Paricap Soft Capsule

Secondary hyperparathyroidism

May be taken with or without food.

Oral Prevention & Treatment of Secondary Hyperparathyroidism Associated with Chronic Kidney Disease (Stage 3 & 4) PTH <500 pg/mL: 1 mcg PO qDay OR 2 mcg PO 3 times/week PTH >500 pg/mL: 2 mcg PO qDay OR 4 mcg PO 3 times/week Do not administer 3 times/week dosing no more frequently than every other day Titrate dose based on response. Monitoring parameters (Stage 3 & 4) Serum PTH at 2-4 week intervals PTH same or increased: Increase by 1 mcg/day OR 2 mcg three times/week PTH decreased <30%: Increase by 1 mcg/day OR 2 mcg three times/week PTH decreased >30% or <60%: Maintain current dose PTH decreased >60%: Decrease 1 mcg/day OR 2 mcg three times/week PTH <60 pg/mL: Decrease 1 mcg/day OR 2 mcg three times/week

Hypersensitivity, Hypercalcemia, hypervitaminosis D

Synthetic vitamin D analog, reduces parathyroid hormone (PTH).

Monitor serum calcium and phosphorus frequently; reduce dose or stop the drug if calcium (in mg/dL) times phosphorus (in mg/dL) product >75 Patients receiving digitalis; digitalis toxicity is potentiated by hypercalcemia Strong CYP3A4 inhibitors may increase paricalcitol AUC. May increase serum creatinine in pre-dialysis patients. Hepatic impairment Lactation: not known if distributed into breast milk, use caution

>10% Nausea (13%) 1-10% Vomiting,Edema,Palpitation,Chills,Pneumonia,Lightheadedness,GI bleeding,Flu,Sepsis,Hypokalemia,Hypercalcemia,Increase in blood creatinine

Digitalis; ketoconazole & other strong P450 3A inhibitors including atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole. May interfere absorption w/ cholestyramine (cap only). Increased risk of hypercalcemia w/ prescription-based phosphate or vit D-related medicinal products & Ca-containing prep or thiazide diuretics. Mg- & Al-containing prep (eg, antacids, phosphate-binders).