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Paricalcitol

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Overview

What is Paricalcitol?

Paricalcitol, USP, the active ingredient in paricalcitol 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. Paricalcitol is available as soft gelatin capsules for oral administration containing 1 microgram, 2 micrograms or 4 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 and 4 microgram capsules), iron oxide black (1 microgram capsules only), and water. The capsules are printed with black ink composed of purified water, black iron oxide, isopropyl alcohol, propylene glycol and hypromellose.

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-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula:



What does Paricalcitol look like?



What are the available doses of Paricalcitol?

Capsules: 1 mcg, 2 mcg, and 4 mcg ().

What should I talk to my health care provider before I take Paricalcitol?

Lactation: Breastfeeding not recommended ().

Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.’s ZEMPLAR (paricalcitol) capsules. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

How should I use Paricalcitol?

Paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4.

Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.’s Zemplar (paricalcitol) capsules. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Administer paricalcitol capsules orally once daily or three times a week . When dosing three times weekly, do not administer more frequently than every other day.

Initial Dose

Table 1. Recommended Paricalcitol Capsules Starting Dose Based upon Baseline iPTH Level

Dose Titration

Table 2. Recommended Paricalcitol Capsules Dose Titration Base upon iPTH Level

If a patient is taking the lowest dose, 1 mcg, on the daily regimen and a dose reduction is needed, the dose can be decreased to 1 mcg three times a week. If a further dose reduction is required, the drug should be withheld as needed and restarted at a lower dosing frequency.


What interacts with Paricalcitol?

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What are the warnings of Paricalcitol?

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What are the precautions of Paricalcitol?

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What are the side effects of Paricalcitol?

Sorry No records found


What should I look out for while using Paricalcitol?

Paricalcitol capsules should not be given to patients with evidence of


What might happen if I take too much Paricalcitol?

Excessive administration of paricalcitol capsules can cause hypercalcemia, hypercalciuria, and hyperphosphatemia, and over suppression of PTH [see ].

Treatment of Overdosage

The treatment of acute overdosage of paricalcitol 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.


How should I store and handle Paricalcitol?

