Cholecalciferol Chewable Tablets 5000 IU, each chewable tablet contains: Cholecalciferol 5000 IU equivalent to Vitamin D3 125 mcg.
To increase serum 25(OH)D blood level in patients with Vitamin D deficiency (25(OH)D serum level < 30 ng/ml).
DOSAGE AND METHOD OF ADMINISTRATION:
Adults and children over 12 years: 1 chewable tablet, 1 time a day.
Dosage should be adjusted based on serum 25-hydroxycholecalciferol (25(OH)D) levels and not to exceed 5000 IU/day.
Patients with hypersensitivity to Vitamin D and its analogues or to other components of the formula.
Hypercalcemia and/or hypercalciuria.
Calcium nephrolithiasis, nephrocalcinosis, hypervitaminosis D.
Severe kidney damage and kidney failure
Symptoms of hypercalcemia:
Anorexia, thirst, nausea and vomiting, constipation, abdominal pain, muscle weakness, fatigue, confusion, polydipsia, polyuria, bone pain, calcification of the kidneys, kidney stones, vertigo and cardiac arrhythmias in severe cases.
Hypercalcemia in severe cases can lead to coma or death. High calcium levels over a long period of time can lead to kidney damage and calcification of soft tissues.
Overdose can cause hypervitaminosis, hypercalcemia and hyperphosphatemia.
Treatment of hypercalcemia:
Normalization of hypercalcemia due to Vitamin D intoxication takes several weeks. The recommendation for the treatment of hypercalcemia is to avoid further Vitamin D administration, including supplements, dietary intake and avoidance of sunlight.
A low-calcium or calcium-free diet may also be considered.
Rehydration and treatment with a diuretic such as Furosemide to ensure adequate diuresis should be considered. Additional treatment with calcitonin or corticosteroids may also be considered.
Phosphate infusion should not be given to reduce hypercalcemia with hypervitaminosis D because it carries a dangerous risk of calcifying metastases.
- Phosphate infusions should not be given to reduce hypercalcemia with hypervitaminosis D because of the danger of metastatic calcification.
- Patients treated with cardiac glycosides may be prone to high calcium levels and should have ECG parameters and calcium levels monitored. It is recommended to reduce the dose or stop treatment if the calcium content in the urine exceeds 7.5 mmol/24 hours (300 mg/24 hours).
- Simultaneous administration of Benzothiadiazine derivatives (thiazide diuretics) increases the risk of hypercalcemia because it reduces calcium excretion in the urine. Plasma and urine calcium levels should be monitored for patients undergoing long-term treatment.
- If Cholecalciferol is combined with Vitamin D metabolites or analogues, careful monitoring of serum calcium levels is advised.
- Anti-seizures such as Phenytoin, Phenobarbital, Primidone can reduce the effects of Cholecalciferol due to induction of liver enzymes.
- Rifampicin may reduce the effectiveness of Cholecalciferol due to induction of liver enzymes.
- Isoniazid can reduce the effectiveness of Cholecalciferol because it inhibits the activation of Cholecalciferol metabolism.
- Medications that cause fat malabsorption, such as Orlistat, liquid paraffin, Cholestyramine, can interfere with the absorption of Cholecalciferol.
- The cytotoxic drug actinomycin and the antifungal drug Imidazol interfere with Vitamin D activity by inhibiting the conversion of 25-hydroxyvitamin D to 1,25-dihydroxyvitamin D by the kidney enzyme, 25-hydroxyvitamin D-1-hydroxylase.
- Concomitant use of glucocorticoids can reduce the effect of Vitamin D.
- Avoid concomitant use with multivitamins and minerals (Vitamins A, D, E, K, folic acid and iron), calcitonin, etidronate, gallium nitrate, pamidronate or plicamycin.
- Vitamin D may cause increased levels/effects of: Aluminum hydroxide, cardiac glycosides, magnesium salts, Sucralfate, Vitamin D analogues.
- Levels/effects of Vitamin D may be increased when used together with: Calcium salts, Conivaptan.
- Vitamin D can cause a decrease in the levels/effects of: Aripiprazole, Axitinib, Saxagliptin.
- Levels/effect of Vitamin D may decrease when used together with: Bile acid sequestrant, corticosteroids (systemic), inducers.
- CYP3A4, Deferasirox, mineral oil, Orlistat, Sevelamer, Tocilizumab, anticonvulsants, hydantoin, barbiturates or Primidone.
WARNING AND ATTENTION:
- Cholecalciferol should be used with caution in patients with impaired renal function and monitoring of serum calcium and phosphate levels is necessary. The risk of soft tissue calcification must be taken into account. In patients with severe renal insufficiency, Vitamin D in the form of Cholecalciferol is not metabolized normally and other forms of Vitamin D must be used.
- Cholecalciferol should not be taken by patients with a tendency to form calcium-containing kidney stones.
- Caution is required in patients receiving medications for cardiovascular disease, such as cardiac glycosides.
There is a risk of hypocalcemia in patients with digitalis toxicity.
- High doses of cholecalciferol should be prescribed with caution to patients suffering from sarcoidosis because of the risk of increasing the metabolism of Vitamin D to its active form. These patients should be closely monitored for calcium content in serum and urine.
- The need for additional calcium supplementation must be considered for the individual patient. Calcium supplements should be given under close medical supervision.
- Medical supervision is necessary during treatment to prevent hypercalcemia.
- The use of Vitamin D preparations in the treatment of hyperparathyroidism associated with cardiovascular disease is not recommended because it can cause kidney failure.
- Pregnancy : Cholecalciferol 5000 IU should not be used during pregnancy unless the woman’s clinical condition requires treatment with Cholecalciferol, at the dosage required to overcome the deficiency.
During pregnancy women should follow the advice of clinicians as their needs may vary depending on the severity of their disease and their response to treatment.
Based on human experience and animal studies, overdosage of Vitamin D can lead to physical and mental disabilities, and congenital heart and eye conditions, due to hypercalcemia caused by administration of Cholecalciferol during pregnancy.
- Breastfeeding : Cholecalciferol and its metabolites are excreted in breast milk. Overdosage in infants caused by breastfeeding mothers has not been observed. However, when prescribing supplemental Vitamin D to a child who is breastfed, the practitioner should consider any dose of supplemental Vitamin D given to the mother.
- Effects on ability to drive and use machines : No studies on effects on ability to drive or use machines have been conducted. Cholecalciferol has no known side effects that may affect the ability to drive and use or operate machinery.
SIDE EFFECTS :
Stop use if severe allergy symptoms occur, including: Swollen face, lips, tongue and throat, difficulty swallowing, itching and difficulty breathing.
Unusual side effects: Hypercalciuria and hypercalcemia.
Rare side effects: Pruritus, rash, urticaria.
Cholecalciferol 5000 is available in the form of chewable tablets, brown color, brown smell, sweet chocolate taste, marked b breakline f on one side and plain on the other side, packaged in:
Box, 3 strips @ 10 chewable tablets
No. Reg. : GKL2202366263A1
STORE UNDER 30°C, PROTECTED FROM LIGHT
ON MEDICAL PRESCRIPTION
Produced by :
Sidoarjo – Indonesia