Hidroferol

Vit D deficiency in adults for cases where initial administration of high doses is required or administration spaced in time is preferred, as in the following situations: As adjuvant for osteoporosis treatment; in patients w/ malabsorption syndrome; renal osteodystrophy; corticosteroid-induced bone diseases.

Dose to be administered should produce serum Ca levels 9-10 mg/dL. Vit D insufficiency 1 cap per mth for 2 mth. Vit D deficiency 1 cap per mth for 4 mth. Adjuvant for osteoporosis treatment in patients w/ vit D deficiency 1 cap per month for 3-4 mth. Renal osteodystrophy 1 cap wkly or biweekly. Corticosteroid-induced bone diseases 1 cap mthly. Higher vit D deficiencies or malabsorption syndrome Repeat initial dose a wk after starting treatment, followed by 1 cap once a mth for 4 mth, controlling plasma conc of 25-OH-cholecalciferol.

May be taken w/ water, milk or juice.

Hypersensitivity. Hypercalcemia (serum Ca >10.5 mg/dL), hypercalciuria. Ca lithiasis. Hypervitaminosis D.

Monitor serum levels of 25-OH-cholecalciferol, Ca, P & alkaline phosphatase as well as urinary Ca & P in 24 hr. Calcifediol activity may decrease in case of parathyroid insufficiency. Administer vit D supplements in patients w/ kidney stones only if benefits outweigh risks. May be necessary to reduce dose to avoid hypercalcemia in patients w/ prolonged immobilization. May interfere w/ Zlatkis-Zak method, leading to false increases in serum cholesterol levels. Contains 1% ethanol (corresponds to 4.98 mg/cap); sorbitol; sunset yellow (E-110). Should not be taken by patients w/ hereditary fructose intolerance. Can cause asthma, especially in patients allergic to ASA. Inability to absorb calcifediol may occur in case of liver failure. Caution in patients w/ renal impairment; heart failure; sarcoidosis, TB or other granulomatous diseases. Do not use during pregnancy & breast-feeding.

The most common adverse reactions are due to hypercalcemia which can occur initially or at a later stage.

Reduced plasma conc w/ phenytoin, phenobarb, primidone & other enzyme inducers. Calcifediol can cause hyperglycemia, which can enhance the inotropic effects of digoxin & its toxicity, producing cardiac arrhythmias. Decreased absorption w/ cholestyramine, colestipol or orlistat. Decreased intestinal absorption w/ paraffin & mineral oil. Co-administration of hydrochlorothiazide w/ vit D supplements in patients w/ hypoparathyroidism may lead to hypercalcemia. Some antibiotics (eg, penicillin, neomycin, chloramphenicol) can increase Ca absorption. Hypermagnesemia may occur w/ phosphate-binding agents (eg, Mg salts) since vit D has an effect on phosphate transport in the intestine, kidney & bone. Potential inhibition of antianginal action of verapamil. Additive effects & hypercalcemia can occur w/ co-administration of any vit D analogue. Avoid uncontrolled intake of additional Ca-containing prep. Corticosteroids counteract the effects of vit D analogue drugs. Additive effects may occur w/ vit-D-supplemented food.

Vitamins A, D & E

A11CC06 - calcifediol ; Belongs to the class of vitamin D and analogues. Used as dietary supplements.

P₁S₁S₃