Cholecalciferol

Cholecalciferol is a naturally occurring form of vitamin D (a fat-soluble vitamin). Cholecalciferol is produced from 7-dehydrocholesterol, a sterol present in mammalian skin, by ultraviolet irradiations. It used in the treatment and prevention of vitamin D deficiency states and some other bone disorders.

Cholecalciferol is primarily indicated in conditions like Hypocalcemia, Rickets, Vitamin D deficiency, and can also be given in adjunctive therapy as an alternative drug of choice in Hypoparathyroidism, Malignant neoplasms, Osteomalacia, Psoriasis.

Cholecalciferol is contraindicated in conditions like Hypercalcemia, Hypersensitivity to any component of product.

The severe or irreversible adverse effects of Cholecalciferol, which give rise to further complications include Hypercalciuria, Renal damage, Hypercalcemia. The signs and symptoms that are produced after the acute overdosage of Cholecalciferol include Nausea, Vomiting, Diarrhea, Polyuria, Sweating, Headache, Anorexia, Vertigo, Thirst, lassitude. The symptomatic adverse reactions produced by Cholecalciferol are more or less tolerable and if they become severe, they can be treated symptomatically, these include Anorexia, Diarrhea, Nausea and vomiting, Lassitude.

Concerns related to adverse effects: • Vitamin D toxicity: May occur with excessive doses; symptoms may include nausea, vomiting, loss of appetite, constipation, dehydration, fatigue, irritability, confusion, weakness and/or weight loss. Effects of vitamin D can last ≥2 months after therapy is discontinued. Disease related concerns: • Hyperphosphatemia: Normal serum phosphorous concentrations must be maintained in patients treated for hyperphosphatemia to prevent metastatic calcification. • Obesity: Adults with a BMI >30 kg/m 2 are at high risk for vitamin D deficiency due to storage of vitamin D in adipose tissue. Doses higher than the RDA may be required, but must be carefully monitored to avoid toxicity. • Renal impairment: Metabolism of vitamin D may be altered in patients with chronic kidney disease. Supplementation with cholecalciferol may be needed; close monitoring is required (KDIGO 2009). Dosage form specific issues: • Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP 1997; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer's labeling. • Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling. • Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Zar 2007). See manufacturer's labeling.

Concerns related to adverse effects: • Vitamin D toxicity: May occur with excessive doses; symptoms may include nausea, vomiting, loss of appetite, constipation, dehydration, fatigue, irritability, confusion, weakness and/or weight loss. Effects of vitamin D can last ≥2 months after therapy is discontinued. Disease related concerns: • Hyperphosphatemia: Normal serum phosphorous concentrations must be maintained in patients treated for hyperphosphatemia to prevent metastatic calcification. • Obesity: Adults with a BMI >30 kg/m 2 are at high risk for vitamin D deficiency due to storage of vitamin D in adipose tissue. Doses higher than the RDA may be required, but must be carefully monitored to avoid toxicity. • Renal impairment: Metabolism of vitamin D may be altered in patients with chronic kidney disease. Supplementation with cholecalciferol may be needed; close monitoring is required (KDIGO 2009). Dosage form specific issues: • Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP 1997; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer's labeling. • Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling. • Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Zar 2007). See manufacturer's labeling.

