Excessive dosage of PhosLo (calcium acetate tablet) induces hypercalcemia; therefore, early in the treatment during dosage adjustment serum calcium should be determined twice weekly. Should hypercalcemia develop, the dosage should be reduced or the treatment discontinued immediately depending on the severity of hypercalcemia. PhosLo (calcium acetate tablet) should not be given to patients on digitalis, because hypercalcemia may precipitate cardiac arrhythmias. PhosLo (calcium acetate tablet) therapy should always be started at low dose and should not be increased without careful monitoring of serum calcium. An estimate of daily dietary calcium intake should be made initially and the intake adjusted as needed. Serum phosphorus should also be determined periodically. Information for the patient: The patient should be informed about compliance with dosage instructions, adherence to instructions about diet and avoidance of the use of nonprescription antacids. Patients should be informed about the symptoms of hypercalcemia (See ADVERSE REACTIONS section).
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long term animal studies have not been performed to evaluate the carcinogenic potential, mutagenicity, or effect on fertility of PhosLo (calcium acetate tablet) .
Teratogenic Effects: Category C. Animal reproduction studies
have not been conducted with PhosLo (calcium acetate tablet) . It is also not known whether PhosLo (calcium acetate tablet) can
cause fetal harm when administered to a pregnant woman or can affect reproduction
capacity. PhosLo (calcium acetate tablet) should be given to a pregnant woman only if clearly needed.
Safety and efficacy of PhosLo (calcium acetate tablet) have not been established. Geriatric Use Of the total number of subjects in clinical studies of PhosLo (calcium acetate tablet) (n=91), 25 percent were 65 and over, while 7 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.