DEXILANT is available as capsules in 30 mg and 60 mg strengths for adult use and patients 12 years of age and older. Directions for use in each indication are summarized in Table 9. (See Table 9.)
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No dosage adjustment for DEXILANT is necessary for patients with mild hepatic impairment (Child-Pugh Class A). DEXILANT 30 mg should be considered 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).
No dosage adjustment is necessary for elderly patients or for patients with renal impairment. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Missed Dose: If a capsule is missed at its usual time, it should be taken as soon as possible. But if it is too close to the time of the next dose, only the prescribed dose should be taken at the appointed time. A double dose should not be taken.
MODE OF ADMINISTRATION: DEXILANT can be taken without regard to food.
DEXILANT should be swallowed whole.
DEXILANT should not be chewed.
For patients who have difficulty swallowing capsules, follow the instructions as follows for administration: 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 administer.
5. Refill the syringe again with 10 mL of water, swirl gently, and administer.