Prescription Drug Information: Calcium Acetate (Page 2 of 2)
13.1 Carcinogenesis, Mutagenesis, Impairment and Fertility
No carcinogenicity, mutagenicity, or fertility studies have been conducted with calcium acetate.
14 CLINICAL STUDIES
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.
Parameter | Pre-Study | Week 4 * | Week 8 | Week 12 | p-value † |
---|---|---|---|---|---|
Phosphorus (mg/dL) ‡ | 7.4 ± 0.17 | 5.9 ± 0.16 | 5.6 ± 0.17 | 5.2± 0.17 | ≤ 0.01 |
Calcium (mg/dL) ‡ | 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.
Post-Treatment | ||||
---|---|---|---|---|
Parameter | Pre-Study | Calcium Acetate | Placebo | p-value * |
Phosphorus (mg/dL) † | 7.3 ± 0.18 | 5.9 ± 0.24 | 7.8 ± 0.22 | < 0.01 |
Calcium (mg/dL) † | 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%.
16 HOW SUPPLIED/STORAGE AND HANDLING
Each capsule for oral administration has a white body and cap imprinted in black ink on the cap with “CE”and body with “0191” containing 667 mg calcium acetate (anhydrous; Ca(CH 3 COO) 2 ; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium.
Capsules NDC 62135-191-30 Bottles of 30
Capsules NDC 62135-191-22 Bottles of 200
Capsules NDC 62135-191-73 Bottles of 750
Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Inform patients to take 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 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 capsules.
Manufactured By:
Chartwell Pharmaceuticals, LLC.
Congers, NY 10920
Manufactured For:
Chartwell RX, LLC.
Congers, NY 10920
Made in USA
L70280
Rev: 01/2020
PRINCIPAL DISPLAY PANEL — 30 Capsule Bottle Label
NDC 62135-191-30
Calcium Acetate
Capsules, USP
667 mg*
Rx Only
30 Capsules
Chartwell Rx
PRINCIPAL DISPLAY PANEL — 200 Capsule Bottle Label
NDC 62135-191-22
Calcium Acetate
Capsules, USP
667 mg*
Rx Only
200 Capsules
Chartwell Rx
PRINCIPAL DISPLAY PANEL — 750 Capsule Bottle Label
NDC 62135-191-73
Calcium Acetate
Capsules, USP
667 mg*
Rx Only
750 Capsules
Chartwell Rx
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Labeler — Chartwell RX, LLC. (079394054) |
Revised: 10/2023 Chartwell RX, LLC.
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