CALCIUM ACETATE- calcium acetate capsule

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

REMEDYREPACK INC.

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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 of calcium acet

產品總結:

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 100: NDC 65162-590-10 Bottles of 200: NDC 65162-590-20 Bottles of 500: NDC 65162-590-50 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].

授权状态:

Abbreviated New Drug Application

产品特点

CALCIUM ACETATE- CALCIUM ACETATE CAPSULE
REMEDYREPACK INC.
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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 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 AMNEAL PHARMACEUTICALS
AT 1-877-835-5472 AND
WWW.AMNEAL.COM 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: 8/2019
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 USE WITH MEDICATIONS_
6