Citrates (Systemic)

This monograph includes information on the following:

1) Potassium Citrate
2) Potassium Citrate and Citric Acid
3) Potassium Citrate and Sodium Citrate
4) Sodium Citrate and Citric Acid
5) Tricitrates

VA CLASSIFICATION
Potassium Citrate
Primary: TN410
Secondary: GU900

Potassium Citrate and Citric Acid
Primary: TN410
Secondary: GU900; TN900

Potassium Citrate and Sodium Citrate
Primary: TN410
Secondary: GU900

Sodium Citrate and Citric Acid
Primary: TN410
Secondary: GU900; TN900

Tricitrates
Primary: TN410
Secondary: GU900; TN900


Commonly used brand name(s): Bicitra4; Citrolith3; Oracit4; Polycitra Syrup5; Polycitra-K2; Polycitra-K Crystals2; Polycitra-LC5; Urocit-K1.

Other commonly used names for sodium citrate and citric acid are
Albright"s solution and modified Shohl"s solution .
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antiurolithic, uric acid calculi—Potassium Citrate; Potassium Citrate and Citric Acid; Potassium Citrate and Sodium Citrate; Sodium Citrate and Citric Acid; Tricitrates;

Antiurolithic, cystine calculi—Potassium Citrate; Potassium Citrate and Citric Acid; Potassium Citrate and Sodium Citrate; Sodium Citrate and Citric Acid; Tricitrates;

Antiurolithic, calcium oxalate calculi—Potassium Citrate; Potassium Citrate and Citric Acid;

Antiurolithic, calcium phosphate calculi—Potassium Citrate; Potassium Citrate and Citric Acid;

Alkalizer, systemic—Potassium Citrate and Citric Acid; Sodium Citrate and Citric Acid; Tricitrates;

Alkalizer, urinary—Potassium Citrate; Potassium Citrate and Citric Acid; Potassium Citrate and Sodium Citrate; Sodium Citrate and Citric Acid; Tricitrates;

Buffer, neutralizing—Sodium Citrate and Citric Acid; Tricitrates;

Indications

Accepted

Renal calculi, cystine (prophylaxis and treatment) or
Renal calculi, uric acid (prophylaxis and treatment)—Citrates are indicated as urinary alkalizers in the prevention and treatment of uric acid or cystine lithiasis. They are often used in gout therapy as urinary alkalizers to prevent crystallization of urates. {08} {22} {31} {32} {33}

Renal calculi, calcium (prophylaxis and treatment) or
Hypocitraturia (prophylaxis and treatment){03}—Potassium citrate and potassium citrate and citric acid are also indicated to increase urinary citrate in the prevention and treatment of calcium phosphate, calcium oxalate, or uric acid kidney stones in such conditions as renal tubular acidosis with calcium stones, hypocitraturic calcium oxalate nephrolithiasis of any etiology, and uric acid or cystine lithiasis with or without calcium stones. {21} {31}

Acidosis, in renal tubular disorders (treatment)—Potassium citrate and citric acid, sodium citrate and citric acid, and tricitrates are also used in the treatment of chronic metabolic acidosis resulting from chronic renal insufficiency or the syndrome of renal tubular acidosis. Sodium citrate is especially useful when the administration of potassium salts is undesirable or contraindicated. {31}

Pneumonitis, aspiration (prophylaxis)—Sodium citrate and citric acid and tricitrates are used in preanesthesia medication as nonparticulate acid-neutralizing buffers of gastric acid {32} to lessen the danger from acid-aspiration pneumonitis in patients at risk. Citrates have generally been replaced by the equally or more effective H 2-receptor antagonists in the prevention of acid aspiration in elective surgery. However, citrates and other antacids have a more rapid onset of action than H 2-receptor antagonists and may be more useful in emergency situations. {07} {09} {23} {29} {32} {47}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    Potassium citrate: 324.41
    Sodium citrate: 258.07 (anhydrous)
    Citric acid: 192.12

Mechanism of action/Effect:

Alkalizer, urinary or

Antiurolithic, uric acid calculi or

Antiurolithic, cystine calculi—Sodium citrate and potassium citrate are metabolized to bicarbonates, which increase urinary pH by increasing the excretion of free bicarbonate ions, without producing systemic alkalosis when administered in recommended doses. A rise in urinary pH increases the solubility of cystine in the urine and the ionization of uric acid to more soluble urate ion. By maintaining an alkaline urine, the actual dissolution of uric acid stones may be accomplished. {05}

Antiurolithic, calcium calculi—Metabolism of absorbed potassium citrate produces an alkaline load, raising urinary pH and increasing urinary citrate by augmenting citrate clearance. Thus, potassium citrate therapy appears to increase urinary citrate mainly by changing the renal handling of citrate, and, to a smaller extent, {48} by increasing the filterable load of citrate. Increased urinary citrate and pH decreases calcium ion activity by increasing calcium complexation to dissociated anions and thus decreasing the saturation of calcium oxalate. {31}

