Calcitriol: Precautions of Calcitriol

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Calcitriol is a form of vitamin D that is used to treat and prevent low levels of calcium in the blood of patients whose kidneys or parathyroid glands (glands in the neck that release natural substances to control the amount of calcium in the blood) are not working normally. Low blood levels of calcium may cause bone disease. There are differents precautions :

General : Excessive dosage of Calcitriol Injection induces hypocalcaemia and in some instances hypercalciuria; therefore, early in treatment during dosage adjustment, serum calcium and phosphorus should be determined at least twice weekly. Should hypocalcaemia develop, the drug should be discontinued immediately. Calcitriol Injection should be given cautiously to patients on digitalis, because hypocalcaemia in such patients may precipitate cardiac arrhythmias.

Information for the Patient : The patient and his or her parents should be informed about adherence to instructions about diet and calcium supplementation and avoidance of the use of unapproved non-prescription drugs, including magnesium-containing antacids.

Essential Laboratory Tests: Serum calcium, phosphorus, magnesium and alkaline phosphatase and 24-hour urinary calcium and phosphorus should be determined periodically. During the initial phase of the medication, serum calcium and phosphorus should be determined more frequently (twice weekly).

Drug Interactions: Magnesium-containing antacid and Calcitriol Injection should not be used concomitantly, because such use may lead to the development of hypermagnesemia.

Pregnancy: Teratogenic Effects: Calcitriol has been found to be teratogenic in rabbits when given orally at doses of 0.08 and 0.3 mcg/kg. Teratogenicity studies in rats at doses up to 0.45 mcg/kg orally showed no evidence of teratogenic potential. There are no adequate and well-controlled studies in pregnant women.

Nursing Mothers : It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from calcitriol, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use : Pediatric use information is approved for Abbott Laboratories' calcitriol injection. However, due to Abbott Laboratories' marketing exclusivity rights, this drug product is not labeled for pediatric use.