Dexlansoprazole

What it is used for

Dexlansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: Healing of all grades of erosive esophagitis (EE). Maintenance of healed EE and relief of heartburn. Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). 1.1 Healing of Erosive Esophagitis Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (EE) for up to eight weeks.

1.2 Maintenance of Healed Erosive Esophagitis and Relief of Heartburn Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older to maintain healing of EE and relief of heartburn for up to six months in adults and 16 weeks in patients 12 to 17 years of age. 1.3 Treatment of Symptomatic Non-Erosive Gastroesophageal Reflux Disease Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.

Storing it

• Store dexlansoprazole delayed-release capsules at room temperature between 68°F to 77°F (20°C to 25°C). Keep dexlansoprazole delayed-release capsules and all medicines out of the reach of children. This Instructions for Use has been approved by the U.S. Food and Drug Administration. All other trademark names are the property of their respective owners. Manufactured by: Alembic Pharmaceuticals Limited Formulations Division IV, Jarod 391510, Gujarat, India Revised: 03/2025

More about this medicine

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 03/2025

INSTRUCTIONS FOR USE Dexlansoprazole (DEX lan SOE pra zole) Delayed-Release Capsules, for oral use

Taking dexlansoprazole delayed-release capsules with applesauce: 1. Place 1 tablespoon of applesauce into a clean container. 2. Carefully open the capsule and sprinkle the pellets onto the applesauce. 3. Swallow the applesauce and pellets right away. Do not chew the pellets.

Do not save the applesauce and pellets for later use. Giving dexlansoprazole delayed-release capsules with water using an oral syringe: 1. Place 20 mL of water into a clean container. 2. Carefully open the capsule and empty the pellets into the container of water. 3. Use an oral syringe to draw up the water and pellet mixture. 4. Gently swirl the oral syringe to keep the pellets from settling. 5. Place the tip of the oral syringe in your mouth. Give the medicine right away. Do not save the water and pellet mixture for later use. 6. Refill the syringe with 10 mL of water and swirl gently. Place the tip of the oral syringe in your mouth and give the medicine that is left in the syringe. 7. Repeat step 6.

Giving dexlansoprazole delayed-release capsules with water through a nasogastric tube (NG tube): For people who have an NG tube that is size 16 French or larger, dexlansoprazole delayed-release capsules may be given as follows: 1. Place 20 mL of water into a clean container. 2. Carefully open the capsule and empty the pellets into the container of water. 3. Use a 60 mL catheter-tip syringe to draw up the water and pellet mixture. 4. Gently swirl the catheter-tip syringe to keep the pellets from settling. 5. Connect the catheter-tip syringe to the NG tube. 6. Give the mixture right away through the NG tube that goes into the stomach. Do not save the water and pellet mixture for later use. 7. Refill the catheter-tip syringe with 10 mL of water and swirl gently. Flush the NG tube with the water. 8. Repeat step 7.