D-Rise 2000 IU

Description

Indications Vitamin D3 deficiency may occur in individuals with limited sun exposure or insufficient dietary intake of vitamin D3. It plays a crucial role in calcium and phosphate absorption, which is necessary for maintaining healthy bones and teeth, as well as preventing conditions like rickets, osteomalacia, and osteoporosis.

Vitamin D3 is also vital during pregnancy and breastfeeding, as it helps prevent pre-eclampsia and supports the nutritional needs of a growing infant. Additionally, it plays an essential role in boosting immunity.

Pharmacology Vitamin D3 is converted into its active form, Calcitriol, which binds to Vitamin D receptors (VDRs) present in various body tissues. Being fat-soluble, Vitamin D3 has a half-life of approximately 50 days. It is absorbed in the small intestine and transported to the liver, where it is metabolized into 25-hydroxy Vitamin D3 (Calcidiol). Further hydroxylation in the kidneys results in the formation of 1,25-dihydroxy Vitamin D3 (Calcitriol), which enhances calcium absorption. Excess Vitamin D3 is stored in fatty and muscle tissues and is excreted via feces and urine.

Dosage & Administration

Capsules:

• Adults:
  • Treatment of deficiency: 40,000 IU once weekly for 7 weeks. Maintenance dose: 1,400-2,000 IU/day. Serum 25-hydroxyvitamin D levels should be assessed 3-4 months after starting maintenance therapy.
  • Prevention of deficiency: 20,000 IU every 4 weeks. Higher doses may be necessary in specific conditions.
  • Osteoporosis support: 20,000 IU once a month.
• Children (12-18 years):
  • Treatment of deficiency: 20,000 IU once every 2 weeks for 6 weeks.
  • Prevention of deficiency: 20,000 IU every 6 weeks.

Film-coated Tablets:

• 1,000 IU (1-2 tablets) daily, or as directed by a physician. Take with food or within 1 hour after a meal.

Oroflash or Chewable Tablets:

• 1,000-2,000 IU daily, or as directed by a physician. Take with food or within 1 hour after a meal. Chew before swallowing.

Syrup:

• For at-risk patients:
  • 0-1 year: 400 IU/day (2 ml)
  • Above 1 year: 600 IU/day (3 ml)
• For deficient patients:
  • 0-1 year: 2,000 IU/day (+50,000 IU weekly) for 6 weeks.
  • 1-18 years: 2,000 IU/day for 6 weeks.

Injection (Prevention & Treatment):

• Infants receiving vitamin D-enriched milk: ½ ampoule (0.5 ml) = 100,000 IU every 6 months.
• Infants not receiving vitamin D-enriched milk or 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 during the 6th or 7th month of pregnancy.
• Elderly individuals: ½ ampoule (0.5 ml) = 100,000 IU every 3 months.
• Digestive disorders, epilepsy treatment, or specific conditions: ½ ampoule (100,000 IU) or 1 ampoule (200,000 IU) every 3-6 months.
• Vitamin D deficiency: 1 ampoule (1 ml) = 200,000 IU, which can be repeated after 1-6 months or as prescribed by a physician.

Drug Interactions Several medications can reduce Vitamin D3 absorption or metabolism, including magnesium-containing antacids, Digoxin, Thiazide diuretics, Cholestyramine, Colestipol, Phenytoin, Phenobarbital, Orlistat, and Mineral oil. Corticosteroids, such as Prednisolone, may increase the need for Vitamin D3.

Contraindications Vitamin D3 should not be used in individuals with conditions associated with hypercalcemia, known hypersensitivity to Vitamin D3 or its components, or evidence of Vitamin D3 toxicity.

Side Effects Although rare, side effects may include anorexia, fatigue, nausea, vomiting, diarrhea, constipation, weight loss, excessive urination, sweating, headache, thirst, dizziness, and increased calcium and phosphate levels in plasma and urine.

Pregnancy & Lactation Research indicates that doses up to 4,000 IU daily are safe during pregnancy. The recommended intake for pregnant women is 400 IU per day, but higher doses may be required for those with a deficiency. Pregnant women should consult their healthcare provider for appropriate dosing.

Vitamin D3 and its metabolites are present in breast milk. No cases of infant overdose due to maternal supplementation have been reported. However, when prescribing additional Vitamin D3 for a breastfed infant, the practitioner should consider the mother’s dosage.

Precautions & Warnings Regular monitoring of plasma calcium levels is advised in patients on high-dose Vitamin D3 therapy, those with renal impairment, and during pregnancy and lactation. Patients taking Digoxin or Thiazide diuretics should consult a healthcare provider before using Vitamin D3. Individuals with liver or kidney disease, primary hyperparathyroidism, lymphoma, tuberculosis, or granulomatous disease should seek medical advice before supplementation.

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

Overdose Effects Excessive intake of Vitamin D3 can lead to hypervitaminosis D, which may result in hypercalcemia and associated complications.

Therapeutic Class Vitamin for bone formation, Vitamin D preparations.

Storage Conditions Store below 30ºC, protected from light and moisture. Keep out of reach of children.