Calomin Special Precautions

Softcap: There is a close correlation between treatment with calcitriol and the development of hypercalcemia. In patients with normal renal function, chronic hypercalcemia may be associated with an increase in serum creatinine. Calcitriol increases inorganic phosphate levels in serum. Immobilized patients are particularly exposed to the risk of hypercalcemia.
Since calcitriol is the most effective vitamin D metabolite available, no other vitamin D preparation should be prescribed during treatment with calcitriol thereby ensuring that the development of hypervitaminosis D is avoided.
Injection: Excessive dosage induces hypercalcemia and in some instances hypercalciuria therefore, early in treatment during dosage adjustment, serum calcium and phosphorus should be determined at least twice weekly. Should hypercalcemia develop, Calomin should be discontinued immediately. Calomin Inj should be given cautiously to patients on digitalis, because hypercalcemia 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. Patients should also be carefully informed about the symptoms of hypercalcemia (see Adverse Reactions).
Essential Laboratory Tests: Serum calcium, phosphorus, magnesium and alkaline phosphatase and 24-hr 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).
Because the effect of calcitriol in the treatment of bone loss after implantation has not been established, Calomin should not be used.
Because  the effect of calcitriol in patients with post menopausal osteoporosis cause by decrease of estrogen have not been established, Calomin should not be used.
Carcinogenesis, Mutagenesis & Impairment of Fertility: Long-term studies in animals have not been performed to evaluate the carcinogenic potential of Calomin Inj (calcitriol).
There was no evidence of mutagenicity as studies by the Ames method.
No significant effects of calcitriol on fertility were reported using oral calcitriol.
Use in pregnancy: Calcitriol given orally has been reported to be teratogenic in rabbits when given in doses 4 and 15 times the dose recommended for human use. All 15 fetuses in 3 L at these doses showed external and skeletal abnormalities however, none of the other 23 letters (156 fetuses) showed significant abnormalities compared with controls. Teratology studies in rats showed no evidence of teratogenic potential.
Safety and efficacy in pregnant women have not been established.
Calomin Inj should be used during pregnancy only if the potential benefit justifies potential risk to the fetus.
Use in lactation: It is not known whether Calomin Inj is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reaction in nursing infants from calcitriol, a decision should be made whether to discontinue nursing or to discontinue Calomin Inj, taking into account the importance of the drug to the mother.
Use in children: Safety and efficacy of Calomin Inj in children have not been established.