CALCIUM ACETATE capsule

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

AvKARE, Inc.

INN (Kansainvälinen yleisnimi):

CALCIUM ACETATE

Koostumus:

CALCIUM ACETATE 667 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Calcium acetate, USP is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). - Patients with hypercalcemia. 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

Tuoteyhteenveto:

Calcium Acetate Capsules, 667 mg are hard gelatin capsules with white opaque body imprinted with “590” and light-blue opaque cap imprinted with “AMNEAL” with black ink.  Each capsule contains 667 mg calcium acetate, USP (anhydrous; Ca(CH 3 COO) 2 ; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium. They are available as follows: Bottles of 200:  NDC 42291-189-20 STORAGE: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

CALCIUM ACETATE- CALCIUM ACETATE CAPSULE
AVKARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
CALCIUM ACETATE CAPSULES
RX ONLY
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 CAPSULES: 667 MG, FOR ORAL USE
INITIAL U.S. APPROVAL: 1990
INDICATIONS AND USAGE
Calcium acetate, USP 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 capsule. (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 AVKARE, INC. AT
1-855-361-3993; EMAIL
[e-mail]; 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: 4/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS & USAGE
2 DOSAGE & ADMINISTRATION
3 DOSAGE FORMS & STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 HYPERCALCEMIA
5.2 CONCOMITANT