Hidroferol Special Precautions

Serum levels of 25-OH-cholecalciferol reflect vitamin D status of the patient. However, in order to obtain an adequate clinical response to oral administration of calcifediol, an appropriate dietary calcium intake is also required. Therefore, to control the therapeutic effects, the following parameters should be monitored, in addition to 25-OH-cholecalciferol: serum calcium, phosphorus and alkaline phosphatase as well as urinary calcium and phosphorus in 24 hours. A decrease in serum levels of alkaline phosphatase normally precedes the onset of hypercalcemia. Once parameters are stabilized and the patient is under maintenance treatment, the previously mentioned determinations should be performed regularly, especially for serum levels of 25-OH-calciferol and calcium.
In patients with prolonged immobilization it may be necessary to reduce the dose in order to avoid hypercalcemia.
Some diseases reduce the ability of the intestine to absorb vitamin D, as in the case of malabsorption syndrome or Crohn's disease.
Patients and their families and/or caregivers should be informed of the importance of complying with the prescribed dosage and with recommendations about diet and concomitant intake of calcium supplements in order to prevent overdosing.
Liver or biliary insufficiency: In case of liver failure, an inability to absorb calcifediol may occur since no bile salts are produced.
Renal impairment: To be administered with caution. Use of this drug in patients with chronic kidney disease should be accompanied by periodic monitoring of serum calcium and phosphorus, and hypercalcemia prevention. Transformation to calcitriol takes place in the kidney; thus, in case of severe renal impairment (creatinine clearance of less than 30 ml/min) a very significant reduction in the pharmacological effects may occur.
Heart failure: Special caution is required. The patient's serum calcium should be monitored constantly, especially in patients on digitalis, because hypercalcemia may occur and arrhythmias appear. Twice-a-week determinations are recommended at the beginning of treatment.
Hypoparathyroidism: 1-alpha-hydroxylase is activated by parathyroid hormone. As a result, in case of parathyroid insufficiency the activity of calcifediol may decrease.
Kidney stones: Calcemia should be monitored, since vitamin D increases absorption of calcium and may aggravate the situation. In these patients supplements of vitamin D should be administered only if the benefits outweigh the risks.
Patients with sarcoidosis, tuberculosis or other granulomatous diseases: To be administered with caution, since these conditions lead to a greater sensitivity to the effect of vitamin D as well as to an increase of the risk of adverse effects at doses lower than the recommended dose. It is necessary to monitor serum and urinary calcium concentrations in these patients.
Interference with laboratory tests: Patients should be warned that this drug contains a component that can alter the results of laboratory tests.
Determination of cholesterol: Calcifediol may interfere with Zlatkis-Zak method, leading to false increases in serum cholesterol levels.
Warnings on excipients: This medicine contains 1% ethanol (alcohol), which corresponds to 4.98 mg/capsule.
This medicine contains sorbitol. Patients with hereditary fructose intolerance should not take this drug.
This medicine may cause allergic reactions because it contains sunset yellow (E-110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.
Effects on ability to drive and use machines: Calcifediol capsules has no or negligible influence on the ability to drive and use machines.
Use in the Elderly: Elderly people generally have greater needs for vitamin D due to a decreased ability of the skin to produce cholecalciferol from its precursor 7-dehydrocholesterol, to a reduction of exposure to the sun, to changes in renal function or to digestive disorders that decrease absorption of vitamin D.