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Dexilant

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Dexilant

Indications
Dosage
How Supplied

INDICATIONS

Healing of Erosive Esophagitis

DEXILANT is indicated for healing of all grades of erosive esophagitis (EE) for up to eight weeks.

Maintenance of Healed Erosive Esophagitis

DEXILANT is indicated to maintain healing of EE and relief of heartburn for up to six months.

Symptomatic Non-Erosive Gastroesophageal Reflux Disease

DEXILANT is indicated for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.

DOSAGE AND ADMINISTRATION

Recommended Dose

DEXILANT is available as capsules in 30 mg and 60 mg strengths for adult use. Directions for use in each indication are summarized in Table 1.

Table 1: DEXILANT Dosing Recommendations

Indication Recommended Dose Frequency
Healing of EE 60 mg Once daily for up to 8 weeks
Maintenance of Healed EE and relief of heartburn 30 mg Once daily*
Symptomatic Non-Erosive GERD 30 mg Once daily for 4 weeks
*Controlled studies did not extend beyond 6 months.

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 and CLINICAL PHARMACOLOGY].

Important Administration Information

  • 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 below for administration:

Administration with Applesauce
  1. Place one tablespoon of applesauce into a clean container.
  2. Open capsule.
  3. Sprinkle intact granules on applesauce.
  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 mixturer mixture for later use.
  5. Refill the syringe with 10Refill 10 mL of water, swirl gently, and administer.
  6. Refill the syringe again Refill again with 10 mL of water, swirl gently, and administer.
Administration with Water via a Nasogastric Tubnistration 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.

HOW SUPPLIED

Dosage Forms And Strengths

  • 30 mg delayed-release capsules are opaque, blue and gray with TAP and “30” imprinted on the capsule.
  • 60 mg delayed-release capsules are opaque, blue with TAP and “60” imprinted on the capsule.

Storage And Handling

DEXILANT delayed-release capsules, 30 mg, are opaque, blue and gray with TAP and “30” imprinted on the capsule and supplied as:

NDC Number Size
64764-171-11 Unit dose package of 100
64764-171-30 Bottle of 30
64764-171-90 Bottle of 90
64764-171-19 Bottle of 1000

DEXILANT delayed-release capsules, 60 mg, are opaque, blue with TAP and “60” imprinted on the capsule and supplied as:

NDC Number Size
64764-175-11 Unit dose package of 100
64764-175-30 Bottle of 30
64764-175-90 Bottle of 90
64764-175-19 Bottle of 1000

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

Distributed by: Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015. Revised: August 2013

Last reviewed on RxList: 9/4/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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