Hyperkalemia
In patients with impaired mechanisms for excreting potassium, Urocit®-K administration can produce hyperkalemia and cardiac arrest. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of Urocit®-K 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.
Gastrointestinal lesions
Because of reports of upper gastrointestinal mucosal lesions following administration of potassium-chloride (wax-matrix), an endoscopic examination of the upper gastrointestinal mucosa was performed in 30 normal volunteers after they had taken glycopyrrolate 2 mg p.o. t.i.d., Urocit®-K 95 mEq/day, wax-matrix potassium chloride 96 mEq/day or wax-matrix placebo, in thrice daily schedule in the fasting state for one week. Urocit®-K and the wax-matrix formulation of potassium chloride were indistinguishable but both were significantly more irritating than the wax-matrix placebo. In a subsequent, similar study, lesions were less severe when glycopyrrolate was omitted.
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 Urocit®-K is limited, but a similar frequency of gastrointestinal lesions should be anticipated.
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.
Important Safety Information
Contraindications
- Patients with hyperkalemia, peptic ulcer disease, active urinary tract infection, and renal insufficiency
- Conditions predisposing patients to hyperkalemia, including chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, and extensive tissue breakdown
Warnings and Precautions
- Hyperkalemia: In patients with impaired mechanisms for excreting potassium, Urocit-K administration can produce hyperkalemia and cardiac arrest. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of Urocit-K 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
- Gastrointestinal lesions: 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
Patient Counseling Information
Administration of Drug- Patients should be told to take Urocit-K 15 mEq without crushing, chewing, or sucking the tablet
- Patients should be told to take Urocit-K 15 mEq only as directed, especially if the patient is also taking both diuretics and digitalis preparations
- Patients should be told to check with the doctor if they experience difficulty swallowing the tablet or it seems to stick in the throat
- Patients should be told to check with the doctor at once if they notice tarry stools or other signs of gastrointestinal bleeding
- Patients should be advised that regular blood tests and electrocardiograms will be performed to ensure safety
Patient Monitoring Information
Hyperkalemia
- Patients with impaired mechanisms for excreting potassium should be closely monitored for signs of hyperkalemia with periodic blood tests and ECGs
This material is intended to provide basic information. Patients should discuss all medical advice, diagnosis, and treatment with their healthcare provider.
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