DEXILANT Dosage & Rx Info | Uses, Side Effects

Dexilant Generic Name & Formulations

Legal Class

General Description

Dexlansoprazole 30mg, 60mg; del-rel caps.

Pharmacological Class

Proton pump inhibitor.

How Supplied

Caps—30, 90, 100, 1000

Manufacturer

Takeda Pharmaceutical Company

Generic Availability

Caps 30mg (NO); 60mg (YES)

Mechanism of Action

Dexlansoprazole suppresses gastric acid secretion by specific inhibition of the (H⁺,K⁺)-ATPase in the gastric parietal cell. By acting specifically on the proton pump, dexlansoprazole blocks the final step of acid production.

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. Severe hepatic impairment (Child-Pugh Class C): not recommended.

Children

<12yrs: not established.

Administration

Swallow whole, or sprinkle granules on 1 tablespoon of applesauce and swallow immediately. Granules should not be chewed.

Nursing Considerations

Swallow whole, or sprinkle granules on 1 tablespoon of applesauce and swallow immediately. Granules should not be chewed.

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. Severe hepatic impairment (Child-Pugh Class C): not recommended. Risk of heart valve thickening (in children <2yrs of age); not recommended. Pregnancy. Nursing mothers.

Dexilant Pharmacokinetics

Distribution

Plasma protein bound: 96–99%.

Apparent volume of distribution: 40 L.

Metabolism

Hepatic (CYP2C19, 3A4).

Elimination

Renal (50.7%), fecal (47.6%). Half-life: ~1–2 hours.

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