Generic Name and Formulations:
Dexlansoprazole 30mg, 60mg; del-rel caps.
Takeda Pharmaceuticals USA, Inc.
Indications for DEXILANT:
Healing of all grades of erosive esophagitis (EE). Treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD). Maintenance of healing of EE and relief of heartburn.
Two 30mg SoluTabs are not interchangeable with one 60mg capsule. Caps: Swallow whole, or sprinkle granules on 1 tablespoon of applesauce and swallow immediately. SoluTabs: Take ≥30mins before meal. Place tab on tongue, allow to disintegrate, and swallow without water. May also swallow whole with water or give via oral syringe or NG tube; see full labeling. EE healing: 60mg cap once daily for up to 8 weeks. Maintenance of healed EE and relief of heartburn: 30mg once daily for up to 6 months in adults or 4 months for ages 12–17. Symptomatic GERD: 30mg once daily for 4 weeks. Moderate hepatic impairment (Child-Pugh Class B) for EE healing: 30mg once day for up to 8 weeks.
<12yrs: not established.
Concomitant rilpivirine-containing products.
Symptomatic response does not preclude gastric malignancy. Discontinue if acute interstitial nephritis, cutaneous/systemic lupus erythematosus occurs. Long-term therapy (eg, >3yrs) may lead to malabsorption or deficiency of Vit.B12. Use lowest dose for shortest duration appropriate to condition. If diarrhea occurs that does not improve, consider C. difficile diagnosis. Increased risk of osteoporosis-related fractures (hip, wrist or spine) with long-term and multiple daily dose PPI therapy. Severe hepatic impairment: not recommended. Monitor magnesium levels with long-term therapy. Pregnancy. Nursing mothers.
See Contraindications. Avoid concomitant nelfinavir, St. John's Wort, rifampin. May decrease atazanavir levels. May potentiate saquinavir, digoxin, tacrolimus, methotrexate (consider temporary withdrawal of the PPI); monitor. May alter absorption of pH-dependent drugs (eg, iron, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole, itraconazole). Caution with drugs that may cause hypomagnesemia (eg, diuretics); monitor. Monitor warfarin. May cause false (+) results in diagnostic investigations for neuroendocrine tumors; withhold dexlansoprazole ≥14 days prior to CgA level assessment. May cause false (+) urine screening tests for THC; use alternatives. May interfere with secretin stimulation test; withhold dexlansoprazole ≥30 days prior to assessment. SoluTabs: avoid alcohol.
Proton pump inhibitor.
Diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, flatulence, headache, nasopharyngitis, oropharyngeal pain; rare: hypomagnesemia (w. prolonged PPI therapy).
Hepatic (CYP2C19, 3A4); 96.1–98.8% protein bound.
Caps—30, 90, 100, 1000; SoluTabs—100