Zifam Pinnacle


Pinnacle House
Full Prescribing Info
Each 5 ml contains: Cholecalciferol USP (as stabilized) (In Nano droplet form) 60000 IU.
In a Flavoured base q.s.
The primary constituent of NANO-D is Vitamin D3 (Cholecalciferol). This vitamin is an essential component in human body, which helps in the absorption of calcium and phosphates from the bowel. It is vital for keeping bones and teeth healthy.
Excipients/Inactive Ingredients: Colour: Approved colour used.
Appropriate overage of vitamin added.
Pharmacotherapeutic group: Vitamin D3, Cholecalciferol.
Pharmacology: Pharmacodynamics: In its biologically active form Vitamin D3 stimulates intestinal calcium absorption, incorporation of calcium into the osteoid, and release of calcium from bone tissue. In the small intestine it promotes rapid and delayed calcium uptake. The passive and active transport of phosphate is also stimulated. In the kidney, it inhibits the excretion of calcium and phosphate by promoting tubular resorption. The production of parathyroid hormone (PTH) in the parathyroids is inhibited directly by the biologically active form of Vitamin D3. PTH secretion is inhibited additionally by the increased calcium uptake in the small intestine under the influence of biologically active Vitamin D3.
Pharmacokinetics: The pharmacokinetics of Vitamin D3 is well known.
Absorption: Vitamin D3 is well absorbed from the gastro-intestinal tract in the presence of bile, so the administration with the major meal of the day might therefore facilitate the absorption of Vitamin D3.
Distribution and biotransformation: It is hydroxylated in the liver to form 25-hydroxy-colecalciferol and then undergoes further hydroxylation in the kidney to form the active metabolite 1, 25-dihydroxycolecalciferol (calcitriol).
Elimination: The metabolites circulate in the blood bound to a specific α-globulin. Vitamin D3 and its metabolites are excreted mainly in the bile and faeces.
Characteristics in Specific Groups of Subjects or Patients: A 57% lower metabolic clearance rate is reported in subjects with renal impairment as compared with that of healthy volunteers. Decreased absorption and increased elimination of Vitamin D3 occurs in subjects with malabsorption. Obese subjects are less able to maintain Vitamin D3 levels with sun exposure, and are likely to require larger oral doses of Vitamin D3 to replace deficits.
NANO-D is indicated for: Treatment and prevention of Vitamin D3 deficiency in adults, elderly and children over 12 years of age.
As adjunct to specific therapy for osteoporosis in patients with Vitamin D3 deficiency or at risk of Vitamin D3 insufficiency.
Dosage/Direction for Use
Treatment of Vitamin D3 deficiency (<25 nmol/l) 60,000 IU/week (1 single-dose oral solution) for 6-8 weeks, followed by maintenance therapy (equivalent to 1400-2000 IU/day, such as 1 single-dose 60,000 IU oral solution per month) is recommended, follow-up 25(OH) D measurements should be made approximately three to four months after initiating maintenance therapy to confirm that the target level has been achieved).
Method of administration: Patients is advised to take NANO-D preferably with meal through oral route.
Administration to adults: The single-dose oral solution should be either emptied into the mouth and swallowed orally, or emptied onto a spoon and taken orally.
Symptoms of chronic Vitamin D3 overdosage may require forced diuresis as well as administration of glucocorticoids or calcitonin.
No special antidote exists.
It is recommended to point out the symptoms of potential overdose to patients under chronic therapy with higher doses of Vitamin D3.
Allergy: Allergy to Vitamin D3 or Hypersensitivity to the active substance(s) or to any of the excipients.
Hypercalcaemia and/or hypercalciuria: The blood calcium levels should be confirmed before taking this medication.
Nephrolithiasis and/or nephrocalcinosis.
Serious renal impairment.
Hypervitaminosis D.
Malabsorption Syndrome.
Pseudohypoparathyroidism as the Vitamin D3 requirement may be reduced due to phases of normal Vitamin D3 sensitivity, involving the risk of prolonged overdose. Better regulatable Vitamin D3 derivatives are available for this.
Special Precautions
NANO-D should be used with caution in patients with impairment of renal function. In such patient the effect on calcium and phosphate levels should be monitored regularly. The risk of soft tissue calcification should be taken into account.
