Calcium acetate capsules are a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).

The recommended initial dose of calcium acetate 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 3-4 capsules with each meal.

Capsule: 667 mg calcium acetate per capsule.

Patients with hypercalcemia.

Hypercalcemia is discussed elsewhere [see Warnings and Precautions (5.1)].

The drug interaction of calcium acetate is characterized by the potential of calcium to bind to drugs with anionic functions (e.g., carboxyl, and hydroxyl groups). 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 and most concomitant drugs. When administering an oral medication with 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. 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.

Administration of calcium acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1)].

Calcium acetate acts as a phosphate binder. Its chemical name is calcium acetate. Its molecular formula is C 4H 6CaO 4, and its molecular weight is 158.17. Its structural formula is:

Calcium Acetate Capsules are Hard Gelatin Capsules filled with white to off-white granular powder having a blue opaque cap and white opaque body imprinted "S086" on both parts. Each capsule contains 667 mg calcium acetate, USP (anhydrous; Ca(CH 3COO) 2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium. Each capsule contains the following inactive ingredients: Crospovidone NF, Sodium lauryl Sulfate NF, Magnesium Stearate NF. The gelatin cap and body have the following inactive ingredients: FD&C blue #1, D&C red #28, titanium dioxide, USP and gelatin, USP. The Imprinting black ink contain shellac NF, black iron oxide NF and potassium hydroxide NF.

Calcium acetate capsules are administered orally for the control of hyperphosphatemia in end-stage renal failure.

“FDA approved dissolution test specifications differ from USP".

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.

Effectiveness of calcium acetate in decreasing serum phosphorus has been demonstrated in two studies of the 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 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 in the treatment of hyperphosphatemia in end-stage renal disease 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

aValues expressed as mean ± SE.

bNinety-one patients completed at least 6 weeks of the study.

cANOVA of difference in values at pre-study and study completion.

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

aValues expressed as mean ± SEM

bANOVA of calcium acetate vs. placebo after 2 weeks of treatment.

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%.

Calcium acetate capsules, USP are available as hard gelatin capsule filled with white to off-white granular powder having a blue opaque cap and white opaque body imprinted "S086" on both parts. Each capsule contains 667 mg calcium acetate, USP (anhydrous; Ca(CH 3COO) 2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium.

Supplied in Bottles of 200 (NDC 72789-422-97).

STORAGE:Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Inform patients to take calcium acetate 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 Warnings and Precautions (5.1)and Adverse Reactions (6.1)].

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.

Manufactured by:

Square Pharmaceuticals PLC.

Dhaka Unit, Kaliakoir, Gazipur-1750,

Bangladesh

Manufactured for:

Nivagen Pharmaceuticals, Inc.

Sacramento, CA 95827 USA

Toll free number: 1-877-977-0687

Rev. 08/2023

CALCIUM ACETATE CAPSULES

Rx Only

667 mg