Calcidol

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ergocalciferol falls into category C. This medication may be given to a pregnant woman if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn baby.

Take ergocalciferol exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

• For vitamin D resistant rickets, dosing range: 12,000 to 500,000 USP units daily
• For hypoparathyroidism (underactive parathyroid), dosing range: 50,000 to 200,000 USP units daily typically given along with calcium lactate 4 grams, six times per day

If you take too much ergocalciferol call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Applies to ergocalciferol: compounding powder, injectable solution, oral capsule, oral solution, oral tablet

Metabolic

Rare (less than 0.1%): Hypercalcemia
Frequency not reported: Hypervitaminosis D[Ref]

Hypervitaminosis D is characterized by: impairment of renal function with polyuria, nocturia, polydipsia, hypercalciuria, reversible azotemia, hypertension, nephrocalcinosis, generalized vascular calcification, or irreversible renal insufficiency which may result in death; mental retardation; widespread calcification of the soft tissues, including the heart, blood vessels, renal tubules, and lungs; bone demineralization (osteoporosis) in adults; decline in the average rate of linear growth and increased mineralization of bones in infants and children (dwarfism), vague aches, stiffness, and weakness; nausea, anorexia, constipation; and mild acidosis, anemia, and weight loss.[Ref]

Genitourinary

Rare (less than 0.1%): Hypercalciuria[Ref]

Dermatologic

Rare (less than 0.1%): Pruritus, rash, urticaria[Ref]

Some side effects of Calcidol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

50,000 to 200,000 international units orally daily, concomitantly with calcium lactate 4 g, six times per day

Comments:
-Pediatric doses must be individualized.
-The range between therapeutic and toxic doses is narrow.
-Dosage must be individualized under close medical supervision.
-Calcium intake should be adequate.
-Monitor blood calcium and phosphorus every 2 weeks, or more frequently if necessary.

Data not available

Data not available

Safety has not been established during pregnancy. Use only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: Exempt US FDA pregnancy category: C Comments: -Avoid use of vitamin D in excess of the recommended dietary allowance. -The safety of vitamin D doses in excess of 400 international units has not been established.

Animal studies have shown fetal abnormalities associated with hypervitaminosis D, similar to supravalvular aortic stenosis syndrome. There are no controlled data in human pregnancy. AU Exempt: Medications exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.