Rocaltrol Generic Name & Formulations
Calcitriol 0.25mcg, 0.5mcg; caps.
Vit. D analog.
Caps 0.25mcg—30, 100; 0.5mcg—100; Soln—15mL (w. 20 single-use dispensers)
Secondary hyperparathyroidism and resultant metabolic bone disease in predialysis patients (CrCl 15–55mL/min). Hypocalcemia and resultant metabolic bone disease in patients on chronic renal dialysis. Hypocalcemia in hypoparathyroidism, pseudohypoparathyroidism.
Rocaltrol Dosage and Administration
Predialysis: initially 0.25mcg daily; may increase to 0.5mcg daily. Dialysis: initially 0.25mcg daily; may increase by 0.25mcg daily at 4–8 week intervals; usual maintenance: 0.5–1mcg daily. Hypoparathyroidism: initially 0.25mcg daily in the AM; may increase by 0.25mcg daily at 2–4 week intervals; usual maintenance: 0.5–2mcg daily.
Predialysis: <3yrs: 10–15nanograms/kg per day; ≥3yrs: initially 0.25mcg daily; may increase to 0.5mcg daily. Dialysis: not recommended. Hypoparathyroidism: initially 0.25mcg daily in the AM; may increase by 0.25mcg daily at 2–4 week intervals. Usual maintenance (1–5 yrs): 0.25–0.75mcg daily; (>6 yrs): 0.5–2mcg daily. Pseudohypoparathyroidism: (<6 yrs): insufficient data; see literature.
Hypercalcemia. Concurrent Vit. D therapy. Vit. D toxicity. Nursing mothers.
Rocaltrol Boxed Warnings
Maintain adequate daily calcium and fluid intake. Keep serum calcium times phosphate (Ca x P) product below 70. Monitor serum calcium (esp. during dose titration), phosphorus, other lab values (see literature for frequency). Pregnancy (Cat.C).
Hypermagnesemia with magnesium-containing antacids. Decreased absorption with cholestyramine, mineral oil. Arrhythmias with digitalis if hypercalcemia occurs. Antagonized by phenobarbital. Thiazides increase urinary excretion of calcium. Serum levels may be affected by ketoconazole.
Rocaltrol Adverse Reactions
Symptoms of hypervitaminosis D, hypercalcemia, hypercalciuria, elevated creatinine, erythema multiforme, hyperphosphatemia.
Rocaltrol Clinical Trials
Rocaltrol Patient Counseling