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Paricalcitol (Zemplar)

Trade Name : Zemplar

AbbVie Inc.

CAPSULE, LIQUID FILLED

Strength 2 ug/1

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

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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 (Zemplar) which is also known as Zemplar and Manufactured by AbbVie Inc.. It is available in strength of 2 ug/1 per ml. Read more

Paricalcitol (Zemplar) 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

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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.

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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.

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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.

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.

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  • No data
  • 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 ().
  • CKD Stage 5 in patients on hemodialysis or peritoneal dialysis ().
  • No data
  • CKD Stage 5: To avoid hypercalcemia only treat patients after their baseline serum calcium has been reduced to 9.5 mg/dL or lower ().
  • ZEMPLAR capsules are available as 1 mcg and 2 mcg soft gelatin capsules.
  • Capsules: 1 mcg and 2 mcg ().
  • ZEMPLAR capsules should not be given to patients with evidence of
  • Evidence of hypercalcemia ().
  • Evidence of vitamin D toxicity ().
  • Excessive administration of vitamin D compounds, including ZEMPLAR capsules, can cause over suppression of PTH, hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease.
  • Hypercalcemia: Excessive administration of ZEMPLAR capsules can cause over suppression of PTH, hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease. Prescription-based doses of vitamin D and its derivatives should be withheld during ZEMPLAR treatment ().
  • Digitalis toxicity: Potentiated by hypercalcemia of any cause. Use caution when ZEMPLAR capsules are prescribed concomitantly with digitalis compounds ().
  • Laboratory tests: Monitor serum calcium, serum phosphorus, and serum or plasma iPTH during initial dosing or following any dose adjustment. ZEMPLAR capsules may increase serum creatinine and therefore decrease the estimated GFR (eGFR) ().
  • Aluminum overload and toxicity: Avoid excessive use of aluminum containing compounds ().
  • Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
  • The most common adverse reactions (> 5% and more frequent than placebo) include diarrhea, nasopharyngitis, dizziness, vomiting, hypertension, hypersensitivity, nausea, and edema ().
  • To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • Table 6 shows the clinically significant drug interactions with ZEMPLAR capsules.
  • Strong CYP3A inhibitors (e.g. ketoconazole) will increase the exposure of paricalcitol. Use with caution ().
  • Cholestyramine, Mineral Oil: Intestinal absorption of paricalcitol may be reduced if administered simultaneously with cholestyramine or mineral oil. Take ZEMPLAR Capsules at least 1 hour before or 4 to 6 hours after taking cholestyramine or mineral oil ().
  • Lactation: Breastfeeding not recommended ().
  • Excessive administration of ZEMPLAR capsules can cause hypercalcemia, hypercalciuria, and hyperphosphatemia, and over suppression of PTH .
  • Treatment of Overdosage
  • The treatment of acute overdosage of ZEMPLAR capsules should consist of general supportive measures. If drug ingestion is discovered within a relatively short time, induction of emesis or gastric lavage may be of benefit in preventing further absorption. If the drug has passed through the stomach, the administration of mineral oil may promote its fecal elimination. Serial serum electrolyte determinations (especially calcium), rate of urinary calcium excretion, and assessment of electrocardiographic abnormalities due to hypercalcemia should be obtained. Such monitoring is critical in patients receiving digitalis. Discontinuation of supplemental calcium and institution of a low-calcium diet are also indicated in accidental overdosage. Due to the relatively short duration of the pharmacological action of paricalcitol, further measures are probably unnecessary. If persistent and markedly elevated serum calcium levels occur, there are a variety of therapeutic alternatives that may be considered depending on the patient's underlying condition. These include the use of drugs such as phosphates and corticosteroids, as well as measures to induce an appropriate forced diuresis.
