CALCIUM ACETATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cipla USA Inc.,

INN (International Name):

CALCIUM ACETATE

Composition:

CALCIUM ACETATE 667 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Calcium acetate 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 unknown. A

Product summary:

Each capsule is of size ‘00el’ hard gelatin capsule shell with blue opaque cap and white opaque body imprinted with “667 mg” on cap and “IG 377” on body in black ink filled with white to off white powder. Supplied in Bottles of 60 (NDC 69097-862-03) and 200 (NDC 69097-862-83). STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CALCIUM ACETATE- CALCIUM ACETATE CAPSULE
CIPLA 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, USP 667 MG
INITIAL U.S. APPROVAL: 1990
INDICATIONS AND USAGE
Calcium acetate 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
2-3 weeks until acceptable serum
phosphorus level is reached. Most patients require 3-4 capsules with
each meal. (2) (2)
DOSAGE FORMS AND STRENGTHS
Capsule: 667 mg calcium acetate capsules. (3)
CONTRAINDICATIONS
Hypercalcemia. (4)
WARNINGS AND PRECAUTIONS
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)
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 CIPLA LTD. AT
1-866-604-3268 OR FDA AT
1-800-FDA-1088 OR www.fda.gov/medwatch
DRUG INTERACTIONS
Calcium acetate 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 or consider monitoring
blood levels of the drug. (7)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 6/2021
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 REACTI