CALCIUM ACETATE capsule

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CALCIUM ACETATE (UNII: Y882YXF34X) (CALCIUM CATION - UNII:2M83C4R6ZB)
Available from:
Sandoz Inc
INN (International Name):
CALCIUM ACETATE
Composition:
CALCIUM ACETATE 667 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Calcium Acetate Gelcaps is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). Patients with hypercalcemia. Pregnancy Category C Calcium acetate gelcaps contains calcium acetate. Animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see Warnings and Precautions ( 5.1)] . 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 treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following t
Product summary:
Gelcap A white and blue gelcap for oral administration containing 667 mg calcium acetate (anhydrous Ca(CH 3 COO) 2 ; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium. Gelcap NDC 0781-2081-02 Bottles of 200 Gelcap NDC 0781-2672-02 Bottles of 200 STORAGE: Store at 25°C (77°F); excursions permitted to 15-30°C (59- 86°F) [See USP "Controlled Room Temperature"] .
Authorization status:
New Drug Application Authorized Generic
Authorization number:
0781-2081-02, 0781-2672-02

CALCIUM ACETATE- calcium acetate capsule

Sandoz Inc

----------

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use calcium acetate gelcaps safely and

effectively. See full prescribing information for calcium acetate gelcaps.

Calcium Acetate Gelcaps (calcium acetate): 667 mg

Initial U.S. Approval: 1990

INDICATIONS AND USAGE

Calcium Acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal

disease. ( 1)

DOSAGE AND ADMINISTRATION

Starting dose is 2 gelcaps with each meal. ( 2)

Titrate the dose every 2-3 weeks until acceptable serum phosphorus level is reached. Most patients require 3-4 gelcaps

with each meal. ( 2)

DOSAGE FORMS AND STRENGTHS

Capsule: 667 mg calcium acetate gelcap. ( 3)

CONTRAINDICATIONS

Hypercalcemia. ( 4)

WARNINGS AND PRECAUTIONS

Treat mild hypercalcemia by reducing or interrupting calcium acetate and Vitamin D. Severe hypercalcemia may

require hemodialysis and discontinuation of calcium acetate. ( 5.1)

Hypercalcemia may aggravate digitalis toxicity. ( 5.2)

ADVERSE REACTIONS

The most common (> 10%) adverse reactions are hypercalcemia, nausea and vomiting. ( 6.1)

In clinical studies, patients have occasionally experienced nausea during calcium acetate therapy. ( 6)

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Medical Care North America at 1-800-323-

5188 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS

Calcium acetate may decrease the bioavailability 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)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 3/2013

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Hypercalcemia

5.2 Concomitant Use with Medications

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Ciprofloxacin

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Labor and Delivery

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Calcium Acetate Gelcaps is a phosphate binder indicated to reduce serum phosphorus in patients with

end stage renal disease (ESRD).

2 DOSAGE AND ADMINISTRATION

The recommended initial dose of calcium acetate for the adult dialysis patient is 2 gelcaps 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 gelcaps with each meal.

3 DOSAGE FORMS AND STRENGTHS

Capsule: 667 mg calcium acetate per gelcap.

4 CONTRAINDICATIONS

Patients with hypercalcemia.

5 WARNINGS AND PRECAUTIONS

5.1 Hypercalcemia

Patients with end stage renal disease may develop hypercalcemia when treated with calcium, including

calcium acetate. Avoid the use of calcium supplements, including calcium-based nonprescription

antacids, concurrently with calcium acetate.

An overdose of 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 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 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

Sections or subsections omitted from the full prescribing information are not listed.

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

5.2 Concomitant Use with Medications

Hypercalcemia may aggravate digitalis toxicity.

6 ADVERSE REACTIONS

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

6.1 Clinical Trials Experience

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 has been generally well tolerated.

Calcium acetate was studied in a 3-month, open-label, non-randomized study of 98 enrolled ESRD

hemodialysis patients and 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.

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.

7 DRUG INTERACTIONS

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.