Potassium citrate also inhibits the crystallization and spontaneous nucleation of calcium oxalate and calcium phosphate in hypocitraturic calcium nephrolithiasis. {31} However, potassium citrate does not alter the urinary saturation of calcium phosphate, because the effect of increased citrate complexation of calcium is antagonized by the rise in pH-dependent dissociation of phosphate. Calcium phosphate stones are more stable in alkaline urine. {05}

Alkalizer, systemic—Increases the plasma bicarbonate, buffers excess hydrogen ion concentration, and raises blood pH, thereby reversing the clinical manifestations of acidosis.

Neutralizing buffer—Reacts chemically to neutralize or buffer existing quantities of gastric hydrochloric acid but has no direct effect on its output.

Biotransformation:

Oxidized in the body to form potassium bicarbonate or sodium bicarbonate. Effects are essentially those of chlorides before absorption and those of bicarbonates after absorption. {06} {32} {35}

Onset of action:

Potassium citrate—Single dose: Within 1 hour.

Duration of action:


Potassium citrate tablets {31}:

Single dose: Up to 12 hours.

Multiple doses: 3 days.



Potassium citrate and citric acid oral solution—Up to 24 hours at dosage of::

10 to 15 mL four times a day: Maintains a urine pH of 6.5 to 7.4.

15 to 20 mL four times a day: Maintains a urine pH of 7.0 to 7.6.



Tricitrates oral solution—Up to 24 hours at dosage of::

10 to 15 mL four times a day—Maintains a urine pH of 6.5 to 7.4.

15 to 20 mL four times a day—Maintains a urine pH of 7.0 to 7.6.


Elimination:
    Urinary; less than 5% unchanged.


Precautions to Consider

Carcinogenicity

Long-term carcinogenicity studies in animals have not been performed. {10}

Pregnancy/Reproduction

Pregnancy—
Studies have not been done in humans. {10} {31} {32} {33}

Studies have not been done in animals. {10} {31} {32} {33}

Potassium citrate; and potassium citrate and sodium citrate—FDA Pregnancy Category C.

Breast-feeding

It is not known whether citrates are distributed into breast milk. However, problems in humans have not been documented.

Pediatrics

Appropriate studies on the relationship of age to the effects of citrates have not been performed in the pediatric population. However, no pediatrics-specific problems have been documented to date.


Geriatrics


No information is available on the relationship of age to the effects of citrates in geriatric patients.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Amphetamines or
Ephedrine or
Pseudoephedrine or
» Quinidine    (concurrent use with citrates may inhibit urinary excretion and prolong the duration of action of these medications {17} {20} {40})


» Antacids, especially those containing aluminum or sodium bicarbonate    (concurrent use with citrates may result in systemic alkalosis)

    (concurrent use of sodium citrate with sodium bicarbonate may promote the development of calcium stones in patients with uric acid stones, due to sodium ion opposition to the hypocalciuric effect of the alkaline load; may also cause hypernatremia {19})

    (concurrent use of aluminum-containing antacids with citrate salts can increase aluminum absorption, possibly resulting in acute aluminum toxicity, especially in patients with renal insufficiency {01} {02} {04} {24} {28} {29} {32} {43} {44})


Anticholinergics or other medications with anticholinergic activity (See Appendix II )    (concurrent use with potassium citrate may increase risk of gastrointestinal irritation because of slowed gastrointestinal transit time; patients should be carefully monitored endoscopically for evidence of lesions {31})


» Angiotensin-converting enzyme (ACE) inhibitors or{35}{55}{64}
» Anti-inflammatory drugs, nonsteroidal (NSAIDs) or{55}{63}
Cyclosporine or{55}{63}
» Diuretics, potassium-sparing or{19}{31}{35}{40}{45}
» Heparin or{12}{13}{14}{15}{55}{62}
» Low-salt milk or
» Potassium-containing medications, other or{10}{31}
» Salt substitutes{11}{45}    (concurrent use with potassium citrate may increase serum potassium concentrations, which may cause severe hyperkalemia and lead to cardiac arrest, especially in renal insufficiency; {31} low-salt milk may contain up to 60 mEq of potassium per liter and most salt substitutes contain substantial amounts of potassium)


Ciprofloxacin or{26}{27}{54}
Norfloxacin or{53}
Ofloxacin    (citrates may reduce the solubility of ciprofloxacin, norfloxacin, or ofloxacin in the urine; patients should be observed for signs of crystalluria and nephrotoxicity)


» Digitalis glycosides{10}{31}{33}{35}    (concurrent use with potassium citrate may increase risk of hyperkalemia in digitalized patients; careful monitoring of serum potassium concentrations during concurrent use is recommended)


