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Dexilant

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Dexilant and Dexilant SoluTabs




Indications
Dosage
How Supplied

INDICATIONS

Healing of Erosive Esophagitis

DEXILANT delayed-release capsules (DEXILANT capsules) are indicated in adults for healing of all grades of erosive esophagitis (EE) for up to eight weeks.

Maintenance Of Healed Erosive Esophagitis

DEXILANT capsules and DEXILANT SoluTab delayed-release orally disintegrating tablets (DEXILANT SoluTab) are indicated in adults to maintain healing of EE and relief of heartburn for up to six months.

Symptomatic Non-Erosive Gastroesophageal Reflux Disease

DEXILANT capsules and DEXILANT SoluTab are indicated in adults for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.

DOSAGE AND ADMINISTRATION

Recommended Adult Dosage

Two 30 mg DEXILANT SoluTab are not interchangeable with one 60 mg DEXILANT capsule [see CLINICAL PHARMACOLOGY].

Table 1: DEXILANT Capsules Adult Dosing Recommendations

Indication Recommended Dosage Regimen
Healing of EE One 60 mg capsule once daily for up to 8 weeks
Maintenance of Healed EE and Relief of Heartburn One 30 mg capsule once daily*
Symptomatic Non-Erosive GERD One 30 mg capsule daily for 4 weeks
*Controlled studies did not extend beyond 6 months.

Table 2: DEXILANT SoluTab Adult Dosing Recommendations

Indication Recommended Dosage Regimen
Maintenance of Healed EE and Relief of Heartburn One 30 mg tablet once daily*
Symptomatic Non-Erosive GERD One 30 mg tablet once daily for 4 weeks
*Controlled studies did not extend beyond 6 months.

Dosage Adjustment In Adults With Hepatic Impairment For The Healing Of EE

For adult patients with moderate hepatic impairment (Child-Pugh Class B), the recommended dosage is 30 mg DEXILANT capsule or DEXILANT SoluTab once daily for up to 8 weeks. The use of DEXILANT capsule or DEXILANT SoluTab is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) [see Use in Specific Populations].

Important Administration Information

  • 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.
DEXILANT Capsules
  • Take without regard to food.
  • Swallow whole; do not chew.
  • For patients who have trouble swallowing capsules, DEXILANT capsules can be opened and administered with applesauce as follows:
  1. Place one tablespoonful 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.
  • Alternatively, the capsule can be administered with water via oral syringe or nasogastric (NG) tube.

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 NG 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 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.
  4. Refill the catheter-tip syringe with 10 mL of water, swirl gently, and flush the tube.
  5. Refill the catheter-tip syringe again with 10 mL of water, swirl gently, and administer.
DEXILANT SoluTab
  • Take at least 30 minutes before a meal.
  • Do not break or cut.
  • Place the tablet on the tongue, allow it to disintegrate, and swallow the microgranules without water. Do not chew the microgranules.
  • May also be swallowed whole with water.
  • Avoid use of alcohol when taking DEXILANT SoluTab [see DRUG INTERACTIONS].

Alternatively, the tablet can be administered with water via oral syringe or NG tube (see below).

Administration with Water in an Oral Syringe

  1. Place one tablet in an oral syringe and draw up 20 mL of water.
  2. Swirl gently to allow for a quick dispersal.
  3. After the tablet has dispersed, administer the contents immediately into the mouth. Do not save the water and microgranule mixture for later use.
  4. Refill the syringe with approximately 10 mL of water, swirl gently, and administer any remaining contents.
  5. Refill the syringe again with approximately 10 mL of water, swirl gently, and administer any remaining contents.

Administration with Water via a NG Tube ( ≥ 8 French)

  1. Place one tablet in a catheter-tip syringe and draw up 20 mL of water.
  2. Shake gently to allow for a quick dispersal.
  3. After the tablet has dispersed, swirl the catheter-tip syringe gently in order to keep the microgranules from settling, and immediately inject the mixture through the NG tube into the stomach. Do not save the water and microgranule mixture for later use.
  4. Refill the catheter-tip syringe with approximately 10 mL of water, shake gently, and flush the tube.
  5. Refill the catheter-tip syringe again with 10 mL of water, swirl gently, and administer.

HOW SUPPLIED

Dosage Forms And Strengths

DEXILANT Delayed-release Capsules
  • 30 mg: strength is an opaque, blue and gray capsule imprinted with TAP and “30”.
  • 60 mg: strength is an opaque, blue capsule imprinted with TAP and “60”.
DEXILANT SoluTab Delayed-release Orally Disintegrating Tablets
  • 30 mg: strength is a white to yellowish-white, round, tablet containing orange to dark brown speckles, with “D30” debossed on one side.

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

DEXILANT SoluTab delayed-release orally disintegrating tablets, 30 mg, are white to yellowish-white, round, tablets containing orange to dark brown speckles, with “D30” debossed on one side and supplied as:

NDC Number Size
64764-177-11 Unit dose package of 100

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].

Distributed by: Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015. Revised: Jan 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/7/2016

Indications
Dosage
How Supplied

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