Renal tubular acidosis (RTA) with calcium stones

Potassium citrate is indicated for the management of renal tubular acidosis [see Clinical Studies].

Hypocitraturic calcium oxalate nephrolithiasis of any etiology

Potassium citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies].

Uric acid lithiasis with or without calcium stones

Potassium citrate is indicated for the management of Uric acid lithiasis with or without calcium stones [see Clinical Studies].

Dosing Instructions

Treatment with extended release potassium citrate 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 (potassium citrate extended-release tablets) is to provide Urocit®-K (potassium citrate extended-release tablets) 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 or 7.0.

Monitor serum electrolytes (sodium, potassium, chloride and carbon dioxide), serum creatinine and complete blood counts every four months and more frequently in patients with cardiac disease, renal disease or acidosis. Perform electrocardiograms periodically. Treatment should be discontinued if there is hyperkalemia, a significant rise in serum creatinine or a significant fall in blood hemocrit or hemoglobin.

Severe Hypocitraturia

In patients with severe hypocitraturia (urinary citrate < 150 mg/day), therapy should be initiated at a dosage of 60 mEq /day (30 mEq two times/day or 20 mEq three times/day with meals or within 30 minutes after meals or bedtime snack). 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 (potassium citrate extended-release tablets) greater than 100 mEq/day have not been studied and should be avoided.

Mild to Moderate Hypocitraturia

In patients with mild to moderate hypocitraturia (urinary citrate > 150 mg/day) therapy should be initiated at 30 mEq/day (15 mEq two times/day or 10 mEq three times/day with meals or within 30 minutes after meals or bedtime snack). 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. Doses of Urocit®-K (potassium citrate extended-release tablets) greater than 100 mEq/day have not been studied and should be avoided.

Dosage Forms And Strengths

• 5 mEq tablets are uncoated, tan to yellowish in color, modified ball shaped, with MPC 600 debossed on one side and blank on the other
• 10 mEq tablets are uncoated, tan to yellowish in color, elliptical shaped, with 610 debossed on one side and MISSION on the other
• 15 mEq tablets are uncoated, tan to yellowish in color, modified rectangle shaped, with M15 debossed on one side and blank on the other

Storage And Handling

Urocit®-K (potassium citrate extended-release tablets) 5 mEq tablets are uncoated, tan to yellowish in color, modified ball shaped, with MPC 600 debossed on one side and blank on the other, supplied in bottles as:

NDC 0178-0600-01 Bottle of 100

Urocit®-K (potassium citrate extended-release tablets) 10 mEq tablets are uncoated, tan to yellowish in color, elliptical shaped, with MPC 610 debossed on one side and MISSION on the other, supplied in bottles as:

NDC 0178-0610-01 Bottle of 100

Urocit®-K (potassium citrate extended-release tablets) 15 mEq tablets are uncoated, tan to yellowish in color, modified rectangle shaped, with M15 debossed on one side and blank on the other, supplied in bottles as:

NDC 0178-0615-01 Bottle of 100

Storage: Store in a tight container.

Mission Pharmacal Company, San Antonio, TX USA 78230

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