Osteo-D

Indications

Vitamin D3 deficiency may arise in individuals with limited sunlight exposure or insufficient dietary intake. This essential vitamin plays a crucial role in the absorption of calcium and phosphate, which are vital for maintaining healthy bones and teeth. Adequate Vitamin D3 levels can help prevent conditions such as rickets, osteomalacia, and osteoporosis. It is particularly important during pregnancy and breastfeeding to prevent pre-eclampsia and support the nutritional needs of a growing infant. Furthermore, Vitamin D3 is significant for enhancing immune function.

Consult a registered healthcare professional before taking this medication.

Pharmacology

The active form of Vitamin D3, known as Calcitriol, functions by binding to Vitamin D receptors (VDRs) found throughout various tissues in the body. With a half-life of approximately 50 days due to its fat-soluble nature, Vitamin D3 is absorbed in the small intestine, where it binds to specific alpha-globulins and is then transported to the liver. In the liver, it is metabolized to 25-hydroxy Vitamin D3 (Calcidiol), followed by a second hydroxylation in the kidneys to form 1,25-dihydroxy Vitamin D3 (Calcitriol). This active metabolite is responsible for increasing calcium absorption. Non-metabolized Vitamin D3 is stored in fatty tissues and muscles, and it is eliminated from the body via feces and urine.

Dosage & Administration

For Capsules:

• Adults:
  • Vitamin D3 Deficiency Treatment: 40,000 IU weekly for 7 weeks, followed by a maintenance dose of 1,400-2,000 IU daily. Measure serum 25-hydroxyvitamin D levels 3-4 months after starting maintenance therapy.
  • Deficiency Prevention: 20,000 IU every 4 weeks; higher doses may be necessary in certain situations.
  • Supplementation for Osteoporosis: 20,000 IU once a month.
• Children (12-18 years):
  • Vitamin D3 Deficiency Treatment: 20,000 IU every 2 weeks for 6 weeks.
  • Deficiency Prevention: 20,000 IU every 6 weeks.

For Film-Coated Tablets:

• 1,000 IU (1-2 tablets) daily, or as prescribed. Take with food or within one hour after meals.

For Oroflash or Chewable Tablets:

• 1,000 to 2,000 IU daily, or as directed. Take with food or within one hour after meals; chew thoroughly before swallowing.

For Syrup:

• At Risk for Cholecalciferol Deficiency:
  • 0-1 Year: 400 IU/day (2 ml)
  • >1 Year: 600 IU/day (3 ml)
• Cholecalciferol Deficient Patients:
  • 0-1 Year: 2,000 IU/day (+50,000 IU/week) for 6 weeks
  • 1-18 Years: 2,000 IU/day for 6 weeks.

For Injections:

• Prevention:
  • Infants on Vitamin D-Enriched Milk: ½ ampoule (0.5 ml, 100,000 IU) every 6 months.
  • Nursed Infants/Children up to 5 Years: 1 ampoule (1 ml, 200,000 IU) every 6 months.
  • Adolescents: 1 ampoule (1 ml, 200,000 IU) every 6 months during winter.
  • Pregnant Women: ½ ampoule (0.5 ml, 100,000 IU) from the 6th or 7th month of pregnancy.
  • Elderly: ½ ampoule (0.5 ml, 100,000 IU) every 3 months. In cases of digestive disorders or other specific conditions, consult a healthcare professional for appropriate dosing.
• Vitamin D Deficiency Treatment:
  • 1 ampoule (1 ml, 200,000 IU) may be repeated every 1 to 6 months, or as prescribed by a healthcare professional.

Consult a registered healthcare professional before taking this medication.

Interactions

Certain medications can lead to Vitamin D3 deficiency by disrupting its absorption and metabolism. These include magnesium-containing antacids, digoxin, thiazide diuretics, cholestyramine, colestipol, phenytoin, phenobarbital, orlistat, and mineral oil. Additionally, corticosteroids like prednisolone may increase the requirement for Vitamin D3.

Contraindications

Vitamin D3 is contraindicated in conditions associated with hypercalcemia, in patients with known hypersensitivity to Vitamin D3 or its components, and where evidence of Vitamin D3 toxicity is present.

Side Effects

Potential side effects may include anorexia, fatigue, nausea and vomiting, diarrhea, constipation, weight loss, increased urination, excessive sweating, headaches, thirst, dizziness, and elevated levels of calcium and phosphate in plasma and urine.

Pregnancy & Lactation

Research indicates that doses up to 4,000 IU are safe during pregnancy. The recommended daily intake for pregnant women is 400 IU, though higher doses may be necessary for those who are Vitamin D3 deficient. Women should consult their healthcare providers, as needs may vary based on their health status and treatment response.

Vitamin D3 and its metabolites can be excreted in breast milk. Although no overdose cases in infants due to nursing mothers have been reported, healthcare practitioners should account for any additional Vitamin D3 given to breastfeeding mothers when prescribing for their infants.

Precautions & Warnings

Monitor plasma calcium levels periodically in patients receiving high doses of Vitamin D3, those with renal impairment, and during pregnancy and lactation. Individuals on digoxin or thiazide diuretics should seek guidance from healthcare professionals before starting Vitamin D3 supplementation. Those with liver or kidney diseases, primary hyperthyroidism, lymphoma, tuberculosis, or granulomatous disease should also consult healthcare providers before supplementation.

Use in Special Populations

The safety and efficacy of Vitamin D3 in children under 12 years have not been established.

Overdose Effects

Overdose may result in hypervitaminosis D.

Therapeutic Class

Vitamin for bone health, Vitamin D preparations.

Storage Conditions

Store below 30°C, shielded from light and moisture. Keep out of reach of children.