CALCIUM ACETATE capsule

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

DCI (Denominação Comum Internacional):

CALCIUM ACETATE

Composição:

CALCIUM ACETATE 667 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Calcium acetate capsule 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 capsules contains 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

Resumo do produto:

Calcium Acetate Capsules, USP are blue opaque capsules imprinted with "HP 531" for oral administration containing 667 mg calcium acetate (anhydrous Ca(CH3 COO)2 ; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium. Capsule NDC 23155-531-02 Bottles of 200 NDC 23155-531-10 Bottles of 1000 STORAGE:   Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [See USP Controlled Room Temperature].

Status de autorização:

Abbreviated New Drug Application

Características técnicas

CALCIUM ACETATE- CALCIUM ACETATE CAPSULE
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS 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, 667 MG, FOR ORAL USE.
INITIAL U.S. APPROVAL: 1990
INDICATIONS AND USAGE
Calcium acetate capsule 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 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 AVET PHARMACEUTICALS
INC. AT 1-866-
901-DRUG (3784) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Calcium acetate capsule 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 capsule, or consider
monitoring blood levels of the drug.
(7)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 12/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATION