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Kapidex

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Kapidex Delayed Release Capsules

Indications
Dosage
How Supplied

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.

Indications
Dosage
How Supplied
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