Vitanova-D3 Sachet

Cholecalciferol Granules

Each sachet of 1gm contains:

Cholecalciferol IP 60000 IU.

Excipients q.s.

Granules, 60000 IU per sachet

4.1 Therapeutic indication

For the treatment of Vitamin-D3 deficiency.

4.2 Posology and method of administration

1/4 to 1 sachet with milk or as directed by the physician

4.3 Contraindications

• Hypersensitivity to vitamin D or any of the excipients in the product
• Hypervitaminosis D
• Nephrolithiasis
• Diseases or conditions resulting in hypercalcaemia and/or hypercalciuria
• Severe renal impairment

4.4 Special warnings and precautions for use

• Patients with gastrointestinal malabsorption syndromes may require higher doses of vitamin D3 supplementation and measurement of 25-hydroxyvitamin D should be considered.
• Vitamin D3 supplementation may worsen hypercalcemia and/or hypercalciuria when administered to patients with diseases associated with unregulated overproduction of 1,25 dihydroxyvitamin D (e.g., leukaemia, lymphoma, sarcoidosis). Urine and serum calcium should be monitored in these patients.
• It should be used with caution in patients with renal impairment or calculi, or heart disease, who might be at increased risk of organ damage if hypercalcaemia occurred.
• Plasma phosphate concentrations should be controlled during vitamin D3 therapy to reduce the risk of ectopic calcification.
• It is advised that patients receiving pharmacological doses of vitamin D3 should have their plasma-calcium concentration monitored at regular intervals, especially initially or if symptoms suggest toxicity.

4.5 Drugs interactions

• Olestra, mineral oils, orlistat, and bile acid sequestrants (e.g., cholestyramine, colestipol) may impair the absorption of vitamin D3.
• Anticonvulsants, cimetidine, and thiazides may increase the catabolism of vitamin D.
• There is an increased risk of hypercalcaemia if vitamin D3 is given with thiazide diuretics, calcium, or phosphate. Plasma-calcium concentrations should be monitored in such situations.
• Some antiepileptics may increase vitamin D3 requirements (e.g. carbamazepine, phenobarbital, phenytoin, and primidone).
• Rifampicin and isoniazid may reduce the effectiveness of vitamin D3.
• Corticosteroids may counteract the effect of vitamin D3.

4.6 Use in special populations

Pregnancy

No data are available for cholecalciferol (vitamin D3). There are no studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.

Nursing Mothers

Cholecalciferol and some of its active metabolites pass into breast milk. Infants should be closely monitored for hypercalcemia or clinical manifestations of vitamin D toxicity if the mother is taking pharmacological doses of vitamin D3.

Infants

Vitamin D3 should be used with caution in infants, who may have increased sensitivity to its effects.

4.7 Effects on ability to drive and use machines

It is not expected that Vitanova sachet would affect your ability to drive or to operate machinery.

4.8 Undesirable effects

Major & minor side effects for Vitanova D3 Sachet

• Increased blood calcium levels
• Increased calcium levels in urine
• Constipation
• Skin rash, hives, or itching
• Chest pain
• Shortness of breath

Reporting of suspected adverse reactions

• Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to: medico@zuventus.com
• Website: http://www.zuventus.co.in/safety.aspx
• By reporting side effects, you can help provide more information on the safety of this medicine.

4.9 Overdose

There is limited information regarding doses of cholecalciferol associated with acute toxicity, although intermittent (yearly or twice yearly) single doses of ergocalciferol (vitamin D2) as high as 600,000 IU have been given without reports of toxicity. Signs and symptoms of vitamin D toxicity include hypercalcemia, hypercalciuria, anorexia, nausea, vomiting, polyuria, polydipsia, weakness, and lethargy. Serum and urine calcium levels should be monitored in patients with suspected vitamin D toxicity.

Treatment

Standard therapy includes restriction of dietary calcium, hydration, and systemic glucocorticoids in patients with severe hypercalcemia. Dialysis to remove vitamin D would not be beneficial.

