ailability of tetracyclines or fluoroquinolones. ( 7 ) when clinically significant drug interactions are expected, administer the drug at least one hour before or at least three hours after calcium acetate or consider monitoring blood levels of the drug. ( 7 ) 7.1 ciprofloxacin in a study of 15 healthy subjects, a co-administered single dose of 4 calcium acetate tablets, approximately 2.7 g, decreased the bioavailability of ciprofloxacin by approximately 50%.

cemia can be treated by acute hemodialysis and discontinuing calcium acetate therapy. mild hypercalcemia (10.5 to 11.9 mg/dl) may be asymptomatic or manifest as constipation, anorexia, nausea, and vomiting. mild hypercalcemia is usually controlled by reducing the calcium acetate dose or temporarily discontinuing therapy. decreasing or discontinuing vitamin d therapy is recommended as well. chronic hypercalcemia may lead to vascular calcification and other soft-tissue calcification. radiographic evaluation of suspected anatomical regions may be helpful in early detection of soft tissue calcification. the long term effect of calcium acetate on the progression of vascular or soft tissue calcification has not been determined. hypercalcemia (>11 mg/dl) was reported in 16% of patients in a 3-month study of solid dose formulation of calcium acetate; all cases resolved upon lowering the dose or discontinuing treatment. maintain the serum calcium-phosphorus (ca x p) product below 55 mg 2 /dl 2 . 5.2 concomitant use with medications hypercalcemia may aggravate digitalis toxicity.

69 enrolled esrd hemodialysis patients. adverse reactions (>2% on treatment) from these trials are presented in table 1. table 1: adverse reactions in patients with end-stage renal disease undergoing hemodialysis preferred term total adverse reactions reported for calcium acetate n=167 n (%) 3-mo, open-label study of calcium acetate n=98 n (%) double blind, placebo-controlled, cross-over study of calcium acetate n=69 calcium acetate n (%) placebo n (%) nausea 6 (3.6) 6 (6.1) 0 (0.0) 0 (0.0) vomiting 4 (2.4) 4 (4.1) 0 (0.0) 0 (0.0) hypercalcemia 21 (12.6) 16 (16.3) 5 (7.2) 0 (0.0) mild hypercalcemia may be asymptomatic or manifest itself as constipation, anorexia, nausea, and vomiting. more severe hypercalcemia is associated with confusion, delirium, stupor, and coma. decreasing dialysate calcium concentration could reduce the incidence and severity of calcium acetate-induced hypercalcemia. isolated cases pruritus have been reported, which may represent allergic reactions. 6.2 postmarketing experience because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure. the following additional adverse reactions have been identified during post-approval of calcium acetate: dizziness, edema, and weakness.

ailability of tetracyclines or fluoroquinolones. ( 7 ) when clinically significant drug interactions are expected, administer the drug at least one hour before or at least three hours after calcium acetate or consider monitoring blood levels of the drug. ( 7 ) 7.1 ciprofloxacin in a study of 15 healthy subjects, a co-administered single dose of 4 calcium acetate tablets, approximately 2.7 g, decreased the bioavailability of ciprofloxacin by approximately 50%.

. human milk feeding by a mother receiving calcium acetate is not expected to harm an infant, provided maternal serum calcium levels are appropriately monitored. 8.4 pediatric use safety and effectiveness in pediatric patients have not been established. 8.5 geriatric use clinical studies of calcium acetate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other clinical experience has not identified differences in responses between elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

se patients. the effects on serum calcium levels are also presented. table 2: average serum phosphorous and calcium levels at pre-study, interim, and study completion time points a values expressed as mean ± se. b ninety-one patients completed at least 6 weeks of the study. c anova of difference in values at pre-study and study completion. parameter pre-study week 4 b week 8 week 12 p-value c phosphorus (mg/dl) a 7.4 ± 0.17 5.9 ± 0.16 5.6 ± 0.17 5.2 ± 0.17 ≤0.01 calcium (mg/dl) a 8.9 ± 0.09 9.5 ± 0.10 9.7 ± 0.10 9.7 ± 0.10 ≤0.01 there was a 30% decrease in serum phosphorus levels during the 12 week study period (p<0.01). two-thirds of the decline occurred in the first month of the study. serum calcium increased 9% during the study mostly in the first month of the study. treatment with the phosphate binder was discontinued for patients from the open-label study, and those patients whose serum phosphorus exceeded 5.5 mg/dl were eligible for entry into a double-blind, placebo-controlled, cross-over study. patients were randomized to receive calcium acetate or placebo, and each continued to receive the same number of tablets as had been individually established during the previous study. following 2 weeks of treatment, patients switched to the alternative therapy for an additional 2 weeks. the phosphate binding effect of calcium acetate is shown in the table 3. table 3: serum phosphorous and calcium levels at study initiation and after completion of each treatment arm a values expressed as mean ± sem b anova of calcium acetate vs. placebo after 2 weeks of treatment. parameter pre-study post-treatment p-value b calcium acetate placebo phosphorus (mg/dl) a 7.3 ± 0.18 5.9 ± 0.24 7.8 ± 0.22 <0.01 calcium (mg/dl) a 8.9 ± 0.11 9.5 ± 0.13 8.8 ± 0.12 <0.01 overall, 2 weeks of treatment with calcium acetate statistically significantly (p<0.01) decreased serum phosphorus by a mean of 19% and increased serum calcium by a statistically significant (p<0.01) but clinically unimportant mean of 7%.