Paricalcitol

FDA Drug Profile — Zemplar, Paricalcitol

Drug Details

Generic Name
Paricalcitol
Brand Names
Zemplar, Paricalcitol
Application Number
NDA021606
Sponsor
Sigma-Aldrich Corporation
NDC Codes
44
Dosage Forms
POWDER, CAPSULE, LIQUID FILLED, CAPSULE, INJECTION, INJECTION, SOLUTION
Routes
ORAL, INTRAVENOUS
Active Ingredients
PARICALCITOL

Indications and Usage

1 INDICATIONS AND USAGE ZEMPLAR is a vitamin D analog indicated in adults and pediatric patients 10 years and older for the prevention and treatment of secondary hyperparathyroidism associated with: Chronic kidney disease (CKD) Stages 3 and 4 ( 1.1 ). CKD Stage 5 in patients on hemodialysis or peritoneal dialysis ( 1.2 ). 1.1 Chronic Kidney Disease Stages 3 and 4 ZEMPLAR capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4. 1.2 Chronic Kidney Disease Stage 5 ZEMPLAR capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD).