Potassium Citrate

Potassium citrate is 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)

1.1Renal Tubular Acidosis (RTA) with Calcium Stones

Potassium citrate is indicated for the management of renal tubular acidosis [see Clinical Studies (14.1)] .

1.2Hypocitraturic Calcium Oxalate Nephrolithiasis

of any Etiology Potassium citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies (14.2)] .

1.3Uric Acid Llithiasis 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)] .

Potassium citrate extended-release tablets are contraindicated:

• In patients with hyperkalemia (or who have conditions predisposing them to hyperkalemia), as a further rise in serum potassium concentration may produce cardiac arrest. Such conditions include: chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown or the administration of a potassium-sparing agent (such as triamterene, spironolactone or amiloride).
• In patients in whom there is cause for arrest or delay in tablet passage through the gastrointestinal tract, such as those suffering from delayed gastric emptying, esophageal compression, intestinal obstruction or stricture, or those taking anticholinergic medication.
• In patients with peptic ulcer disease because of its ulcerogenic potential.
• In patients with active urinary tract infection (with either urea-splitting or other organisms, in association with either calcium or struvite stones). The ability of Potassium citrate extended–release tablets to increase urinary citrate may be attenuated by bacterial enzymatic degradation of citrate. Moreover, the rise in urinary pH resulting from potassium citrate therapy might promote further bacterial growth.