Potassium Citrate-Sodium Citrate-Citric Acid Solution

Potassium citrate is absorbed and metabolized to potassium bicarbonate, thus acting as a systemic alkalizer. The effects are essentially those of chlorides before absorption and those of bicarbonates subsequently. Oxidation is virtually complete so that less than 5% of the potassium citrate is excreted in the urine unchanged.

Potassium Citrate and Citric Acid Oral Solution USP is an effective alkalinizing agent useful in those conditions where long-term maintenance of an alkaline urine is desirable, such as in patients with uric acid and cystine calculi of the urinary tract, especially when the administration of sodium salts is undesirable or contraindicated. In addition, it is a valuable adjuvant when administered with uricosuric agents in gout therapy, since urates tend to crystallize out of an acid urine. It is also effective in correcting the acidosis of certain renal tubular disorders where the administration of potassium citrate may be preferable. This product is highly concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urinary pH around the clock, usually without the necessity of a 2 A.M. dose. This product alkalinizes the urine without producing a systemic alkalosis in recommended dosage. It is highly palatable, pleasant tasting and tolerable, even when administered for long periods. Potassium citrate does not neutralize the gastric juice or disturb digestion.

Large doses may cause hyperkalemia and alkalosis, especially in the presence of renal disease. Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, or cardiac glycosides may lead to toxicity.

The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, hyperkalemia can result (see Contraindications and Warnings). Hyperkalemia, when detected, must be treated immediately because lethal levels can be reached in a few hours.

Potassium Citrate and Citric Acid Oral Solution USP should be taken diluted in water according to directions, followed by additional water, if desired. Palatability is enhanced if chilled before taking.

Usual Adult Dose

3 to 6 teaspoonfuls (15 to 30 mL), diluted with 1 glass of water, after meals and at bedtime, or as directed by a physician.

Usual Pediatric Dose

1 to 3 teaspoonfuls (5 to 15 mL), diluted with 1/2 glass of water, after meals and at bedtime, or as directed by a physician.

Usual Dosage Range

2 to 3 teaspoonfuls (10 to 15 mL), diluted with a glassful of water, taken four times a day. Potassium Citrate and Citric Acid Oral Solution USP, diluted with a glassful of water, taken four times a day will usually maintain a urinary pH of 7.0-7.6 throughout most of the 24 hours without unpleasant side effects. To check urinary pH, HYDRION Paper (pH 6.0-8.0) or NITRAZINE Paper (pH 4.5-7.5) are available and easy to use.

Potassium Citrate and Citric Acid Oral Solution USP (clear pink to red colored; berry-citrus flavored) is supplied in the following oral dosage form:

NDC 0121-0676-16: 16 fl oz (473 mL) bottle

STORAGE

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F). Protect from excessive heat and freezing.