Paricalcitol (Paricalcitol)

Trade Name : Paricalcitol

West-Ward Pharmaceuticals Corp

INJECTION

Strength 5 ug/mL

PARICALCITOL Cholecalciferol [CS],Vitamin D3 Analog [EPC]

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Paricalcitol (Paricalcitol) which is also known as Paricalcitol and Manufactured by West-Ward Pharmaceuticals Corp. It is available in strength of 5 ug/mL per ml. Read more

Paricalcitol (Paricalcitol) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

Inquire directly from our website and get 5% off on any medicine!

About GNH

No data

Paricalcitol Injection is an active vitamin D analogue indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 5.
Paricalcitol Injection is an active vitamin D analog indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease Stage 5. ()

For intravenous use through hemodialysis vascular access port only.
The recommended starting dose of Paricalcitol Injection is 0.04 mcg/kg to 0.1 mcg/kg (2.8 u2013 7 mcg) administered through a hemodialysis vascular access port as a bolus dose at any time during dialysis. Dosing should not occur more frequently than every other day. The drug product should not be injected directly into a vein. Dosage should be individualized.u00a0 If a satisfactory parathyroid hormone (PTH) lowering response is not observed using the recommended starting dose, the dose may be increased by 2 to 4 mcg every 2 to 4 weeks based on PTH levels (refer to Table 1).
When initiating Paricalcitol Injection or adjusting Paricalcitol Injection dose, measure serum calcium and phosphorus frequently (e.g., twice weekly) and PTH every 2 to 4 weeks. Once a maintenance dose has been established, serum calcium and phosphorus should be measured at least monthly and plasma PTH every 3 months.
Suggested Dosage Adjustment

The recommended starting dose is 0.04 mcg/kg to 0.1 mcg/kg (2.8 u2013 7 mcg). nn
Administer Paricalcitol Injection as a bolus through a hemodialysis vascular access port at any time during dialysis. Dosing should not occur more frequently than every other day. nn
Do not inject Paricalcitol Injection directly into a vein. nn
Paricalcitol Injection dose should be individualized. If a satisfactory PTH lowering response is not observed with the initial dose, the dose may be increased by 2 to 4 mcg at 2- to 4- week intervals based on parathyroid hormone (PTH) levels. ()

Paricalcitol Injection is available in the following presentations:
Paricalcitol Injection is available in the following presentations: 2 mcg per mL single dose vial, 5 mcg per mL single dose vial, 10 mcg per 2 mL (5 mcg per mL) multiple dose vial.u00a0()

Paricalcitol Injection is contraindicated in patients with evidence of:
Evidence of hypercalcemia, vitamin D toxicity or hypersensitivity. ()

No data

Hypercalcemia
Digitalis Toxicity
Risk of Increased Paricalcitol Levels With Concomitant Use of Strong CYP3A Inhibitors
Adynamic Bone Disease

The most common adverse reactions (greater than 5% and more frequent than placebo) include nausea, vomiting and edema. ()
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-233-2001 or FDA at 1-800-FDA-1088 or .

Paricalcitol is partially metabolized by CYP3A. Paricalcitol blood levels will be increased when paricalcitol is co-administered with strong CYP3A inhibitors. If a patient initiates or discontinues therapy with a strong CYP3A inhibitor, monitor both PTH and serum calcium more frequently and adjust Paricalcitol Injection dose as required [see n ].
Co-administration with strong CYP3A inhibitors (e.g. ketoconazole) increases paricalcitol blood levels. See WARNINGS AND PRECAUTIONS. (, )

No data

Pregnancy
Nursing Mothers

Overdosage of Paricalcitol Injection may lead to hypercalcemia, hypercalciuria, hyperphosphatemia, and oversuppression of PTH resulting in adynamic bone disease. [seen ].
The treatment of acute overdosage should consist of supportive measures, discontinuation of drug administration and supplemental calcium, institution of a low calcium diet. Serum calcium levels should be measured until normocalcemia ensues. When serum calcium levels have returned to within normal limits, Paricalcitol Injection may be reinitiated at a lower dose.
Paricalcitol is not significantly removed by dialysis.