5.1 Mechanism of Action

The mechanism of action of 1,25(OH)2D(calcitriol) is mediated by the interaction of calcitriol with the vitamin D receptor (VDR). Calcitriol binds to cytosolic VDRs within target cells, and the receptor-hormone complex translocates to the nucleus and interacts with DNA to modify gene transcription. The VDR belongs to the steroid and thyroid hormone receptor supergene family. Calcitriol also exerts nongenomic effects that may require the presence of a functional VDR.

5.2 Pharmacodynamic properties

Vitamin D3 is converted to 25-hydroxyvitamin D3 in the liver. Conversion to the active calcium-mobilizing hormone 1, 25-dihydroxyvitamin D3 (calcitriol) in the kidney is stimulated by both parathyroid hormone and hypophosphatemia. The principal action of 1,25-dihydroxyvitamin D3 is to increase intestinal absorption of both calcium and phosphate as well as regulate serum calcium, renal calcium and phosphate excretion, bone formation and bone resorption.

Vitamin D is required for normal bone formation. Vitamin D insufficiency develops when both sunlight exposure and dietary intake are inadequate. Insufficiency is associated with negative calcium balance, increased parathyroid hormone levels, bone loss, and increased risk of skeletal fracture. In severe cases, deficiency results in more severe hyperparathyroidism, hypophosphatemia, proximal muscle weakness, bone pain and osteomalacia.

5.3 Pharmacokinetic properties

Absorption

Vitamin D substances are well absorbed from the gastrointestinal tract. The presence of bile is essential for adequate intestinal absorption; absorption may be decreased in patients with decreased fat absorption.

Distribution

Following absorption, vitamin D3 enters the blood as part of chylomicrons. Vitamin D3 is rapidly distributed mostly to the liver where it undergoes metabolism to 25-hydroxyvitamin D3, the major storage form. Lesser amounts are distributed to adipose tissue and stored as vitamin D3 at these sites for later release into the circulation. Circulating vitamin D3 is bound to vitamin D-binding protein.

Metabolism

Vitamin D3 is rapidly metabolized by hydroxylation in the liver to 25-hydroxyvitamin D3, and subsequently metabolized in the kidney to 1,25-dihydroxyvitamin D3, which represents the biologically active form. Further hydroxylation occurs prior to elimination. A small percentage of vitamin D3 undergoes glucuronidation prior to elimination.

Excretion

When radioactive vitamin D3 was intravenously administered to healthy subjects, the mean urinary excretion of radioactivity after 48 hours was 2.4% of the administered dose, and the mean fecal excretion of radioactivity after 48 hours was 4.9% of the administered dose. In both cases, the excreted radioactivity was almost exclusively as metabolites of the parent. The mean half-life of vitamin D3 in the serum following an oral dose is approximately 14 hours.

6.1 Animal Toxicology or Pharmacology

No known animal toxicology data

Vitanova D3 contains cholecalciferol (Vitamin D3). Vitamin D3 is essential for the proper growth and development of the body. It is synthesized within the body after exposure to sunlight and is essential for many important functions of the human body. Vitamin D3 in Vitanova D3 also increases the Calcium absorption from the intestines.

8.1 Incompatibilities

Not applicable.

8.2 Shelf-life

Refer on pack

8.3 Packaging information

4 sachets of 1 gram each

8.4 Storage and handing instructions

Store protected from light & moisture at a temperature not exceeding 25°C. Keep out of reach of children.

• Take exactly as directed by your doctor or on the label. Do not increase the dosage or take for longer than is recommended.
• Vitanova-D3 Sachets 1 gm may interfere with cholesterol tests, hence please inform your physician and laboratory staff that you are taking Vitanova-D3 Sachets 1 gm before undergoing blood tests.
• Clinical monitoring of serum electrolyte concentrations and cardiac function is recommended.