KAPIDEX 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.
|* Controlled studies did not extend beyond 6 months.|
|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|
No adjustment for KAPIDEX 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 (8.7) and Clinical Pharmacology (12.5)].
Important Administration Information
KAPIDEX can be taken without regard to food.
KAPIDEX should be swallowed whole.
- Alternatively, KAPIDEX capsules can be opened and administered as follows: – Open capsule; – Sprinkle intact granules on one tablespoon of applesauce; – Swallow immediately.
Usual Adult Dose for Erosive Esophagitis
Initial dose: 60 mg orally once a day for up to 8 weeks
Maintenance dose: 30 mg orally once a day for up to 6 months
Usual Adult Dose for Gastroesophageal Reflux Disease
For treatment of heartburn associated with non-erosive GERD: 30 mg once a day for 4 weeks
Renal Dose Adjustments
No adjustment recommended
Liver Dose Adjustments
Mild hepatic impairment (Child-Pugh A): No adjustment recommended
Moderate hepatic impairment (Child-Pugh B): Maximum daily dose should not exceed 30 mg.
Severe hepatic impairment (Child-Pugh C): No studies have been conducted
Systemic exposure of dexlansoprazole is generally higher in intermediate and poor metabolizers of the polymorphic liver enzyme CYP450 2C19. In subjects who received a single dose of dexlansoprazole 30 mg or 60 mg, mean dexlansoprazole Cmax and AUC values were up to 2 times higher in intermediate compared to extensive metabolizers; in poor metabolizers, mean Cmax was up to 4 times higher and mean AUC was up to 12 times higher compared to extensive metabolizers.
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Data not available
Dexlansoprazole may be taken without regard to food; however, some patients may benefit from administering the dose prior to a meal if post-meal symptoms do not resolve under post-fed conditions.
Dexlansoprazole should be swallowed whole; alternatively, the capsules can be opened and sprinkled on one teaspoonful of applesauce and immediately swallowed.