Classes
DEA Class; Rx
Common Brand Names; Calcijex, Rocaltrol, Vectical
- Vitamin D Analogs
- Antipsoriatics, Topical
Description
Active form of vitamin D3 (cholecalciferol)
Used for secondary hyperparathyroidism, metabolic bone disease in chronic renal failure patients not receiving dialysis, hypoparathyroidism, familial hypophosphatemia, and vitamin D-dependent rickets
More than twice the vitamin D activity of calcifediol
Indications
Indicated for the treatment of hypocalcemia and secondary hyperparathyroidism and resultant metabolic bone disease (renal osteodystrophy) in patients with chronic kidney disease.
For the management of hypocalcemia associated with vitamin D deficiency.
Contraindications
Hypercalcemia or evidence of vitamin D toxicity
Hypersensitivity to calcitriol, other vitamin D analogues, or other ingredients
Adverse Effects
- Abdominal pain
- Apathy
- BUN and creatinine increased
- Cardiac arrhythmia
- Constipation
- Dry mouth
- Dehydration
- Growth suppression
- Headache
- Hyperthermia
- Hypercalcemia
- Hypercholesteremia
- Hypermagnesemia
- Hyperphosphatemia
- Hypertension
- Libido decreased
- Metallic taste
- Muscle or bone pain
- N/V
- Nocturia
- Pruritus
- Psychosis
- Somnolence
- Weakness
Warnings
Other vitamin D compounds should be withheld during treatment in order to avoid the development of hypervitaminosis D; excessive vitamin D may suppress parathyroid hormone
If patients are “changed over” from ergocalciferol to calcitriol it may take many months for blood levels of ergocalciferol to return to pre-treatment values; overdosage of any form of vitamin D is dangerous; chronic hypercalcemia can lead to generalised vascular calcification, nephrocalcinosis and other soft-tissue calcification
Patients with hypophosphatemic rickets (familial hypophosphatemia) should pursue their oral phosphate therapy; however, the possible stimulation of intestinal phosphate absorption may modify the requirement for phosphate supplements; during the stabilisation phase of treatment, serum calcium levels should be checked at least twice weekly
Efficacy may be unpredictable in patients with malabsorption syndrome
Sudden increases in calcium consumption due to dietary change (eg, dairy products) or injudicious calcium supplements may precipitate hypercalcaemia; patients and relatives should receive instruction in dietary management, be informed about symptoms of hypercalcaemia, and be warned of consequences of not adhering to dietary recommendations
In patients with normal renal function, chronic hypercalcaemia may be associated with an increase in serum creatinine
Therapy raises serum inorganic phosphate levels; while this is a desirable effect in patients with hypophosphatemic states, caution must be taken in patients with renal failure
Calcitriol may increase plasma phosphate levels; while this effect is desirable in hypophosphatemic osteomalacia, it may cause ectopic calcification, especially in patients with renal failure; plasma phosphate levels should be kept normal in such patients by the oral administration of phosphate binding agents
Patients with normal renal function should avoid dehydration; adequate fluid intake should be maintained
Use caution in malabsorption syndrome, renal/hepatic impairment
Patients immobilized after surgical procedures are more at risk of developing hypercalcaemia, therefore more frequent monitoring is recommended
Special care should be taken when administering therapy to patients with renal dysfunction; more frequent monitoring in these patients is appropriate
In elderly patients suffering from ischemic heart disease, serum calcium levels should be carefully monitored; if hypercalcemia is observed, therapy should be suspended immediately; it should also be remembered that geriatric patients receive many other drugs and that their compliance may not be ideal
Pregnancy and Lactation
Pregnancy category: C
Lactation: Enters breast milk; not recommended
Maximum Dosage
200 g ointment/week topically. Specific maximum dosage information for systemic use is not available; individualize dosage based on clinical parameters.
200 g ointment/week topically. Specific maximum dosage information for systemic use is not available; individualize dosage based on clinical parameters.
200 g ointment/week topically. Specific maximum dosage information for systemic use is not available; individualize dosage based on clinical parameters.
7 to 12 years: 200 g ointment/week topically. Specific maximum dosage information for systemic use is not available; individualize dosage based on clinical parameters.
2 to 6 years: 100 g ointment/week topically. Specific maximum dosage information for systemic use is not available; individualize dosage based on clinical parameters.
Safety and efficacy of the topical ointment have not been established. Specific maximum dosage information for systemic use is not available; individualize dosage based on clinical parameters.
Safety and efficacy have not been established; however, 0.25 mcg/day PO has been used off-label.
How supplied
Calcitriol
capsule
0.25mcg
0.5mcg
oral solution
1mcg/mL
injectable solution
1mcg/mL
topical ointment
3mcg/g