D Rise (Vitamin D): Consensus, Evolution & Overview

D Rise contains Cholecalciferol, a fat-soluble vitamin that helps regulate serum calcium and phosphorous concentrations by enhancing the efficiency of the small intestine in absorbing these minerals from the diet.

D Rise is indicated for the treatment of Vitamin D3 (Cholecalciferol) deficiency.

Dosage forms and strengths of D Rise

Soft Gelatin Capsules

D Rise ® 60K

Cholecalciferol 60000IU

D Rise ® 2000

Cholecalciferol 2000IU

D Rise is available as:

Soft Gelatin Capsules

• D Rise ® 60K
  Cholecalciferol 60000IU
• D Rise ® 2000
  Cholecalciferol 2000IU

Sachet

• D Rise ®
  Cholecalciferol Granules 60000IU

Composition:

D Rise ® 60K

Vitamin D3 Capsule 60000 JU

Each soft gelatin capsule contains:

Cholecalciferol IP………………. 60000 IU

(Vitamin D3)

Excipients………….. q.s

Approved colours used in capsule shell

Tartrazine Yellow

Appropriate overages of Vitamin added to compensate for loss on storage.

D Rise ® 2000

Vitamin D3 Capsules 2000 IU

Each soft gelatin capsule contains:

Cholecalciferol IP ……2000 IU

Excipients…… q.s

Posology:

In adults for correcting vitamin D deficiency recommended dosage of cholecalciferol is 60,000 IU/weekly for 8 weeks. This may need to be followed up with cholecalciferol 60,000 IU/once a month. To maintain serum concentrations consistently >30 ng/ml may require cholecalciferol up to 2000 IU/day. The exact dosage and duration of the treatment depend upon the patient’s clinical condition and the decision of the physician

Route of Administration: Oral

D Rise is contraindicated for those patients who are hypersensitive to Cholecalciferol, ergocalciferol or Vitamin D metabolites (e.g. Calcitriol, Calcifediol, Alfa-calcidol, Calcipotriol) are not supposed to take Cholecalciferol.

Special warnings and precautions for use of D Rise:

Caution should be taken while prolonged use of Calcium- containing preparations, other vitamin D-containing preparations as this may lead to hypercalcemia, renal impairment, etc.

Hepatic & Renal Insufficiency: The intestinal absorption of Cholecalciferol may be markedly impaired; conversion to Calcifediol and Calcitriol may be reduced respectively with the requirement of high doses in hepatic and renal insufficiency.

Renal Insufficiency: Although only small amounts of Vitamin D dose are recovered in the urine, metabolic conversion to Calcitriol is impaired & higher doses are generally required in most conditions.

Pharmacological properties of D Rise

Pharmacodynamics:

Vitamin D regulates the blood levels of calcium and phosphorus, by increasing the absorption of these minerals and by promoting them into the bones. Vitamin D does this by stimulating DNA to produce transport proteins, which bind to the calcium and phosphorus and increase absorption through the small intestine. This stimulating feature is unusual for a vitamin and normally a function of hormones. Vitamin D also stimulates the uptake of these minerals by bone cells. This process is helpful in building strong bones and healthy teeth.

Pharmacokinetics:

• Cholecalciferol is synthesized in the skin from 7dehydrocholesterol under the action of ultraviolet B light. It reaches an equilibrium after several minutes depending on several factors including conditions of sunlight (latitude, season, cloud cover, altitude), age of skin, and colour of skin.
• Hydroxylation in the endoplasmic reticulum of liver hepatocytes of cholecalciferol to calcifediol (25 hydroxycholecalciferol) by 25 hydroxylase is loosely regulated, if at all, and blood levels of this molecule largely reflect the amount of vitamin D3 produced in the skin or the vitamin D2 or D3 ingested.
• Hydroxylation in the kidneys of calcifediol to calcitriol by 1 alpha-hydroxylase is tightly regulated (stimulated by either parathyroid hormone or hypophosphatemia) and serves as the major control point in the production of the most active circulating hormone calcitriol (1,25dihydroxyvitamin D3).

Nonclinical properties of D Rise

Animal Toxicology or Pharmacology

Cholecalciferol is well known and established product and has been used in clinical practice for many years. No further specific toxicological hazard for humans is expected other than in chronic overdosage where hypercalcaemia could be seen.

Cholecalciferol overdosage in animals has been shown to induce malformations in rats, mice and rabbits at doses significantly higher than the human dose. The malformations included skeletal defects, microcephaly, and cardiac malformations.

At doses equivalent to those used therapeutically, Cholecalciferol has no teratogenic activity. Cholecalciferol has no potential mutagenic or carcinogenic activity.

Acute or chronic overdose of D Rise (Cholecalciferol) can cause hypercalcaemia, an increase in the serum and urinary concentrations of calcium. The symptoms of hypercalcaemia are not very specific and consist of nausea, vomiting, diarrhoea often in the early stages and later constipation, anorexia, fatigue, headache, muscle and joint pain, muscle weakness, polydipsia, polyuria formation of renal calculi, nephrocalcinosis, kidney failure, calcification of soft tissues, changes in ECG measurements, arrhythmias, and pancreatitis. In rare and isolated cases there are reports that hypercalcaemia is fatal.

Treatment of overdose

A normalisation of hypercalcaemia due to D Rise (Cholecalciferol) intoxication lasts several weeks. The recommendation for the treatment of hypercalcaemia is the avoidance of any further administration of D Rise (Vitamin D), including supplements, dietary intake, and the avoidance of sunlight. Low calcium or calcium-free diet can also be considered. Rehydration and the treatment with diuretics e.g., furosemide to ensure adequate diuresis should be considered. Additional treatment with calcitonin or corticosteroids can also be considered. Phosphate infusions should not be administered to lower hypercalcaemia of hypervitaminosis D because of the dangers of metastatic calcification.

Storage and handling instructions for D Rise:

• D Rise ® 60K: Store in cool & dry place. Protected from light.
• D Rise ® 2000: Store in Cool place, protected from light.

Packaging information of D Rise

• Each strip of D Rise ® 60K contains 4 capsules .
• Each strip of D Rise ® 2000 contains 10 capsules.