Kapidex Recommended Dose Dexlansoprazole Dosage

 

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.

Table 1: KAPIDEX Dosing Recommendations

Indication Recommended Dose Frequency impairment Child-Pugh

* 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

Special Populations

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

KAPIDEX

  

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

  

Precautions

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).

  

Dialysis

Data not available

  

Other Comments

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.