Drug Catalog - Product Detail
CALCIUM ACETATE CAPS 667MG 200CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 23155-0531-02 | AVET PHARMACEUTICALS | 200 | 667MG | CAPSULE |
PACKAGE FILES
Generic Name
CALCIUM ACETATE
Substance Name
CALCIUM ACETATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA202315
Description
11 DESCRIPTION Calcium acetate, USP acts 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: Calcium acetate capsules, USP are hard gelatin capsules with blue opaque cap and body both imprinted "HP 531" in black ink. Each capsule contains 667 mg calcium acetate, USP (anhydrous; Ca(CH 3 COO) 2 ; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium and following inactive ingredients crospovidone, FD&C Blue No. 1, FD&C Blue No. 3, gelatin, magnesium stearate, sodium lauryl sulfate and titanium dioxide. In addition to the ingredients listed above, each capsule contains following inactive ingredients from imprinting ink: butyl alcohol, iron oxide black, propylene glycol and shellac. FDA approved dissolution test specifications differ from USP. structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Calcium Acetate Capsules, USP are blue opaque capsules imprinted with "HP 531" for oral administration containing 667 mg calcium acetate (anhydrous Ca(CH 3 COO) 2 ; MW=158.17 grams) equal to 169 mg (8.45 mEq) calcium. Capsule NDC 23155-531-02 Bottles of 200 NDC 23155-531-10 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].
Indications & Usage
1 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 ) Calcium acetate capsule is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Starting dose is 2 capsules with each meal. ( 2 ) Titrate the dose every 2 to 3 weeks until acceptable serum phosphorus level is reached. Most patients require 3 to 4 capsules with each meal.( 2 ) 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.