• Healing of Erosive Esophagitis
  • Maintenance of Healed Erosive Esophagitis
  • Symptomatic Non-Erosive Gastroesophageal Reflux Disease

Dosage & Administration

Recommended Dose
Dexlansoprazoleis available as capsules in 30 mg and 60 mg strengths for adult use. Directions for use in each indication are summarized in Table.


Table: Dexlansoprazole Dosing Recommendations



Recommended Dose



Healing of EE


60 mg


Once daily for up to 8 weeks

Maintenance of Healed EE





and relief of heartburn


30 mg


Once daily up to 6 months

Symptomatic Non-Erosive GERD


30 mg


Once daily for 4 weeks


Use in Specific Populations

Pregnancy Category B. There are no adequate and well-controlled studies with dexlansoprazole in pregnant women. There were no adverse fetal effects in animal reproduction studies of dexlansoprazole in rabbits. Because
animal reproduction studies are not always predictive of human response, dexlansoprazole should be used during pregnancy only if clearly needed.

Nursing Mothers
It is not known whether dexlansoprazole is excreted in human milk. However, lansoprazole and its metabolites are present in rat milk following the administration of lansoprazole. As many drugs are excreted in human milk, and because of the potential for tumorigenicity shown for lansoprazole in rat carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use
Safety and effectiveness of dexlansoprazole in pediatric patients (less than 12 years of age) have not been established.

Geriatric Use
In clinical studies of dexlansoprazole, 11% of patients were aged 65 years and over. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified significant differences in responses between geriatric and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Renal Impairment
No dosage adjustment of dexlansoprazole is necessary in patients with renal impairment. The pharmacokinetics of dexlansoprazole in patients with renal impairment are not expected to be altered since dexlansoprazole is extensively metabolized in the liver to inactive metabolites, and no parent drug is recovered in the urine following an oral dose of dexlansoprazole.

Hepatic Impairment
No dosage adjustment for dexlansoprazole is necessary for patients with mild hepatic impairment (Child-Pugh Class A). dexlansoprazole 30 mg should be considered 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).



Gastric Malignancy:

Symptomatic response with dexlansoprazoledoes not preclude the presence of gastric malignancy.


Clostridium Difficile Associated Diarrhea:

Published observational studies suggest that PPI therapy like dexlansoprazolemay be associated with an increased risk of Clostridium difficile associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.


Bone Fracture:

Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the conditions being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines.



Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.


Concomitant use of dexlansoprazolewith Methotrexate: Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients.

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