CALCIUM ACETATE tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Camber Pharmaceuticals, Inc.

INN (International Adı):

CALCIUM ACETATE

Kompozisyon:

CALCIUM ACETATE 667 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 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 unknown. A c

Ürün özeti:

Calcium acetate tablets, USP are available in tablet form with “IG ” debossed on one side and “393 ” on the other, for oral administration. Each white round tablet contains 667 mg of calcium acetate equivalent to 169 mg of calcium. Inactive Ingredients: polyethylene glycol 8000, sodium lauryl sulfate, crospovidone and sodium stearyl fumarate. NDC 31722-393-60              Bottles of 60 STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

CALCIUM ACETATE- CALCIUM ACETATE TABLET
CAMBER PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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, 667 MG
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 tablets with each meal. (2)
• Titrate the dose every 2-3 weeks until acceptable serum phosphorus
level is reached. Most patients require 3-4 tablets
with each meal. (2)
DOSAGE FORMS AND STRENGTHS
• Tablets: 667 mg calcium acetate tablet. (3)
CONTRAINDICATIONS
• Hypercalcemia. (4)
WARNINGS AND PRECAUTIONS
Treat mild hypercalcemia by reducing or interrupting calcium acetate
tablets 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 CAMBER PHARMACEUTICALS
INC. AT 1-866-495-8330 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: 1/2014
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