Calcium acetate

Calcium acetate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Overview

Calcium acetate is a Genitourinary Agent that is FDA approved for the treatment of hyperphosphatemia in end stage renal failure. Common adverse reactions include Hypercalcemia, Nausea, Vomiting.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• Calcium Acetate Capsules are indicated for the control of hyperphosphatemia in end stage renal failure and do not promote aluminum absorption.

Dosage

• The recommended initial dose of calcium acetate capsules for the adult dialysis patient is 2 capsules with each meal. The dosage may be increased gradually to bring the serum phosphate value below 6 mg/dl, as long as hypercalcemia does not develop. Most patients require 3 to 4 capsules with each meal.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Calcium acetate in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Calcium acetate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Calcium acetate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Calcium acetate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Calcium acetate in pediatric patients.

Contraindications

• Patients with hypercalcemia.

Warnings

• Patients with end stage renal failure may develop hypercalcemia when given calcium with meals. No other calcium supplements should be given concurrently with calcium acetate capsules. Progressive hypercalcemia due to overdose of calcium acetate may be severe as to require emergency measures. Chronic hypercalcemia may lead to vascular calcification, and other soft-tissue calcification. The serum calcium level should be monitored twice weekly during the early dose adjustment period. Theserum calcium times phosphate(CaXP) product should not be allowedto exceed 66. Radiographic evaluation of suspect anatomical region may be helpful in early detection of soft-tissue calcification.

Precautions

General Excessive dosage of calcium acetate induces hypercalcemia; therefore, early in the treatment during dosage adjustment serum calcium should be determined twice weekly. Should hypercalcemia develop, the dosage should be reduced or the treatment discontinued immediately depending on the severity of hypercalcemia. Calcium acetate should not be given to patients on digitalis, because hypercalcemia may precipitate cardiac arrhythmias. Calcium acetate therapy should always be started at low dose and should not be increased without careful monitoring of serum calcium. An estimate of daily calcium intake should be made initially and the intake adjusted as needed. Serum phosphorus should also be determined periodically.

Adverse Reactions

Clinical Trials Experience

In clinical studies, patients have occasionally experienced nausea during calcium acetate therapy. Hypercalcemia may occur during treatment with calcium acetate. Mild hypercalcemia (Ca>10.5 mg/dl) may be asymptomatic or manifest itself as constipation, anorexia, nausea and vomiting. More severe hypercalcemia (Ca>12 mg/dl) is associated with confusion, delirium, stupor and coma. Mild hypercalcemia is easily controlled by reducing the calcium acetate dose or temporarily discontinuing therapy. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing calcium acetate therapy. Decreasing dialysate calcium concentration could reduce the incidence and severity of calcium acetate induced hypercalcemia. The long-term effect of calcium acetate on the progression of vascular or soft-tissue calcification has not been determined. Isolated cases of pruritus have been reported which may represent allergic reactions.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Calcium acetate in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

• Animal reproduction studies have not been conducted with calcium acetate. It is not known whether calcium acetate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Calcium acetate should be given to a pregnant woman only if clearly needed.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Calcium acetate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Calcium acetate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Calcium acetate with respect to nursing mothers.

Pediatric Use

• Safety and effectiveness in pediatric patients have not been established.

Geriatic Use

• Of the total number of subjects in clinical studies of calcium acetate (N=91), 25 percent were 65 and over, while 7 percent were 75 and over. No overall differences in safety or effectiveness were

observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Gender

There is no FDA guidance on the use of Calcium acetate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Calcium acetate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Calcium acetate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Calcium acetate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Calcium acetate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Calcium acetate in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

Monitoring

• The serum calcium level should be monitored twice weekly during the early dose adjustment period.
• Calcium acetate therapy should always be started at low dose and should not be increased without careful monitoring of serum calcium.

IV Compatibility

There is limited information regarding IV Compatibility of Calcium acetate in the drug label.

Overdosage

• Administration of calcium acetate in excess of the appropriate daily dosage can cause severe hypercalcemia

Pharmacology

There is limited information regarding Calcium acetate Pharmacology in the drug label.

Mechanism of Action

Structure

File:Calcium acetate01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Calcium acetate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Calcium acetate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Calcium acetate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Calcium acetate in the drug label.

How Supplied

Storage

There is limited information regarding Calcium acetate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Calcium acetate in the drug label.

Precautions with Alcohol

• Alcohol-Calcium acetate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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