Dexilant
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Dexilant
INDICATIONS
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
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.
- 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.
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 15-30°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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