Caution is required in patients receiving treatment for cardiovascular disease.
NANO-D should be prescribed with caution in patients with sarcoidosis, due to a possible increase in the metabolism of Vitamin D3 in its active form. In these patients the serum and urinary calcium levels should be monitored.
Total dose of Vitamin D3 should be adjusted in patients which are already associated on Vitamin D3 treatment, foods enriched with Vitamin D3, milk enriched with Vitamin D3, and level of sun exposure.
There is no clear evidence for causation between Vitamin D3 supplementation and renal stones, but the risk is plausible, especially in the context of concomitant calcium supplementation. The need for additional calcium supplementation should be considered for individual patients. Calcium supplements should be given under close medical supervision.
Oral administration of high-dose Vitamin D3 was reported to result in an increased risk of fractures in elderly subjects, with the greatest increase occurring during the first 3 months after dosing.
Use In Pregnancy & Lactation
In pregnancy and lactation the high strength formulation is not recommended; a low strength formulation should be preferred.
Pregnancy: There are no or limited data for the use of colecalciferol in pregnant women. Studies in animals have shown reproductive toxicity. The recommended daily intake for pregnant women is 400 IU, however, in women who are considered to be Vitamin D3 deficient a higher dose may be required. During pregnancy women should follow the advice of their medical practicioner as their requirements may vary depending on the severity of their disease and their response to treatment with Vitamin D3.
Breast-feeding: Vitamin D3 can be prescribed while the patient is breast-feeding if necessary. This supplementation does not replace the administration of Vitamin D3 in the neonate.
Fertility: There is no data regarding treatment with Vitamin D3 and its effects on fertility.
Adverse Reactions
Adverse reactions are listed as follows, by system organ class and frequency. Frequencies are defined as: Uncommon (>1/1,000, <1/100) or rare (>1/10,000, <1/1,000).
Metabolism and nutrition disorders: Uncommon: Hypercalcaemia and hypercalciuria.
Skin and subcutaneous disorders: Rare, pruritus, rash and urticaria.
Drug Interactions
All drugs act different in each individual. The patient should check all the possible interactions of this medicine with any drug/food with their doctor before starting this medication.
Concomitant use of anticonvulsants (such as phenytoin) or barbiturates (and possibly other drugs that induce hepatic enzymes) may reduce the effect of Vitamin D3 by metabolic interactions.
In cases of treatment with thiazide diuretics, which decrease urinary elimination of calcium, monitoring of serum calcium concentration is recommended during treatment.
Concomitant use of glucocorticoids can decrease the effect of Vitamin D3.
In cases of treatment with drugs containing digitalis and other cardiac glycosides, administration of Vitamin D3 may increase the risk of digitalis toxicity (arrhythmia). Strict medical supervision is needed, together with serum calcium concentration and electrocardiographic monitoring.
Simultaneous treatment with ion exchange resin such as cholestyramine, colestipol hydrochloride, orlistat or laxative such as paraffin oil may reduce the gastrointestinal absorption of Vitamin D3.
The cytotoxic agent actinomycin and imidazole antifungal agents interfere with Vitamin D3 activity by inhibiting the conversion of 25-hydroxyvitamin D to 1, 25-dihydroxyvitamin D by the kidney enzyme, 25-hydroxyvitamin D-1-hydroxylase.
Interaction with Alcohol: Interaction with alcohol is unknown. It is advisable to consult the doctor before consumption.
Interaction with Medicine: Phenytoin, Aluminum Hydroxide/Magnesium Hydroxide, Calcitriol, Hydrochlorothiazide.
Disease Interactions: Disease: Information not available.
Food interactions: Information not available.
Lab interactions: Information not available.
This is not an exhaustive list of possible drug interactions. The patient should consult the doctor about all the possible interactions of the drugs the patient is taking.
Store below 30°C. Protect from light.
Shelf Life: 24 Months from the date of manufacturing.
MIMS Class
Vitamins A, D & E
ATC Classification
A11CC05 - colecalciferol ; Belongs to the class of vitamin D and analogues. Used as dietary supplements.
Oral soln 60,000 IU/5 mL (yellow coloured, clear solution, sweet in taste with flavoured odor) x 4's.
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