Name: Paricalcitol

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Type: small molecule

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Groups: Array

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Indication: For treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 3 and 4

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Accession Number: DB00910 ( APRD01165)

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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.

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Structure:

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Prescription Products:

Name	Dosage	Strength	Route	Marketing Start	Marketing End	Country
Paricalcitol	injection, solution	2 ug/mL	intravenous	01-11-2014		US
Paricalcitol	injection, solution	5 ug/mL	intravenous	01-11-2014		US
Paricalcitol	injection	5 ug/mL	intravenous	18-11-2014		US
Paricalcitol	injection	5 ug/mL	intravenous	18-11-2014		US
Paricalcitol	injection	2 ug/mL	intravenous	18-11-2014		US
Paricalcitol	capsule, liquid filled	1 ug/1	oral	14-06-2010		US
Paricalcitol	capsule, liquid filled	2 ug/1	oral	14-06-2010		US
Zemplar	capsule, liquid filled	4 ug/1	oral	14-06-2010	29-12-2015	US
Zemplar	injection, solution	5 ug/mL	intravenous	17-04-1998		US
Zemplar	capsule, liquid filled	2 ug/1	oral	14-06-2010		US
Zemplar	capsule, liquid filled	1 ug/1	oral	14-06-2010		US
Zemplar	injection, solution	2 ug/mL	intravenous	17-04-1998		US
Zemplar	solution	5 mcg	intravenous	01-12-2005	03-11-2012	Canada
Zemplar	capsule, liquid filled	1 ug/1	oral	26-05-2005		US

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Generic Prescription Products:

Name	Dosage	Strength	Route	Marketing Start	Marketing End	Country
Paricalcitol	capsule	1 ug/1	oral	17-01-2016		US
Paricalcitol	capsule	2 ug/1	oral	17-01-2016		US
Paricalcitol	capsule	4 ug/1	oral	17-01-2016		US
Paricalcitol	capsule, liquid filled	1 ug/1	oral	14-01-2016		US
Paricalcitol	capsule, liquid filled	2 ug/1	oral	14-01-2016		US
Paricalcitol	capsule, liquid filled	4 ug/1	oral	14-01-2016		US
Paricalcitol	capsule	1 mg/1	oral	02-09-2015		US
Paricalcitol	capsule	2 mg/1	oral	01-10-2015		US
Paricalcitol	capsule	4 mg/1	oral	01-10-2015		US
Paricalcitol	capsule, gelatin coated	1 ug/1	oral	03-11-2015		US
Paricalcitol	capsule, gelatin coated	2 ug/1	oral	03-11-2015		US
Paricalcitol	capsule, gelatin coated	4 ug/1	oral	03-11-2015		US
Paricalcitol	capsule, liquid filled	1 ug/1	oral	27-03-2014		US
Paricalcitol	capsule, liquid filled	2 ug/1	oral	27-03-2014		US
Paricalcitol	capsule, liquid filled	4 ug/1	oral	27-03-2014		US
Paricalcitol	capsule, liquid filled	1 ug/1	oral	07-12-2015		US
Paricalcitol	capsule, liquid filled	2 ug/1	oral	07-12-2015		US
Paricalcitol	capsule, liquid filled	4 ug/1	oral	07-12-2015		US
Paricalcitol	capsule, liquid filled	1 ug/1	oral	31-03-2015		US
Paricalcitol	capsule, liquid filled	1 ug/1	oral	23-04-2014		US
Paricalcitol	capsule, liquid filled	2 ug/1	oral	23-04-2014		US
Paricalcitol	capsule, liquid filled	4 ug/1	oral	27-03-2014		US
Paricalcitol	capsule, liquid filled	1 ug/1	oral	25-06-2014		US
Paricalcitol	capsule, liquid filled	2 ug/1	oral	25-06-2014		US
Paricalcitol	capsule, liquid filled	4 ug/1	oral	25-06-2014		US
Paricalcitol	capsule, liquid filled	1 ug/1	oral	30-09-2013		US
Paricalcitol	capsule, liquid filled	2 ug/1	oral	30-09-2013		US
Paricalcitol	capsule, liquid filled	4 ug/1	oral	30-09-2013		US

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Over the Counter Products: Not Available

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International Brands

• No Brands

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Brand Names

• No Brands

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Brand Mixtures

Brand Name	Ingredients
Zemplar	Paricalcitol
Zemplar	Paricalcitol
Zemplar	Paricalcitol
Zemplar	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Zemplar	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Zemplar	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Zemplar	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol

Brand Name	Ingredients
Zemplar	Paricalcitol
Zemplar	Paricalcitol
Zemplar	Paricalcitol
Zemplar	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Zemplar	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Zemplar	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Zemplar	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol
Paricalcitol	Paricalcitol

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Categories

• No Category

Indication: For treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 3 and 4

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Pharmacodynamics: Not Available

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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.

