CALCIUM ACETATE capsule

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

REMEDYREPACK INC.

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Calcium acetate 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 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 of calcium acetate on labor and deli

Produktsammanfattning:

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(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium. NDC:70518-2723-00 30 in 1 BLISTER PACK Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

CALCIUM ACETATE- CALCIUM ACETATE CAPSULE
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CALCIUM ACETATE
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CALCIUM ACETATE
CAPSULES.
CALCIUM ACETATE CAPSULES, FOR ORAL USE
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 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 per capsule. ( 3)
CONTRAINDICATIONS
Hypercalcemia. ( 4)
WARNINGS AND PRECAUTIONS
Treat mild hypercalcemia by reducing or interrupting calcium acetate
capsules and Vitamin D. Severe
hypercalcemia may require hemodialysis and discontinuation of calcium
acetate capsules. ( 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 CHARTWELL RX, LLC. AT
845-232-1683 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: 5/2020
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