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:

REMEDYREPACK INC.

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 treatment. The effects of calcium acetate on labor and delivery are unknown. 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. Safety and effectiveness in pediatric patients have not been established. 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.

Product summary:

Gelcap A white and blue gelcap for oral administration containing 667 mg calcium acetate (anhydrous Ca(CH 3COO) 2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium. NDC: 70518-2372-00 PACKAGING: 30 in 1 BLISTER PACK STORAGE: Store at 25°C (77°F); excursions permitted to 15-30°C (59- 86°F) [See USP "Controlled Room Temperature"] Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

CALCIUM ACETATE- CALCIUM ACETATE CAPSULE
REMEDYREPACK 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: 11/2023
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 Me