Adult Dosing
Renal failure, dialysis patients (for hypocalcemia and resultant metabolic bone disease)
- Start 0.25 mcg PO qd. May increase 0.25 mcg/day q4-8 wks
- Alt: 0.25 mcg PO qod if normal or only slightly reduced calcium levels
- Usual range: 0.5-1 mcg/day
Renal failure, predialysis patients (for secondary hyperparathyroidism and resulting metabolic bone disease)
- Start 0.25 mcg PO qd
- May increase dosage up to 0.5 mcg/day
- Usual range: 0.25-0.5 mcg/day
Hypoparathyroidism, hypocalcemia
- Start 0.25 mcg PO qd in morning
- May increase 0.25 mcg/day q2-4 wks
- Start 0.25 mcg PO qd; May increase 0.25 mcg/day q4-8 wks
- Usual range: 0.5-2 mcg/day
Rickets, vitamin D-dependent (Non FDA approved)
Familial hypophosphatemia (Non FDA approved)
Notes- Initiate therapy with the lowest possible dose and increase dose only with careful monitoring of the serum calcium
- Monitor serum calcium 2x/wk while dose titration
- Discontinue on occurrence of hypercalcemia/ Ca x PO4 product > 70
Pediatric Dosing
Renal failure, predialysis patients (for secondary hyperparathyroidism and resulting metabolic bone disease)
<3 yrs
- Start with 0.01 mcg/kg/day PO
- May increase 0.005-0.01 mcg/kg/day q4-8 wks
- Usual range: 0.01-0.015 mcg/kg/day PO
>3 yrs
- Start 0.25 mcg PO qd
- May increase dosage up to 0.5 mcg/day
- Usual range: 0.25-0.5 mcg/day
Hypoparathyroidism, hypocalcemia
<1 yrs
1-5 yrs
- Start 0.25 mcg PO qd; May increase 0.25 mcg/day q2-4 wks
- Usual dose range: 0.25-0.75 mcg/day
6yrs
- Start 0.25 mcg PO qd; May increase 0.25 mcg/day q2-4 wks
- Usual dose range: 0.5-2 mcg PO once a day
Hypocalcemia in premature infant
Renal failure, dialysis patients for hypocalcemia and resultant metabolic bone disease (Non FDA Unapproved)
1-5 yrs
- Start 0.25 mcg PO qd; May increase 0.25 mcg/day q4-8 wks
- Usual dose range: 0.25-2 mcg PO once a day
>6 yrs
- Start 0.25 mcg PO qd; May increase 0.25 mcg/day q4-8 wks
- Usual dose range: 0.25-1 mcg PO once a day
Notes:- Initiate therapy with the lowest possible dose and increase dose only with careful monitoring of the serum calcium
- Monitor serum calcium 2x/wk while dose titration
- Discontinue on occurrence of hypercalcemia/ Ca x PO4 product > 70
[Outline]
See Supplemental Patient Information
- Overdosage can be fatal, emergency situation may occur due to progressive hypercalcemia; and vascular calcification, nephrocalcinosis and other soft-tissue calcification can occur due to chronic hypercalcemia
- Do not exceed serum calcium times phosphate (Ca × P) product >70 mg2/dL2
- Perform radiographic evaluation of suspected anatomical regions
- Hypercalcemia, hypercalciuria, and hyperphosphatemia have occurred in patients exceeding daily requirements of calcitriol. Withheld pharmacologic doses of vitamin D and its derivatives to avoid possible additive effects and hypercalcemia
- On shifting treatment from ergocalciferol (vitamin D2) to calcitriol, it may take several months for the ergocalciferol level in the blood to return to the baseline value
- Ectopic calcification have occurred in patients with renal failure due to increase in inorganic phosphate levels in serum
- Use nonaluminum phosphate-binding compound and a low-phosphate diet to control serum phosphorus levels in patients undergoing dialysis
- Avoid concomitant administration of magnesium-containing antacids or other vitamin D supplements in patients on chronic renal dialysis
- Avoid abrupt increase in calcium intake (eg, increased consumption of dairy products) or uncontrolled intake of calcium preparations as it may trigger hypercalcemia. Discontinue therapy on occurrence of hypercalcemia; on regaining normal levels continue treatment with a daily dose of 0.25 mcg PO lower than that previously used
- Immobilized patients are more prone to hypercalcemia
- Increase in serum creatinine have occurred in association with chronic hypercalcemia
- Maintain adequate fluid intake to avoid dehydration
- In predialysis patients, monitor phosphorus, alkaline phosphatase, and Cr at baseline, qmo x6 and then periodically; Monitor serum Ca at baseline, 2x/wk during dose titration, then qmo x6 and then periodically; if continuous hypercalcemia, monitor daily; Monitor iPTH at baseline, then q3-4mo
- On dialysis, monitor serum Ca 2x/wk during dose titration/dose modification then periodically; if continuous hypercalcemia, monitor daily; monitor serum PO4, alkaline phosphatase, Mg periodically
- In hypoparathyroidism patients, monitor serum Ca 2x/wk during dose titration, then qmo; if continuous hypercalcemia, monitor daily; monitor PO4 periodically; monitor 24-hour urinary calcium
Cautions: Use cautiously in:
- Patients on digitalis
- Cardiac arrhythmias
- If surgery
- Prolonged immobilization
- Geriatrics
Supplemental Patient Information
- Inform patients and caretakers about compliance with dosage instructions, adherence to diet and calcium supplementation instructions and avoidance of the use of unapproved nonprescription drugs
- Educate patients and their caregivers about the symptoms of hypercalcemia
- Advise patients to have a dietary intake of calcium at a minimum of 600 mg/day
Pregnancy Category:C
Breastfeeding: Appropriately adjusted doses in nursing mothers does not affect breastfed infant. Calcitriol and calcium requirements are usually reduced during lactation in women with hypoparathyroidism. Administration of a minimum of 400 IU of vitamin D daily to all infants, children and adolescents is recommended by the American Academy of Pediatrics. This information is based on LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 10 December 2010). Manufacturer advises to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother because of the potential for possible serious adverse reactions in nursing infants.
Pricing data from www.DrugStore.com in U.S.A.
- Calcitriol 0.25 MCG CAPS [Bottle] (TEVA PHARMACEUTICALS USA)
30 mcg = $35.99
90 mcg = $75.74 - Rocaltrol 0.5 MCG CAPS [Bottle] (VALIDUS PHARMACEUTICALS)
30 mcg = $79.99
90 mcg = $219.96 - Rocaltrol 0.25 MCG CAPS [Bottle] (VALIDUS PHARMACEUTICALS)
30 mcg = $32.99
90 mcg = $74.97 - Calcitriol 0.5 MCG CAPS [Bottle] (TEVA PHARMACEUTICALS USA)
30 mcg = $57.99
90 mcg = $168.98
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
