DEXILANT 30/MG CAP 28/CAP

Indications

Approved Uses

Healing of erosive esophagitis (EE) (all grades); maintenance of healed EE and relief of heartburn; treatment of heartburn associated with symptomatic non-erosive GERD.

Dosage & Administration

Dosing by Condition

Healing of erosive esophagitis: 60 mg once daily for up to 8 weeks. Maintenance of healed erosive esophagitis: 30 mg once daily for up to 6 months. Symptomatic non-erosive GERD: 30 mg once daily for 4 weeks.

Initial Dose

30 mg once daily (non-erosive GERD and maintenance); 60 mg once daily (healing of erosive esophagitis)

Maintenance Dose

30 mg once daily for maintenance of healed erosive esophagitis.

Maximum Dose

60 mg once daily.

Children's Dosage

Approved for adolescents 12 years and older: 30 mg once daily for 4 weeks (symptomatic non-erosive GERD). Not approved for children under 12 years.

Dose Adjustment Notes

Moderate hepatic impairment (Child-Pugh Class B): Consider a maximum daily dose of 30 mg. Severe hepatic impairment (Child-Pugh Class C): Use is not recommended. No adjustment needed for renal impairment or mild hepatic impairment.

How to Take

Swallow capsule whole; do not chew/crush. May be taken with or without food. If unable to swallow, open capsule and sprinkle intact granules on one tablespoon of applesauce, swallow immediately without chewing; do not store mixture. May also be administered via nasogastric (NG) tube by opening capsule and mixing granules with water per labeling instructions.

Safety & Warnings

Age Restriction

Not approved for children under 12 years.

Drug Interactions

Food Interaction

No clinically meaningful food restriction; can be taken with or without food.

Special Populations

Children

Approved for adolescents 12 years and older: 30 mg once daily for 4 weeks (symptomatic non-erosive GERD). Not approved for children under 12 years.

Elderly

Standard adult dosing. No dose adjustment is necessary based on age alone, but a daily dose of 60 mg should not be exceeded unless there are compelling clinical indications.

Liver Impairment

Mild hepatic impairment (Child-Pugh A): no adjustment. Moderate impairment (Child-Pugh B): maximum 30 mg once daily. Severe impairment (Child-Pugh C): not recommended/avoid (insufficient data).

Pharmacology

Mechanism of Action

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

Onset of Action

Symptom relief/acid suppression can begin within hours after the first dose; peak plasma concentrations occur twice (about 1-2 hours and ~4-5 hours) due to dual delayed-release; maximal acid suppression typically occurs after several days of daily dosing.

Duration of Effect

Up to 24 hours of acid suppression with once-daily dosing (dual delayed-release formulation).

Metabolism

Extensively hepatic metabolism primarily via CYP2C19 and CYP3A4 to inactive metabolites.

Product Information

Available Dosage Forms

Delayed-release (prolonged-release) oral capsule only for this product (DEXILANT 30 mg prolonged-release capsule).

Composition per Dose

Each prolonged-release capsule: 30 mg dexlansoprazole (as dual delayed-release granules)

Gi Condition

Acid Reflux/GERD

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