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Uses

Alkalinizing Alternatives to Sodium Bicarbonate

Administration of sodium citrate and other citrate preparations appears to be associated with formation of bicarbonate; therefore, the drugs are used as alkalinizing agents.

Oral citrate solutions, including potassium citrate and citric acid, sodium citrate and citric acid, and tricitrates, are used as alkalinizing agents in conditions where long-term maintenance of an alkaline urine is desirable and in the management of chronic metabolic acidosis associated with conditions such as chronic renal insufficiency or renal tubular acidosis.

Selection of a specific preparation may in part be determined by the potassium and sodium contents. Preparations containing sodium citrate and citric acid are especially useful when administration of potassium salts is undesirable or contraindicated, while those containing potassium citrate and citric acid are used when administration of sodium salts is undesirable or contraindicated. Unlike sodium bicarbonate solution, these preparations are generally considered highly palatable and pleasant tasting, and may be particularly useful as an alkalinizing agent in patients who do not tolerate the taste of sodium bicarbonate oral solution.

Adjuvant in Gout Therapy

Potassium citrate and citric acid oral solution and tricitrates oral solution are used as adjuvant therapy to uricosuric agents in gout therapy.

Prevention of Milk Curdling

Sodium citrate has been used to alter cow's milk so that large hard curds are not formed in the stomach of feeding infants.

Dosage and Administration

Administration

Citrate preparations (i.e., potassium citrate and citric acid, sodium citrate, sodium citrate and citric acid, tricitrates) are administered orally. Oral citrate solutions should be diluted with adequate amounts of water prior to administration to minimize the risk of GI complications, and followed by additional water after administration; palatability may be enhanced by chilling the solution before administration. For reconstitution of potassium citrate and citric acid for oral solution in single-dose packets, the contents of one packet should be mixed thoroughly with at least 180 mL of cool water or juice prior to administration and followed by additional water or juice after administration. Oral citrate solutions should preferably be taken after meals to avoid the saline laxative effect of the drug.

Dosage

Potassium Citrate and Citric Acid

The usual adult dosage of potassium citrate and citric acid solution is 15-30 mL after meals and at bedtime. The usual dosage of potassium citrate and citric acid solution in children is 5-15 mL after meals and at bedtime. The usual adult dosage of potassium citrate and citric acid for oral solution is one single-dose packet (containing 3300 mg of potassium citrate monohydrate and 1002 mg of citric acid monohydrate), reconstituted as directed 4 times daily, after meals and at bedtime. The single-dose packets of potassium citrate and citric acid for oral solution are not recommended for pediatric use, since dosage for these patients can be more easily regulated with the commercially available oral solution. Dosage should be individualized according to the patient's tolerance and response.

Sodium Citrate

The usual adult dosage of sodium citrate as an alkalinizing agent is 1-2 g every 2-4 hours as necessary.

To prevent formation of large curds in the stomach of feeding infants, 100 mg of sodium citrate has been added to each 30 mL of cow's milk.

Sodium Citrate and Citric Acid

The usual adult dosage of sodium citrate and citric acid solution is 10-30 mL, diluted in 30-90 mL of water, after meals and at bedtime. The usual dosage of sodium citrate and citric acid solution in children 2 years of age or older is 5-15 mL of solution, diluted in 30-90 mL of water, after meals and at bedtime. A clinician should be consulted for use of the drug in children younger than 2 years of age. Dosage should be individualized according to the patient's tolerance and response.

Sodium citrate and citric acid may be used as a buffer to maintain an approximate pH in various extemporaneous formulations. Addition of the following concentration of the drugs should generally produce a solution buffered to the approximate pH listed:

Table 1. Citrate Buffer

pH	Citric Acid Monohydrate g/L	Sodium Citrate Dihydrate g/L
2.5	64.4	7.8
3.0	57.4	17.6
3.5	47.6	31.4
4.0	40.6	41.2
4.5	30.8	54.9
5.0	19.6	70.6
5.5	9.8	84.3
6.0	4.2	92.1
6.5	1.8	95.6

Adapted from Schumacher GE. Buffer formulations. Am J Hosp Pharm. 1966; 23:628-9.

Tricitrates

The usual adult dosage of tricitrates solution is 15-30 mL diluted in water 4 times daily, after meals and at bedtime. The usual dosage of tricitrates solution in children is 5-15 mL 4 times daily, after meals and at bedtime. Dosage should be individualized according to the patient's tolerance and response.

