Trade Name: Paricalcitol

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Amneal Pharmaceuticals LLC

Presentation: INJECTION, HUMAN PRESCRIPTION DRUG

Strength: 5 ug/mL

Storage and handling

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

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • Paricalcitol injection is indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease (CKD) on dialysis.
  • Paricalcitol injection is a vitamin D analog indicated for the prevention and treatment of secondary hyperparathyroidism in patients 5 years of age and older with chronic kidney disease on dialysis. ()
  • Adult Dose:
  • Pediatric Dose:
  • Injection: clear, colorless solution available as follows:
  • Paricalcitol injection is available as ():
  • Injection: 2 mcg/mL single-dose vial
  • Injection: 5 mcg/mL single-dose vial
  • Injection: 10 mcg/2 mL (5 mcg/mL) single-dose vial
  • Injection: 10 mcg/2 mL (5 mcg/mL) multiple-dose vial
  • Paricalcitol injection is contraindicated in patients with:
  • Hypercalcemia ()
  • Vitamin D toxicity ()
  • Known hypersensitivity to paricalcitol or any inactive ingredient. ()
  • No data
  • Hypercalcemia:
  • Digitalis toxicity:
  • Adynamic Bone Disease:
  • The following serious adverse reactions are described below and elsewhere in the labeling:
  • The most common adverse reactions (> 5% and more frequent than placebo) are nausea, vomiting and edema. ()n
  • Table 4 includes clinically significant drug interactions with paricalcitol.
  • Table 4: Clinically Significant Drug Interactions with u00a0Paricalcitol
  • Strong CYP3A Inhibitors:
  • 2.4
  • 7
  • No data
  • Overdosage of paricalcitol may lead to hypercalcemia, hypercalciuria, and hyperphosphatemia .
  • The treatment of acute overdosage should consist of supportive measures and discontinuation of drug administration. Serum calcium levels should be measured until normal.
  • Paricalcitol is not significantly removed by dialysis.
  • Paricalcitol, USP, is a synthetically manufactured active vitamin D analog. 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:
  • Molecular formula is CHO.
  • Molecular weight is 416.64.
  • Paricalcitol injection, USP is a sterile, aqueous solution for intravenous use. Each mL contains paricalcitol USP, 2 mcg or 5 mcg and the following inactive ingredients: alcohol, 20% (v/v) and propylene glycol, 30% (v/v).
  • No data
  • In a 104-week carcinogenicity study in CD-1 mice, an increased incidence of uterine leiomyoma and leiomyosarcoma was observed at subcutaneous doses of 1, 3, 10 mcg/kg administered 3 times per week (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, there was an increased incidence of benign adrenal pheochromocytoma at subcutaneous doses of 0.15, 0.5, 1.5 mcg/kg administered 3 times per week (at less than clinical exposure 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 (13 times a human dose of 14 mcg, equivalent to 0.24 mcg/kg based on surface area, mg/m).
  • Adult Studies in CKD on Dialysis
  • Three 12-week, placebo-controlled studies were conducted in 78 patients with CKD on hemodialysis. In these studies, patients ranged in age from 22 to 90 years, 51% were males, 13% were Caucasian, 79% were African-American, and 8% were Hispanic. The most common causes of renal failure were hypertension and diabetes. The dose of paricalcitol was started at 0.04 mcg/kg 3 times per week intravenously. The dose was increased by 0.04 mcg/kg every 2 weeks until intact PTH levels were decreased at least 30% from baseline or a fifth escalation brought the dose to 0.24 mcg/kg, or intact PTH fell to less than 100 pg/mL, or the Ca u00d7 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 intact PTH reduction of 30% within 6 weeks. The results from these studies are as follows:
  • Table 6: Mean Changes from Baseline to Final Evaluation in intact PTH, Alkaline Phosphatase, Phosphorus and Calcium u00d7 Phosphorus Product in Adult Patients with CKD on Dialysis in Three 12-Week Placebo-Controlled Studies
  • Pediatric Study in CKD on Dialysis
