Calcium Acetate
Generic Name: calcium acetate
Brand Names:
Calcium Acetate
11. DESCRIPTION Calcium acetate capsules, USP act as a phosphate binder. Its chemical name is calcium acetate. Its molecular formula is C 4 H 6 CaO 4 , and its molecular weight is 158.17. Its structural formula is: Each capsule 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 and the inactive ingredients magnesium stearate and polyethylene glycol.
Overview
11. DESCRIPTION Calcium acetate capsules, USP act as a phosphate binder. Its chemical name is calcium acetate. Its molecular formula is C 4 H 6 CaO 4 , and its molecular weight is 158.17. Its structural formula is: Each capsule 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 and the inactive ingredients magnesium stearate and polyethylene glycol.
Uses
1. INDICATIONS & USAGE Calcium acetate capsules are a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). Calcium acetate capsules are a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. ( 1 )
Dosage
2. DOSAGE & ADMINISTRATION The recommended initial dose of calcium acetate capsules for the adult dialysis patient is 2 capsules with each meal. Increase the dose gradually to lower serum phosphorus levels to the target range, as long as hypercalcemia does not develop. Most patients require 3-4 capsules with each meal. 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 )
Side Effects
6. ADVERSE REACTIONS Hypercalcemia is discussed elsewhere [see Warnings and Precautions (5.1) ] 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 Westminster Pharmaceuticals, LLC. at 1-844-221-7294 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Interactions
7. DRUG INTERACTIONS The drug interaction of calcium acetate capsules is characterized by the potential of calcium to bind to drugs with anionic functions (e.g., carboxyl and hydroxyl groups). Calcium acetate capsules may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism. There are no empirical data on avoiding drug interactions between calcium acetate or calcium acetate capsules and most concomitant drugs. When administering an oral medication with calcium acetate capsules where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, administer the drug one hour before or three hours after calcium acetate capsules or calcium acetate.
Warnings
5. 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 ) 5.1 Hypercalcemia Patients with end stage renal disease may develop hypercalcemia when treated with calcium, including calcium acetate (calcium acetate capsules). Avoid the use of calcium supplements, including calcium-based nonprescription antacids, concurrently with calcium acetate capsules. An overdose of calcium acetate capsules may lead to progressive hypercalcemia, which may require emergency measures. 4. CONTRAINDICATIONS Patients with hypercalcemia. Hypercalcemia. ( 4 )
Pregnancy
8.1 PREGNANCY Pregnancy Category C Calcium acetate capsules contain 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.
Storage
STORAGE: Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [See USP "Controlled Room Temperature"].
Frequently Asked Questions
What is Calcium Acetate used for?▼
1. INDICATIONS & USAGE Calcium acetate capsules are a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD). Calcium acetate capsules are a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. ( 1 )
What are the side effects of Calcium Acetate?▼
6. ADVERSE REACTIONS Hypercalcemia is discussed elsewhere [see Warnings and Precautions (5.1) ] 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 Westminster Pharmaceuticals, LLC. at 1-844-221-7294 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Can I take Calcium Acetate during pregnancy?▼
8.1 PREGNANCY Pregnancy Category C Calcium acetate capsules contain 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.
What are the important warnings for Calcium Acetate?▼
5. 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 ) 5.1 Hypercalcemia Patients with end stage renal disease may develop hypercalcemia when treated with calcium, including calcium acetate (calcium acetate capsules). Avoid the use of calcium supplements, including calcium-based nonprescription antacids, concurrently with calcium acetate capsules. An overdose of calcium acetate capsules may lead to progressive hypercalcemia, which may require emergency measures. 4. CONTRAINDICATIONS Patients with hypercalcemia. Hypercalcemia. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.