ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Potassium Citrate and Citric Acid Oral Solution USP 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 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 wave, widening and slurring of QRS complex, changes of the S-T segment, tall peaked waves, etc.

CONTRAINDICATIONS SECTION.

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

DESCRIPTION SECTION.

DESCRIPTION. Potassium Citrate and Citric Acid Oral Solution USP is stable and pleasant-tasting oral systemic alkalizer containing potassium citrate and citric acid in sugar-free, non-alcoholic base.Potassium Citrate and Citric Acid Oral Solution USP contains in each teaspoonful (5 mL):POTASSIUM CITRATE Monohydrate 1100 mgCITRIC ACID Monohydrate 334 mgEach mL contains mEq potassium ion and is equivalent to mEq bicarbonate (HCO 3). Inactive Ingredients: FD&C Red No. 40, flavoring, polyethylene glycol, propylene glycol, purified water, sodium benzoate, and sorbitol solution.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. 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. to teaspoonfuls (15 to 30 mL), diluted with glass of water, after meals and at bedtime, or as directed by physician.. Usual Pediatric Dose. to teaspoonfuls (5 to 15 mL), diluted with 1/2 glass of water, after meals and at bedtime, or as directed by physician.. Usual Dosage Range. to teaspoonfuls (10 to 15 mL), diluted with glassful of water, taken four times day. Potassium Citrate and Citric Acid Oral Solution USP, diluted with glassful of water, taken four times day will usually maintain 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.

HOW SUPPLIED SECTION.

HOW SUPPLIED. 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, 20-25C (68-77F). Protect from excessive heat and freezing.

INDICATIONS & USAGE SECTION.

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 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 2 A.M. dose. This product alkalinizes the urine without producing 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.

MECHANISM OF ACTION SECTION.

ACTIONS. Potassium citrate is absorbed and metabolized to potassium bicarbonate, thus acting as 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.

OVERDOSAGE SECTION.

OVERDOSAGE. 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 few hours.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 473 mL Bottle Label. NDC 0121-0676-16Potassium Citrate and Citric Acid Oral Solution USP 1100 mg/334 mg per mL SUGAR-FREE SYSTEMIC ALKALIZEREach teaspoonful (5 mL) contains: Potassium Citrate Monohydrate.....1100 mg Citric Acid Monohydrate.....334 mg Each mL contains mEq Potassium Ion, and is equivalent to mEq Bicarbonate (HCO3). Rx ONLY16 fl oz (473 mL)Pharmaceutical Associates, Inc. Greenville, SC 29605 INDICATIONS AND USAGE: Potassium Citrate and Citric Acid Oral Solution USP is stable and pleasant-tasting oral systemic alkalizer. It is effective for long- term maintenance of an alkaline urine, especially when the administration of sodium salts is undesirable or contra- indicated. SEE ACCOMPANYING LITERATUREDOSAGE AND ADMINISTRATION:Usual Adult Dosage: to teaspoonfuls (15 to 30 mL) DILUTED with glass of water, after meals and at bedtime, or as directed by physician. SHAKE WELL BEFORE USING.STORAGE: Keep tightly closed. Store at controlled room temperature. 20 -25 (68 -77 F). Protect from excessive heat or freezing. Dispense in tight, light-resistance container with child-resistant closure. L06761600R08/14. 473 mL Bottle Label.

PRECAUTIONS SECTION.

PRECAUTIONS. Should be used with caution by patients with low urinary output unless under the supervision of physician. As with all liquids containing 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.

STORAGE AND HANDLING SECTION.

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

WARNINGS SECTION.

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.