Classes
DEA Class; Rx
Common Brand Names; Dexilant, Kapidex, Dexilant SoluTab
- Proton Pump Inhibitors
Description
Proton-pump inhibitor (PPI); R-enantiomer of lansoprazole
Used for healing and maintenance of erosive esophagitis and treatment of GERD
Available as a delay-release capsule and disintegrating tablet
Indications
Indicated for healing of all grades of erosive esophagitis (EE) and maintaining healing of EE
Indicated for treating heartburn associated with symptomatic nonerosive GERD
Contraindications
Hypersensitivity reactions, including anaphylaxis and acute interstitial nephritis reported
PPIs are contraindicated with rilpivirine-containing products
Adverse Effects
- Diarrhea (5%)
- Abdominal pain (4%)
- Nausea (3%)
- URI (2-3%)
- Vomiting (1-2%)
- Flatulence (1%)
- Arrhythmia
- Bradycardia
- Barrett’s esophagus
- DVT
- Dyspnea
- Hepatomegaly
- Hypertension
- Paresthesia
- Rectal hemorrhage
- Vulvovaginal infection
Warnings
Proton pump inhibitors (PPIs) are possibly associated with increased incidence of Clostridium difficile-associated diarrhea (CDAD); consider diagnosis of CDAD for patients taking PPIs who have diarrhea that does not improve
May interfere with absorption of drugs for which pH is a determinant of oral bioavailability (eg, atazanavir)
Proton pump inhibitors may decrease the efficacy of clopidogrel by reducing the formation of the active metabolite
Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) reported with PPIs; avoid using for longer than medically indicated; discontinue if signs or symptoms consistent with CLE or SLE are observed and refer patient to specialist; most patients improve with discontinuation of PPI alone in 4- 12 weeks; serological testing (e.g. ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations
Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) reported in association with use of PPIs; discontinue therapy at first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation
Published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine; particularly with prolonged (>1 yr), high-dose therapy
Relief of symptoms does not eliminate the possibility of a gastric malignancy; consider additional follow-up and diagnostic testing in adult patients who have suboptimal response or early symptomatic relapse after completing treatment with a PPI
Decreased gastric acidity increases serum chromogranin A (CgA) levels and may cause false-positive diagnostic results for neuroendocrine tumors; temporarily discontinue PPIs before assessing CgA levels
Therapy increases risk of Salmonella, Campylobacter, and other infections
Brand name changed from Kapidex to Dexilant
Daily long-term use (eg, >3 yr) may lead to malabsorption or a deficiency of cyanocobalamin
Acute interstitial nephritis reported in patients taking proton pump inhibitors (see Contraindications)
Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity; increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors; temporarily stop dexlansoprazole treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high
Pregnancy and Lactation
There are no studies with dexlansoprazole use in pregnant women to inform a drug-associated risk; dexlansoprazole is R-enantiomer of lansoprazole, and published observational studies of lansoprazole use during pregnancy did not demonstrate an association of adverse pregnancy-related outcomes with lansoprazole
There is no information regarding presence of dexlansoprazole in human milk, effects on breastfed infant, or on milk production
Maximum Dosage
60 mg/day PO for delayed-release capsules; 30 mg/day for delayed-release orally disintegrating tablets.
60 mg/day PO for delayed-release capsules; 30 mg/day for delayed-release orally disintegrating tablets.
60 mg/day PO for delayed-release capsules; 30 mg/day for delayed-release orally disintegrating tablets.
12 years: 60 mg/day PO for delayed-release capsules; 30 mg/day for delayed-release orally disintegrating tablets.
1 to 11 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Dexlansoprazole
delayed-release capsule
- 30mg
- 60mg
delayed-release oral disintegrating tablet (ODT)
- 30mg