🔰Zad Injection 5.0mg/ml🔰
◾Cholecalciferol Injection BP (Vitamin D3)
◾FOR ORAL/I.M. USE
♓COMPOSITION:-
◾Each ml contains:-
💡Choleclaciferol (Vitamin Da) BP 5mg (200,000 IU)
♓DESCRIPTION:-
◾Cholecalciferol is a form of vitamin D3 or calciol.
◾It is the natural form of vitamin D produced when skin is exposed to the sun.
◾Vitamin D is necessary for proper absorption of calcium from the intestine and the use of absorbed calcium in the mineralization of bone.
◾Cholecalciferol is the natural precursor of calcitriol (1,25-dihydroxy-cholecaliferol), the physiologically active form of vitamin D in bone
◾It is described as (3su, 5Z, 7E)-9, 10-secocholesta-5, 7, 10 (19)-triene-3-ol
◾The empirical formula is C27H44O, its molecular weight is 384.6.
♓PHARMACOLOGICAL PROPERTIES:-
➡️Mechanism of Action:-
◾Vitamin D may have anti-osteoporotic,immunomodulatory,anticarcinogenic, antipsoriatic, antioxidant & mood-modulatory activities.
◾Along with parathyroid hormone & calcitonin, regulate serum calcium conc.
♓Onest:-
◾Slow
♓Duration:-
◾Relatively prolonged duration of action.
♓Absorption:-
◾Well absorbed from the GI tract.
◾Presence of bile is essential for adequate intestinal absorption.
◾Hence absorption may be decreased in patients with decreased fat absorption.
♓Distribution:-
◾Bound to a specific a-globulin.
◾Can be stored in adipose & muscle tissue for long periods of time.
◾Slowly released from storage sites & skin where it is formed in the presence of sunlight or UV light.
◾May distribute into breast milk.
♓Metabolism:-
◾Hydroxylated in the liver by the enzyme vitamin D 25-hydroxylase to form 25- hydroxycholecaciferol "calcifediol).
◾Further hydroxylated in the kidneys by the enzyme vitamin D1-hydroxylase to form the active metabolites 1,25- hihydroxycholecalciferol (calcitriol).
◾Further metabolism also occurs in the kidneys, including the formation of the 1,24,25-trihydroxy derivatives.
♓Excretion:-
◾Mainly in the bile & faeces with only small amounts appearing in urine.
♓INDICATION:-
◾Vitamin D3 helps the body absorb calcium and works to control the immune system.
◾A lack of sufficient vitamin D3 can leave body more vulnerable to Autoimmune diseases and cancer.
◾Vitamin D3 is involved in bone fixation of calcium. It is indicated in prevention and treatment of vitamin D deficiencies.
♓DOSAGE AND ADMINISTRATION:-
◾Dosage should be followed as prescribed by doctor.
♓Usual dosages are:-
⏸️Prevention:-
◾Infants receiving vitamin enriched milk:1/2 ampoule (i.e. 100,000 IU) every 6 months.
◾Nursed Infants or infants not receiving vitamin D enriched milk or young children upto 5 years of age:1 ampoule (200,000 IU) every 6 months.
◾Adolescents:1 ampoule (200,000 IU) every 6 months during winter.
◾Pregnancy:1/2 ampoule (100,000 IU) from 6th or 7th month of pregnancy.
◾Elderly:1/2 ampoule (100,000 IU) every 3 months.
◾Digestive disorders, concomitant treatment with antiepileptics, other particular conditions not described above:1/2 or 1 ampoule every 3 or 6 months.
◾Vitamin D deficiency:1 ampoule (200,000 IU), which can be renewed once 1 to 6 months later or as directed by the physician.
♓Administration:-
◾I.M route. The ampoule can also be administered by oral route.
◾May be taken with or without food.
♓WARNING & PRECAUTIONS:-
◾This medicine has been prescribed to patient for particular conditions:1
🖱️It cannot be adapted for another condition
🖱️Did not recommend it to another person.
🖱️This drug must not be used in the following cases:-
✒️Hypersensitivity to any of the ingredients mainly to vitamin D.
✒️Hypercalcaemia (abnormally high blood calcium levels) Hypercalciuria (excessive urinary elimination of calcium)
✒️Calcium lithiasis (kidney stones)
🏟️For concomitant treatment with drugs containing-Vitamin D, consult with registered physician
♓SPECIAL POPULATION:-
◾Pregnancy and breast-feeding
🖱️Category A
◾Controlled studies in women fail to demonstrate a risk to the foetus in the 1st trimester (and there no evidence of a risk on later trimesters), and the possibility of foetal harm remains remote
◾If dose > US RDA
🖱️Category D
◾There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g, if the drug is needed threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
◾This medicinal product can be prescribed during pregnancy or lactation if necessary
◾However it is preferable to consult doctor before using this drug
♓DRUG INTERACTONS:-
◾Increased risk of hypercalcaemia if given with thiazide diuretics, calcium or phosphate
◾Antiepileptics (e.g. carbamazepine, phenobarbitone, phenytoin & primidone) may increase vitamin D-requirements.
◾Rifampicin & isoniazid may reduce efficacy of vitamin D.
◾Corticosteroid may counteract the effect of vitamin D.
◾Digoxin or any cardiac glycoside.
◾Reduced absorption when taken with cholestyramine, colestipol or mineral oil.
♓OVERDOSE:-
◾In the event of an overdose of vitamin D, following symptoms may occur:-
🎙️headache
🎙️fatigue
🎙️slimming
🎙️growth retardation
🎙️nausea
🎙️vomiting
🎙️excess of urines
🎙️intense thirst and
🎙️arterial hypertension
➡️consult doctor immediately.
♓ADVERSE EFFECTS:-
◾As with any medicine, this product may produce unpleasant effects of varying severity in some people.
◾Consult doctor for unwanted or unpleasant effect which is not mentioned in this leaflet
♓INSTRUCTIONS:-
◾Do not refrigerate.
◾Injection should not be used if the ampoule is leaking or it contains undissolved particles or as directed by the physician
♓STORAGE:-
◾Store between (15-25°C) in a dry place.
◾Protect from heat and light.
◾Keep out of the reach of children.
♓PRESENTATION:-
◾ZAD 5mg/ml (200,000 IU) injection (ready to drink) for oral or I.M.
◾use is available in 1ml x 1 ampoule
◾Break the ampoule by pushing with slight Bumb pressure against the white line.
◾By this method ampoule will be broken safely and easily
◾Take out the liquid and inject, LM. Or as directed by physician
◾Coincide the white mark on the
ampoule with the edge of sleeve
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