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.

Table 2: Average Serum Phosphorous and Calcium Levels at Pre-Study, Interim, and Study Completion Time points
Parameter Pre-Study Week 4 * Week 8 Week 12 p-value
*
Ninety-one patients completed at least 6 weeks of the study.
ANOVA of difference in values at pre-study and study completion.
Values expressed as mean ± SE.
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.

Table 3: Serum Phosphorus and Calcium Levels at Study Initiation and After Completion of Each Treatment Arm
Post-Treatment
Parameter Pre-Study Calcium Acetate Placebo p-value *
*
ANOVA of calcium acetate vs. placebo after 2 weeks of treatment.
Values expressed as mean ± SEM.
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 -- 30 Capsule Bottle Label
(click image for full-size original)

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 -- 200 Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 750 Capsule Bottle Label

NDC 62135-191-73

Calcium Acetate
Capsules, USP

667 mg*

Rx Only

750 Capsules

Chartwell Rx

PRINCIPAL DISPLAY PANEL -- 750 Capsule Bottle Label
(click image for full-size original)
CALCIUM ACETATE calcium acetate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62135-191
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM ACETATE (CALCIUM CATION) CALCIUM ACETATE 667 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 8000
GELATIN, UNSPECIFIED
GLYCINE
TITANIUM DIOXIDE
ANHYDROUS CITRIC ACID
SHELLAC
ALCOHOL
ISOPROPYL ALCOHOL
BUTYL ALCOHOL
PROPYLENE GLYCOL
AMMONIA
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
FD&C RED NO. 40
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
DIMETHICONE 350
SILICA, TRIMETHYLSILYL CAPPED
Product Characteristics
Color white Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code CE;0191
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62135-191-30 30 CAPSULE in 1 BOTTLE None
2 NDC:62135-191-22 200 CAPSULE in 1 BOTTLE None
3 NDC:62135-191-73 750 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091312 06/29/2018
Labeler — Chartwell RX, LLC. (079394054)

Revised: 10/2023 Chartwell RX, LLC.

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