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Healing of Erosive Esophagitis
DEXILANT is indicated for healing of all grades of erosive esophagitis (EE) for up to 8 weeks.
Maintenance of Healed Erosive Esophagitis
DEXILANT is indicated to maintain healing of EE and relief of heartburn for up to 6 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 4 weeks.
DOSAGE AND ADMINISTRATION
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
|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.|
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.
- Alternatively, DEXILANT capsules
can be administered as follows:
- Open capsule;
- Sprinkle intact granules on one tablespoon of applesauce;
- Swallow immediately. Granules should not be chewed.
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:
|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:
|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 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Distributed by : Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015. Revised: September 2012
Last reviewed on RxList: 10/15/2012
This monograph has been modified to include the generic and brand name in many instances.
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