Potassium

Potassium Citrate

Approved 6 Aug 2014OralTablet, extended release

The FDA lists this product in 26 strengths and forms.

Indications

Potassium citrate extended-release tablet 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 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)].

Contraindications

Patients with hyperkalemia (or who have conditions predisposing them to hyperkalemia). Such conditions include chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown (4) Patients for 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 (4) Patients with peptic ulcer disease (4) Patients with active urinary tract infection (4) Patients with renal insufficiency (glomerular filtration rate of less than 0.7 ml/kg/min) (4) 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.

Indications

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 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)].

Contraindications

Warnings and precautions

Hyperkalemia: In patients with impaired mechanisms for excreting potassium, potassium citrate administration can produce hyperkalemia and cardiac arrest. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of potassium citrate in patients with chronic renal failure, or any other condition which impairs potassium excretion such as severe myocardial damage or heart failure, should be avoided (5.1) Gastrointestinal lesions: if there is severe vomiting, abdominal pain or gastrointestinal bleeding, potassium citrate should be discontinued immediately and the possibility of bowel perforation or obstruction investigated (5.2)

5.1Hyperkalemia

In patients with impaired mechanisms for excreting potassium, potassium citrate administration can produce hyperkalemia and cardiac arrest. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of potassium citrate in patients with chronic renal failure, or any other condition which impairs potassium excretion such as severe myocardial damage or heart failure, should be avoided. Closely monitor for signs of hyperkalemia with periodic blood tests and ECGs.

5.2Gastrointestinal Lesions

Solid dosage forms of potassium chlorides have produced stenotic and/or ulcerative lesions of the small bowel and deaths. These lesions are caused by a high local concentration of potassium ions in the region of the dissolving tablets, which injured the bowel. In addition, perhaps because wax-matrix preparations are not enteric-coated and release some of their potassium content in the stomach, there have been reports of upper gastrointestinal bleeding associated with these products.

The frequency of gastrointestinal lesions with wax-matrix potassium chloride products is estimated at one per 100,000 patient-years. Experience with potassium citrate is limited, but a similar frequency of gastrointestinal lesions should be anticipated. If there is severe vomiting, abdominal pain or gastrointestinal bleeding, potassium citrate should be discontinued immediately and the possibility of bowel perforation or obstruction investigated.

Potassium Citrate

Indications

1.1Renal Tubular Acidosis (RTA) with Calcium Stones

1.2Hypocitraturic Calcium Oxalate Nephrolithiasis

1.3Uric Acid Lithiasis with or without Calcium Stones

Contraindications

Two medicines in one question?

Potassium Citrate

Indications

1.1Renal Tubular Acidosis (RTA) with Calcium Stones

1.2Hypocitraturic Calcium Oxalate Nephrolithiasis

1.3Uric Acid Lithiasis with or without Calcium Stones

Contraindications

Two medicines in one question?

Warnings and precautions

5.1Hyperkalemia

5.2Gastrointestinal Lesions

Interactions

7.1Potential Effects of Potassium Citrate on Other Drugs Potassium-sparing Diuretics:

7.2Potential Effects of Other Drugs on Potassium Citrate

7.3Renin-Angiotensin-Aldosterone System Inhibitors

7.4Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Pregnancy and breastfeeding

8.1Pregnancy

Adverse reactions

6.1Postmarketing Experience

Composition

Strengths and forms

Official product information

At a glance