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DEXILANT SOLUTAB
Hyperacidity, GERD, and ulcers
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Drug Name:

DEXILANT SOLUTAB Rx

Generic Name and Formulations:
Dexlansoprazole 30mg; del-rel orally disintegrating tabs.

Company:
Takeda Pharmaceutical Company

Therapeutic Use:

Indications for DEXILANT SOLUTAB:

Treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD). Maintenance of healing of EE and relief of heartburn.

Adult:

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.

Children:

<12yrs: not established.

Contraindications:

Concomitant rilpivirine-containing products.

Warnings/Precautions:

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/deficiency of Vit. B12. Monitor magnesium levels during prolonged therapy. Increased risk of fundic gland polyps with long-term use (esp. >1yr) or 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. Pregnancy. Nursing mothers.

See Also:

DEXILANT

Pharmacological Class:

Proton pump inhibitor.

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. SoluTabs: avoid alcohol.

Adverse Reactions:

Diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, flatulence, headache, nasopharyngitis, oropharyngeal pain; possible C. difficile-associated diarrhea; rare: hypomagnesemia.

Metabolism:

Hepatic (CYP2C19, 3A4); 96.1–98.8% protein bound.

Elimination:

Renal, fecal

Generic Availability:

NO

How Supplied:

Caps—30, 90, 100, 1000; SoluTabs—100

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