CALCIUM ACETATE capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Nostrum Laboratories, Inc.

INN (Internationale Bezeichnung):

CALCIUM ACETATE

Zusammensetzung:

CALCIUM ACETATE 667 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Calcium acetate capsules are 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 contains calcium acetate.  Animal reproduction studies have not been conducted with calcium acetate capsules, and there are no adequate and well controlled studies of calcium acetate capsules 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 capsules 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 a

Produktbesonderheiten:

Each calcium acetate capsule USP, for oral administration contains 667 mg of Calcium Acetate, USP (anhydrous Ca(CH3 COO)2 ; MW=158.17 grams) equivalent to 169 mg (8.45 mEq) of calcium. The capsules are size 00EL with light green opaque cap and white opaque body with black imprint on cap “NC” above “667”. NDC 29033-026-02 Bottles of 200 STORAGE :  Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [See USP “Controlled Room Temperature”].

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

CALCIUM ACETATE- CALCIUM ACETATE CAPSULE
NOSTRUM LABORATORIES, 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 capsules are 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 2-3 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 (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 NOSTRUM LABORATORIES
INC. AT
[e-mail] OR FDA AT 1-800-FDA-1088 OR
_WWW.FDA.GOV/MEDWATCH._
DRUG INTERACTIONS
Calcium acetate capsules 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 capsules, or consider
monitoring blood levels of the drug.
(7)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 8/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS & USAGE
2 DOSAGE & ADMINISTRATION
3 DOSAGE FORMS & STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
_5.1 HYPERCALCEMI