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Drug Details

CALCICHEW D3 FORTE

• Drug Class Description
  Calcium supplements.
• Generic Name
  Calcium carbonate, vitamin D3 - deficiency
• Presentation
  Chewable tablet. Round, white, uncoated and convex tablets. May have small specks
• Description
  Per tablet: Calcium carbonate 1250 mg (equivalent to 500 mg of elemental calcium) Colecalciferol 400 IU (equivalent to 10 micrograms vitamin D3) Contains sorbitol, 390mg; isomalt, 49.90mg; aspartame, 1mg; sucrose, 1.52mg; and soya bean oil, hydrogenated, 0.30mg.
• Indications
  The treatment and prevention of vitamin D/calcium deficiency (characterised by raised serum alkaline phosphatase levels associated with increased bone loss, raised levels of serum PTH and lowered 25-hydroxyvitamin D) particularly in the housebound and institutionalised elderly subjects. The supplementation of vitamin D and calcium as an adjunct to specific therapy for osteoporosis, in pregnancy, in established vitamin D dependent osteomalacia, and in other situations requiring therapeutic supplementation of malnutrition.
• Adult Dosage
  

  Oral.

  Adults and elderly:

  2 chewable tablets per day, preferably one tablet morning and evening.

  The tablet may be chewed or sucked.

  Dosage in hepatic impairment:

  No dose adjustment is required.

  Dosage in renal impairment:

  Calcichew-D₃ Forte Chewable Tablets should not be used in patients with severe renal impairment.

• Child Dosage
  Not recommended.
• Contra Indications
  
  • Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria
  • Nephrolithiasis
  • Hypervitaminosis D
  • Hypersensitivity to soya or peanut
  • Hypersensitivity to the active substances or to any of the excipients
• Special Precautions
  

  During long-term treatment, serum calcium levels should be followed and renal function should be monitored through measurements of serum creatinine. Monitoring is especially important in elderly patients on concomitant treatment with cardiac glycosides or diuretics and in patients with a high tendency to calculus formation. In case of hypercalcaemia or signs of impaired renal function the dose should be reduced or the treatment discontinued.

  Vitamin D should be used with caution in patients with impairment of renal function and the effect on calcium and phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account. In patients with severe renal insufficiency, vitamin D in the form of colecalciferol is not metabolised normally and other forms of vitamin D should be used.

  Calcichew-D₃ Forte Chewable Tablets should be prescribed with caution to patients suffering from sarcoidosis because of the risk of increased metabolism of vitamin D to its active form. These patients should be monitored with regard to the calcium content in serum and urine.

  Calcichew-D₃ Forte Chewable Tablets should be used with caution in immobilised patients with osteoporosis due to the increased risk of hypercalcaemia.

  The content of colecalciferol (400 IU) in Calcichew-D₃ Forte Chewable Tablets should be considered when prescribing other medicinal products containing vitamin D. Additional doses of calcium or vitamin D should be taken under close medical supervision. In such cases it is necessary to monitor serum calcium levels and urinary calcium excretion frequently.

  CalcichewD₃ ForteChewable Tablets contain aspartame (a source of phenylalanine) which may be harmful for people with phenylketonuria.

  CalcichewD₃ ForteChewable Tablets contain sorbitol (E420), isomalt and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

  CalcichewD₃ ForteChewable Tablets are not intended for use in children.

• Interactions
  

  Thiazide diuretics reduce the urinary excretion of calcium. Due to increased risk of hypercalcaemia, serum calcium should be regularly monitored during concomitant use of thiazide diuretics.

  Systemic corticosteroids reduce calcium absorption. During concomitant use, it may be necessary to increase the dose of Calcichew-D₃ Forte Chewable Tablets.

  Simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the gastrointestinal absorption of vitamin D.

  Calcium carbonate may interfere with the absorption of concomitantly administered tetracycline preparations. For this reason, tetracycline preparations should be administered at least two hours before, or four to six hours after, oral intake of calcium.

  Hypercalcaemia may increase the toxicity of cardiac glycosides during treatment with calcium and vitamin D. Patients should be monitored with regard to electrocardiogram (ECG) and serum calcium levels.

  If a bisphosphonate or sodium fluoride is used concomitantly, this preparation should be administered at least three hours before the intake of Calcichew-D₃ Forte Chewable Tablets since gastrointestinal absorption may be reduced.

  Oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole cereals) may inhibit calcium absorption through formation of insoluble calcium salts. The patient should not take calcium products within two hours of eating foods high in oxalic acid and phytic acid.

• Adverse Drug Reactions
  

  Adverse reactions are listed below, 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.

  Gastrointestinal disorders

  Rare: Constipation, flatulence, nausea, abdominal pain and diarrhoea.

  Skin and subcutaneous disorders

  Rare: Pruritus, rash and urticaria.