Monograph Details
|
|
Urogenital System
> Miscellaneous urogenital disorders
|
|
ROCALTROL |
| Manufacturer |
|
Roche Laboratories |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
Vit. D analogue. |
| Generic Name |
|
Calcitriol 0.25microgram, 0.5microgram; caps. |
| Also |
|
• ROCALTROL SOLUTION
|
| 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. |
| Children |
|
Predialysis: <3yrs: 10–15nanograms/kg per day; ≥3yrs: initially 0.25micrograms daily; may increase to 0.5micrograms daily. Dialysis: not recommended. Hypoparathyroidism: initially 0.25microgram daily in the AM; may increase by 0.25microgram daily at 2–4 week intervals. Usual maintenance (1–5 yrs): 0.25–0.75microgram daily; (>6 yrs): 0.5–2micrograms daily. Pseudohypoparathyroidism: (<6 yrs): insufficient data; see literature. |
| Adults |
|
Predialysis: initially 0.25microgram daily; may increase to 0.5microgram daily. Dialysis: initially 0.25microgram daily; may increase by 0.25microgram daily at 4–8 week intervals; usual maintenance: 0.5–1microgram daily. Hypoparathyroidism: initially 0.25microgram daily in the AM; may increase by 0.25microgram daily at 2–4 week intervals; usual maintenance: 0.5–2microgram daily. |
| Contraindications |
|
Hypercalcemia. Concurrent Vit. D therapy. Vit. D toxicity. Nursing mothers. |
| 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). |
| 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. |
| Adverse Reactions |
|
Symptoms of hypervitaminosis D, hypercalcemia, hypercalciuria, elevated creatinine, erythema multiforme, hyperphosphatemia. |
| How Supplied |
Caps 0.25micrograms—30, 100
0.5micrograms—100
Soln—15mL (w. 20 single-use dispensers) |
|
|
|
|
