DEXILANT Delayed-release capsules Ref.[10006] Active ingredients: Dexlansoprazole

2.1 Recommended Dosage in Patients 12 Years of Age and Older

Table 1. Recommended DEXILANT Capsules Dosage Regimen by Indication in Patients 12 Years of Age and Older:

2.2 Dosage Adjustment in Patients with Hepatic Impairment for the Healing of Erosive Esophagitis

For patients with moderate hepatic impairment (Child-Pugh Class B), the recommended dosage is 30 mg DEXILANT once daily for up to eight weeks. DEXILANT is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) [see Use in Specific Populations (8.6)].

2.3 Important Administration Information

• Take without regard to food.
• Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose.
• Swallow whole; do not chew.
• For patients who have trouble swallowing capsules, DEXILANT capsules can be opened and administered with applesauce as follows:
  • Place one tablespoonful of applesauce into a clean container.
  • Open capsule.
  • Sprinkle intact granules on applesauce.
  • Swallow applesauce and granules immediately. Do not chew granules. Do not save the applesauce and granules for later use.
• Alternatively, the capsule can be administered with water via oral syringe or nasogastric (NG) tube.

Administration with Water in an Oral Syringe:

• • Open the capsule and empty the granules into a clean container with 20 mL of water.
  • Withdraw the entire mixture into a syringe.
  • Gently swirl the syringe in order to keep granules from settling.
  • Administer the mixture immediately into the mouth. Do not save the water and granule mixture for later use.
  • Refill the syringe with 10 mL of water, swirl gently, and administer.
  • Refill the syringe again with 10 mL of water, swirl gently, and administer.Administration with Water via a NG Tube (≥16 French)
  • Open the capsule and empty the granules into a clean container with 20 mL of water.
  • Withdraw the entire mixture into a catheter-tip syringe.
  • Swirl the catheter-tip syringe gently in order to keep the granules from settling, and immediately inject the mixture through the NG tube into the stomach. Do not save the water and granule mixture for later use.
  • Refill the catheter-tip syringe with 10 mL of water, swirl gently, and flush the tube.
  • Refill the catheter-tip syringe again with 10 mL of water, swirl gently, and administer.

There have been no reports of significant overdose with DEXILANT. Multiple doses of DEXILANT 120 mg and a single dose of DEXILANT 300 mg did not result in death or other severe adverse events. However, serious adverse events of hypertension have been reported in association with twice daily doses of DEXILANT 60 mg. Nonserious adverse reactions observed with twice daily doses of DEXILANT 60 mg include hot flashes, contusion, oropharyngeal pain, and weight loss. Dexlansoprazole is not expected to be removed from the circulation by hemodialysis.

In the event of over-exposure, treatment should be symptomatic and supportive.

If over-exposure occurs, call your poison control center at 1-800-222-1222 for current information on the management of poisoning or over-exposure.

Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].