CALCIUM ACETATE capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Marlex Pharmaceuticals Inc

INN (International Name):

CALCIUM ACETATE

Sammensætning:

CALCIUM ACETATE 667 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Calcium acetate, USP 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 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 deliver

Produkt oversigt:

Calcium Acetate Capsules, 667 mg are hard gelatin capsules with white opaque body imprinted with “825” and blue opaque cap imprinted with “ECI” with black ink. Each capsule contains 667 mg calcium acetate, USP (anhydrous; Ca(CH3 COO)2 ; MW=158 .17 grams) equal to 169 mg (8.45 mEq) calcium. They are available as follows: Bottles of 200: NDC 10135-0629-02 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].

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

CALCIUM ACETATE- CALCIUM ACETATE CAPSULE
MARLEX PHARMACEUTICALS 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
Hype rcalcemia. (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)
Hype rcalcemia 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 FDA AT 1-800-FDA-1088
OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Calcium acetate may decrease the bioavailability of tetracycline s or
fluoroquinolone s. (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: 12/2017
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 WITH MEDICATIONS_
6 ADVERSE REACTIONS
_6.1_ _CLINICAL TRIALS