Urocit-K

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Hyperkalemia

In patients with impaired mechanisms for excreting potassium, Urocit®-K (potassium citrate extended-release tablets) administration can produce hyperkalemia and cardiac arrest. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of Urocit®-K (potassium citrate extended-release tablets) 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 (potassium citrate extended-release tablets) 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 (potassium citrate extended-release tablets) 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 (potassium citrate extended-release tablets) is limited, but a similar frequency of gastrointestinal lesions should be anticipated.

If there is severe vomiting, abdominal pain or gastrointestinal bleeding, Urocit®-K (potassium citrate extended-release tablets) should be discontinued immediately and the possibility of bowel perforation or obstruction investigated.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted. It is also not known whether Urocit®-K (potassium citrate extended-release tablets) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Urocit®-K (potassium citrate extended-release tablets) 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 (potassium citrate extended-release tablets) has an effect on this content. Urocit®-K (potassium citrate extended-release tablets) should be given to a woman who is breast feeding only if clearly needed.

Pediatric Use

In patients with active urinary tract infection (with either urea-splitting Safety and effectiveness in children have not been established. or other organisms, in association with either calcium or struvite stones). The ability of Urocit®-K (potassium citrate extended-release tablets) to increase urinary citrate may be attenuated by bacterial enzymatic degradation of citrate. Moreover, the rise in urinary

Last reviewed on RxList: 1/21/2010
This monograph has been modified to include the generic and brand name in many instances.

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