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:

SQUARE PHARMACEUTICALS LIMITED

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Calcium acetate capsules are a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). Patients with hypercalcemia. 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 are unknown. Calcium ace

Product summary:

Calcium acetate capsules, USP are available as hard gelatin capsule filled with white to off-white granular powder having a blue opaque cap and white opaque body imprinted "S086" on both parts. 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. Supplied in Bottles of 200 (NDC 76483-086-00). STORAGE: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CALCIUM ACETATE- CALCIUM ACETATE CAPSULE
SQUARE PHARMACEUTICALS LIMITED
----------
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 capsules are 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)
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
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 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: 3/2023
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 Expe