Vidrop
COMPANY NAME :
Medical Union Phamaceutical
TRADE NAME :
Vidrop
FORM :
oral solution
Vidrop is a stabilized aqueous solution of vitamin D, (cholecalciferol).
COMPOSITION :
Each 1 mI (=28 drops) of oral solution contains:
Vitamin D, (cholecalciferol) 2800 IU. (each drop contains100 lU of vitamin D)
Exciptents: polysorbate 20,vitamin E , glycerin , disodium edetate ,
b cydodextrin , purified water
PROPERTIES / ACTIONS :
Vitamin D which is effective in there peutic 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 a small quantities from
dietary source such as milk, butter. liver and egg yolks. Vitamin D
reguates 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 – 400 iu depending on age.
PHARMACOKINETICS :
vitamin D is rapidly absorbed from the proximal and distal small
intestine and transported to its main storage sites (liver and adipose
tissue) bound to specific gtobulins Vitamin D, 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). Vitarrin D is stored in the body and excreted mainly in the form of inactive glucurorides. it is exaeted both in faeces via the bile and in urine.
INDICATIONS / USES :
– Prevention of rickets – Treatment of all forms and stages of rickets
– Osteomalacia
– Acute postoperative hypoparathyroidism
– Chronic hypoparathyroidism
DOSAGE / ADMINISTRATION :
– Full term infants : 400 IU (= 4 drops) daily in the first year of life starting in week 2-5.
– Preterm infants: 4oo – 800 IU (= 4-8 drops) daily in the first year of lifeTreatment 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 THE ORAL SOLUTION :
add the required number of drobs to food or drink
RESTRICTIONS ON USE :
To use Vidrop for rickets prevention in infants : hypothyroidism
idiopathic hypercalcaemia. vitamin-D) hypersensitivity.to high dose of vitamin-D therapy in adults : skeletal disoroers 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 admintration of vitamin D analogues.
PRECAUTIONS :
– caution is required in patients with disturbances of calcium metabolism kidney failure. kidney stones. arteriosclerosis of coronary disease.
– All forms of vitamin D are toxic in high doses. causing a significant
increase i1 calcium absorption. Toxic effects may also occur if doses of1000 – 3000 iu/kg body weight daily are administered over a period of several months
– The fact that milk. fats and baby foods Of other foods are often
enriched with vitamin D shoold be taken i1to account when determining dosage.
– caution should be exercised in patients receiving treatment with
cardiac glycosides since hypercalcemia may lead to arrhythmia in
such cases.
– Partiaiar care should be taken to avoid the following :
– Prophytactx: 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. babyfoods).
– Massive doses of vitamin 0 at short intervals.This areceuse the
body’s- attempts to etimtnate the resultant calcium excess overload the excretory capacity of the Kidneys: the first symptoms of
overdosage are polyuria and Polydipsia.
– Patients receiving the recommended dose of vidrop for the preventionof rickets or osteomalacia or as a supplement to the nannal diet should avoid other drugs containing vitamin 0 and vitamin-D enriched foods.
– Particular care should be exercised in the prophyiactic use of vitamin-Dof preparations in infants receiving vitamin-D enriched baby foods(nonnally containing 400 IU perdaily portion).
– The recommended dose should be taken regularty but not exceeded.
– Care should be taken for patients receive sufficient dietary calcium regular blood calcium checks should be performed on patients
PREGNANCY AND LACTATION :
Vidrop may be taken by women who are pregnant Of 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, although this may be outweighed by the therapeuticbenefit to the mother.
ADVERSE REACTIONS :
in recominended daily allowance adverse effects are very rare; thesemay include mild gastrointestinal symptoms.
INTERACTIONS :
– colestyramine colestipol and mineral oils may reduce the intestinal
absorption of vitamin 0 and as long an interval as possible (at least
4 hours) should Iherefore be allowed between ingestion.
– Concomitant administration with thiazide diuretics may lead to
hypercalcaemia, possibly necessitating the withdrawal ofVldrop.
– Phenobarbitat and phenytoin (and presumably otherliver-enzymeinducing agents) may causea reduction in plasma levels of
cholecalciferol.
– Corticosteroids may lessen the effect of cholecalciferol.
– Concomitant administration with cardiac gtycosides may resultin
cardiac arrhythmia.
OVERDOSAGE :
it vitamin D overdosage exceeds the excretory capacity of the kidneys,calcium deposits may be formed in the kidneys and vascular walls,The signs and symptoms of oven:Iosage are thirst, polyuria, loss ofappetite, nausea, vomiting, constipation, headache, joint pain, muscleweakness, dehydration (especially wizened, dry skin in children),tremOf affecting the extremities, muscular atrophy with fibrillary contractions and hypertension these symptoms are reversible provided vitamin 0 is withdrawn in time.
OTHER INFOMATION :
note like all drugs vidrop should be kept outof reach of children.
SHELF LIFE :
the drug should not be used after the expiry date (=EXP) printed 00 the pack
Store oral solution at a temperature not exceeding 30°C, away from
light.
PACK :
Carton box containing glass bottle type HI of 10 or 15 mt with plastic
dropper with white cap and off/white rubber pump and inner leaflet
Produced by :
Medical Union Pharmaceuticals
Abu Sultan, Ismailia, Egypt.