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Absorption: Well absorbed

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Volume of distribution:

• 30.8 ± 7.5 L [CKD Stage 5-HD]
• 34.9 ± 9.5 L [CKD Stage 5-PD]
• 23.8 L [healthy subjects]

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Protein binding: 99.8% (bound to plasma proteins)

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Metabolism: Not Available

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Route of elimination: Paricalcitol is excreted primarily by hepatobiliary excretion.

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Half life: 4 to 6 hours

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Clearance: Not Available

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Toxicity: Not Available

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Affected organisms

• Not Available

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SNP Mediated Adverse Drug Reactions

• Not Available

Manufacturers:

• Abbott laboratories pharmaceutical products div
• Abbott laboratories

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Packagers:

• Abbott Laboratories Ltd.
• Cardinal Health
• Catalent Pharma Solutions
• Hospira Inc.
• Murfreesboro Pharmaceutical Nursing Supply
• Remedy Repack

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Dosage forms

Form	Route	Strength
Capsule	oral	1 mg/1
Capsule	oral	1 ug/1
Capsule	oral	2 ug/1
Capsule	oral	2 mg/1
Capsule	oral	4 mg/1
Capsule	oral	4 ug/1
Capsule, gelatin coated	oral	1 ug/1
Capsule, gelatin coated	oral	2 ug/1
Capsule, gelatin coated	oral	4 ug/1
Capsule, liquid filled	oral	4 ug/1
Injection	intravenous	2 ug/mL
Injection	intravenous	5 ug/mL
Capsule, liquid filled	oral	1 ug/1
Capsule, liquid filled	oral	2 ug/1
Injection, solution	intravenous	2 ug/mL
Injection, solution	intravenous	5 ug/mL
Solution	intravenous	5 mcg

Form	Route	Strength
Capsule	oral	1 mg/1
Capsule	oral	1 ug/1
Capsule	oral	2 ug/1
Capsule	oral	2 mg/1
Capsule	oral	4 mg/1
Capsule	oral	4 ug/1
Capsule, gelatin coated	oral	1 ug/1
Capsule, gelatin coated	oral	2 ug/1
Capsule, gelatin coated	oral	4 ug/1
Capsule, liquid filled	oral	4 ug/1
Injection	intravenous	2 ug/mL
Injection	intravenous	5 ug/mL
Capsule, liquid filled	oral	1 ug/1
Capsule, liquid filled	oral	2 ug/1
Injection, solution	intravenous	2 ug/mL
Injection, solution	intravenous	5 ug/mL
Solution	intravenous	5 mcg

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Prices

Unit description	Cost	Unit
Zemplar 1 mcg capsule	$9.39	capsule
Zemplar 2 mcg/ml vial	$11.22	ml
Zemplar 2 mcg capsule	$18.79	capsule
Zemplar 5 mcg/ml vial	$28.03	ml
Zemplar 4 mcg capsule	$37.58	capsule

Unit description	Cost	Unit
Zemplar 1 mcg capsule	$9.39	capsule
Zemplar 2 mcg/ml vial	$11.22	ml
Zemplar 2 mcg capsule	$18.79	capsule
Zemplar 5 mcg/ml vial	$28.03	ml
Zemplar 4 mcg capsule	$37.58	capsule

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Patents

Country	Patent Number	Approved	Expires (estimated)
5246925	United States	1995-04-17	2012-04-17
6136799	United States	1998-10-08	2018-10-08

Drug Interactions

Drug	Interaction
Aluminum hydroxide	The serum concentration of Aluminum hydroxide can be increased when it is combined with Paricalcitol.
Atazanavir	The serum concentration of Paricalcitol can be increased when it is combined with Atazanavir.
Boceprevir	The serum concentration of Paricalcitol can be increased when it is combined with Boceprevir.
Ceritinib	The serum concentration of Paricalcitol can be increased when it is combined with Ceritinib.
Clarithromycin	The serum concentration of Paricalcitol can be increased when it is combined with Clarithromycin.
Cobicistat	The serum concentration of Paricalcitol can be increased when it is combined with Cobicistat.
Colesevelam	The serum concentration of Paricalcitol can be decreased when it is combined with Colesevelam.
Danazol	Danazol may increase the hypercalcemic activities of Paricalcitol.
Darunavir	The serum concentration of Paricalcitol can be increased when it is combined with Darunavir.
Digoxin	The risk or severity of adverse effects can be increased when Paricalcitol is combined with Digoxin.
Dihydrotachysterol	The risk or severity of adverse effects can be increased when Dihydrotachysterol is combined with Paricalcitol.
Idelalisib	The serum concentration of Paricalcitol can be increased when it is combined with Idelalisib.
Indinavir	The serum concentration of Paricalcitol can be increased when it is combined with Indinavir.
Itraconazole	The serum concentration of Paricalcitol can be increased when it is combined with Itraconazole.
Ketoconazole	The serum concentration of Paricalcitol can be increased when it is combined with Ketoconazole.
Mineral oil	The serum concentration of Paricalcitol can be decreased when it is combined with Mineral oil.
Nefazodone	The serum concentration of Paricalcitol can be increased when it is combined with Nefazodone.
Nelfinavir	The serum concentration of Paricalcitol can be increased when it is combined with Nelfinavir.
Orlistat	The serum concentration of Paricalcitol can be decreased when it is combined with Orlistat.
Posaconazole	The serum concentration of Paricalcitol can be increased when it is combined with Posaconazole.
Ritonavir	The serum concentration of Paricalcitol can be increased when it is combined with Ritonavir.
Saquinavir	The serum concentration of Paricalcitol can be increased when it is combined with Saquinavir.
Sucralfate	The serum concentration of Sucralfate can be increased when it is combined with Paricalcitol.
Telaprevir	The serum concentration of Paricalcitol can be increased when it is combined with Telaprevir.
Telithromycin	The serum concentration of Paricalcitol can be increased when it is combined with Telithromycin.
Trichlormethiazide	Trichlormethiazide may increase the hypercalcemic activities of Paricalcitol.
Voriconazole	The serum concentration of Paricalcitol can be increased when it is combined with Voriconazole.

