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:

ECI Pharmaceuticals, LLC

INN (International Name):

CALCIUM ACETATE

Composition:

CALCIUM ACETATE 667 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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. Calciu

Product summary:

Calcium Acetate Capsules are supplied as opaque capsules with blue cap and white body. The capsules are imprinted in black ink with “ECI” on the cap and “825” on the body. Each capsule contains 667 mg calcium acetate equivalent to 169 mg calcium. They are available as follows: Bottles of 200: NDC 51293-825-02 STORAGE : Store at 25°C (77°F); excursions permitted to 15-30°C (59- 86°F) [See USP "Controlled Room Temperature"].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CALCIUM ACETATE - CALCIUM ACETATE CAPSULE
ECI PHARMACEUTICALS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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 (CALCIUM ACETATE) CAPSULE 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
dise ase .(1)
DOSAGE AND ADMINISTRATION
Starting dose is 2 capsules with each meal.(2)
Titrate the dose every 2-3 weeks until acceptable serum phosphorus
level is reached. Most patients require 3-4
capsules with each meal.(2)
DOSAGE FORMS AND STRENGTHS
Capsule: 667 mg calcium acetate capsule.(3)
CONTRAINDICATIONS
Hype rcalce mia.(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 ECI PHARMACEUTICALS LLC
AT 1-888-514-4727 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: 12/2017
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 REACTIO