CALCIUM ACETATE capsule

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Lupin Pharmaceuticals, Inc.

INN (Kansainvälinen yleisnimi):

CALCIUM ACETATE

Koostumus:

CALCIUM ACETATE 667 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 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 unk

Tuoteyhteenveto:

Calcium acetate capsules USP are s ize "00" capsules with blue cap and white body, imprinted with "LU" in white ink on the cap and "G41" in blue ink on the body containing white to off white granular powder 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. Bottle of 200 capsules NDC 68180-134-15 STORAGE: Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP "Controlled Room Temperature"].

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

CALCIUM ACETATE- CALCIUM ACETATE CAPSULE
LUPIN 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, 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. (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 LUPIN PHARMACEUTICALS,
INC. AT 1-800-399-2561 OR FDA
AT 1-800-FDA-1088 OR OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Calcium acetate 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: 5/2019
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 Medicatio