Laxatives    (concurrent administration with citrates may have an additive effect since sodium or potassium citrate may act as a saline laxative; however, these medications may be used concurrently as a preoperative for therapeutic advantage {35})


Lithium{21}{41}    (concurrent use with sodium citrate may increase the urinary excretion of lithium and reduce its therapeutic effects, possibly due to the sodium content of the citrate and/or the effect of urinary alkalinization)


» Methenamine{40}{42}{64}    (concurrent use with citrates is not recommended because alkalinizing the urine may inhibit the effects of methenamine)


Salicylates{40}    (concurrent use with citrates may increase the urinary excretion and decrease the therapeutic effects of salicylates due to alkalinization of the urine)


Sodium-containing medications    (concurrent use with sodium citrate may increase the risk of hypernatremia, especially in patients with renal disease {35})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, this medication should not be used when the following medical problems exist:

For potassium citrate– and/or sodium citrate–containing:
» Aluminum toxicity    (citrate salts have been found to increase aluminum absorption and may exacerbate the condition, especially in renal insufficiency {29} {32} {49})


» Heart failure or{10}
» Myocardial damage, severe{10}{19}    (because of impaired mechanisms for excreting potassium, potentially fatal asymptomatic hyperkalemia can develop, rapidly leading to cardiovascular failure and cardiac arrest {31})

    (sodium retention may result when patients with congestive heart failure are administered sodium citrate)


» Renal impairment, severe, with azotemia or oliguria or{10}{19}
» Renal insufficiency, when glomerular filtration rate (GFR) is less than 0.7 mL per kg per minute{19}{32}    (danger of soft tissue calcification; increased risk of hyperkalemia or alkalosis {31})

    (sodium retention may occur with use of sodium citrate)


» Urinary tract infection,{19} active, with urea-splitting or other organisms, in association with calcium or struvite stones    (bacterial enzymatic degradation of citrate may occur, preventing it from increasing urinary citrate; also, the rise in urinary pH may promote further bacterial growth {31})


For potassium citrate–containing only (in addition to those listed above):
» Hyperkalemia, or conditions predisposing to hyperkalemia such as:{46}
Adrenal insufficiency{19}
Dehydration, acute
Diabetes mellitus, uncontrolled{19}
Physical exercise, strenuous, in unconditioned persons{16}{19}{57}
Renal failure, chronic{19}
Tissue breakdown, extensive{31}    (increased serum potassium concentrations leading to cardiac arrest may occur; exercise-induced hyperkalemia is transient and is a problem only in patients with renal insufficiency from dehydration or those taking medications that increase serum potassium {55} {56} {57} {58})


» Peptic ulcer{19}    (increased risk of gastrointestinal lesions with potassium citrate, especially with tablets {31})


For potassium citrate tablets only (in addition to those listed above):
» Gastric emptying, delayed or{19}
» Esophageal compression or
» Intestinal obstruction or stricture{19}    (delayed passage of tablets through gastrointestinal tract may increase risk of gastrointestinal irritation {31})


Risk-benefit should be considered when the following medical problems exist

For potassium citrate– and sodium citrate–containing:
» Acidosis, renal tubular, severe or{10}{31}
Diarrheal syndromes, chronic, such as ulcerative colitis, regional enteritis, or jejuno-ileal bypass surgery{05}{31}    (when urinary citrate in these conditions is very low [below 100 mg per day], citrates may be relatively ineffective in raising urinary citrate; higher doses may be required to produce the desired citraturic response; when urinary pH is high in renal tubular acidosis, citrates may produce only a small rise in pH; {31} rapid transit time associated with diarrheal syndromes may prevent proper breakdown of tablets [especially wax matrix], liquid preparations should be used in diarrheal syndromes {59})


For sodium citrate–containing only (in addition to those listed above):
Edema, peripheral or pulmonary or
Hypertension or
Toxemia of pregnancy    (sodium salts should be used cautiously in patients with these conditions to prevent exacerbation; also, patients on sodium restricted diets should not take sodium citrate {10} {32})



Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

Acid-base balance, serum, including pH and carbon dioxide and{31}
Complete blood counts, including hematocrit and hemoglobin and{31}
Creatinine concentrations, serum and
Electrolyte concentrations, serum, including sodium, potassium, chloride, and bicarbonate{31}    (determinations recommended every 4 months during therapy, especially for patients with renal disease; treatment should be discontinued if there is a significant rise in serum potassium or in serum creatinine, or a significant fall in hematocrit or hemoglobin values {10} {31})


Citrate, urinary, 24-hour, determinations and/or
pH determinations, urinary    (recommended at start of therapy, to determine adequacy of initial dosage, and every 4 months thereafter; patients taking citrate solutions should frequently check urinary pH to maintain alkalinity at all times {10} {31})