  • Paricalcitol is not significantly removed by dialysis.
  • Paricalcitol, USP, the active ingredient in ZEMPLAR capsules, is a synthetically manufactured, metabolically active vitamin D analog of calcitriol with modifications to the side chain (D) and the A (19-nor) ring. ZEMPLAR is available as soft gelatin capsules for oral administration containing 1 microgram or 2 micrograms of paricalcitol. Each capsule also contains medium chain triglycerides, alcohol, and butylated hydroxytoluene. The medium chain triglycerides are fractionated from coconut oil or palm kernel oil. The capsule shell is composed of gelatin, glycerin, titanium dioxide, iron oxide red (2 microgram capsules only), iron oxide yellow (2 microgram capsules only), iron oxide black (1 microgram capsules only), and water.
  • Paricalcitol is a white, crystalline powder with the empirical formula of CHO, which corresponds to a molecular weight of 416.64. Paricalcitol is 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:
  • Secondary hyperparathyroidism is characterized by an elevation in parathyroid hormone (PTH) associated with inadequate levels of active vitamin D hormone. The source of vitamin D in the body is from synthesis in the skin as vitamin D and from dietary intake as either vitamin D or D. Both vitamin D and D require two sequential hydroxylations in the liver and the kidney to bind to and to activate the vitamin D receptor (VDR). The endogenous VDR activator, calcitriol [1,25(OH)D], is a hormone that binds to VDRs that are present in the parathyroid gland, intestine, kidney, and bone to maintain parathyroid function and calcium and phosphorus homeostasis, and to VDRs found in many other tissues, including prostate, endothelium and immune cells. VDR activation is essential for the proper formation and maintenance of normal bone. In the diseased kidney, the activation of vitamin D is diminished, resulting in a rise of PTH, subsequently leading to secondary hyperparathyroidism and disturbances in the calcium and phosphorus homeostasis. Decreased levels of 1,25(OH)D have been observed in early stages of chronic kidney disease. The decreased levels of 1,25(OH)D and resultant elevated PTH levels, both of which often precede abnormalities in serum calcium and phosphorus, affect bone turnover rate and may result in renal osteodystrophy.
  • 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 given three times weekly (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 (< 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 a human dose of 14 mcg based on surface area, mcg/m).
  • No data
  • ZEMPLAR capsules are available as 1 mcg and 2 mcg capsules.
  • The 1 mcg capsule is an oval, gray, soft gelatin capsule supplied and imprinted as follows:
  • Bottles of 30 u2013 NDC 0074-9036-30 (imprinted with u201cZAu201d)
  • Bottles of 30 u2013 NDC 0074-4317-30 (imprinted with the u201cau201d logo and u201cZAu201d)
  • The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule supplied and imprinted as follows:
  • Bottles of 30 u2013 NDC 0074-9037-30 (imprinted with u201cZFu201d)
  • Bottles of 30 u2013 NDC 0074-4314-30 (imprinted with the u201cau201d logo and u201cZFu201d)
  • Storage
  • Store ZEMPLAR capsules at 25u00b0C (77u00b0F). Excursions permitted between 15u00b0- 30u00b0C (59u00b0- 86u00b0F). See USP Controlled Room Temperature.
  • Advise patients of the following:
  • u00a9 2019 AbbVie Inc.
  • Manufactured for
  • AbbVie Inc.
  • North Chicago, IL 60064, U.S.A.
  • 03-C012 October 2019
  • NDC 0074u20139036u201330
  • Zemplar (paricalcitol) Capsules
  • 1 mcg 30 Capsules
  • Rx only abbvie
  • NDC 0074u20139037u201330
  • Zemplar (paricalcitol) Capsules
  • 2 mcg 30 Capsules
  • Rx only abbvie
  • NDC 0074u20134317u201330
  • Zemplar (paricalcitol) Capsules
  • 1 mcg 30 Capsules
  • Rx only abbvie
  • NDC 0074u20134314u201330
  • Zemplar (paricalcitol) Capsules
  • 2 mcg 30 Capsules
  • Rx only abbvie

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