D-Rise 20000 IU

Description

Indications Vitamin D3 deficiency can develop in individuals with limited exposure to sunlight or insufficient dietary intake of vitamin D3.

Vitamin D3 plays a crucial role in calcium and phosphate absorption, essential for maintaining healthy bones and teeth. It helps prevent conditions such as rickets, osteomalacia, and osteoporosis.

Additionally, Vitamin D3 is vital during pregnancy and breastfeeding to prevent pre-eclampsia and support the nutritional needs of a growing infant. It also plays a significant role in strengthening the immune system.

Pharmacology Vitamin D3 is metabolized into its active form, Calcitriol, which binds to Vitamin D receptors (VDRs) found in various body tissues. As a fat-soluble vitamin, Vitamin D3 has a half-life of approximately 50 days. It is absorbed in the small intestine, binds to specific alpha-globulins, and is transported to the liver, where it is converted into 25-hydroxy Vitamin D3 (Calcidiol). This undergoes further hydroxylation in the kidneys to form 1,25-dihydroxy Vitamin D3 (Calcitriol), the metabolite responsible for enhancing calcium absorption. Any unprocessed Vitamin D3 is stored in fat and muscle tissues and is eventually excreted through feces and urine.

Dosage & Administration

Capsule (Adults):

• Treatment of Vitamin D3 deficiency: 40,000 IU once weekly for 7 weeks, followed by a maintenance dose of 1,400-2,000 IU per day. A blood test to measure 25-hydroxyvitamin D levels should be conducted 3-4 months after initiating maintenance therapy.
• Prevention of Vitamin D3 deficiency: 20,000 IU every 4 weeks. Higher doses may be necessary in specific conditions.
• Adjunct to osteoporosis therapy: 20,000 IU once a month.

Capsule (Children 12-18 years):

• Treatment of Vitamin D3 deficiency: 20,000 IU once every 2 weeks for 6 weeks.
• Prevention of Vitamin D3 deficiency: 20,000 IU every 6 weeks.

Film-Coated Tablet:

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

Oroflash or Chewable Tablet:

• 1,000 IU to 2,000 IU daily, or as prescribed by a physician. Take with food or within one hour after a meal. Place the tablet in the mouth, chew, and swallow.

Syrup:

• For patients at risk of Vitamin D3 deficiency:
  • 0-1 year: 400 IU/day (2 ml)
  • Above 1 year: 600 IU/day (3 ml)
• For patients with Vitamin D3 deficiency:
  • 0-1 year: 2,000 IU/day (+50,000 IU/week) for 6 weeks
  • 1-18 years: 2,000 IU/day for 6 weeks

Injection (Prevention):

• Infants on Vitamin D-enriched milk: ½ ampoule (0.5 ml) = 100,000 IU every 6 months.
• Infants not receiving Vitamin D-enriched milk & 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.
• Patients with digestive disorders, epilepsy treatment, or other conditions requiring additional Vitamin D3: ½ to 1 ampoule (100,000-200,000 IU) every 3-6 months.

Injection (Vitamin D3 Deficiency):

• 1 ampoule (1 ml) = 200,000 IU, with a possible repeat dose in 1-6 months, as directed by a physician.

Drug Interactions Certain medications interfere with Vitamin D3 absorption and metabolism, including:

• Magnesium-containing antacids
• Digoxin
• Thiazide diuretics
• Cholestyramine and colestipol
• Phenytoin, phenobarbital
• Orlistat
• Mineral oil
• Corticosteroids (e.g., Prednisolone) increase the body’s need for Vitamin D3.

Contraindications Vitamin D3 should not be used in individuals with hypercalcemia or those with known hypersensitivity to Vitamin D3 or its components. It is also contraindicated in cases of Vitamin D3 toxicity.

Side Effects Although uncommon, side effects may include:

• Loss of appetite, nausea, vomiting, constipation, or diarrhea
• Weight loss, increased urination, excessive sweating
• Headache, dizziness, increased thirst
• Elevated calcium and phosphate levels in the blood and urine

Pregnancy & Lactation Studies indicate that doses up to 4,000 IU per day are safe during pregnancy. The recommended daily intake is 400 IU, though higher doses may be necessary in Vitamin D3-deficient individuals. Pregnant women should consult their healthcare provider for appropriate dosing based on their condition.

Vitamin D3 and its metabolites are present in breast milk. While no cases of overdose in infants due to maternal supplementation have been reported, healthcare providers should carefully assess any additional Vitamin D3 supplementation for breastfed infants.

Precautions & Warnings

• Patients on high doses of Vitamin D3, individuals with kidney impairment, and pregnant or lactating women should have their plasma calcium levels monitored regularly.
• Individuals taking Digoxin or Thiazide diuretics should seek medical advice before using Vitamin D3 supplements.
• Those with liver or kidney disease, primary hyperthyroidism, lymphoma, tuberculosis, or granulomatous diseases should consult a healthcare provider 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 Vitamin D3 intake can lead to hypervitaminosis D, resulting in elevated calcium levels and associated complications.

Therapeutic Class

• Vitamin D preparations
• Essential vitamin for bone formation

Storage Conditions

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