Kapidex
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Kapidex Delayed Release Capsules
INDICATIONS
Healing of Erosive Esophagitis
KAPIDEX (dexlansoprazole delayed release capsules) is indicated for healing of all grades of erosive esophagitis (EE) for up to 8 weeks.
Maintenance of Healed Erosive Esophagitis
KAPIDEX (dexlansoprazole delayed release capsules) is indicated to maintain healing of EE for up to 6 months.
Symptomatic Non-Erosive Gastroesophageal Reflux Disease
KAPIDEX (dexlansoprazole delayed release capsules) is indicated for the treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks.
DOSAGE AND ADMINISTRATION
Recommended Dose
KAPIDEX (dexlansoprazole delayed release capsules) 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: KAPIDEX (dexlansoprazole delayed release capsules) Dosing Recommendations
| Indication | Recommended Dose | Frequency |
| Healing of EE | 60 mg | Once daily for up to 8 weeks |
| Maintenance of Healed EE | 30 mg | Once daily* |
| Symptomatic Non -Erosive GERD | 30 mg | Once daily for 4 weeks |
| *Controlled studies did not extend beyond 6 months. | ||
Special Populations
No adjustment for KAPIDEX (dexlansoprazole delayed release capsules) 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].
No dosage adjustment is necessary for elderly patients or for patients with renal impairment [see CLINICAL PHARMACOLOGY].
Important Administration Information
KAPIDEX (dexlansoprazole delayed release capsules) can be taken without regard to food. KAPIDEX (dexlansoprazole delayed release capsules) should be swallowed whole.
- Alternatively, KAPIDEX (dexlansoprazole delayed release capsules) capsules can be opened and administered as follows:
- Open capsule;
- Sprinkle intact granules on one tablespoon of applesauce;
- Swallow immediately.
HOW SUPPLIED
Dosage Forms And Strengths
- 30 mg capsules are opaque, blue and gray with TAP and “30” imprinted on the capsule.
- 60 mg capsules are opaque, blue with TAP and “60” imprinted on the capsule.
Storage And Handling
KAPIDEX (dexlansoprazole delayed release capsules) delayed release capsules, 30 mg, are opaque, blue and gray with TAP and “30” imprinted on the capsule and supplied as:
| NDC Number | Size |
| 64764-905-11 | Unit dose package of 100 |
| 64764-905-30 | Bottle of 30 |
| 64764-905-90 | Bottle of 90 |
| 64764-905-19 |
Bottle of 1000 |
KAPIDEX (dexlansoprazole delayed release capsules) delayed release capsules, 60 mg, are opaque, blue with TAP and “60” imprinted on the capsule and supplied as:
| NDC Number | Size |
| 64764-915-11 | Unit dose package of 100 |
| 64764-915-30 | Bottle of 30 |
| 64764-915-90 | Bottle of 90 |
| 64764-915-19 |
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. Rev March 2010
Last reviewed on RxList: 4/14/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Kapidex Delayed Release Capsules Information
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