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Rocaltrol Solution Generic Name & Formulations
Legal Class
Rx
General Description
Calcitriol 1mcg/mL.
Pharmacological Class
Vit. D analog.
See Also
How Supplied
Caps 0.25mcg—30, 100; 0.5mcg—100; Soln—15mL (w. 20 single-use dispensers)
Manufacturer
Rocaltrol Solution Indications
Indications
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 Solution Dosage and Administration
Adult
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.
Children
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.
Rocaltrol Solution Contraindications
Contraindications
Hypercalcemia. Concurrent Vit. D therapy. Vit. D toxicity. Nursing mothers.
Rocaltrol Solution Boxed Warnings
Not Applicable
Rocaltrol Solution Warnings/Precautions
Warnings/Precautions
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).
Rocaltrol Solution Pharmacokinetics
See Literature
Rocaltrol Solution Interactions
Interactions
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 Solution Adverse Reactions
Adverse Reactions
Symptoms of hypervitaminosis D, hypercalcemia, hypercalciuria, elevated creatinine, erythema multiforme, hyperphosphatemia.
Rocaltrol Solution Clinical Trials
See Literature
Rocaltrol Solution Note
Not Applicable
Rocaltrol Solution Patient Counseling
See Literature
