Concise Prescribing Info
Healing of all grades of erosive esophagitis (EE) for up to 8 wk in patients ≥2 yr. Maintenance of healed EE & relief of heartburn up to 6 mth in adults & 16 wk in patients 12-17 yr. Heartburn associated w/ symptomatic non-erosive GERD for 4 wk in patients ≥12 yr.
Dosage/Direction for Use
Patients ≥12 yr Healing of EE 60 mg once daily for up to 8 wk. Symptomatic non-erosive GERD 30 mg once daily for 4 wk. Maintenance of healed EE & relief of heartburn Adult 30 mg once daily for up to 6 mth. Patients 12-17 yr 30 mg once daily for up to 16 wk. Moderate hepatic impairment (Child-Pugh Class B) 30 mg once daily for up to 8 wk.
May be taken with or without food: Swallow whole, do not chew. For patients w/ swallowing difficulties, open cap & sprinkle contents in 1 tbsp of applesauce. Swallow immediately w/o chewing. Contents may also be dispersed in 20 mL water & administered immediately via oral syringe/nasogastric tube (≥ 16 French). Refill syringe w/ 10 mL water twice & administer.
Hypersensitivity. Acute interstitial nephritis w/ other proton pump inhibitors including lansoprazole. Rilvipirine-containing products.
Special Precautions
Gastric malignancy. Acute interstitial nephritis. Increased risk of Clostridium difficile-associated diarrhea & osteoporosis-related fractures of hip, wrist or spine. Vit B12 deficiency. Hypomagnesemia. Monitor Mg levels prior to treatment & periodically thereafter. False positive results in diagnostic investigations for neuroendocrine tumors due to increase in serum chromogranin A levels; secretin stimulative test; urine screening tests for tetrahydrocannabinol. Concomitant use w/ methotrexate. Cutaneous lupus erythematosus & SLE. Moderate & severe hepatic impairment. Pregnancy & lactation. Childn <12 yr; not recommended for symptomatic non-erosive GERD in ped patients <1 yr.
Adverse Reactions
Diarrhea, abdominal pain, nausea, upper resp tract infection, vomiting, flatulence.
Drug Interactions
Decreased exposure of some antiretroviral drugs (eg, rilpivirine, atazanavir & nelfinavir). Increased exposure of other antiretroviral drugs (eg, saquinavir). Increased INR & prothrombin time w/ warfarin. May elevate & prolong serum conc of methotrexate &/or its metabolite hydroxymethotrexate, possibly leading to toxicities. Potential for increased exposure of digoxin & tacrolimus. Reduced absorption of drugs dependent on gastric pH for absorption (eg, Fe salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole). Decreased exposure w/ strong CYP2C19 or CYP3A4 inducers (eg, St. John's wort, rifampin, ritonavir-containing products). Increased exposure w/ strong CYP2C19 or CYP3A4 inhibitors (eg, voriconazole).
ATC Classification
A02BC06 - dexlansoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Dexilant DR cap 60 mg
4 × 7's
Dexilant DR cap 30 mg
4 × 7's
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