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Zemplar
Overview
What is Zemplar?
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-1α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene and has the following structural formula:
What does Zemplar look like?
What are the available doses of Zemplar?
Capsules: 1 mcg and 2 mcg ().
What should I talk to my health care provider before I take Zemplar?
Lactation: Breastfeeding not recommended ().
How should I use Zemplar?
ZEMPLAR capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4.
Administer ZEMPLAR 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
Dose Titration
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 Zemplar?
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What are the warnings of Zemplar?
Sorry No Records found
What are the precautions of Zemplar?
Sorry No Records found
What are the side effects of Zemplar?
Sorry No records found
What should I look out for while using Zemplar?
ZEMPLAR capsules should not be given to patients with evidence of
What might happen if I take too much Zemplar?
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.
How should I store and handle Zemplar?
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 – NDC 0074-9036-30 (imprinted with “ZA”)Bottles of 30 – NDC 0074-4317-30 (imprinted with the “a” logo and “ZA”)The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule supplied and imprinted as follows:Bottles of 30 – NDC 0074-9037-30 (imprinted with “ZF”)Bottles of 30 – NDC 0074-4314-30 (imprinted with the “a” logo and “ZF”)StorageStore ZEMPLAR capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.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 – NDC 0074-9036-30 (imprinted with “ZA”)Bottles of 30 – NDC 0074-4317-30 (imprinted with the “a” logo and “ZA”)The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule supplied and imprinted as follows:Bottles of 30 – NDC 0074-9037-30 (imprinted with “ZF”)Bottles of 30 – NDC 0074-4314-30 (imprinted with the “a” logo and “ZF”)StorageStore ZEMPLAR capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.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 – NDC 0074-9036-30 (imprinted with “ZA”)Bottles of 30 – NDC 0074-4317-30 (imprinted with the “a” logo and “ZA”)The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule supplied and imprinted as follows:Bottles of 30 – NDC 0074-9037-30 (imprinted with “ZF”)Bottles of 30 – NDC 0074-4314-30 (imprinted with the “a” logo and “ZF”)StorageStore ZEMPLAR capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.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 – NDC 0074-9036-30 (imprinted with “ZA”)Bottles of 30 – NDC 0074-4317-30 (imprinted with the “a” logo and “ZA”)The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule supplied and imprinted as follows:Bottles of 30 – NDC 0074-9037-30 (imprinted with “ZF”)Bottles of 30 – NDC 0074-4314-30 (imprinted with the “a” logo and “ZF”)StorageStore ZEMPLAR capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.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 – NDC 0074-9036-30 (imprinted with “ZA”)Bottles of 30 – NDC 0074-4317-30 (imprinted with the “a” logo and “ZA”)The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule supplied and imprinted as follows:Bottles of 30 – NDC 0074-9037-30 (imprinted with “ZF”)Bottles of 30 – NDC 0074-4314-30 (imprinted with the “a” logo and “ZF”)StorageStore ZEMPLAR capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.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 – NDC 0074-9036-30 (imprinted with “ZA”)Bottles of 30 – NDC 0074-4317-30 (imprinted with the “a” logo and “ZA”)The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule supplied and imprinted as follows:Bottles of 30 – NDC 0074-9037-30 (imprinted with “ZF”)Bottles of 30 – NDC 0074-4314-30 (imprinted with the “a” logo and “ZF”)StorageStore ZEMPLAR capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.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 – NDC 0074-9036-30 (imprinted with “ZA”)Bottles of 30 – NDC 0074-4317-30 (imprinted with the “a” logo and “ZA”)The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule supplied and imprinted as follows:Bottles of 30 – NDC 0074-9037-30 (imprinted with “ZF”)Bottles of 30 – NDC 0074-4314-30 (imprinted with the “a” logo and “ZF”)StorageStore ZEMPLAR capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.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 – NDC 0074-9036-30 (imprinted with “ZA”)Bottles of 30 – NDC 0074-4317-30 (imprinted with the “a” logo and “ZA”)The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule supplied and imprinted as follows:Bottles of 30 – NDC 0074-9037-30 (imprinted with “ZF”)Bottles of 30 – NDC 0074-4314-30 (imprinted with the “a” logo and “ZF”)StorageStore ZEMPLAR capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.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 – NDC 0074-9036-30 (imprinted with “ZA”)Bottles of 30 – NDC 0074-4317-30 (imprinted with the “a” logo and “ZA”)The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule supplied and imprinted as follows:Bottles of 30 – NDC 0074-9037-30 (imprinted with “ZF”)Bottles of 30 – NDC 0074-4314-30 (imprinted with the “a” logo and “ZF”)StorageStore ZEMPLAR capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.
Clinical Information
Chemical Structure
No Image foundClinical 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
ZEMPLAR capsules should not be given to patients with evidence ofNo significant drug-drug pharmacokinetic interactions have been found in interaction studies with hydrochlorothiazide, digoxin, warfarin, cimetidine and phenobarbital. Rifampin, an inducer of drug metabolism, decreased the concentrations of losartan and its active metabolite. (See , .) In humans, two inhibitors of P450 3A4 have been studied. Ketoconazole did not affect the conversion of losartan to the active metabolite after intravenous administration of losartan, and erythromycin had no clinically significant effect after oral administration. Fluconazole, an inhibitor of P450 2C9, decreased active metabolite concentration and increased losartan concentration. The pharmacodynamic consequences of concomitant use of losartan and inhibitors of P450 2C9 have not been examined. Subjects who do not metabolize losartan to active metabolite have been shown to have a specific, rare defect in cytochrome P450 2C9. These data suggest that the conversion of losartan to its active metabolite is mediated primarily by P450 2C9 and not P450 3A4.
As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium.
Excessive administration of vitamin D compounds, including ZEMPLAR 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.
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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