Paricalcitol, USP, the active ingredient in Paricalcitol Injection, is a synthetically manufactured active vitamin Danalog. It is a white powder chemically designated as 19-nor-1u03b1,3u03b2,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula:
Paricalcitol Injection is available as a sterile, clear, colorless, aqueous solution for intravenous injection. Each mL contains paricalcitol 2 mcg or 5 mcg and the following inactive ingredients: alcohol, 35% (v/v) and 70% sorbitol solution 7% (v/v) in water for injection.

No data

In a 104-week carcinogenicity study in CD-1 mice conducted with paricalcitol, an increased incidence of uterine leiomyoma and leiomyosarcoma was observed at subcutaneous doses of 1, 3, 10 mcg/kg (2 to 15 times the AUC at a human dose of 14 mcg, equivalent to 0.24 mcg/kg based on AUC). The incidence rate of uterine leiomyoma was significantly different than the control group at the highest dose of 10 mcg/kg.
In a 104-week carcinogenicity study in rats conducted with paricalcitol, there was an increased incidence of benign adrenal pheochromocytoma at subcutaneous doses of 0.15, 0.5, 1.5 mcg/kg (< 1 to 7 times the exposure following a human dose of 14 mcg, equivalent to 0.24 mcg/kg based on AUC). The increased incidence of pheochromocytomas in rats may be related to the alteration of calcium homeostasis by paricalcitol.
Paricalcitol did not exhibit genetic toxicity with or without metabolic activation in the microbial mutagenesis assay (Ames Assay), mouse lymphoma mutagenesis assay (L5178Y), or a human lymphocyte cell chromosomal aberration assay. There was also no evidence of genetic toxicity in an mouse micronucleus assay. Paricalcitol had no effect on fertility (male or female) in rats at intravenous doses up to 20 mcg/kg/dose [equivalent to 13 times the highest recommended human dose (0.24 mcg/kg) based on surface area, mg/m].

In three 12-week, placebo-controlled, phase 3 studies conducted with another paricalcitol injection product u00a0in patients with Stage 5 chronic kidney disease on dialysis, the dose of paricalcitol was started at 0.04 mcg/kg 3 times per week. The dose was increased by 0.04 mcg/kg every 2 weeks until intact parathyroid hormone (iPTH) levels were decreased at least 30% from baseline, or a fifth escalation brought the dose to 0.24 mcg/kg, or iPTH fell to less than 100 pg/mL, or the Ca x P product was greater than 75 within any 2 week period, or serum calcium became greater than 11.5 mg/dL at any time.
Patients treated with paricalcitol achieved a mean iPTH reduction of 30% within 6 weeks. In these studies, there was no significant difference in the incidence of hypercalcemia or hyperphosphatemia between paricalcitol and placebo-treated patients. The results from these studies are as follows:
A long-term, open-label safety study of 164 CKD Stage 5 patients conducted with another paricalcitol injection product (mean dose of 7.5 mcg three times per week), demonstrated that mean serum Ca, P, and Ca x P remained within clinically appropriate ranges with PTH reduction (mean decrease of 319 pg/mL at 13 months).
Figure 1: Mean Values for Serum iPTH, Calcium and Phosphorus Over Time in CKD Stage 5 Patients in a Phase 3 Study

Paricalcitol Injection is available in 2 mcg/mL single dose vials (NDC 0143-9625-25), 5 mcg/mL single dose vials (NDC 0143-9624-25) and 10 mcg/2 mL (5 mcg/mL) multiple dose vials (NDC 0143-9596-25) in cartons of 25 vials.
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature]. Do not freeze. After initial vial use, the contents of the multiple dose vial remain stable up to seven days when stored at controlled room temperature. Discard unused portion of the single dose vial.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Patients should be advised:
Manufactured by:n
Distributed by:n
9625-0415-00u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 April 2015

NDC 0143-9625-01u00a0u00a0n n n 1 mL Single Dose VialFor Intravenous Use Only

NDC 0143-9624-01u00a0u00a0 n 1 mL Single Dose VialFor Intravenous Use Only

NDC 0143-9596-012u00a0mL Multiple Dose VialFor Intravenous Use Only

No data

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71245 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Get Price

Paricalcitol (Paricalcitol)

Trade Name : Paricalcitol

INJECTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what
you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Paricalcitol (Paricalcitol)

Trade Name : Paricalcitol

INJECTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?