Aqueous Vitamin D

• It is used to treat or prevent vitamin D deficiency.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Applies to cholecalciferol: oral capsule, oral capsule liquid filled, oral solution, oral tablet, oral tablet chewable, oral wafer

Along with its needed effects, cholecalciferol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking cholecalciferol:

• Cough
• difficulty swallowing
• dizziness
• fast heartbeat
• hives or itching
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• skin rash
• tightness in the chest
• unusual tiredness or weakness

Over 70 years: 800 to 2,000 international units, orally, once a day

0 to 12 months: 400 international units once a day
1 to 18 years: 600 international units once a day

Maximum dose:
-Up to 6 months: 1,000 international units per day
-7 months to 1 year: 1,500 international units per day
-1 to 3 years: 2,500 international units per day
-4 to 8 years: 3,000 international units per day
-9 years and older: 4,000 international units per day

Do not use in severe renal impairment

Use is not recommended unless there is a deficiency. AU TGA pregnancy category: Exempt US FDA pregnancy category: Not assigned Comments: -Vitamin D supplementation should begin a few months prior to pregnancy.

Animal studies at high doses have shown teratogenicity. There are no controlled data in human pregnancy. Because vitamin D raises calcium levels, it is suspect in the pathogenesis of supravalvular aortic stenosis syndrome, which is often associated with idiopathic hypercalcemia of infancy, but excessive vitamin D intake or retention has not been found consistently in these mothers. A study of 15 patients with maternal hypoparathyroidism, treated with high dose vitamin D during pregnancy (average 107,000 international units per day) to maintain normal calcium levels, produced all normal children. Vitamin D deficiency is associated with reduced fetal growth, neonatal hypocalcemia (with and without convulsions), rickets, and defective tooth enamel. AU TGA pregnancy category Exempt: Medicines 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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decision and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.