Prior to reconstitution, TYGACIL should be stored at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] The reconstituted solution of TYGACIL may be stored at room temperature (not to exceed 25°C/77°F) for up to 24 hours (up to 6 hours in the vial and the remaining time in the intravenous bag) .Paricalcitol capsules are available as 1 mcg, 2 mcg, and 4 mcg capsules.The 1 mcg capsule is an oval, gray, soft gelatin capsule imprinted with "PA1", and is available in the following package size:Bottles of 30 (NDC 69452-145-13)The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule imprinted with "PA2", and is available in the following package size:Bottles of 30 (NDC 69452-146-13)The 4 mcg capsule is an oval, yellow soft gelatin capsule imprinted with "PA4", and is available in the following package size:Bottles of 30 (NDC 69452-147-13)StorageStore paricalcitol capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.Paricalcitol capsules are available as 1 mcg, 2 mcg, and 4 mcg capsules.The 1 mcg capsule is an oval, gray, soft gelatin capsule imprinted with "PA1", and is available in the following package size:Bottles of 30 (NDC 69452-145-13)The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule imprinted with "PA2", and is available in the following package size:Bottles of 30 (NDC 69452-146-13)The 4 mcg capsule is an oval, yellow soft gelatin capsule imprinted with "PA4", and is available in the following package size:Bottles of 30 (NDC 69452-147-13)StorageStore paricalcitol capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.Paricalcitol capsules are available as 1 mcg, 2 mcg, and 4 mcg capsules.The 1 mcg capsule is an oval, gray, soft gelatin capsule imprinted with "PA1", and is available in the following package size:Bottles of 30 (NDC 69452-145-13)The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule imprinted with "PA2", and is available in the following package size:Bottles of 30 (NDC 69452-146-13)The 4 mcg capsule is an oval, yellow soft gelatin capsule imprinted with "PA4", and is available in the following package size:Bottles of 30 (NDC 69452-147-13)StorageStore paricalcitol capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.Paricalcitol capsules are available as 1 mcg, 2 mcg, and 4 mcg capsules.The 1 mcg capsule is an oval, gray, soft gelatin capsule imprinted with "PA1", and is available in the following package size:Bottles of 30 (NDC 69452-145-13)The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule imprinted with "PA2", and is available in the following package size:Bottles of 30 (NDC 69452-146-13)The 4 mcg capsule is an oval, yellow soft gelatin capsule imprinted with "PA4", and is available in the following package size:Bottles of 30 (NDC 69452-147-13)StorageStore paricalcitol capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.Paricalcitol capsules are available as 1 mcg, 2 mcg, and 4 mcg capsules.The 1 mcg capsule is an oval, gray, soft gelatin capsule imprinted with "PA1", and is available in the following package size:Bottles of 30 (NDC 69452-145-13)The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule imprinted with "PA2", and is available in the following package size:Bottles of 30 (NDC 69452-146-13)The 4 mcg capsule is an oval, yellow soft gelatin capsule imprinted with "PA4", and is available in the following package size:Bottles of 30 (NDC 69452-147-13)StorageStore paricalcitol capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.Paricalcitol capsules are available as 1 mcg, 2 mcg, and 4 mcg capsules.The 1 mcg capsule is an oval, gray, soft gelatin capsule imprinted with "PA1", and is available in the following package size:Bottles of 30 (NDC 69452-145-13)The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule imprinted with "PA2", and is available in the following package size:Bottles of 30 (NDC 69452-146-13)The 4 mcg capsule is an oval, yellow soft gelatin capsule imprinted with "PA4", and is available in the following package size:Bottles of 30 (NDC 69452-147-13)StorageStore paricalcitol capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.Paricalcitol capsules are available as 1 mcg, 2 mcg, and 4 mcg capsules.The 1 mcg capsule is an oval, gray, soft gelatin capsule imprinted with "PA1", and is available in the following package size:Bottles of 30 (NDC 69452-145-13)The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule imprinted with "PA2", and is available in the following package size:Bottles of 30 (NDC 69452-146-13)The 4 mcg capsule is an oval, yellow soft gelatin capsule imprinted with "PA4", and is available in the following package size:Bottles of 30 (NDC 69452-147-13)StorageStore paricalcitol capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.Paricalcitol capsules are available as 1 mcg, 2 mcg, and 4 mcg capsules.The 1 mcg capsule is an oval, gray, soft gelatin capsule imprinted with "PA1", and is available in the following package size:Bottles of 30 (NDC 69452-145-13)The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule imprinted with "PA2", and is available in the following package size:Bottles of 30 (NDC 69452-146-13)The 4 mcg capsule is an oval, yellow soft gelatin capsule imprinted with "PA4", and is available in the following package size:Bottles of 30 (NDC 69452-147-13)StorageStore paricalcitol capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.Paricalcitol capsules are available as 1 mcg, 2 mcg, and 4 mcg capsules.The 1 mcg capsule is an oval, gray, soft gelatin capsule imprinted with "PA1", and is available in the following package size:Bottles of 30 (NDC 69452-145-13)The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule imprinted with "PA2", and is available in the following package size:Bottles of 30 (NDC 69452-146-13)The 4 mcg capsule is an oval, yellow soft gelatin capsule imprinted with "PA4", and is available in the following package size:Bottles of 30 (NDC 69452-147-13)StorageStore paricalcitol capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Paricalcitol is a synthetic, biologically active vitamin D analog of calcitriol. Preclinical and 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.

Non-Clinical Toxicology
Paricalcitol capsules should not be given to patients with evidence of

Although the pressor activity of DDAVP is very low compared with the antidiuretic activity, use of doses as large as 0.3 mcg/kg of DDAVP with other pressor agents should be done only with careful patient monitoring. The concomitant administration of drugs that may increase the risk of water intoxication with hyponatremia, (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, NSAIDs, lamotrigine and carbamazepine) should be performed with caution.

DDAVP has been used with epsilon aminocaproic acid without adverse effects.

Excessive administration of vitamin D compounds, including paricalcitol capsules, can cause over suppression of PTH, hypercalcemia, hypercalciuria, hyperphosphatemia, and adynamic bone disease.

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.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Interactions

Interactions

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