potassium citrate
Drug Details
- Generic Name
- potassium citrate
- Brand Names
- Potassium Citrate, UROCIT-K, POTASSIUM CITRATE
- Application Number
- NDA019071
- Sponsor
- Biocomp Pharma, Inc.
- NDC Codes
- 8
- Dosage Forms
- TABLET, TABLET, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- POTASSIUM CITRATE
Indications and Usage
1 INDICATIONS AND USAGE Potassium citrate extended-release tablets are a citrate salt of potassium indicated for the management of: Renal tubular acidosis (RTA) with calcium stones (1.1) Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2) Uric acid lithiasis with or without calcium stones (1.3) 1.1 Renal Tubular Acidosis (RTA) with Calcium Stones Potassium citrate is indicated for the management of renal tubular acidosis [see Clinical Studies (14.1)]. 1.2 Hypocitraturic Calcium Oxalate Nephrolithiasis of any Etiology Potassium citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies (14.2)] . 1.3 Uric Acid Lithiasis with or without Calcium Stones Potassium citrate is indicated for the management of Uric acid lithiasis with or without calcium stones [see Clinical Studies (14.3)].