CALCIUM ACETATE tablet

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Zydus Pharmaceuticals USA Inc.

INN (الاسم الدولي):

CALCIUM ACETATE

تركيب:

CALCIUM ACETATE 667 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Calcium acetate tablet 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 tablets 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 delivery are

ملخص المنتج:

Each Calcium Acetate Tablet USP, intended for oral administration, is white, round compressed tablet with engraving EP above 114 on one side and plain on the opposite side. Each calcium acetate tablet contains 667 mg of calcium acetate (anhydrous Ca(CH3 COO)2 ; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium and are supplied as follows: NDC 68382-642-66             Bottles of 200 NDC 68382-642-10             Bottles of 1000 STORAGE:  Store at 20° to 25°C (68° to 77°F) excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

CALCIUM ACETATE- CALCIUM ACETATE TABLET
ZYDUS PHARMACEUTICALS USA INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
RX ONLY
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CALCIUM ACETATE TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CALCIUM ACETATE
TABLETS.
CALCIUM ACETATE TABLETS USP FOR ORAL USE.
INITIAL U.S. APPROVAL: 1990
INDICATIONS AND USAGE
Calcium acetate tablet 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 tablets 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
tablets with each meal. (2)
DOSAGE FORMS AND STRENGTHS
Tablets: 667 mg calcium acetate per tablet.(3)
CONTRAINDICATIONS
Hypercalcemia. (4)
WARNINGS AND PRECAUTIONS
Treat mild hypercalcemia by reducing or interrupting calcium acetate
tablet and Vitamin D. Severe hypercalcemia may
require hemodialysis and discontinuation of calcium acetate
tablets.(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 HERITAGE
PHARMACEUTICALS INC. AT 1- 866-901-DRUG
(3784) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
PLEASE ADDRESS MEDICAL INQUIRIES TO [e-mail]_,
TEL: [phone].
DRUG INTERACTIONS
Calcium acetate tablet 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 tablet, or consider monitoring blood
levels of the drug. (7)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 1/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND AD