400 to 1000 units (700 (700)) 24 hourly PO — Scraped Dose — Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product Capsule, Oral: D3-50: 1250 mcg (50000 unit) [dairy free, egg free, fish derivative free, gluten free, kosher certified, no artificial color(s), nut free, soy free, sugar free, wheat free, yeast free] Decara: 1250 mcg (50000 unit) [contains fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow), soybean oil] Decara: 250 mcg (10000 unit) [contains fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake, gelatin (bovine)] Decara: 625 mcg (25000 unit) [contains soybean oil] Dialyvite Vitamin D 5000: 125 mcg (5000 unit) Pronutrients Vitamin D3: 25 mcg (1000 unit) [contains soybean oil] Weekly-D: 1250 mcg (50000 unit) [contains fd&c red #40] Generic: 1250 mcg (50000 unit), 250 mcg (10000 unit) Capsule, Oral [preservative free]: D-3-5: 125 mcg (5000 unit) [dairy free, dye free, egg free, gluten free, no artificial color(s), nut free, soy free, sugar free, wheat free, yeast free] D3-50: 1250 mcg (50000 unit) [dairy free, egg free, fish derivative free, gluten free, kosher certified, no artificial color(s), nut free, soy free, sugar free, wheat free, yeast free] Generic: 10,000 units, 125 mcg (5000 unit), 25 mcg (1000 unit), 50 mcg (2000 unit) Liquid, Oral: Aqueous Vitamin D: 10 mcg/mL (400 unit/mL) (50 mL) [gluten free, lactose free, sugar free; contains corn oil, methylparaben, polysorbate 80] Bio-D-Mulsion: 10 mcg/0.03 mL (400 unit/0.03 mL) (30 mL [DSC]) [contains sesame oil] Bio-D-Mulsion Forte: 50 mcg/0.03 mL (2000 unit/0.03 mL) (30 mL [DSC]) [contains sesame oil] BProtected Pedia D-Vite: 10 mcg/mL (400 unit/mL) (50 mL) [alcohol free, sugar free; contains polysorbate 80, propylene glycol, sodium benzoate; cherry flavor] D-Vi-Sol: 10 mcg/mL (400 unit/mL) (50 mL) [gluten free, lactose free, sugar free; contains polysorbate 80] D-Vita: 10 mcg/mL (400 unit/mL) (50 mL [DSC]) [alcohol free, gluten free, lactose free, sugar free; contains polysorbate 80, propylene glycol, sodium benzoate] D-Vite Pediatric: 10 mcg/mL (400 unit/mL) (50 mL) [alcohol free, gluten free, lactose free, no artificial color(s), sugar free; contains disodium edta, polysorbate 80, propylene glycol, saccharin sodium, sodium benzoate] D3 Vitamin: 10 mcg/mL (400 unit/mL) (50 mL [DSC]) [contains polysorbate 80, sodium benzoate] Generic: 10 mcg/mL (400 unit/mL) (50 mL, 52 mL) Liquid, Oral [preservative free]: Generic: 125 mcg/mL (5000 unit/mL) (52 mL) Liquid, Sublingual: Generic: 125 mcg/mL (5000 units/mL) (60 mL) Tablet, Oral: Delta D3: 10 mcg (400 unit) [gelatin free, gluten free, lactose free, no artificial color(s), no artificial flavor(s), starch free, sugar free, yeast free] Dialyvite Vitamin D3 Max: 1250 mcg (50000 unit) [scored] Vitamin D3 Super Strength: 50 mcg (2000 unit) [gluten free] Vitamin D3 Ultra Potency: 1250 mcg (50000 unit) Generic: 10 mcg (400 unit), 125 mcg (5000 unit), 20 mcg (800 unit), 25 mcg (1000 unit), 250 mcg (10000 unit), 50 mcg (2000 unit), 75 mcg (3000 unit) Tablet, Oral [preservative free]: Generic: 5000 units, 10 mcg (400 unit), 25 mcg (1000 unit), 50 mcg (2000 unit) Tablet Chewable, Oral: Generic: 10 mcg (400 unit) Tablet Chewable, Oral [preservative free]: Generic: 50 mcg (2000 unit)

No child dosage information is recorded for this medicine yet.

No neonatal dosage information is recorded for this medicine yet.

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. Avoid combination 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). Separate administration of these agents by several hours to minimize the potential risk of interaction. Monitor plasma calcium concentrations. Consider therapy modification Calcium Salts: May enhance the adverse/toxic effect of Vitamin D Analogs. Monitor therapy Cardiac Glycosides: Vitamin D Analogs may enhance the arrhythmogenic effect of Cardiac Glycosides. Monitor therapy Danazol: May enhance the hypercalcemic effect of Vitamin D Analogs. Monitor therapy Erdafitinib: Serum Phosphate Level-Altering Agents may diminish the therapeutic effect of Erdafitinib. Management: Avoid coadministration of serum phosphate level-altering agents with erdafitinib before initial dose increase period based on serum phosphate levels (Days 14 to 21). Consider therapy modification Mineral Oil: May decrease the serum concentration of Vitamin D Analogs. More specifically, mineral oil may interfere with the absorption of Vitamin D Analogs. Management: Avoid concomitant, oral administration of mineral oil and vitamin D analogs. Consider separating the administration of these agents by several hours to minimize the risk of interaction. Monitor plasma calcium concentrations. Consider therapy modification Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Vitamin D Analogs. Avoid combination Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Vitamin D Analogs. Avoid combination Orlistat: May decrease the serum concentration of Vitamin D Analogs. More specifically, orlistat may impair absorption of Vitamin D Analogs. Monitor therapy Sucralfate: Vitamin D Analogs may increase the serum concentration of Sucralfate. Specifically, the absorption of aluminum from sucralfate may be increased, leading to an increase in the serum aluminum concentration. Avoid combination Thiazide and Thiazide-Like Diuretics: May enhance the hypercalcemic effect of Vitamin D Analogs. Monitor therapy Vitamin D Analogs: May enhance the adverse/toxic effect of other Vitamin D Analogs. Avoid combination

Tabs,caps Store in a well closed container, at room temperature, Between 15°C-30°C. Protect from Sunlight, Moisture and Heat.