INDICATIONS: Urocit^®-K (potassium citrate) extended-release tablets are indicated for the management of renal tubular acidosis (RTA) with calcium stones, hypocitraturic calcium oxalate nephrolithiasis of any etiology, and uric acid lithiasis with or without calcium stones.

Important Safety Information

CONTRAINDICATIONS:

• With hyperkalemia or in conditions associated with hyperkalemia, such as chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical activity in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown
• For whom there might be delayed tablet passage through the GI tract, e.g., gastric stasis, esophageal compression, intestinal obstruction or stricture
• With peptic ulcer disease
• With active urinary tract infection
• With renal insufficiency (GFR < 0.7 ml/kg/min)

WARNINGS AND PRECAUTIONS:

• Hyperkalemia: In patients with impaired mechanisms for excreting potassium, Urocit-K administration can produce hyperkalemia (which can develop rapidly and may be asymptomatic) and cardiac arrest. The use of Urocit-K in any condition that impairs potassium excretion (e.g., chronic renal failure, severe myocardial damage, heart failure) should be avoided. Closely monitor for signs of hyperkalemia with periodic blood tests and ECGs.
• Gastrointestinal lesions: Solid dosage forms of potassium chlorides have produced stenotic and/or ulcerative lesions of the small bowel and deaths. There have also been reports of upper GI bleeding associated with these products. If there is severe vomiting, abdominal pain, or gastrointestinal bleeding, Urocit-K should be discontinued immediately and the possibility of bowel perforation or obstruction investigated.

ADVERSE REACTIONS: Adverse reactions associated with Urocit-K include minor gastrointestinal complaints such as gastrointestinal discomfort, vomiting, diarrhea, loose bowel movements, or nausea. These may be alleviated by taking the dose with meals or snacks or by reducing the dosage.

DRUG INTERACTIONS:

• Potassium-sparing diuretics: concomitant administration of Urocit-K and a potassium sparing diuretic (e.g., triamterene, spironolactone, or amiloride) should be avoided since simultaneous administration can produce severe hyperkalemia.
• Drugs that slow gastrointestinal transit time (e.g., anticholinergics) can be expected to increase the gastrointestinal irritation produced by potassium salt.
• Renin-angiotensin-aldosterone system inhibitors including angiotensin converting (ACE) inhibitors, angiotensin receptor blockers (ARBs), spironolactone, eplerenone, or aliskiren produce potassium retention: closely monitor potassium.
• Nonsteroidal anti-inflammatory drugs (NSAIDs) may produce potassium retention: closely monitor potassium.

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