Calcium Acetate Information
Calcium acetate (Calcium acetate) Indications And Usage
Calcium acetate (Calcium acetate) Capsules are a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).
Calcium acetate (Calcium acetate) Dosage And Administration
The recommended initial dose of Calcium acetate (Calcium acetate) capsules for the adult dialysis patient is 2 capsules with each meal. Increase the dose gradually to lower serum phosphorus levels to the target range, as long as hypercalcemia does not develop. Most patients require 3 to 4 capsules with each meal.
Calcium acetate (Calcium acetate) Dosage Forms And Strengths
Capsule: 667 mg Calcium acetate (Calcium acetate) capsule.
Calcium acetate (Calcium acetate) Contraindications
Patients with hypercalcemia.
Calcium acetate (Calcium acetate) Warnings And Precautions
Patients with end stage renal disease may develop hypercalcemia when treated with calcium, including Calcium acetate (Calcium acetate) Avoid the use of calcium supplements, including calcium based nonprescription antacids, concurrently with Calcium acetate (Calcium acetate) .
An overdose of Calcium acetate (Calcium acetate) may lead to progressive hypercalcemia, which may require emergency measures. Therefore, early in the treatment phase during the dosage adjustment period, monitor serum calcium levels twice weekly. Should hypercalcemia develop, reduce the Calcium acetate (Calcium acetate) dosage, or discontinue the treatment, depending on the severity of hypercalcemia.
More severe hypercalcemia (Ca >12 mg/dL) is associated with confusion, delirium, stupor and coma. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing Calcium acetate (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 (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 (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 (Calcium acetate) ; all cases resolved upon lowering the dose or discontinuing treatment.
Maintain the serum calcium-phosphorus (Ca x P) product below 55 mg/dL
Calcium acetate (Calcium acetate) Adverse Reactions
Hypercalcemia is discussed elsewhere [see ]
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical studies, Calcium acetate (Calcium acetate) has been generally well tolerated.
Calcium acetate (Calcium acetate) was studied in a 3 month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and an alternate liquid formulation of Calcium acetate (Calcium acetate) was studied in a two week double-blind, placebo-controlled, cross-over study with 69 enrolled ESRD hemodialysis patients. Adverse reactions (>2% on treatment) from these trials are presented in Table 1.
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 (Calcium acetate) induced hypercalcemia. Isolated cases pruritus have been reported, which may represent allergic reactions.
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 (Calcium acetate) : dizziness, edema, and weakness.
Calcium acetate (Calcium acetate) Drug Interactions
The drug interaction of Calcium acetate (Calcium acetate) is characterized by the potential of calcium to bind to drugs with anionic functions (e.g., carboxyl, and hydroxyl groups). Calcium acetate (Calcium acetate) may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism.
There are no empirical data on avoiding drug interactions between Calcium acetate (Calcium acetate) and most concomitant drugs. When administering an oral medication with Calcium acetate (Calcium acetate) where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, administer the drug one hour before or three hours after Calcium acetate (Calcium acetate) . Monitor blood levels of the concomitant drugs that have a narrow therapeutic range. Patients taking anti-arrhythmic medications for the control of arrhythmias and anti-seizure medications for the control of seizure disorders were excluded from the clinical trials with all forms of Calcium acetate (Calcium acetate) .
Calcium acetate (Calcium acetate) Use In Specific Populations
Pregnancy Category C
Calcium acetate (Calcium acetate) Capsules contains Calcium acetate (Calcium acetate) . Animal reproduction studies have not been conducted with Calcium acetate (Calcium acetate) , and there are no adequate and well controlled studies of Calcium acetate (Calcium acetate) use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with Calcium acetate (Calcium acetate) treatment []. Maintenance of normal serum calcium levels is important for maternal and fetal well being. Hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. Calcium acetate (Calcium acetate) treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment.
Calcium acetate (Calcium acetate) Overdosage
Administration of Calcium acetate (Calcium acetate) Capsules in excess of the appropriate daily dosage may result in hypercalcemia []
Calcium acetate (Calcium acetate) Description
Calcium acetate (Calcium acetate) Capsules acts as a phosphate binder. Its chemical name is Calcium acetate (Calcium acetate) . Its molecular formula is CHCaO, and its molecular weight is 158.17. Its structural formula is:
Each white opaque/blue opaque capsule contains 667 mg of Calcium acetate (Calcium acetate) e, USP (anhydrous; Ca(CHCOO); MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium, and 10 mg of the inert binder, polyethylene glycol 8000 NF and the following inactive ingredients: FD&C blue #1, FD&C red #3, gelatin, magnesium stearate, polyethylene glycol 8000 and titanium dioxide. In addition to the ingredients listed above, each capsule contains Opacode (Black) monogramming ink. Opacode (Black) contains ethanol, FD&C blue #2, FD&C red #40, FD&C yellow #6, iron oxide black, N-butyl alchol, propylene glycol and shellac.
Calcium acetate (Calcium acetate) Capsules are administered orally for the control of hyperphosphatemia in end-stage renal failure.
Calcium acetate (Calcium acetate) Clinical Pharmacology
Patients with ESRD retain phosphorus and can develop hyperphosphatemia. High serum phosphorus can precipitate serum calcium resulting in ectopic calcification. Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD.
Calcium acetate (Calcium acetate) Clinical Studies
Effectiveness of Calcium acetate (Calcium acetate) in decreasing serum phosphorus has been demonstrated in two studies of the Calcium acetate (Calcium acetate) solid oral dosage form.
Ninety-one patients with end-stage renal disease who were undergoing hemodialysis and were hyperphosphatemic (serum phosphorus >5.5 mg/dL) following a 1 week phosphate binder washout period contributed efficacy data to an open-label, non-randomized study.
The patients received Calcium acetate (Calcium acetate) 667 mg tablets at each meal for a period of 12 weeks. The initial starting dose was 2 tablets per meal for 3 meals a day, and the dose was adjusted as necessary to control serum phosphorus levels. The average final dose after 12 weeks of treatment was 3.4 tablets per meal. Although there was a decrease in serum phosphorus, in the absence of a control group the true magnitude of effect is uncertain.
The data presented in Table 2 demonstrate the efficacy of Calcium acetate (Calcium acetate) in the treatment of hyperphosphatemia in end-stage renal disease patients. The effects on serum calcium levels are also presented.
There was a 30% decrease in serum phosphorus levels during the 12 week study period (p
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 (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 (Calcium acetate) is shown in the Table 3.
Overall, 2 weeks of treatment with Calcium acetate (Calcium acetate) statistically significantly (p
Calcium acetate (Calcium acetate) How Supplied/storage And Handling
Calcium acetate (Calcium acetate) Capsules are supplied as white opaque/blue opaque capsules imprinted with “54 215” on the cap and body.
0054-0088-26 667 mg, white opaque/blue opaque capsule, bottle of 200
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Calcium acetate (Calcium acetate) Patient Counseling Information
Inform patients to take Calcium acetate (Calcium acetate) capsules with meals, adhere to their prescribed diets, and avoid the use of calcium supplements including nonprescription antacids. Inform the patients about the symptoms of hypercalcemia [see and].
Advise patients who are taking an oral medication where reduction in the bioavailability of that medication would have clinically significant effect on its safety or efficacy to take the drug one hour before or three hours after Calcium acetate (Calcium acetate) capsules.
© RLI, 2011
Calcium acetate (Calcium acetate) Package Label
Calcium acetate (Calcium acetate) Capsules, 667 mg
Roxane Laboratories, Inc.
Rx Only
