DESCRIPTION SECTION.

DESCRIPTION. Tricitrates SF Oral Solution is stable and pleasant-tasting oral systemic alkalizer containing potassium citrate, sodium citrate, and citric acid in sugar-free, non-alcoholic base. Tricitrates SF Oral Solution contains in each teaspoonful (5 mL): POTASSIUM CITRATE Monohydrate 550 mgSODIUM CITRATE Dihydrate 500 mgCITRIC ACID Monohydrate 334 mgEach mL contains mEq potassium ion and mEq sodium ion and is equivalent to mEq bicarbonate (HCO 3). Inactive Ingredients: FD&C Yellow No. 6, flavoring, polyethylene glycol, propylene glycol, purified water, sodium benzoate, and sorbitol solution.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Tricitrates SF 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, especially in the presence of hypocalcemia. Potassium intoxication causes listlessness, weakness, mental confusion, and tingling of extremities.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS. Severe renal impairment with oliguria or azotemia, untreated Addisons disease, or severe myocardial damage. In certain situations, when patients are on sodium-restricted diet, the use of potassium citrate may be preferable; or, when patients are on potassium-restricted diet, the use of sodium citrate may be preferable.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. Tricitrates SF Oral Solution should be taken diluted in water, followed by additional water, if desired. Palatability is enhanced if chilled before taking. Usual Adult Dose. to teaspoonfuls (15 to 30 mL), diluted in water, four times day, after meals and at bedtime, or as directed by physician.. Usual Pediatric Dose. to teaspoonfuls (5 to 15 mL), diluted in water, four times day, after meals and at bedtime, or as directed by physician.. Usual Dosage Range. to teaspoonfuls (10 to 15 mL), diluted with water, taken four times day, will usually maintain urinary pH of 6.5-7.4. to teaspoonfuls (15 to 20 mL), diluted with 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 urine 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. Tricitrates SF Oral Solution (orange colored, raspberry flavored) is supplied in the following oral dosage form: NDC 0121-0677-16: 16 fl oz (473 mL) bottles. STORAGE. Keep tightly closed. Store at controlled room temperature, 20-25C (68-77F). Protect from excessive heat and freezing.SHAKE WELL BEFORE USING.

INDICATIONS & USAGE SECTION.

INDICATIONS AND ADVANTAGES. Tricitrates SF 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. 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. This product is highly concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urine 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 and sodium citrate do not neutralize the gastric juice or disturb digestion.

MECHANISM OF ACTION SECTION.

ACTIONS. Potassium citrate and sodium citrate are absorbed and metabolized to potassium bicarbonate and sodium bicarbonate, thus acting as systemic alkalizers. 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 citrates are excreted in the urine unchanged.

OVERDOSAGE SECTION.

OVERDOSAGE. Overdosage with sodium salts may cause diarrhea, nausea and vomiting, hypernoia, and convulsions. Overdosage with potassium salts may cause hyperkalemia and alkalosis, especially in the presence of renal disease.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 473 mL Bottle Label. NDC 0121-0677-16Tricitrates SF Oral Solution 550 mg/500 mg/334 mg per mLA SUGAR-FREE SYSTEMIC ALKALIZEREach teaspoonful (5 mL) contains: Potassium Citrate Monohydrate 550 mg Sodium Citrate Dihydrate 500 mg Citric Acid Monohydrate 334 mg Each mL contains mEq Potassium Ion and mEq Sodium Ion, and is equivalent to mEq Bicarbonate (HCO 3). May not meet USP monograph requirements for pH. 16 fl oz (473 mL)Pharmaceutical Associates, Inc. Greenville, SC 29605 PRINCIPAL DISPLAY PANEL 473 mL Bottle Label.

PRECAUTIONS SECTION.

Should be used with caution by patients with low urinary output or reduced glomerular filtration rates unless under the supervision of physician. Aluminum-based antacids should be avoided in these patients. Patients should be directed to dilute adequately with water and, preferably, to take each dose after meals, to minimize the possibility of gastrointestinal injury associated with oral ingestion of potassium salt preparations and to avoid saline laxative effect. Sodium salts should be used cautiously in patients with cardiac failure, hypertension, peripheral and pulmonary edema, and toxemia of pregnancy.Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, or cardiac glycosides may lead to toxicity. Periodic examination and determinations of serum electrolytes, particularly serum bicarbonate level, should be carried out in those patients with renal disease in order to avoid these complications.

STORAGE AND HANDLING SECTION.

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

WARNINGS SECTION.

PRECAUTIONS AND WARNINGS. Should be used with caution by patients with low urinary output or reduced glomerular filtration rates unless under the supervision of physician. Aluminum-based antacids should be avoided in these patients. Patients should be directed to dilute adequately with water and, preferably, to take each dose after meals, to minimize the possibility of gastrointestinal injury associated with oral ingestion of potassium salt preparations and to avoid saline laxative effect. Sodium salts should be used cautiously in patients with cardiac failure, hypertension, peripheral and pulmonary edema, and toxemia of pregnancy.Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, or cardiac glycosides may lead to toxicity. Periodic examination and determinations of serum electrolytes, particularly serum bicarbonate level, should be carried out in those patients with renal disease in order to avoid these complications.