WARNINGS
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.
INTERACTION WITH POTASSIUM-SPARING DIURETICS
Concomitant administration of Urocit®-K and a potassium-sparing diuretic (such as triamterene, spironolactone or amiloride) should be avoided, since the simultaneous administration of these agents can produce severe hyperkalemia.
GASTROINTESTINAL LESIONS
Because of reports of upper gastrointestinal mucosal lesions following administration of potassium chloride (wax-matrix), and 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 chloride 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 gastro-intestinal bleeding, Urocit®-K should be discontinued immediately and the possibility of bowel perforation or obstruction investigated.
PRECAUTIONS
INFORMATION FOR PATIENTS:
Physicians should consider reminding the patient of the following:
To take each dose without crushing, chewing or sucking the tablet.
To take this medicine only as directed. This is especially important if the patient is also taking both diuretics and digitalis preparations.
To check with physician if there is trouble swallowing tablets or if the tablet seems to stick in the throat.
To check with the doctor at once if tarry stools or other evidence of gastrointestinal bleeding is noticed. Laboratory Tests: Regular serum potassium determinations are recommended. Careful attention should be paid to acid-base balance, other serum electrolyte levels, the electrocardiogram, and the clinical status of the patient, particularly in the presence of cardiac disease, renal disease or acidosis.
Drug Interactions: POTASSIUM-SPARING DIURETICS: See WARNINGS section.
DRUGS THAT SLOW GASTROINTESTINAL TRANSIT TIME (such as anticholinergics) can be expected to increase the gastrointestinal irritation produced by potassium salts. (See CONTRAINDICATIONS section).
Carcinogenesis, Mutagenesis, Impairment Of Fertility: Long-term carcinogenicity studies in animals have not been performed. Pregnancy Category C: Animal reproduction studies have not been conducted with Urocit®-K. It is also not known whether Urocit®-K can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Urocit®-K should be given to a pregnant woman only if clearly needed. Nursing Mothers: The normal potassium ion content of human milk is about 13 mEq/l. It is not known if Urocit®-K has an effect on this content. Caution should be exercised when Urocit®-K is administered to a nursing woman. Pediatric Use: Safety and effectiveness in children have not been established.
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