Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
CALCIUM ACETATE (UNII: Y882YXF34X) (CALCIUM CATION - UNII:2M83C4R6ZB)
Golden State Medical Supply, Inc.
CALCIUM ACETATE
CALCIUM ACETATE 667 mg
ORAL
PRESCRIPTION DRUG
Calcium acetate capsules are 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 capsules, and there are no adequate and well controlled studies of calcium acetate capsules 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 capsules treatment, as recommended, is not expected to harm a fetus if maternal calcium levels are properly monitored during and following treatment. The effec
Each calcium acetate capsule USP, for oral administration contains 667 mg of Calcium Acetate, USP (anhydrous Ca(CH 3 COO) 2 ; MW=158.17 grams) equivalent to 169 mg (8.45 mEq) of calcium. The capsules are size 00EL with light green opaque cap and white opaque body with black imprint on cap “NC” above “667”. NDC 60429-491-02 Bottles of 200 STORAGE : Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [See USP “Controlled Room Temperature”].
Abbreviated New Drug Application
CALCIUM ACETATE- CALCIUM ACETATE CAPSULE GOLDEN STATE MEDICAL SUPPLY, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION CALCIUM ACETATE CAPSULES. 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 ( 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 NOSTRUM LABORATORIES INC. AT QUALITY@NOSTRUMPHARMA.COM OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH._ DRUG INTERACTIONS 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) SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 8/2020 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS & USAGE 2 DOSAGE & ADMINISTRATION 3 DOSAGE FORMS & STRENGTHS 4 CONTRAINDICATIONS Belgenin tamamını okuyun