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Potassium citrate.

Each extended-release tablet contains Potassium Citrate USP 1.06 g equivalent to 10 mEq Potassium.
Potassium Citrate USP is a citrate salt of potassium. After oral administration, the metabolism of absorbed citrate produces an alkaline load. The induced alkaline load in turn increases urinary pH and raises urinary citrate by augmenting citrate clearance without measurably altering ultra-filterable serum citrate. Thus Potassium Citrate appears to increase urinary citrate principally by modifying the renal handling of citrate, rather than by increasing the filtered load of citrate. The increased filtered load of citrate may play some role, however, as in small comparisons of oral citrate and oral bicarbonate, citrate had a greater effect on urinary citrate. In addition to raising urinary pH and citrate, Potassium Citrate increases urinary potassium by approximately the amount contained in the medication.
Potassium Citrate is supplied as wax matrix extended-release tablet for oral administration.

Potassium Citrate USP 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.

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), Potassium Citrate 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.
Treatment with 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 Potassium Citrate is to provide potassium citrate 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.
Doses of Potassium Citrate 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.
Use in children: Safety and effectiveness in children has not been established.

Potassium Citrate is contraindicated in patients with hyperkalemia or who have conditions predisposing them to hyperkalemia including 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.
Potassium Citrate is contraindicated in patients in whom there is cause for arrest or delay in tablet passage through the gastrointestinal tract, such as those suffering from delayed gastric emptying, esophageal compression, intestinal obstruction or stricture or those taking anticholinergic medication. Because of its ulcerogenic potential, Potassium Citrate should not be given to patients with peptic ulcer disease.
Potassium Citrate is contraindicated in patients with active urinary tract infection (with either urea splitting or other organisms, in association with either calcium or struvite stones).
Potassium Citrate is contraindicated in patients with renal insufficiency (glomerular filtration rate of less than 0.7 ml/kg/min), because of the danger of soft tissue calcification and increased risk for the development of hyperkalemia.

Use in pregnancy: Animal reproduction studies have not been conducted with Potassium Citrate. It is also not known whether Potassium Citrate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium Citrate should be given to a pregnant woman only if clearly needed.
Use in lactation: The normal potassium ion content of human milk is about 13 mEq/l. It is not known if Potassium Citrate has an effect on this content. Caution should be exercised when Potassium Citrate is administered to a nursing woman.

Some patients may develop minor gastrointestinal complaints such as abdominal discomfort, vomiting, diarrhea, loose bowel movements or nausea. These symptoms are due to the irritation of the gastrointestinal tract, and may be alleviated by taking the dose with meals or snack, or by reducing the dosage. Patents may find intact matrices in feces.

Concomitant administration of Potassium Citrate and a potassium-sparing diuretic (such as triamterene, spironolactone or amlioride) should be avoided, since the simultaneous administration of these agents can produce severe hyperkalemia. Drugs that have slowed gastrointestinal transit time (such as anticholinergics) can be expected to increase the gastrointestinal irritation produced by potassium salts.

Store at temperatures not exceeding 30°C.

Other Drugs Acting on the Genito-Urinary System

A12BA02 - potassium citrate ; Belongs to the class of potassium-containing preparations. Used as dietary supplements.

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