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BRIEF SUMMARY; CONSULT THE PACKAGE INSERT FOR FULL PRESCRIBING INDICATIONS AND USAGE: Potassium citrate is 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.
CONTRAINDICATIONS: UROCIT®-K is 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. Such conditions include: chronic
renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical
exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown,
or the administration of a potassium-sparing agent (such as triamterene, spironolactone
or amiloride).
UROCIT-K is contraindicated in patients in whom there is cause for arrest or delay intablet passage through the gastrointestinal tract, such as those suffering from delayedgastric emptying, esophageal compression, intestinal obstruction or stricture or thosetaking anticholinergic medication. Because of its ulcerogenic potential, UROCIT-K shouldnot be given to patients with peptic ulcer disease.
UROCIT-K is contraindicated in patients with renal insufficiency (glomerular filtration rateof less than 0.7 ml/kg/min), because of the danger of soft tissue calcification andincreased risk for the development of hyperkalemia.
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.
If there is severe vomiting, abdominal pain or gastro-intestinal bleeding, UROCIT-Kshould be discontinued immediately and the possibility of bowel perforation orobstruction 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 isalso taking both diuretics and digitalis preparations.
To check with physician if there is trouble swallowing tablets or if the tablet seemsto stick in the throat.
To check with the doctor at once if tarry stools or other evidence ofgastrointestinal 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.
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.
PEDIATRIC USE: Safety and effectiveness in children have not been established.
ADVERSE REACTIONS: Some patients may develop minor gastrointestinal complaints
during UROCIT-K therapy, such as abdominal discomfort, vomiting, diarrhea, loose bowel
movements or nausea.
OVERDOSAGE: In overdosage of UROCIT-K treat for hyperkalemia.
DOSAGE AND ADMINISTRATION: Treatment with UROCIT-K should be added to a
regimen that limits salt intake (avoidance of foods with high salt content and of added
salt at the table) and encourages high fluid intake (urine volume should be at least two
liters per day). The objective of treatment with UROCIT-K is to provide UROCIT-K in
sufficient dosage to restore normal urinary citrate (greater than 320 mg/day and as close
to the normal mean of 640 mg/day as possible), and to increase urinary pH to a level of
6.0 to 7.0.
In patients with severe hypocitraturia (urinary citrate of less than 150 mg/day), therapyshould be initiated at a dosage of 60 meq/day (20 meq three times/day or 15 meq fourtimes/day with meals or within 30 minutes after meals or bedtime snack). In patientswith mild-moderate hypocitraturia (>150 mg/day), UROCIT-K should be initiated at adosage of 30 meq/day (10 meq three times/day with meals). Twenty-four hour urinarycitrate and/or urinary pH measurements should be used to determine the adequacy ofthe initial dosage and to evaluate the effectiveness of any dosage change. In addition,urinary citrate and/or pH should be measured every four months.
Doses of UROCIT-K greater than 100 meq/day have not been studied and should beavoided.
HOW SUPPLIED: UROCIT-K is available for oral administration in tablet form in thefollowing sizes: (NDC 0178-0600-01) 5 meq potassium citrate and (NDC 0178-0610-01) 10 meqpotassium citrate, packaged in bottles of 100 each.
References: 1. Preminger GM, Sakhaee K, Skurla C, et al. Prevention of recurrent
calcium stone formation with potassium citrate therapy in patients with distal renal
tubular acidosis. J Urol. 1985;134:20-23. 2. Pak CYC, Peterson R, Sakhaee K, et al.
Correction of hypocitraturia and prevention of stone formation by combined thiazide and
potassium citrate therapy in thiazide-unresponsive hypercalciuric nephrolithiasis. Am J
Med. 1985;79:284-288. 3. Pak CYC, Fuller C. Idiopathic hypocitraturic calcium-oxalate
nephrolithiasis successfully treated with potassium citrate. Ann Intern Med. 1986;104:33-
37.
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