CALCIUM ACETATE capsule

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Avera McKennan Hospital

INN (Medzinárodný Name):

CALCIUM ACETATE

Zloženie:

CALCIUM ACETATE 667 mg

Typ predpisu:

PRESCRIPTION DRUG

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

CALCIUM ACETATE- CALCIUM ACETATE CAPSULE
AVERA MCKENNAN HOSPITAL
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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
INITIAL U.S. APPROVAL: 1990
INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ROXANE LABORATORIES,
INC. AT 1-800-962-8364 OR FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 12/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
Calcium Acetate Capsules is a phosphate binder indicated for the
reduction of serum phosphorus in patients with end
stage renal disease. (1)
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)
Capsule: 667 mg calcium acetate capsule. (3)
Hypercalcemia. (4)
Treat mild hypercalcemia by reducing or interrupting Calcium Acetate
Capsules and Vitamin D. Severe
hypercalcemia may require hemodialysis and discontinuation of Calcium
Acetate Capsules. (5.1)
Hypercalcemia may aggravate digitalis toxicity. (5.2)
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)
Calcium Acetate Capsules 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 Capsules or consider monitoring
blood levels of the drug. (7)
4 CONTRAINDICATIONS
5 WARN