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Calcitriol

    DEA Class; Rx

    Common Brand Names; Calcijex, Rocaltrol, Vectical

    • Vitamin D Analogs
    • Antipsoriatics, Topical

    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

    Indicated for the treatment of hypocalcemia and secondary hyperparathyroidism and resultant metabolic bone disease (renal osteodystrophy) in patients with chronic kidney disease.

    For the treatment of patients with postsurgical hypoparathyroidism, idiopathic hypoparathyroidism and pseudohypoparathyroidism manifesting as hypocalcemia.
    For the treatment of mild to moderate plaque psoriasis.
    For the management of hypocalcemia associated with vitamin D deficiency.
    For the treatment of vitamin D-dependent rickets.
    For the treatment of familial hypophosphatemia.
    For the treatment of postmenopausal osteoporosis.
    For osteoporosis prophylaxis in recipients of chronic corticosteroid therapy.

    Hypercalcemia or evidence of vitamin D toxicity

    Hypersensitivity to calcitriol, other vitamin D analogues, or other ingredients

    • 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

    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 category: C

    Lactation: Enters breast milk; not recommended

    Adults

    200 g ointment/week topically. Specific maximum dosage information for systemic use is not available; individualize dosage based on clinical parameters.

    Geriatric

    200 g ointment/week topically. Specific maximum dosage information for systemic use is not available; individualize dosage based on clinical parameters.

    Adolescents

    200 g ointment/week topically. Specific maximum dosage information for systemic use is not available; individualize dosage based on clinical parameters.

    Children

    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.

    Infants

    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.

    Neonates

    Safety and efficacy have not been established; however, 0.25 mcg/day PO has been used off-label.

    Calcitriol

    capsule

    • 0.25mcg

    • 0.5mcg

    oral solution

    • 1mcg/mL

    injectable solution

    • 1mcg/mL

    topical ointment

    • 3mcg/g