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:

Zydus Pharmaceuticals USA Inc.

INN (Medzinárodný Name):

CALCIUM ACETATE

Zloženie:

CALCIUM ACETATE 667 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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

Prehľad produktov:

Calcium Acetate Capsules are blue opaque capsules imprinted with "EP 115" 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 68382-539-66 Bottles of 200 NDC 68382-539-10 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].

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

CALCIUM ACETATE- CALCIUM ACETATE CAPSULE
ZYDUS PHARMACEUTICALS USA 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 to3 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
Capsule 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 FDA AT 1-800-FDA-1088
OR WWW.FDA.GOV/MEDWATCH
PLEASE ADDRESS MEDICAL INQUIRIES TO [e-mail], TEL:
1-877-993-9779.
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: 7/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARN