatively, the capsule may be opened and the intact granules sprinkled onto one tablespoon of applesauce and swallowed immediately without chewing. Can be taken with or without food.

Side Effects

Common Side Effects

Diarrhea, abdominal pain, nausea, vomiting, flatulence, upper respiratory tract infection.

Side Effect Frequency

Common (≥2%): diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, flatulence; no adverse reaction is consistently reported at >10% in adult trials.

Safety & Warnings

Age Restriction

Approved for patients ≥12 years; not established/approved for <12 years.

Driving Warning

Safe

Drug Interactions

Drug Interactions

Key interactions: contraindicated with rilpivirine; avoid/monitor with atazanavir or nelfinavir (reduced exposure), high-dose methotrexate (increased levels/toxicity-consider temporary PPI hold), warfarin (monitor INR), tacrolimus (monitor levels), digoxin (monitor-possible increased exposure), and drugs with pH-dependent absorption (e.g., ketoconazole/itraconazole, iron salts, erlotinib). Clopidogrel interaction is less clinically significant than with omeprazole/esomeprazole but caution/monitoring may be considered in high-risk patients.

Food Interaction

Can be taken without regard to food (with or without food).

Special Populations

Breastfeeding

Consult Doctor

Children

Not approved for children under 12 years. Adolescents 12-17 years: 30 mg once daily for symptomatic non-erosive GERD for 4 weeks (approved in the US); consult local prescribing information for Saudi Arabia authorization.

Elderly

Standard adult dosing. No substantial differences in safety and efficacy, but increased sensitivity cannot be ruled out.

Kidney Impairment

No adjustment needed.

Liver Impairment

Mild (Child-Pugh A): No adjustment needed. Moderate (Child-Pugh B): Consider a maximum daily dose of 30 mg. Severe (Child-Pugh C): Not recommended.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule-do not double doses.

Overdose

Overdose experience is limited; no specific toxidrome is expected-manage with symptomatic/supportive care; dexlansoprazole is not expected to be removed by hemodialysis; seek urgent medical attention/poison center guidance.

Patient Counseling

Take once daily with or without food; swallow capsule whole (do not crush/chew). If unable to swallow, open capsule and sprinkle granules on applesauce and swallow immediately without chewing. Report persistent/severe diarrhea, symptoms of low magnesium (cramps, palpitations), or new/unusual bone pain; inform clinicians about warfarin, tacrolimus, methotrexate, and HIV meds (rilpivirine/atazanavir). Long-term use may be associated with low magnesium and vitamin B12 deficiency and fracture risk-use the lowest effective dose and reassess need.

Pharmacology

Mechanism of Action

Proton pump inhibitor that irreversibly inhibits the gastric parietal cell H+/K+-ATPase, suppressing basal and stimulated acid secretion; Dexilant uses a dual delayed-release system producing two pH-dependent release phases to prolong acid suppression.

Onset of Action

Onset of acid suppression begins within a few hours after the first dose; dual absorption peaks occur at ~1-2 hours and ~4-5 hours, with maximal acid suppression typically achieved after 2-3 days of daily dosing.

Duration of Effect

Provides acid suppression for approximately 24 hours (up to 24 hours) due to the dual delayed-release formulation.

Half-Life

Terminal plasma half-life is about 1-2 hours (despite a longer pharmacodynamic effect).

Bioavailability

Approximately 50% (reported range ~30-57%, increasing with dose).

Metabolism

Extensively metabolized in the liver primarily by CYP2C19 and also by CYP3A4 to inactive metabolites (e.g., dexlansoprazole sulfone and 5-hydroxydexlansoprazole).

Product Information

Available Dosage Forms

Oral delayed-/prolonged-release capsules (Dexilant) in 30 mg and 60 mg strengths; no orally disintegrating tablet formulation for dexlansoprazole (Dexilant).

Composition per Dose

Each prolonged-release capsule: 60 mg dexlansoprazole (as dual delayed-release granules)

Generic Availability

Yes

Gi Condition

Acid Reflux/GERD

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