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Dexilant Generic Name & Formulations
Legal Class
Rx
General Description
Dexlansoprazole 30mg, 60mg; del-rel caps.
Pharmacological Class
Proton pump inhibitor.
How Supplied
Caps—30, 90, 100, 1000
Manufacturer
Generic Availability
Caps 30mg (NO); 60mg (YES)
Dexilant Indications
Indications
Healing of all grades of erosive esophagitis (EE). Maintenance of healing of EE and relief of heartburn. Treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD).
Dexilant Dosage and Administration
Adult
Swallow whole, or sprinkle granules on 1 tablespoon of applesauce and swallow immediately. 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.
Children
<12yrs: not established.
Dexilant Contraindications
Contraindications
Concomitant rilpivirine-containing products.
Dexilant Boxed Warnings
Not Applicable
Dexilant Warnings/Precautions
Warnings/Precautions
Symptomatic response does not preclude gastric malignancy. Discontinue and evaluate if acute tubulointerstitial nephritis, severe cutaneous adverse reactions, or cutaneous/systemic lupus erythematosus occurs. Long-term therapy (eg, >3yrs) may lead to malabsorption/deficiency of Vit. B12. Monitor magnesium levels during prolonged therapy. Consider monitoring magnesium, calcium levels in those with preexisting risk of hypocalcemia (eg, hypoparathyroidism). Increased risk for fundic gland polyps with long-term use (esp. >1yr) or risk for osteoporosis-related fractures (hip, wrist or spine) with long-term (>1yr) and multiple daily dose PPI therapy. Use lowest dose for shortest duration appropriate to condition. Risk of heart valve thickening (in children <2yrs old); not recommended. Pregnancy. Nursing mothers.
Dexilant Pharmacokinetics
See Literature
Dexilant Interactions
Interactions
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.
Dexilant Adverse Reactions
Adverse Reactions
Diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, flatulence, headache, nasopharyngitis, oropharyngeal pain; possible C. difficile-associated diarrhea; rare: hypomagnesemia and mineral metabolism.
Dexilant Clinical Trials
See Literature
Dexilant Note
Not Applicable
Dexilant Patient Counseling
See Literature
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