  • Paricalcitol was evaluated in a 12-week randomized, double-blind, placebo-controlled study of 29 pediatric patients, aged 5 to 19 years, with CKD on hemodialysis; nearly all had received some form of vitamin D prior to the study. Of the 29 patients, 76% were male, 52% were Caucasian and 45% were African-American. The initial dose of paricalcitol was 0.04 mcg/kg 3 times per week, based on baseline intact PTH level of less than 500 pg/mL, or 0.08 mcg/kg 3 times per week, based on baseline intact PTH level of 500 pg/mL or greater. The dose of paricalcitol was adjusted in 0.04 mcg/kg increments based on the levels of serum intact PTH, calcium and Ca u00d7 P. The mean baseline levels of intact PTH were 841 pg/mL for the 15 u00a0paricalcitol-treated patients and 740 pg/mL for the 14 placebo-treated patients. The mean dose of paricalcitol administered was 4.6 mcg (range: 0.8 mcg to 9.6 mcg). Sixty-seven percent of the u00a0paricalcitol-treated patients and 14% of the placebo-treated patients completed the trial. Seventy-one percent of the placebo-treated patients discontinued due to excessive elevations in intact PTH levels, as defined by 2 consecutive intact PTH levels greater than 700 pg/mL and greater than baseline after 4 weeks of treatment.
  • The primary efficacy analysis demonstrated that 60% of u00a0paricalcitol-treated patients and 21% of placebo-treated patients achieved two consecutive greater than or equal to 30% reductions from baseline in intact PTH.
  • Paricalcitol injection, USP is supplied as a sterile, clear, colorless, aqueous solution for intravenous injection. It is available as follows:
  • 2 mcg/ mL (1 mL)n- 2 mcg
  • 1 mL Single-Dose Vial u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1033-1
  • 25 Vials in a Carton u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1033-5
  • 10 Vials in a Cartonu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1033-7
  • 5 mcg/ mL (1 mL)n- 5 mcg
  • 1 mL Single-Dose Vial u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1034-1
  • 25 Vials in a Carton u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1034-5
  • 10 Vials in a Cartonu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1034-7
  • 10 mcg/2 mL (5 mcg/mL) (2 mL)n- 10 mcg
  • 2 mL Single-Dose Vial u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1035-1
  • 25 Vials in a Carton u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1035-5
  • 10 Vials in a Cartonu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1035-7
  • 10 mcg/2 mL (5 mcg/mL) (2 mL)n- 10 mcg
  • 2 mL Multiple-Dose Vial u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1036-1
  • 25 Vials in a Carton u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1036-5
  • 10 Vials in a Cartonu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 NDC 70121-1036-7
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted between 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [see USP Controlled Room Temperature].n Discard any unused portion of the single-dose vial after use.n The contents of the multiple-dose vial remain stable up to seven days after initial use when stored at controlled room temperature.
  • Hypercalcemia
  • Advise patients to contact a health care provider if they develop symptoms of elevated calcium (e.g. feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination and weight loss) .
  • Monitoring
  • Inform patients that they will need routine monitoring of laboratory parameters such as calcium and intact PTH while receiving paricalcitol injection. Inform patients that more frequent monitoring is necessary during the initiation of therapy, following dose changes or when potentially interacting medications are started or discontinued .
  • Drug Interactions
  • Advise patients to inform their physician of all medications, including prescription and nonprescription drugs, and supplements they are taking. Advise patients to also inform their physician that they are receiving paricalcitol injection if a new medication is prescribed .
  • Manufactured by:n Ahmedabad 382213, INDIA
  • Distributed by:n Bridgewater, NJ 08807
  • Rev. 05-2019-02
  • NDC 70121-1033-1Paricalcitol injection, USP 2 mcg/mLRx OnlyVial LabelAmneal Pharmaceuticals LLC
  • Arrayn- Array
  • NDC 70121-1033-7Paricalcitol injection, USP 2 mcg/mLRx OnlyCarton LabelAmneal Pharmaceuticals LLC
  • NDC 70121-1034-1Paricalcitol injection, USP 5 mcg/mLRx OnlyVial LabelAmneal Pharmaceuticals LLC
  • NDC 70121-1034-7Paricalcitol injection, USP 5 mcg/mLRx OnlyCarton LabelAmneal Pharmaceuticals LLC
  • NDC 70121-1035-1Paricalcitol injection, USP 10 mcg/2 mLRx OnlyVial LabelAmneal Pharmaceuticals LLC
  • NDC 70121-1035-7Paricalcitol injection, USP 10 mcg/2 mLRx OnlyCarton LabelAmneal Pharmaceuticals LLC
  • NDC 70121-1036-1Paricalcitol injection, USP 10 mcg/2 mLRx OnlyMulti-dose Vial LabelAmneal Pharmaceuticals LLC
  • NDC 70121-1036-7Paricalcitol injection, USP 10 mcg/2 mLRx OnlyMulti-dose carton LabelAmneal Pharmaceuticals LLC

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Paricalcitol (Paricalcitol) which is also known as Paricalcitol and Manufactured by Amneal Pharmaceuticals LLC. It is available in strength of 5 ug/mL.

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.

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