Endo International plc announced that one of its operating companies, Par Pharmaceutical Inc., has begun shipping dexlansoprazole 30 mg capsules, a generic version of Takeda's Dexilant®?. This additional dosage strength rounds out the product family, now with both 30 mg and 60 mg delayed-release capsules. Dexlansoprazole is a proton pump inhibitor with a novel delivery system approved for the treatment of erosive gastroesophageal reflux disease (GERD).

According to IQVIA™?, Dexilant®? 30 mg sales were approximately $45 million for the 12 months ended April 30, 2023. Dexlansopazole Delayed-Release Capsules, 60 mg, contain FD&C Yellow #5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons.

Although the overall incidence of FD&C Yellow #5(tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. Presence of Gastric Malignancy: In adults, symptomatic response to therapy with dexlansoprazole does not eliminate the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI.

In older patients, also consider an endoscopy. Acute Tubulo Nephritis (TIN): TIN has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms, from symptomatic symptoms of decreased renal function (eg, malaise, nausea, anorexia).

Discontinue dexlansoprazole and evaluate patients with suspected acute TIN. Clostridium difficile-Associated Diarrhea: Published observational studies suggest that PPI therapy like dexlansoprazole may be associated with an increased risk of Clostridium difficiles-associated diarrhea, especially in hospitalized patients.