FDA Approves Sprinkle Formulation of Rosuvastatin

The Food and Drug Administration (FDA) has approved a new sprinkle formulation of rosuvastatin, an HMG Co-A reductase inhibitor. 

Ezallor Sprinkle (Sun Pharma) is indicated for the treatment of adult patients with: hypertriglyceridemia as an adjunct to diet; primary dysbetalipoproteinemia (Type III hyperlipoproteinemia) as an adjunct to diet; and homozygous familial hypercholesterolemia to reduce LDL-C, total-C, and ApoB. 

For patients who have difficulty swallowing, Ezallor Sprinkle capsules can be opened and the granules emptied into one teaspoon of applesauce; the mixture should be swallowed immediately, without chewing. The product may also be administered via nasogastric tube. 

Ezallor Sprinkle capsules contain 5mg, 10mg, 20mg, or 40mg of rosuvastatin (present as 5.198mg, 10.395mg, 20.790mg, or 41.580mg of rosuvastatin calcium) in the form of granules; treatment is administered once-daily.  

“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,” said Dr Chris Chappel, certified Medical Director, Chappel Senior Care and Chappel Group Research. “This formulation will help in administering medication for patients with common types of elevated lipid disorders, especially in the geriatric population.”

In addition to Ezallor Sprinkle, Sun Pharma also manufactures Kapspargo Sprinkle, an extended-release sprinkle formulation of metoprolol succinate, a beta1-selective (cardioselective) adrenoreceptor blocking agent.

For more information visit ezallorsprinklerx.com.