Medical Description
Vitamin D analog used in the treatment of vitamin D insufficiency/deficiency, prevention of osteoporosis and prevention of rickets in children.
Indication & Usage
-High-dose therapy: May be preferred in patients with a serum 25(OH)D level <12 ng/mL (<30 nmol/L) or who are symptomatic (eg, bone fracture/pain, muscle weakness). Oral: 50,000 units, once weekly (or equivalent dose administered once daily) for 6 to 12 weeks, then recheck 25(OH)D level; may repeat high-dose therapy if needed to achieve target 25(OH)D level.
-Low-dose therapy: May be preferred in patients with a serum 25(OH)D level 12 to <20 ng/mL (30 to <50 nmol/L). Oral: 800 to 1,000 units (20 to 25 mcg) once daily for ~3 to 4 months; may adjust dose if needed every 3 to 4 months based on 25(OH)D level.
-Maintenance dosing: Oral: Once target 25(OH)D level is achieved, continue at a maintenance dose of 600 to 2,000 units (15 to 50 mcg) once daily.
-Osteoporosis, prevention: Adults ≥50 years of age: Oral: 800 to 1,000 units/day (20 to 25 mcg/day) is recommended.
-Vitamin D deficiency prevention:Breastfed infants (fully or partially): Oral: 400 units (10 mcg) daily beginning in the first few days of life. Children and Adolescents without adequate intake: Oral: 600 units.
-Vitamin D deficiency (severe, symptomatic)treatment: Infants: Oral: 2,000 units (50 mcg) daily for 6 weeks to achieve a serum 25(OH)D level >20 ng/mL; followed by a maintenance dose of 400 to 1,000 units (10 to 25 mcg) daily, Children and Adolescents: Oral: 2,000 units (50 mcg) daily for 6 to 8 weeks to achieve serum 25(OH)D level >20 ng/mL; followed by a maintenance dose of 600 to 1,000 units (15 to 25 mcg) daily.
Active Ingredients
Cholecalciferol
Dosage & Administration
Oral: can be taken directly or with juice, administer with the largest meal of the day.
Side Effects
-do not use if you have hypercalcemia, primary hyperparathyroidism, sarcoidosis, hypervitaminosis D, Williams syndrome, or are pregnant.
-Documentation of allergenic cross-reactivity for vitamin D is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Safety Advice
-Incase of over dose be ready to tell or show what was taken, how much and when it happened, and seek immediate medical attention. For additional information call us on 16676. Always tell your physician your detailed medical history.
Storage
Store at room temperature.
Drug Interactions
-Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Vitamin D Analogs.
-Orlistat: May decrease the serum concentration of Vitamin D Analogs. More specifically, orlistat may impair absorption of Vitamin D Analogs.
-Mineral Oil: May decrease the serum concentration of Vitamin D Analogs. More specifically, mineral oil may interfere with the absorption of Vitamin D Analogs.
-Bile Acid Sequestrants: May decrease the serum concentration of Vitamin D Analogs. More specifically, bile acid sequestrants may impair absorption of Vitamin D Analogs. Management: Avoid concomitant administration of vitamin D analogs and bile acid sequestrants (eg, cholestyramine).
-Aluminum Hydroxide: Vitamin D Analogs may increase the serum concentration of Aluminum Hydroxide. Specifically, the absorption of aluminum may be increased, leading to increased serum aluminum concentrations. Management: Consider avoiding chronic use of aluminum and aluminum-containing products in patients who are also taking vitamin D analogs.
Pregnancy & Lactation
-Adequate maternal vitamin D is required for fetal growth and development .
-Vitamin D deficiency in a pregnant woman may lead to a vitamin D deficiency in the neonate.Serum 25(OH)D concentrations should be measured in pregnant women considered to be at increased risk of deficiency. 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.
-Vitamin D is present in breast milk following normal maternal exposure via sunlight and diet.