ERGOCALCIFEROL

For the Consumer

Applies to ergocalciferol: oral capsules and solution.

Side effects include:

Possible hypervitaminosis D effects: polyuria, nocturia, polydipsia, hypercalciuria, reversible azotemia, hypertension, nephrocalcinosis, generalized vascular calcification, irreversible renal insufficiency (may be fatal), mental retardation, widespread soft tissue calcification, osteoporosis, dwarfism, vague aches, stiffness, weakness, nausea, anorexia, constipation, mild acidosis, anemia, weight loss.

• Pregnancy category C
  • When used within the recommended daily allowance for pregnant women, considered safe.
    • Recommended daily allowance: 400 to 600 intl units.
  • High doses of other vitamin D analogs have been shown to be teratogenic, resulting in external and skeletal abnormalities.
  • Should only be used during pregnancy when benefit outweighs the risk.

Dosage

Applies to the following strength(s): 8000 intl units/mL ; 50,000 intl units ; 500000 intl units/mL ; 25000 intl units ; 400 intl units.

• Usual Adult Dose for Hypocalcemia
  • 50,000 to 200,000 units orally or IM once a day.

• Usual Adult Dose for Hypoparathyroidism
  • 25,000 to 200,000 units orally or IM once a day. Should be given with calcium supplementation.

• Usual Adult Dose for Familial Hypophosphatemia
  • Oral or IM:
    • 250 to 1500 mcg/day (10,000 to 60,000 international units) with phosphate supplements.

• Usual Adult Dose for Osteomalacia
  • 2000 to 5000 units orally once a day. In patients with malabsorption of vitamin D, the dose is 10,000 units IM once a day or 10,000 to 300,000 units orally once a day.
• Usual Pediatric Dose for Hypoparathyroidism
  • 50,000 to 200,000 units orally or IM once a day. Should be given with calcium supplementation.
• Usual Pediatric Dose for Vitamin/Mineral Supplementation
  • Oral:
    • Dietary Supplementation for Prevention of Vitamin D Deficiency:
    • Dietary Intake Reference (DIR) (1997 National Academy of Science Recommendations): Neonates, and Children: 200 international units/day.
  • Alternative dosing:
    • 1 Month to 12 years (Wagner, 2008): 10 mcg/day (400 international units/day)
    • Less than 38 weeks gestational age: 10 to 20 mcg/day (400 to 800 international units), up to 750 mcg/day (30,000 international units).
  • 1 Month to 1 Year Fully or Partially Breastfed: 10 mcg/day (400 international units/day) beginning in the first few days of life. Continue supplementation until infant is weaned to greater than or equal to 1,000 mL/day or 1 qt/day of vitamin D-fortified formula or whole milk (after 12 months of age).
  • Nonbreast-fed infants, older children ingesting less than 1,000 mL of vitamin D-fortified formula or milk: 10 mcg/day (400 international units/day).
  • Children with increased risk of vitamin D deficiency (chronic fat malabsorption, maintained on chronic antiseizure medications): Higher doses may be required. Laboratory testing (25(OH)D, PTH, bone mineral status) should be used to evaluate.
  • Adolescents without adequate intake: 10 mcg/day (400 international units/day).
• Usual Adult Dose for Vitamin/Mineral Supplementation
  • 400 units orally once a day.
• Usual Adult Dose for Rickets
  • Oral or IM
    • Vitamin D-dependent rickets (in addition to calcium supplementation): 250 mcg to 1.5 mg/day (10,000 to 60,000 international units); doses as high as 12.5 mg/day may be necessary.
  • Nutritional rickets:
    • Adults with Normal Absorption: 25 to 125 mg/day (1,000 to 5,000 international units) for 6 to 12 weeks
    • Adults with Malabsorption: 250 to 7500 mcg/day (10,000 to 300,000 international units)
• Usual Adult Dose for Vitamin D Deficiency
  • 1000 units orally once a day. In patients with malabsorption of vitamin D, the dose is 10,000 units IM once a day or 10,000 to 100,000 units orally once a day.
• Usual Adult Dose for Renal Osteodystrophy
  • 20,000 units orally or IM once a day.
• Usual Pediatric Dose for Osteomalacia
  • 1000 to 5000 units orally once a day. In patients with malabsorption of vitamin D, the dose is 10,000 units IM once a day or 10,000 to 25,000 units orally once a day.
• Usual Pediatric Dose for Renal Osteodystrophy
  • 4000 to 40,000 units orally or IM once a day.
• Usual Pediatric Dose for Rickets
  • Oral or IM:
    • Vitamin D-dependent rickets (in addition to calcium supplementation):
      • Less than 1 month: 25 mcg/day (1,000 international units) for 2 to 3 months; once radiologic evidence of healing is observed, dose should be decreased to 10 mcg/day (400 international units/day).
      • 1 to 12 months: 25 to 125 mcg/day (1,000 to 5,000 international units) for 2 to 3 months; once radiologic evidence of healing is observed, dose should be decreased to 10 mcg/day (400 international units/day).
      • Greater than 12 months: 125 to 250 mcg/day (5,000 to 10,000 international units) for 2 to 3 months; once radiologic evidence of healing is observed, dose should be decreased to 10 mcg/day (400 international units/day).
  • Nutritional rickets:
    • Children (with normal absorption): 25 to 125 mcg/day (1,000 to 5,000 international units) for 6 to 12 weeks.
    • Children with malabsorption: 250 to 625 mcg/day (10,000 to 25,000 international units).
• Usual Pediatric Dose for Familial Hypophosphatemia
  • Oral or IM:
    • Initial: 1000 to 2000 mcg/day (40,000 to 80,000 international units) with phosphate supplements. Daily dosage is increased at 3 to 4 month intervals in 250 to 500 mcg (10,000 to 20,000 international units) increments.

• Usual Pediatric Dose for Vitamin D Deficiency
  • Vitamin D insufficiency or deficiency associated with CKD (stages 2-5, 5D): serum 25 hydroxyvitamin D (25[OH]D) level less than 30 ng/mL:
  • Serum 25(OH)D level 16 to 30 ng/mL: Children: 2000 international units/day for 3 months or 50,000 international units every month for 3 months.
  • Serum 25(OH)D level 5 to 15 ng/mL: Children: 4000 international units/day for 12 weeks or 50,000 international units every other week for 12 weeks.
  • Serum 25(OH)D level less than 5 ng/mL: Children: 8000 international units/day for 4 weeks then 4000 international units/day for 2 months for total therapy of 3 months or 50,000 international units/week for 4 weeks followed by 50,000 international units 2 times/month for a total therapy of 3 months.
  • Maintenance dose [once repletion accomplished; serum 25(OH)D level greater than 30 ng/mL]: 200 to 1000 international units/day.
  • Dosage adjustment: Monitor 25(OH)D, corrected total calcium and phosphorus levels 1 month following initiation of therapy, every 3 months during therapy and with any Vitamin D dose change.
  • Prevention and treatment of vitamin D Deficiency in cystic fibrosis:
    • Infants less than 1 year: 400 international units/day.
  • Children greater than 1 year: 400 to 800 international units/day.

• Renal Dose Adjustments
  • Data not available

• Liver Dose Adjustments
  • Data not available

• Dialysis
  • Vitamin D and its metabolites are not dialyzable.

Other Comments

Patients should receive adequate calcium during ergocalciferol therapy. Serum calcium should be monitored 1 to 2 times a week during dosage titration, and approximately once a month after stabilization of dosage. Ergocalciferol should be withheld if hypercalcemia develops.