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Urocit-K (Potassium Citrate) - Indications and Dosage

 


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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.

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), therapy should be initiated at a dosage of 60 mEq/day (20 mEq three times/day or 15 mEq four times/day with meals or within 30 minutes after meals or bedtime snack). In patients with mild-moderate hypocitraturia (>150 mg/day), Urocit®-K should be initiated at a dosage of 30 mEq/day (10 mEq three times/day with meals). Twenty-four hour urinary citrate and/or urinary pH measurements should be used to determine the adequacy of the 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 be avoided.

Serum electrolytes (sodium, potassium, chloride and carbon dioxide), serum creatinine, and complete blood count should be monitored every four months. Treatment should be discontinued if there is hyperkalemia, a significant rise in serum creatinine, or a significant fall in blood hematocrit or hemoglobin.

HOW SUPPLIED

Urocit®-K is available for oral administration in tablet form in the following sizes: (NDC 0178-0600-01) 5 mEq potassium citrate and (NDC 0178-0610-01) 10 mEq potassium citrate, packaged in bottles of 100 each. Urocit®-K 5 mEq tablets are uncoated, modified ball-shaped, and tan to yellowish in color. Each 5 mEq tablet is debossed MPC 600 on one side and blank on the other side. Urocit®-K 10 mEq tablets are uncoated, elliptical-shaped, and tan to yellowish in color. Each 10 mEq tablet is debossed with 610 on one side and MISSION on the other side.

Store in tight container.

Rev. 003030

Page last updated: 2006-09-21

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