Cholecalciferol

You should not use cholecalciferol if you have ever had an allergic reaction to vitamin D, or if you have:

• high levels of calcium in your blood (hypercalcemia);

• high levels of vitamin D in your body (hypervitaminosis D); or

• any condition that makes it hard for your body to absorb nutrients from food (malabsorption).

To make sure cholecalciferol is safe for you, tell your doctor if you have:

• heart disease;

• kidney disease; or

• an electrolyte imbalance.

Your cholecalciferol dose needs may change if you are pregnant or breast-feeding. Tell your doctor if you are pregnant or plan to become pregnant during treatment, or if you are breast-feeding a baby.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking cholecalciferol and call your doctor at once if you have:

• thinking problems, changes in behavior, feeling irritable;

• urinating more than usual;

• chest pain, feeling short of breath; or

• early signs of vitamin D overdose (weakness, metallic taste in your mouth, weight loss, muscle or bone pain, constipation, nausea, and vomiting).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Vitamin D Insufficiency:

600 to 2,000 international units, orally, once a day
Maximum dose: 4,000 international units per day

Usual Adult Dose for Vitamin D Deficiency:

Initial dose:
50,000 international units, once a week, for 8 weeks
or
6,000 international units, once a day, for 8 weeks
Maintenance dose: 1,500 to 2,000 international units, once a day
Maximum dose: 10,000 international units per day

Comments:
-Target blood levels above 30 ng/mL of 25(OH)D.

Usual Adult Dose for Prevention of Falls:

800 international units, orally, once a day
-1,500 to 2,000 international units, once a day, may be needed to achieve blood levels of 25(OH)D above 30 ng/mL.

Usual Geriatric Dose for Prevention of Fractures:

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

Usual Pediatric Dose for Vitamin D Insufficiency:

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

Usual Pediatric Dose for Vitamin D Deficiency:

-Up to 1 year old: 2,000 international units, orally, once a day, for 6 weeks
or
50,000 international units, once a week, for 6 weeks
Maintenance dose: 400 to 1,000 international units per day

-1 to 18 years: 2,000 international units, orally, once a day for at least 6 weeks
or
50,000 international units, once a week, for at least 6 weeks
Maintenance dose: 600 to 1,000 international units per day

Maximum dose:
-Up to 1 year: 2,000 international units per day
-1 to 18 years: 4,000 international units per day

Comments:
-Target blood levels above 30 ng/mL of 25(OH)D.

In the U.S.

• Delta D3

In Canada

• D-Vi-Sol

Available Dosage Forms:

• Solution
• Wafer
• Tablet
• Tablet, Chewable
• Capsule, Liquid Filled
• Capsule

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin D

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

(kole e kal SI fer ole)

Wafers: Chew or crush before swallowing; do not swallow wafer whole; administer with the largest meal of the day.

Infant drops: Administer with syringe directly into mouth (tip against the inside of cheek) or mix with formula, juice, cereal, or other food and use within 1 hour. Liquid vitamin D preparations have the potential for dosing errors when administered to infants. The FDA recommends using a calibrated dropper that delivers no more than 400 units per dose for products intended for infants.

Store at 15°C to 30°C (59°F to 86°F); do not freeze. Protect from light.

Signs and symptoms of vitamin D intoxication.

Serum 25(OH)D should be monitored in patients at risk for vitamin D deficiency; Serum 1,25-dihydroxyvitamin D may be used in conditions such as acquired or inherited vitamin D disorders (eg, chronic kidney disease, vitamin D resistant rickets) or phosphate metabolism (Holick 2011).

When treating vitamin D deficiency in children, monitor serum calcium, phosphorus and alkaline phosphatase (ALP) one month after starting therapy; serum calcium, phosphorous, magnesium, ALP, 25(OH)D, and PTH as well as x-ray (may also consider urine calcium/creatinine ratio) after 3 months; 25(OH)D yearly (Misra 2008).

Children at increased risk of vitamin D deficiency (chronic fat malabsorption, chronic antiseizure medication use) require serum 25(OH)D, PTH, and bone mineral status to evaluate. If vitamin D supplement required, then 25(OH)D levels should be repeated at 3-month intervals until normal. PTH and bone mineral status should be monitored every 6 months until normal. (Wagner 2008).

Vitamin D deficiency/insufficiency in patients with CKD stages 3 to 4: Measure serum 25(OH)D levels after 3 months of treatment in children or after 6 months in adults. Measure corrected total calcium and phosphorous after 1 month and then at least every 3 months in children and at least every 3 months in adults. Discontinue ergocalciferol (or any vitamin D supplements) if the corrected total serum calcium level is >10.2 mg/dL (K/DOQI 2003; K/DOQI 2005).

Serum 25(OH)D in patients on long term anticonvulsant medications, antifungals, cholestyramine, glucocorticoids, or medications to treat HIV; the catabolism of the metabolite 25(OH)D may be increased (Holick 2011).

The cholecalciferol metabolite, 25(OH)D, crosses the placenta; maternal serum concentrations correlate with fetal concentrations at birth (Misra 2008; Wagner 2008). Vitamin D requirements are the same in pregnant and nonpregnant females (IOM 2011).

Vitamin D deficiency in a pregnant woman may lead to a vitamin D deficiency in the neonate (Misra 2008; Wagner 2008). Serum 25(OH)D concentrations should be measured in pregnant women considered to be at increased risk of deficiency (ACOG 2011). The amount of vitamin D contained in prenatal vitamins may not be adequate to treat a deficiency during pregnancy; although larger doses may be needed, current guidelines recommend a total of 1,000 to 2,000 units/day until more safety data is available (ACOG 2011; Holick 2011). In women not at risk for deficiency, doses larger than the RDA should be avoided during pregnancy (ACOG 2011).