Drug	Interaction
Aluminum hydroxide	The serum concentration of Aluminum hydroxide can be increased when it is combined with Paricalcitol.
Atazanavir	The serum concentration of Paricalcitol can be increased when it is combined with Atazanavir.
Boceprevir	The serum concentration of Paricalcitol can be increased when it is combined with Boceprevir.
Ceritinib	The serum concentration of Paricalcitol can be increased when it is combined with Ceritinib.
Clarithromycin	The serum concentration of Paricalcitol can be increased when it is combined with Clarithromycin.
Cobicistat	The serum concentration of Paricalcitol can be increased when it is combined with Cobicistat.
Colesevelam	The serum concentration of Paricalcitol can be decreased when it is combined with Colesevelam.
Danazol	Danazol may increase the hypercalcemic activities of Paricalcitol.
Darunavir	The serum concentration of Paricalcitol can be increased when it is combined with Darunavir.
Digoxin	The risk or severity of adverse effects can be increased when Paricalcitol is combined with Digoxin.
Dihydrotachysterol	The risk or severity of adverse effects can be increased when Dihydrotachysterol is combined with Paricalcitol.
Idelalisib	The serum concentration of Paricalcitol can be increased when it is combined with Idelalisib.
Indinavir	The serum concentration of Paricalcitol can be increased when it is combined with Indinavir.
Itraconazole	The serum concentration of Paricalcitol can be increased when it is combined with Itraconazole.
Ketoconazole	The serum concentration of Paricalcitol can be increased when it is combined with Ketoconazole.
Mineral oil	The serum concentration of Paricalcitol can be decreased when it is combined with Mineral oil.
Nefazodone	The serum concentration of Paricalcitol can be increased when it is combined with Nefazodone.
Nelfinavir	The serum concentration of Paricalcitol can be increased when it is combined with Nelfinavir.
Orlistat	The serum concentration of Paricalcitol can be decreased when it is combined with Orlistat.
Posaconazole	The serum concentration of Paricalcitol can be increased when it is combined with Posaconazole.
Ritonavir	The serum concentration of Paricalcitol can be increased when it is combined with Ritonavir.
Saquinavir	The serum concentration of Paricalcitol can be increased when it is combined with Saquinavir.
Sucralfate	The serum concentration of Sucralfate can be increased when it is combined with Paricalcitol.
Telaprevir	The serum concentration of Paricalcitol can be increased when it is combined with Telaprevir.
Telithromycin	The serum concentration of Paricalcitol can be increased when it is combined with Telithromycin.
Trichlormethiazide	Trichlormethiazide may increase the hypercalcemic activities of Paricalcitol.
Voriconazole	The serum concentration of Paricalcitol can be increased when it is combined with Voriconazole.

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Food Interactions:

• Not Available

Kingdom: Organic compounds

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Super Class: Not Available

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Class: Not Available

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Sub Class: Not Available

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Direct Parent: Not Available

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Alternative Parents:

• Cyclic alcohols and derivatives
• Cyclohexanols
• Hydrocarbon derivatives
• Tertiary alcohols
• Vitamin D and derivatives

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substituent:

• Alcohol
• Aliphatic homopolycyclic compound
• Cyclic alcohol
• Cyclohexanol
• Hydrocarbon derivative
• Organooxygen compound
• Polycyclic triterpenoid
• Secondary alcohol
• Tertiary alcohol
• Triterpenoid

Synthesis Reference: Anchel Schwartz, Alexei Ploutno, Koby Wolfman, "Preparation of paricalcitol." U.S. Patent US20070149489, issued June 28, 2007.

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General Reference: Not Available

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External Links:

Resource	Link
RxList	http://www.rxlist.com/cgi/generic4/zemplar_caps.htm
Drugs.com	http://www.drugs.com/cdi/paricalcitol.html

Resource	Link
RxList	http://www.rxlist.com/cgi/generic4/zemplar_caps.htm
Drugs.com	http://www.drugs.com/cdi/paricalcitol.html

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ATC Codes:

• Array

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AHFS Codes:

• 88:16.00

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MSDS: Download