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paricalcitol 2 mcg capsule generic zemplar

Out of Stock Manufacturer AUROBINDO PHARM 65862093730
Out of Stock

Dosage and Administration

Administration

Paricalcitol is administered orally once daily or 3 times weekly; the drug may be given without regard to meals. When paricalcitol is administered 3 times weekly, the drug should be administered no more frequently than every other day.

Paricalcitol also is administered by direct IV injection at (before, during, or after) dialysis.

Dosage

Paricalcitol dosage must be individualized carefully according to serum or plasma parathyroid hormone (PTH) concentrations, with close monitoring of serum calcium and phosphorus concentrations. An intact PTH (iPTH) assay is recommended for detection of biologically active PTH in patients with chronic kidney disease. In patients receiving oral paricalcitol, serum calcium, serum phosphorus, and serum or plasma iPTH concentrations should be monitored every 2 weeks for 3 months after initiation of therapy or after subsequent dosage changes, then monthly for 3 months (once the dosage is stabilized), and every 3 months thereafter. The manufacturer recommends that iPTH concentrations be determined every 3 months in patients receiving parenteral paricalcitol; more frequent monitoring may be necessary during dosage adjustments. In addition, the manufacturer recommends that serum calcium and phosphorus concentrations be monitored at least twice weekly during the initial dosage adjustments and after subsequent dosage changes and at least monthly once the dosage is stabilized in patients receiving parenteral paricalcitol. Serum calcium and iPTH concentrations should be monitored in paricalcitol-treated patients when initiating or discontinuing therapy with a potent inhibitor of the cytochrome P-450 CYP3A isoenzyme (e.g., ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole).

Hyperparathyroidism Secondary to Chronic Renal Disease

Oral Dosage

The initial oral dosage of paricalcitol for the prevention and treatment of secondary hyperparathyroidism in adults with chronic kidney disease (stage 3 and 4) and a baseline serum iPTH concentration of 500 pg/mL or less is 1 mcg daily or 2 mcg 3 times weekly. The initial dosage of paricalcitol for this indication in adults with chronic kidney disease (stage 3 and 4) and a baseline serum iPTH concentration exceeding 500 pg/mL is 2 mcg daily or 4 mcg 3 times weekly. Dosage of paricalcitol should be adjusted according to the patient's serum or plasma iPTH concentrations. If response is inadequate (i.e., iPTH concentration increases, remains unchanged, or is not reduced by at least 30%), dosage of paricalcitol may be increased by 1 mcg daily (e.g., from 1 mcg daily to 2 mcg daily) or 2 mcg 3 times weekly (e.g., from 2 mcg 3 times weekly to 4 mcg 3 times weekly) at 2- to 4-week intervals. Dosage of paricalcitol should be maintained in patients whose iPTH concentrations have decreased by 30-60% from baseline values. Dosage of paricalcitol should be reduced as iPTH concentrations decline in response to therapy; if iPTH concentrations decrease by more than 60% or if iPTH concentrations decline to less than 60 pg/mL, the dosage of paricalcitol should be reduced by 1 mcg daily or 2 mcg 3 times weekly at 2- to 4-week intervals. Patients receiving the lowest dosage with the daily regimen who require a dosage reduction may receive 1 mcg 3 times weekly; if further dosage reduction is needed, paricalcitol therapy should be withheld as needed and therapy be reinitiated at a lower dosage. In patients receiving a calcium-containing phosphate binder, the dosage of the phosphate binder should be reduced or withheld; alternatively, the patient can be switched to a non-calcium-containing phosphate binder. If hypercalcemia or elevated serum calcium (in mg/dL) times phosphorus (in mg/dL) product (Ca x P) is observed, the dosage of paricalcitol should be reduced or therapy withheld until these parameters are normalized. Dosage adjustment is not required in patients with mild to moderate hepatic impairment.

IV Dosage

The initial dosage of IV paricalcitol for the prevention and treatment of secondary hyperparathyroidism in patients with chronic renal failure is 0.04-0.1 mcg/kg (2.8-7 mcg) at dialysis (no more frequently than every other day). Initial doses as high as 0.24 mcg/kg (16.8 mcg) have been used safely. Dosage of paricalcitol should be adjusted according the patient's PTH concentrations with the goal of reducing PTH concentrations to 1.5-3 times the upper limit of normal. If response is inadequate (i.e., in those patients whose PTH concentration increases, remains the same, or is not reduced by at least 30%), dosage of paricalcitol may be increased by 2-4 mcg per dose at 2- to 4-week intervals. Dosage of paricalcitol should be maintained in patients whose PTH concentrations have decreased by more than 30 to less than 60% of baseline values or in those with iPTH concentrations 1.5-3 times the upper limit of normal. Dosage of paricalcitol should be reduced as PTH concentrations decline in response to therapy; if PTH concentrations decrease by more than 60%, the dosage of paricalcitol should be reduced. If serum calcium concentrations are elevated, or the serum calcium times serum phosphorous (Ca x P) exceeds 75, dosage of paricalcitol should be reduced immediately or therapy withheld. Once these parameters have normalized, therapy can be reinitiated at a lower dosage. Dosage adjustment is not required in patients with mild to moderate hepatic impairment.

In the clinical studies used to establish safety and efficacy of paricalcitol, adults received an initial dosage of 0.04 mcg/kg given 3 times weekly; dose was then increased by 0.04 mcg/kg every 2 weeks until the iPTH concentrations were reduced by 30% or declined to less than 100 pg/mL, the fifth dose escalation reached 0.24 mcg/kg, the serum calcium times serum phosphorous (Ca x P) was more than 75 within any 2-week period, or serum calcium concentrations were greater than 11.5 mg/dL at any time. In these studies, dose of paricalcitol was reduced by 0.04 mcg/kg if iPTH concentrations decreased to less than 100 pg/mL, serum calcium concentrations were greater than 11.5 mg/dL, or serum calcium times serum phosphorus (Ca x P) exceeded 75. Dose of paricalcitol was maintained when PTH concentrations decreased by 30% or more (but remained above 100 pg/mL), serum calcium concentrations were less than 11.5 mg/dL, and the serum calcium times serum phosphorus product was acceptable (75 or less).

In a clinical study that evaluated the safety and efficacy of paricalcitol in children 5-19 years of age with end-stage renal disease (ESRD) on hemodialysis, pediatric patients with a baseline iPTH concentrations less than 500 pg/mL received an initial dosage of 0.04 mcg/kg administered 3 times weekly while those with a baseline iPTH concentrations of at least 500 pg/mL received an initial dosage of 0.08 mcg/kg administered 3 times weekly. The initial dose was then adjusted in increments of 0.04 mcg/kg based on serum concentrations of iPTH, calcium, and calcium times serum phosphorous (Ca x P) product. The mean dose in this study was 4.6 mcg (range: 0.8-9.6 mcg).

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