DailyMed Label: Potassium Citrate and Citric Acid

DailyMed Label: Potassium Citrate and Citric Acid

2022

DailyMed Prescription

Potassium Citrate and Citric Acid

Potassium Citrate and Citric Acid

Chartwell RX, LLC

NDC: 62135-435

NDC: 62135-435

NDC: 62135-435

NDC: 62135-435

NDC: 62135-435

Potassium Citrate and Citric Acid Oral Solution, USP is a stable red colored and cherry flavored oral systemic alkalizer containing potassium citrate and citric acid in a sugar-free, non-alcoholic base. Potassium Citrate and Citric Acid Oral Solution, USP contains in each teaspoonful (5 mL): Potassium Citrate Monohydrate, USP  1100 mg Citric Acid Monohydrate, USP  334 mg Each mL contains 2 mEq potassium ion and is equivalent to 2 mEq bicarbonate (HCO 3 ). Inactive Ingredients: saccharin sodium, sodium benzoate, sorbitol solution, FD&C red # 40, purified water, and wild cherry flavor. ACTIONS 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 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.

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.

Severe renal impairment with oliguria or azotemia, untreated Addison's disease, adynamia episodica hereditaria, acute dehydration, heat cramps, anuria, severe myocardial damage, and hyperkalemia from any cause.

Should be used with caution by patients with low urinary output unless under the supervision of a physician. As with all liquids containing a high concentration of potassium, patients should be directed to dilute adequately with water to minimize the possibility of gastrointestinal injury associated with the oral ingestion of concentrated potassium salt preparations; and preferably, to take each dose after meals to avoid saline laxative effect.

Potassium citrate and citric acid oral solution is generally well tolerated without any unpleasant side effects when given in recommended doses to patients with normal renal function and urinary output. However, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of hyperkalemia or alkalosis. Potassium intoxication causes listlessness, weakness, mental confusion, tingling of extremities, and other symptoms associated with a high concentration of potassium in the serum. Periodic determinations of serum electrolytes should be carried out in those patients with renal disease in order to avoid these complications. Hyperkalemia may exhibit the following electrocardiographic abnormalities: Disappearance of the P wave, widening and slurring of QRS complex, changes of the S-T segment, tall peaked T waves, etc.

Potassium Citrate and Citric Acid Oral Solution, USP (Red color liquid with cherry flavor) is supplied in the following oral dosage form: NDC 62135-435-47: 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. Manufactured for: Chartwell RX, LLC Congers, NY 10920 L71146 Rev. 12/2022

Potassium Citrate and Citric Acid Oral Solution, USP - NDC 62135-435-47 - 16 fl oz (473 mL) Bottle Label Potassium Citrate and Citric Acid Oral Solution, USP - NDC 62135-435-47 - 16 fl oz (473 mL) Bottle Label