Product Information
Registration Status: ActiveZEMPLAR CAPSULE 1MCG is approved to be sold in Singapore with effective from 2007-11-13. It is marketed by ABBVIE PTE LTD, with the registration number of SIN13370P.
This product contains Paricalcitol 1mcg in the form of CAPSULE. It is approved for ORAL use.
This product is manufactured by Catalent Pharma Solutions in UNITED STATES.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
Paricalcitol is a synthetic vitamin D analog. Paricalcitol has been used to reduce parathyroid hormone levels. Paricalcitol is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic renal failure.
Indication
For treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 3 and 4
Mechanism of Action
Paricalcitol is a synthetic, biologically active vitamin D analog of calcitriol with modifications to the side chain (D2) and the A (19-nor) ring. Preclinical andin vitro studies have demonstrated that paricalcitol's biological actions are mediated through binding of the VDR, which results in the selective activation of vitamin D responsive pathways. Vitamin D and paricalcitol have been shown to reduce parathyroid hormone levels by inhibiting PTH synthesis and secretion.
Pharmacokinetics
- Absorption
- Well absorbed
- Distribution
- * 30.8 ± 7.5 L [CKD Stage 5-HD] * 34.9 ± 9.5 L [CKD Stage 5-PD] * 23.8 L [healthy subjects]
- Metabolism
- Metabolized by multiple hepatic and non-hepatic enzymes, including mitochondrial CYP24, as well as CYP3A4 and UGT1A4
- Elimination
Clearance
* 1.49 +/- 0.60 L/h [chronic kidney disease Stage 5 with hemodialysis] * 1.54 +/- 0.95 L/h [chronic kidney disease Stage 5with peritoneal dialysis]
Active Ingredient/Synonyms
19-Nor-1alpha,25-dihydroxyvitamin D2 | Paricalcitol | Paricalcitol |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.