D-Rise: Vitamin D3 Supplementation

D-Rise provides Vitamin D3 (Cholecalciferol), an essential nutrient vital for calcium and phosphate absorption, bone health, immunity, and prevention of certain conditions like rickets, osteomalacia, and osteoporosis. It is also important during pregnancy and breastfeeding.

How D-Rise Works (Pharmacology)

Vitamin D3, being fat-soluble, has a half-life of about 50 days. It is absorbed in the small intestine, transported to the liver, and metabolized to 25-hydroxy Vitamin D3 (Calcidiol). A second hydroxylation occurs in the kidneys, forming 1,25-dihydroxy Vitamin D3 (Calcitriol), which is the active form. Calcitriol exerts its effects by binding to Vitamin D Receptors (VDRs) found throughout the body, ultimately increasing calcium absorption. Non-metabolized Vitamin D3 is stored in fat and muscle tissues and eliminated via feces and urine.

Key Indications & Benefits

D-Rise is indicated for:

• Treatment and prevention of Vitamin D3 deficiency in individuals with limited sun exposure or dietary deficiency.
• Essential for effective calcium and phosphate absorption for healthy bones and teeth, thus preventing:
  • Rickets
  • Osteomalacia
  • Osteoporosis
• Prevention of pre-eclampsia during pregnancy and breastfeeding, as it is an essential nutrient for a growing infant.
• Immunity boost up.

Dosage & Administration

D-Rise is available in various formulations (capsules, film-coated tablets, oroflash/chewable tablets, syrup, injection) with different dosing regimens. Always consult a registered physician for medication use.

For Capsules:

• Adults - Treatment of Vitamin D3 deficiency: 40,000 IU once weekly for 7 weeks. Maintenance therapy: 1,400-2,000 IU/day.
  • Note: 25-hydroxyvitamin D levels should be measured 3-4 months after starting maintenance to confirm target levels.
• Adults - Prevention of Vitamin D3 deficiency: 20,000 IU every 4 weeks. Higher doses may be needed in certain situations.
• Adults - Addition to specific therapy for osteoporosis: 20,000 IU once a month.
• Children (12-18 years) - Treatment of Vitamin D3 deficiency: 20,000 IU once every 2 weeks for 6 weeks.
• Children (12-18 years) - Prevention of Vitamin D3 deficiency: 20,000 IU every 6 weeks.

For Film-Coated Tablet:

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

For Oroflash or Chewable Tablets:

• 1,000 IU to 2,000 IU daily, or as directed by physician. Take with food or within 1 hour after a meal. Place in mouth and swallow after chewing.

For Syrup:

• For patients with risk of Cholecalciferol deficiency:
  • 0-1 yr: 400 IU/day (2 ml)

  • 1 Yr: 600 IU/day (3 ml)

• For Cholecalciferol deficient patients:
  • 0-1 yr: 2,000 IU/day (+ 50,000 IU/week) for 6 weeks.
  • 1-18 yrs: 2,000 IU/day for 6 weeks.

For Injection (Prevention):

• Infants receiving Vitamin D enriched milk: ½ ampoule (0.5 ml, 100,000 I.U.) every 6 months.
• Nursed infants or infants not receiving Vitamin D enriched milk or young children up to 5 years of age: 1 ampoule (1 ml, 200,000 I.U.) every 6 months.
• Adolescents: 1 ampoule (1 ml, 200,000 I.U.) every 6 months during winter.
• Pregnancy: ½ ampoule (0.5 ml, 100,000 I.U.) from the 6th or 7th month of pregnancy.
• Elderly: ½ ampoule (0.5 ml, 100,000 I.U.) every 3 months.
• Digestive disorders, concomitant antiepileptics & other particular conditions: ½ ampoule (0.5 ml, 100,000 I.U.) or 1 ampoule (1 ml, 200,000 I.U.) every 3 or 6 months.

For Injection (Vitamin D deficiency):

• 1 ampoule (1 ml, 200,000 I.U.), which can be repeated 1 to 6 months later. Or, as directed by the registered physician.

Important Considerations & Warnings

It is crucial to discuss your full medical history with your doctor before taking D-Rise.

Contraindications:

• All diseases associated with hypercalcaemia (high calcium levels).
• Patients with known hypersensitivity to Vitamin D3 (or medicines of the same class) and any of the excipients.
• Evidence of Vitamin D3 toxicity.

Side Effects (Rarely occur, usually with excessive intake):

• Anorexia, lassitude (lack of energy), nausea & vomiting, diarrhea, constipation, weight loss.
• Polyuria (excessive urination), sweating, headache, thirst, vertigo.
• Raised concentrations of calcium and phosphate in plasma and urine (indicating hypervitaminosis D).

Pregnancy & Lactation:

• Pregnancy: Studies show safe use of doses up to 4,000 IU during pregnancy. The recommended daily intake is 400 IU, but higher doses may be required for deficient women. Always follow medical advice as requirements vary.
• Lactation: Vitamin D3 and its metabolites are excreted in breast milk. While infant overdose from nursing mothers has not been observed, practitioners should consider the mother's dosage when prescribing additional Vitamin D3 to a breast-fed child.

Precautions & Warnings:

• Plasma-calcium concentration should be monitored at intervals in patients receiving high doses of Vitamin D3, in renal impairment, and during pregnancy & lactation.
• Individuals using Digoxin (risk of cardiac arrhythmias due to hypercalcaemia) and Thiazide Diuretics (risk of hypercalcaemia) should consult a healthcare practitioner before supplementing with Vitamin D3.
• People with liver or kidney disease, primary hyperthyroidism, lymphoma, tuberculosis, and granulomatous disease should consult a healthcare practitioner before supplementing with Vitamin D3, as these conditions can affect Vitamin D metabolism or increase calcium levels.

Use in Special Populations:

• Children under 12 years: The safety and efficacy of Vitamin D3 in this age group (for specific D-Rise formulations) have not been fully established. (Note: Syrup dosage is provided for infants and children, indicating specific formulations may be approved for younger ages).

Overdose Effects:

• Can lead to hypervitaminosis D, characterized by symptoms like those listed under side effects (anorexia, nausea, vomiting, polyuria, etc.) and elevated calcium/phosphate levels.

Storage Conditions

Keep below 30°C temperature, protected from light & moisture. Keep out of the reach of children.