Cautions

Adverse Effects

Oral citrate preparations generally are well tolerated when given in the usual dosages to patients with normal renal function and urine output. Excessive doses of sodium-containing formulations may cause metabolic alkalosis, especially in patients with renal dysfunction or hypocalcemia. Large doses also may cause tetany or depression of the heart associated with decreasing ionized calcium concentrations. Large doses of potassium-containing formulations may cause hyperkalemia and alkalosis, particularly in patients with impaired renal function. Listlessness, weakness, mental confusion, and paresthesia of the extremities may be associated with hyperkalemia. Oral citrate preparations may have a saline laxative effect when administered orally.

Precautions and Contraindications

To avoid complications, the clinical condition of the patient should be evaluated and laboratory determinations (e.g., serum electrolytes, acid-base balance) obtained periodically during therapy with oral citrate preparations, especially in patients with renal disorders. Patients with renal impairment are at risk of developing hypernatremia or alkalosis in the presence of hypocalcemia.

Sodium-containing citrate preparations should be used with caution in patients with low urine output unless the patient is closely supervised during therapy. Citrate preparations containing sodium should be used with extreme caution in patients with congestive heart failure, hypertension, renal dysfunction, peripheral or pulmonary edema, or toxemia of pregnancy. Citrate preparations containing potassium should be used with extreme caution in patients in whom excessive potassium may have a deleterious effect.

Sodium citrate and citric acid oral solution (Cytra-2, Bicitra) is contraindicated in patients receiving a sodium-restricted diet and in those with severe renal impairment. Tricitrates oral solution is contraindicated in patients with severe renal impairment with azotemia or oliguria, untreated Addison's disease, or severe myocardial damage. Sodium citrate and citric acid (Oracit) is contraindicated in patients with severe renal impairment, oliguria or azotemia, untreated Addison's disease, adynamia episodica hereditaria, acute dehydration, heat cramps, anuria, severe myocardial damage, and hyperkalemia. Potassium citrate and citric acid oral solution and potassium citrate and citric acid for oral solution are also contraindicated in patients with adynamia episodica hereditaria, acute dehydration, heat cramps, anuria, severe myocardial damage, or hyperkalemia (from any cause).

Pregnancy and Lactation

Pregnancy

Controlled studies to date in pregnant women receiving potassium citrate have not shown a risk to the fetus in the first trimester of pregnancy and there is no evidence of risk in subsequent trimesters.

Lactation

It is not known whether potassium citrate is distributed into milk. Because potassium freely distributes into and out of milk, use of potassium citrate by a nursing woman with normal plasma potassium concentrations should have no adverse effect on the nursing infant; milk potassium concentrations may be increased in hyperkalemic women.

Drug Interactions

Antacids

Concomitant use of citrate preparations and aluminum-containing antacids may increase GI absorption of aluminum. In patients with chronic kidney disease who require aluminum-containing phosphate binders, concomitant use of citrate preparations should be avoided because of the risk of aluminum absorption and potential toxicity with concomitant use. Sodium bicarbonate may be an alternative to citrates if aluminum-containing phosphate binders are required.

Cardiac Glycosides

The potential for toxicity exists in patients receiving cardiac glycosides concomitantly with citrate preparations.

Drugs Affecting the Renin-Angiotensin-Aldosterone System

Concomitant use of potassium-containing citrate preparations with an angiotensin converting-enzyme (ACE) inhibitor or mineralocorticoid (aldosterone) receptor antagonist (e.g., eplerenone, spironolactone) may increase serum potassium concentrations and increase the risk of hyperkalemia and associated toxicity.

Drugs Increasing Serum Potassium Concentrations

Concomitant administration of potassium-containing citrate preparations with potassium-sparing diuretics (e.g., amiloride, triamterene) or potassium-containing agents may increase serum potassium concentrations and increase the risk of hyperkalemia and associated toxicity.

Drugs with pH-dependent Urinary Excretion

Alkalinization of the urine with citrates may enhance urinary excretion and decrease therapeutic and toxic effects of salicylates. (For further information on the effects of alkalinizing agents on salicylate pharmacokinetics, see Drug Interactions: Acidifying and Alkalinizing Agents and also see Pharmacokinetics: Elimination, in the Salicylates General Statement 28:08.04.24.) Alkalinization of the urine with citrates also may enhance urinary excretion of chlorpropamide and lithium.

Alkalinization of the urine with citrates may decrease urinary excretion of amphetamines, pseudoephedrine, and quinidine and increase serum concentrations of these drugs. Dosage reduction of pseudoephedrine may be necessary. Concomitant use of amphetamines and citrates should be avoided, especially in patients with amphetamine overdosage, since toxicity will be prolonged. If citrate therapy is initiated or discontinued in a patient receiving a stable quinidine dosage regimen, ECGs and serum quinidine concentrations should be monitored.