Chronic Kidney Disease Stages 3 And 4: Paricalcitol 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. Chronic Kidney Disease Stage 5: Paricalcitol capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD).
Vitamin in bone formation,Vitamin-B preparations
Paricalcitol is a synthetic, biologically active vitamin D2 analog of calcitriol Preclinical and in vitro 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.
Usual Adult Dose for Secondary Hyperparathyroidism: Initial dose: Stage 3 or 4 Chronic Kidney Disease (CKD): Initial dosing is based on baseline intact parathyroid hormone (iPTH): 500 pg/mL or less: 1 mcg orally daily OR 2 mcg orally 3 times a week Over 500 pg/mL: 2 mcg orally daily OR 4 mcg orally 3 times a week Stage 5 Chronic Kidney Disease (CKD): Starting dose (micrograms) = baseline iPTH level (pg/mL)/80 Starting dose is given orally 3 times a week; only start if baseline serum calcium has been adjusted to 9.5 mg/dL or lower. Usual Pediatric Dose for Secondary Hyperparathyroidism: Safety and efficacy have not been established in pediatric patients. The following is dosing used in a very small pediatric trial. No data are available on children under 5 years old. Initial dose,children 5 to 18 years: 0.04 mcg/kg three times per week if baseline intact parathyroid hormone (iPTH) is less than 500 pg/mL 0.08 mcg/kg three times per week if baseline iPTH is 500 pg/mL or higher. Injected as a bolus dose through a hemodialysis vascular access port at any time during dialysis Maximum frequency: Every other day
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 paricalcitol capsules at least 1 hour before or 4 to 6 hours after taking cholestyramine or mineral oil.
Hypersensitivity,Hypercalcemia,hypervitaminosis D
Nausea,Vomiting,Edema,Palpitation,Chills,Pneumonia,Lightheadedness,GI bleeding,Flu,Sepsis,Hypokalemia,Hypercalcemia,Increase in blood creatinine
This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: C US FDA pregnancy category: C Lactation: Not known if distributed into breast milk,use caution
Excessive administration of Paricalcitol capsules can cause hypercalcemia, hypercalciuria, and hyperphosphatemia, and over suppression of PTH. 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 electrocardio graphic 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.
Store below 30°C in dry place, protected from light. Keep out of children's reach.
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