D-Tres Injection

🔰D-Tres Injection

(Cholecalciferol) Vitamin D3

◾Oral / IM use

🔰DESCRIPTION:-

◾Cholecalciferol is the naturally occuring form of vitamin D.

🔰COMPOSITION:-

D-Tres Injection

◾Each ml contains Cholectoral Ph. Euro...... 5mg(200,000 IU)

🔰PHARMACOTHERAPEUTIC GROUP:-

◾Vitamin D (Fat soluble vitamin)

🔰PHARMACODYNAMICS:-

◾Vitamin D may have anti-osteoporotic, immunomodulatory, anticarcinogenic, antipsoriatic, anti oxidant and mood - modulator activities. 

◾Along with parathyroid hormone and calcitonin, Regulate serum calcium concentration. 

🔰PHARMACOKINETICS:-

✒️Absorption:-

◾Well absorbed from the Gl tract. 

◾Presence of bile is essential for adequate intestinal absorption. 

◾Hence skorpion may be decreased in patients with deceased fat absorption. 

🔰Distribution:-

◾Bound to a specific c-globulin. 

◾Can be stored in adipose and muscle fissue for long periods of time. 

◾Slowly released from storage siles and skin where it is formed in thep resence 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-hydroxycholecalciferol (calcedial) 

◾Further metabolism also occur in kidneys, including the formation of the 1, 24, 25 trihydroxy derivatives. 

🔰Excretion:-

◾Mainly in the bile and feaces with only small amounts appearing in urine

🔰INDICATIONS:-

🎙️Bone fixation of calcium

🎙️Prevention and treatment of vitamin D deficiencies

🔰DOSAGE AND ADMINISTRATION:-

⏸️Infants receiving vitamin enriched milk:-

◾1/2 Ampoule (Le. 100.000 LU) every 6 months

⏸️Nursed infants or infants not receiving vitamin D enriched milk or young children up to 5 years of age :-

◾1 Ampoule (200,000 LU) every 6 months

⏸️Adolescents:-

◾1 Ampoule (200,000 IU) every 6 months during winter

⏸️Pregnancy:-

◾1/2 Ampoule (.e. 100,000 LU) from 6th to 7 month of pregnancy

⏸️Elderly:-

◾1/2 Ampoule (.e. 100,000 LU) every 3 months

◾Digestive disorders, concomitant treatment with antiepileptics, other particular conditions not described above:-

1/2 or 1 Ampoule every 3 to 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

🔰SIDE EFFECTS/ADVERSE REACTIONS:-

◾Hyperphosphataemia or hypercalcaemia (in excessive intake). 

◾Associated effects of hypercalcaemia include hypercalciuria, ectopic calcification, renal and CV damage. 

🔰PRECAUTIONS:-

◾Excessive intake may lead to development of hyperphosphataemia or hypercalcaemia,Infants, renal impairment or calcul, heart

◾Monitor plasma phosphate and calcium level during pregnancy and lactation

🔰WARNING:-

◾The 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)

🔰SPECIAL WARNING:-

🎙️If high or repeated doses of vitamin D are administered or if high dose of calcium are associated, it is necessary to monitor calcium level in blood and urine

🔰DRUG INTERACTIONS:-

🖱️Interaction with other medicines and other interactions

🖱️Increased risk of hypercalcaemia if given with thiazide diuretics, calcium or phosphate. 

🖱️Antiepileptics (eg, carbamazepine, phenobarbitone, phenytoin and primidone) may Increase vitamin D requirements. 

🖱️Rifampicin and isoniazid may reduce efficacy of vitamin D. 

🖱️Corticosteroids may counteract the effect of vitamin D. 

🖱️Digoxin of any cardiac glycoside reduced absorption when taken with cholestyramine, colestipol, mineral oll, orlistat and ketoconazole.

🔰CHOLECALCIFEROL AND PREGNANCY:-

💠Category A: Controlled studies in women fail to demonstrate a risk to the foetus in the 1st erimester (and there is no evidence of a risk in 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 (eg, if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective)

🔰OVERDOSE:-

◾In the event of an overdose of vitamin D, following symptoms may occur headache, fatigue, slimming growth retardation, nausea, vomiting, excess of urine, intense thirst and arterial hypertension. 

🔰STABILITY:-

◾See expiry on the pack

🔰PRESENTATION:-

◾D-Tres Injection in a pack of 1's

◾D-Tres Injection in a pack of 5's

🔰INSTRUCTIONS:-

◾Keep out of reach of children

◾Avoid exposure to heat, light and freezing

◾Store between 15 to 30°C

◾Improper storage may deteriorate the medicine

🔰Caution:-

◾Injection should not be used if container is leaking,solution is cloudy or it contains undissolved particle(s)

🔰Manufactured by:-

◾SAMI Pharmaceuticals (Pvt.) Ltd.

F-95, S.I.T.E., Karachi-Pakistan

www.samipharmapk.com