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Drug Details

CACIT D3

• Drug Class Description
  Calcium supplements / vitamin D3 .
• Generic Name
  Calcium carbonate, Vitamin D3 - deficiency
• Presentation
  Effervescent white granules for oral solution.
• Description
  One sachet of 4 g contains : Calcium carbonate 1250 mg (equivalent to calcium element 500 mg or 12.5 mmol) Colecalciferol concentrate (powder form) 440 IU (equivalent to colecalciferol (Vitamin D3) 11µg)
• Indications
  Correction of vitamin D and calcium combined deficiency in elderly people. - Vitamin D and calcium supplementation as an adjunct to specific therapy for osteoporosis treatment in patients with established, or at high risk of vitamin D and calcium combined deficiencies
• Adult Dosage
  

  - Posology:

  One or two sachets per day.

  - Method of administration:

  Oral.

  Pour the contents of the sachet into a glass, add a large quantity of water, then drink immediately

• Child Dosage
  Not applicable.
• Contra Indications
  
  • Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria
  • Nephrolithiasis
  • Hypervitaminosis D
  • Hypersensitivity to the active substances or to any of the excipients (in particular soya oil).
• 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 D3 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 cholecalciferol is not metabolised normally and other forms of vitamin D should be used.

  Cacit Vitamin D3 sachets should be prescribed with caution to patients suffering from sarcoidosis, due to the risk of increased metabolism of vitamin D into its active form. These patients, should be monitored with regard to the calcium content in serum and urine.

  Calcium/vitamin D3 sachets should be used with caution in immobilised patients with osteoporosis due to the increased risk of hypercalcaemia.

  The contentof vitamin D3 (440 IU) in Cacit Vitamin D3 sachets 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.

  Cacit Vitamin D3 sachets are not intended for use in children.

  - Special warnings:

  Cacit Vitamin D3 sachets contain sucrose.

  Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

• Interactions
  

  Concomitant use requiring precautions:

  - Digitalis and other cardiac glycosides: the oral administration of calcium combined with vitamin D increases the toxicity of digitalis (risk of dysrythmia). Strict medical supervision, and if necessary, monitoring ECG and calcaemia are necessary.

  - Bisphosphonate, sodium fluoride: it is advisable to allow a minimum period of two hours before taking the calcium (risk of reduction of the gastrointestinal absorption of bisphosphonate and sodium fluoride).

  - Thiazide diuretics : reduce urinary elimination of calcium therefore supervision of calcaemia is recommended.

  - Phenytoin or barbiturates : can decrease the effect of vitamin D because of metabolic inactivation.

  - Glucocorticosteroid : can decrease the effect of vitamin D.

  - Tetracyclines by oral route: it is advisable to delay taking the calcium by at least three hours (calcium salts reduce the absorption of tetracyclines).

  - Possible interactions with food (e.g. containing oxalic acid, phosphate or phytinic 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.