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Drug Details

Kalcipos-D 500 mg/ 800 IU chewable tablets

• Drug Class Description
  Mineral supplements (Vit D3) ATC-code: A12AX
• Generic Name
  calcium carbonate - colecalciferol
• Presentation
  Chewable tablet White, round, engraved R152, diameter 17 mm.
• Description
  Each chewable tablet contains calcium carbonate equivalent to 500 mg calcium, cholecalciferol (Vitamin D3) 800 IU (20 microgram). Excipients: glucose 200 mg, sucrose 3.8 mg and hydrogenated soya-bean oil 0.8 mg.
• Indications
  Prevention and treatment of calcium and vitamin D deficiency in the elderly. Vitamin D and calcium supplement in addition to specific osteoporosis treatment of patients who are at risk of vitamin D and calcium deficiency.
• Adult Dosage
  

   

  Adults and elderly

  One chewable tablet (500 mg/800 IU) daily. To be chewed or slowly melted in the mouth.

  The amount of calcium in Kalcipos-D is less than the usually recommended daily intake.

  Kalcipos-D is therefore primarily to be used by patients with need of D-vitamin substitution but with a dietary intake of calcium of 500 mg-1000 mg per day. The patients dietary intake of calcium should be estimated by the prescriber.

  Dosage in hepatic impairment

  No dose adjustment is required

  Dosage in renal impairment

  Kalcipos-D should not be used in patients with severe renal impairment

• Child Dosage
  

  There is no relevant indication for use of Kalcipos-D chewable tablets in children or adolescents.

• Elderly Dosage
  

  Adults and elderly

  One chewable tablet (500 mg/800 IU) daily. To be chewed or slowly melted in the mouth.

  The amount of calcium in Kalcipos-D is less than the usually recommended daily intake.

  Kalcipos-D is therefore primarily to be used by patients with need of D-vitamin substitution but with a dietary intake of calcium of 500 mg-1000 mg per day. The patients dietary intake of calcium should be estimated by the prescriber.

  Dosage in hepatic impairment

  No dose adjustment is required

  Dosage in renal impairment

  Kalcipos-D should not be used in patients with severe renal impairment

• Contra Indications
  

  • Diseases and/or conditions resulting in hypercalcaemia or hypercalciuria.

  • Nephrolithiasis.

  • Nephrocalcinosis

  • Hypervitaminosis D.

  • Renal failure.

  • Hypersensitivity to calcium carbonate or cholecalciferol.

  • Hypersensitivity to any of the excipients.

  Kalcipos-D contains partially hydrogenated soya-bean oil and must not be used by persons allergic to peanuts or soya

• Special Precautions
  

  Kalcipos-D chewable tablets should be prescribed with caution to patients suffering from sarcoidosis due to 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.

  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 hypercalciuria (exceeding 300 mg (7.5 mmol)/24 hours) 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 cholecalciferol is not metabolised normally and other forms of vitamin D should be used.

  Kalcipos-D chewable tablets should be used cautiously in immobilised patients with osteoporosis due to increased risk of hypercalcaemia.

  The content of vitamin D (800 IU) in Kalcipos-D 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.

  Co-administration with tetracyclines or quinolones is usually not recommended, or must be done with precaution.

  Kalcipos-D chewable tablets contains glucose and 3.8 mg sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

  The content of glucose may be harmful to the teeth.

  Kalcipos-D chewable 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.

  Concomitant use of phenytoin or barbiturates may reduce the effect of vitamin D₃ since the metabolism increases.

  Systemic corticosteroids reduce calcium absorption. During concomitant use, it may be necessary to increase the dose of Kalcipos-D.

  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.

  The efficacy of levothyroxine can be reduced by the concurrent use of calcium, due to decreased levothyroxine absorption. Administration of calcium and levothyroxine should be separated by at least four hours.

  If a bisphosphonate is used concomitantly, this preparation should be administered at least one hour before the intake of Kalcipos-D since gastrointestinal absorption may be reduced.

  Calcium may also reduce absorption of sodium fluoride and iron salts, and such preparations should be administered at least three hours before the intake of Kalcipos-D.

  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.

  The absorption of quinolone antibiotics may be impaired if administered concomitantly with calcium. Quinolone antibiotics should be taken two hours before or six hours after intake of calcium.

  Oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole cereals) may inhibit calcium absorption through formation of insoluble compounds with calcium ions. 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 frequencies are defined as: uncommon (1/1,000, <1/100), rare (>1/10,000, <1/1,000) or not known (cannot be estimated from the available data

  Immune system disorders

  Not known (cannot be estimated from the available data): Hypersensitivity reactions such as angioedema or laryngeal edema.

  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.