DEXILANT DELAYED RELEASE CAPSULE 60mg

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

Therapeutic

Prescription Only

CAPSULE, DELAYED RELEASE

**2 DOSAGE AND ADMINISTRATION** **2.1 Recommended Dose** DEXILANT is available as capsules in 30 mg and 60 mg strengths for adults and in adolescents 12 to 17 years of age. Directions for use in each indication are summarized in Table 1.  **2.2 Special Patient Populations** **Elderly Patients** No dosage adjustment is necessary for elderly patients. **Pediatric Patients** The safety and efficacy of dexlansoprazole in children under 12 years of age have not been established. **Impaired Renal Function** No dosage adjustment is necessary for patients with renal impairment _\[see Clinical Pharmacology (11.3)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. **Hepatic Impairment** No adjustment for DEXILANT is necessary for patients with mild hepatic impairment (Child-Pugh Class A). Consider a maximum daily dose of 30 mg for patients with moderate hepatic impairment (Child-Pugh Class B). No studies have been conducted in patients with severe hepatic impairment (Child-Pugh Class C) _\[see Use in Specific Populations (8.7) and Clinical Pharmacology (11.3)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_. **2.3 Important Administration Information** DEXILANT can be taken without regard to food or timing of food. DEXILANT can be swallowed whole. DEXILANT should not be chewed. - For patients who have difficulty swallowing capsules, follow the instructions below for administration: _Administration with Applesauce_ 1. Place one tablespoon into a clean container 2. Open capsule 3. Sprinkle intact granules on apple sauce 4. Swallow applesauce and granules immediately. Do not chew granules. Do not save the applesauce and granules for later use. _Administration with Water in an Oral Syringe_ 1. Open the capsule and empty the granules into a clean container with 20 mL of water. 2. Withdraw the entire mixture into a syringe. 3. Gently swirl the syringe in order to keep granules from settling. 4. Administer the mixture immediately into the mouth. Do not save the water and granule mixture for later use. 5. Refill the syringe with 10 mL of water, swirl gently, and administer. 6. Refill the syringe again with 10 mL of water, swirl gently, and administer. _Administration with Water via a Nasogastric Tube (≥16 French)_ 1. Open the capsule and empty the granules into a clean container with 20 mL of water. 2. Withdraw the entire mixture into a catheter-tip syringe. 3. Swirl the syringe gently in order to keep the granules from settling, and immediately inject the mixture through the nasogastric tube into the stomach. Do not save the water and granule mixture for later use. 4. Refill the syringe with 10 mL of water, swirl gently, and flush the tube. 5. Refill the syringe again with 10 mL of water, swirl gently, and administer.