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%.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

Calcium acetate gelcaps contains calcium acetate. Animal reproduction studies have not been conducted

with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in

pregnant women. Patients with end stage renal disease may develop hypercalcemia with calcium acetate

treatment [see Warnings and Precautions ( 5.1)] . 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 treatment, as recommended, is not expected to harm a fetus if

maternal calcium levels are properly monitored during and following treatment.

8.2 Labor and Delivery

The effects of calcium acetate on labor and delivery are unknown.

8.3 Nursing Mothers

Calcium acetate is excreted in human milk. 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.

10 OVERDOSAGE

Administration of calcium acetate in excess of the appropriate daily dosage may result in hypercalcemia

[see Warnings and Precautions ( 5.1)].

11 DESCRIPTION

Calcium acetate acts as a phosphate binder. Its chemical name is calcium acetate. Its molecular formula

is C

, and its molecular weight is 158.17. Its structural formula is:

Each opaque gelcap with a blue cap and white body is spin printed in blue and white ink with

“SANDOZ" printed on the cap and “576” printed on the body. Each gelcap contains 667 mg calcium

acetate, USP (anhydrous; Ca(CH

COO)

; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium, and

10 mg of the inert binder, polyethylene glycol 8000 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.

12 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.

12.1 Mechanism of Action

Calcium acetate, when taken with meals, combines with dietary phosphate to form an insoluble calcium

phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus

concentration.

12.2 Pharmacodynamics

Orally administered calcium acetate from pharmaceutical dosage forms is systemically absorbed up to

approximately 40% under fasting conditions and up to approximately 30% under non-fasting conditions.

This range represents data from both healthy subjects and renal dialysis patients under various

conditions.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of 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

Values expressed as mean ± SE.

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

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

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.

b

c

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

Values expressed as mean ± SEM

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

Parameter

Pre-Study

Pos t-Treatment

p-value

Calcium Acetate

Placebo

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

Gelcap A white and blue gelcap for oral administration containing 667 mg calcium acetate (anhydrous

Ca(CH

COO)

; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium.

Gelcap NDC 0781-2081-02 Bottles of 200

Gelcap NDC 0781-2672-02 Bottles of 200

STORAGE: Store at 25°C (77°F); excursions permitted to 15-30°C (59- 86°F) [See USP "Controlled

Room Temperature"].

17 PATIENT COUNSELING INFORMATION

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 for

Fresenius Medical Care North America

Waltham, MA 02451

1-800-323-5188

Distributed by

Sandoz Inc.

Princeton, NJ 08540

PRINCIPAL DISPLAY PANEL - NDC: 0781-2081-02

b

PRINCIPAL DISPLAY PANEL - NDC: 0781-2672-02

CALCIUM ACETATE

calcium acetate capsule

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 78 1-20 8 1

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CALCIUM ACETATE (UNII: Y8 8 2YXF34X) (CALCIUM CATION - UNII:2M8 3C4R6 ZB)

CALCIUM ACETATE

6 6 7 mg

Product Characteristics

Color

white, blue

S core

no sco re

Sandoz Inc

S hap e

CAPSULE

S iz e

21mm

Flavor

Imprint Code

SANDOZ;576

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 78 1-20 8 1-0 2

20 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/14/20 12

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA autho rized generic

NDA0 2116 0

0 3/14/20 12

CALCIUM ACETATE

calcium acetate capsule

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:0 78 1-26 72

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CALCIUM ACETATE (UNII: Y8 8 2YXF34X) (CALCIUM CATION - UNII:2M8 3C4R6 ZB)

CALCIUM ACETATE

6 6 7 mg

Product Characteristics

Color

white, blue

S core

no sco re

S hap e

CAPSULE

S iz e

21mm

Flavor

Imprint Code

SANDOZ;576

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 78 1-26 72-0 2

20 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/14/20 12

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA autho rized generic

NDA0 2116 0

0 3/14/20 12

Labeler -

Sandoz Inc (005387188)

Registrant -

Fresenius Medical Care North America (958291411)

Revised: 6/2020

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