Potassium Citrate and Citric Acid Monohydrate

FDA Drug Profile — Potassium Citrate and Citric Acid

Drug Details

Generic Name
Potassium Citrate and Citric Acid Monohydrate
Brand Names
Potassium Citrate and Citric Acid
Application Number
Sponsor
PAI Holdings, LLC dba PAI Pharma
NDC Codes
1
Dosage Forms
SOLUTION
Routes
ORAL
Active Ingredients
CITRIC ACID MONOHYDRATE, POTASSIUM CITRATE

Indications and Usage

INDICATIONS AND USAGE 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.

Warnings

WARNINGS 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.