VIDROP 2800 I.U. oral drops 15 ML

COMPOSITION

  • Each 1 ml (=28 drops) of oral solution contains: 2800 IU Vitamin D3, (cholecalciferol).Each drop contains 100 IU of vitamin D3.
  • Excipients: Polysorbate 20, Vitamin E, Glycerin, Disodium Edetate, 13-Cyclodextrin, Purified Water.

PROPERTIES & ACTIONS

Vitamin D, which is effective in therapeutic use when given orally is a naturally occurring hormone in humans, being formed from 7-DEHYDROCHOLESTEROL in the skin as a result of exposure to sunlight (ultraviolet irradiation).

It is also obtained in small quantities from dietary source such as milk, butter, liver and egg yolks.

Vitamin D regulates calcium and phosphate metabolism, its main function being to mediate intestinal calcium absorption by an active transport mechanism. It also promotes normal bone formation.

The minimum daily requirement of vitamin D is 100 to 400 IU, depending on age.

PHARMACOKINETICS

Vitamin D3, is rapidly absorbed from the proximal and distal small intestine and transported to its main storage sites (liver and adipose tissue) bound to specific alpha-globulins.

Vitamin D3, is biotransformed in the liver to 25-hydroxycholecalciferol (25-HCC, calcifediol), which then undergoes further hydroxylation at position 1 in the kidneys to give the active metabolite 1,25- dihydroxycholecalciferol(1 ,25-DHCC;calcitriol).

 Vitamin D is stored in the body and excreted mainly in the form of inactive glucuronides. It is excreted both in faeces via the bile and in urine.

INDICATIONS & USES

DOSAGE & ADMINISTRATION

Prevention of rickets

  • Full-term infants: 400  IU (= 4 drops) daily in the first year of life, starting in week 2-5.
  • Preterm infants: 400 to 800 IU (= 4-8 drops) daily in the first year of life.

Treatment of rickets

Dosage should be individualized on the basis of frequent determinations of serum calcium and bone X-rays.

Florid rickets

5000 IU (= 50 drops) daily for three weeks.

INSTRUCTIONS FOR USE OF THE ORAL SOLUTION

Add the required number of drops to food or drink.

RESTRICTIONS ON USE & Contraindicalions

  • Do not use Vidrop for rickets prevention in infants with: hypothyroidism, Idiopathic hypercalcaemia, vitamin-D hypersensitivity.
  • DO NOT USE high dose of vitamin-D  therapy in adults with: skeletal disorders involving complete immobilization (which increase calcium excretion), sarcoidosis (Boeck’s disease), acute pulmonary tuberculosis, immobilization following corrective orthopedic surgery.
  • Vidrop should not be given by I.V. injection.
  • Concomitant administration of vitamin-D analogues.
vidrop - product image
vidrop – product image

PRECAUTIONS

  • Caution is required in patients with disturbances of calcium metabolism. Kidney failure, kidney stones, arteriosclerosis or coronary disease.
  • All forms of vitamin D are toxic in high doses, causing a significant increase in calcrum absorption. Toxic effects may also occur if doses of 1000-3000 IU/kg body weight daily are administered over a period of several months.
  • the fact that milk, fats and baby foods or other foods are often enriched With vitamin D should be taken into account when determining dosage.
  • Caution should be exercised in patients receiving treatment with cardiac glycosides since hypercalcaemia may lead to arrhythmia in such cases.

Particular care should be taken to avoid the following:

  1. Prophylactic administration of vitamin D in large doses over a period of months or even years without proper monitoring or a specific indication especially in conjunction with calcium and/or vitamin¬enriched foods (e.g. baby foods).
  2. Massive doses of vitamin D at short intervals. This is because body’s attempts to eliminate the resultant calcium excess might overload the excretory capacity of the Kidneys; the first symptoms of overdosage are polyuria and Polydipsia.
  3. Patients receiving the recommended dose of Vidrop for the prevention of rickets or osteomalacia or as a supplement to the normal diet should avoid other drugs containing vitamin D and vitamin-D enriched foods.
  4. Particular care should be exercised in the prophylactic use of vitamin-D preparations in infants receiving vitamin-D enriched baby foods (normally containing 400 IU per daily portion).
  5. The recommended dose should be taken regularly but not exceeded.
  6. Care should be taken that patients receive sufficient dietary calcium.
  7. regular blood calcium checks should be performed on patients receiving long-term treatment for vitamin D-RESISTANT RICKETS.

PREGNANCY & LACTATION

Vidrop may be taken by women who are pregnant or breastfeeding at a dosage corresponding to the normal daily requirement.

There is clear evidence that doses in excess of the daily requirement represent a risk to the foetus, althougth this may be outweighed by the therapeutic benefit to the mother.

ADVERSE REACTIONS

In recommended daily allowance. adverse effects are very rare; these may include mild gastrointestinal symptoms.

INTERACTIONS

  • Colestyramine, colestipol and mineral oils may reduce the intestine absorption of vitamin D and as long an interval as possible (at leasl 4 hours) should therefore be allowed between ingestion
  • Concomitant administration with thiazide diuretics may lead to hypercalcaemia, possibly necessitating the withdrawal of vidrop.
  • Phenobarbital and phenytoin (and presumably other liver-enzyme-inducing agents) may cause a reduction in plasma levels of cholecalciferol
  • Corticosteroids may lessen the effect of cholecalciferol.
  • Concomitant administration with cardiac glycosides may result in cardiac arrhythmia.

OVERDOSAGE

If vitamin D overdosage exceeds the excretory capacity of the kidneys, calcium deposits may be formed in the kidneys and vascular wall.

The signs and symptoms of over-dosage are:

  1. thirst.
  2. polyuria.
  3. Loss Of Appetite.
  4. Nausea, Vomiting and Constipation.
  5. headache.
  6. Joint Pain And Muscle Weakness.
  7. Dehydration (Especially Wizened, Dry Skin In Children).
  8. Tremor Affecting The Extremities.
  9. Muscular Atrophy With Fibrillary Contractions.
  10. hypertension

These symptoms are reversible provided vitamin D is withdrawn in time.

MANAGEMENT OF VITAMIN D OVERDOSE

  • Immediate discontinuation of all vitamin D intake, increase of fluid intake and avoidance of calcium-rich foods.
  • Additionally in severe cases prednisolone 25 mg i.v. then 10 mg/day by mouth.

Vidrop Manufactured by : Medical Union Pharmaceuticals AbuSultan,lsmailia, Egypt.

COMPANY NAME

Medical Union Pharmaceuticals.

TRADE NAME

Vidrop.

FORM

oral solution, Vidrop is a stabilized aqueous solution of vitamin D3, (Cholecalciferol).

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