INDICATIONS AND USAGE

DEXILANT is a proton pump inhibitor (PPI) indicated for:

• Healing of all grades of erosive esophagitis (EE). (1.1)
• Maintaining healing of EE. (1.2)
• Treating heartburn associated with non-erosive gastroesophageal reflux disease (GERD). (1.3)

DOSAGE AND ADMINISTRATION

• Healing of EE: 60 mg once daily for up to 8 weeks. (2.1)
• Maintenance of healed EE: 30 mg once daily for up to 6 months. (2.1)
• Symptomatic non-erosive GERD: 30 mg once daily for 4 weeks. (2.1)
• Hepatic impairment: Consider 30 mg maximum daily dose for patients with moderate hepatic impairment (Child-Pugh Class B). No studies were conducted in patients with severe hepatic impairment (Child-Pugh Class C). (2.2, 8.7)
• DEXILANT can be taken without regard to food. (2.3)
• DEXILANT should be swallowed whole. Alternatively, capsules can be opened, sprinkled on one tablespoon of applesauce, and swallowed immediately. (2.3)

DOSAGE FORMS AND STRENGTHS

Capsules: 30 mg and 60 mg. (3)

CONTRAINDICATIONS

Patients with known hypersensitivity to any component of the formulation. (4)

WARNINGS AND PRECAUTIONS

Gastric malignancy: Symptomatic response with DEXILANT does not preclude the presence of gastric malignancy. (