FDA OKs sprinkle formulation of rosuvastatin
The FDA on July 15 approved Sun Pharmaceutical Industries’ sprinkle formulation of rosuvastatin, an alternative to traditional lipid-lowerers for patients who have difficulty swallowing.
The capsules, sold under the brand name Ezallor Sprinkle, is indicated as an adjunct to diet for the treatment of hypertriglyceridemia, hypercholesterolemia and primary dysbetalipoproteinemia in adults, according to a statement from Sun Pharma. It can be utilized alongside lipid-lowering treatments like LDL apheresis or as monotherapy if other options are unavailable.
The new product comes in the form of extended-release, coated pellets that can be sprinkled over soft food, swallowed whole or administered via a nasogastric tube. The formula is designed to help older patients in particular, who are more likely to be in long-term care and have difficulty swallowing their medications.
“The risk of medication errors increases when people have difficulty swallowing, due to crushing of medicines that shouldn’t be crushed or from residual medication left over in crushing devices,” Chris Chappel, MD, the medical director for Chappel Senior Care and Chappel Group Research in Kissimmee, Fla., said in the statement. “This formulation will help in administering medication for patients with common types of elevated lipid disorders, especially in the geriatric population.”
The dose range for Ezallor Sprinkle capsules is 5 mg to 40 mg once daily, with the 40 mg dose indicated only for patients who fail to reach their LDL-C goals at a lower concentration. Sun Pharma disclosed the drug hasn’t been studied in Fredrickson type I and V dyslipidemias and should be used exclusively by adults.
After graduating from Indiana University-Bloomington with a bachelor’s in journalism, Anicka joined TriMed’s Chicago team in 2017 covering cardiology. Close to her heart is long-form journalism, Pilot G-2 pens, dark chocolate and her dog Harper Lee.