CALCIUM ACETATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CALCIUM ACETATE (UNII: Y882YXF34X) (CALCIUM CATION - UNII:2M83C4R6ZB)

Available from:

AvPAK

INN (International Name):

CALCIUM ACETATE

Composition:

CALCIUM ACETATE 667 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Calcium acetate, USP is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). - Patients with hypercalcemia. Patients with hypercalcemia. Pregnancy Category C Calcium acetate capsules contain 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. The effects

Product summary:

Calcium acetate capsules USP, 667 mg are available as hard gelatin capsules with white opaque body imprinted with “590” and light-blue opaque cap imprinted with “AMNEAL” with black ink. Each capsule contains 667 mg calcium acetate, USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium. They are supplied as follows: NDC 50268-148-15 (10 capsules per card, 5 card per carton). Dispensed in Unit Dose Package. For Institutional Use Only.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CALCIUM ACETATE- CALCIUM ACETATE CAPSULE
AVPAK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
CALCIUM ACETATE CAPSULES
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CALCIUM ACETATE SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR CALCIUM ACETATE.
CALCIUM ACETATE CAPSULES: 667 MG, FOR ORAL USE
INITIAL U.S. APPROVAL: 1990
INDICATIONS AND USAGE
Calcium acetate capsules, USP 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 capsules with each meal. (2)
Titrate the dose every 2 to 3 weeks until acceptable serum phosphorus
level is reached. Most patients require 3 to 4
capsules with each meal. (2)
DOSAGE FORMS AND STRENGTHS
Capsule: 667 mg calcium acetate capsule. (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 AVKARE, INC. AT
1-855-361-3993; EMAIL
[e-mail] 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: 1/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS & USAGE
2 DOSAGE & ADMINISTRATION
3 DOSAGE FORMS & STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
_5.1 HYPERCALCEMIA_
5.2 CONCOMITANT US