Electrocardiogram (ECG){31}    (recommended periodically, especially in patients with cardiac disease; characteristic changes such as peaking of T-wave, loss of P-wave, depression of ST-segment, and prolongation of the QT-interval may indicate asymptomatic hyperkalemia {31})




Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
For potassium citrate– and sodium citrate–containing
    
Metabolic alkalosis (mood or mental changes; muscle pain or twitching; nervousness or restlessness; slow breathing; unpleasant taste; unusual tiredness or weakness)

For potassium citrate–containing only (in addition to those listed above)
    
Bowel obstruction or bowel perforation (abdominal or stomach cramps or pain; black, tarry stools; severe vomiting, sometimes with blood)—for tablet dosage form only
    
hyperkalemia {10}{32}(confusion; irregular heartbeat; numbness or tingling in hands, feet, or lips; shortness of breath or difficult breathing; unexplained anxiety; unusual tiredness or weakness; weakness or heaviness of legs)
Note: Bowel obstruction or bowel perforation caused by high concentration of potassium ions in region of dissolving tablets. Because the wax matrix is not an enteric coating, improper release of some of the potassium ions from the wax matrix into the stomach may cause upper gastrointestinal bleeding with the same frequency as other wax-matrix potassium products; if these adverse effects occur, potassium citrate should be discontinued immediately. {31}
Hyperkalemia may often be asymptomatic or manifested only by characteristic ECG changes. Late signs may include muscle paralysis and cardiac arrest. When citrates are used at recommended doses, hyperkalemia is rare in patients without predisposing conditions {31}.



For sodium citrate–containing only (in addition to those listed for potassium citrate– or sodium citrate–containing)
    
Hypernatremia (dizziness; fast heartbeat; high blood pressure; irritability; muscle twitching; restlessness; seizures; swelling of feet or lower legs; weakness)—occurs very rarely{60}{61}




Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent
For potassium citrate– and sodium citrate–containing
    
Laxative effect (diarrhea or loose bowel movements)

For potassium citrate only (in addition to those listed above)
    
Irritation, contact (mild abdominal or stomach soreness or pain; nausea or vomiting{31})—for tablet dosage form only
Note: Contact irritation may be due to possible contact with ulcerous areas or high concentration of potassium ions in one area resulting from improper release of potassium ions from wax-matrix dosage form or delayed passage of dosage form through alimentary tract {31}.








Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Citrates (Systemic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Other medications, especially—
    (For all citrates: Quinidine, calcium-containing medications, methenamine, antacids)


    (For potassium citrate–containing only: Angiotensin-converting enzyme (ACE) inhibitors, digitalis glycosides, heparin, nonsteroidal anti-inflammatory drugs (NSAIDs), potassium-sparing diuretics, other potassium-containing medications)


Other medical problems, especially
    (For potassium citrate– and/or sodium citrate–containing: Aluminum toxicity, heart failure, severe myocardial damage, severe renal function impairment with azotemia or oliguria, renal insufficiency, or urinary tract infection)


    (For potassium citrate–containing only: Hyperkalemia or conditions predisposing to hyperkalemia, peptic ulcer, or severe renal tubular acidosis)


    (For potassium citrate tablets only: Delayed gastric emptying, esophageal compression, or intestinal obstruction or stricture)



Proper use of this medication
Proper administration:

For tablet dosage form
Swallowing tablet whole; not crushing, chewing, or sucking {31}

Taking with a full glass (240 mL) of water or juice {31}

» Checking with physician at once if trouble in swallowing tablets or if tablets seem to stick in the throat

For oral liquid dosage form
Diluting with 6 ounces of water or juice before swallowing; after swallowing, following with additional water, if desired {32}

Chilling, but not freezing, before swallowing to enhance palatability {32}

For crystals dosage form
Adding contents of one packet to at least 6 ounces of cool water or juice; stirring well to dissolve completely {34}

Following with additional water after swallowing mixture, if desired
» Taking each dose immediately after a meal or within 30 minutes after a meal or bedtime snack to lessen gastrointestinal pain or saline laxative effect {32}

» Importance of high fluid intake (at least 3 liters per day) to prevent supersaturation of urine and to assure a minimum urine volume of 2.5 liters per day {05}

Compliance with therapy, especially when taking with diuretics and digitalis

» Proper dosing
Missed dose: Taking as soon as possible if remembered within 2 hours; not taking if almost time for next dose; not doubling doses

» Proper storage

Precautions while using this medication
Regular visits to physician to check progress of therapy

Checking with physician before starting strenuous physical exercise if out of condition, to prevent possible hyperkalemia

For potassium citrate–containing only

Not taking salt substitutes or drinking low-salt milk unless prescribed by physician

For sodium citrate–containing only

Avoiding salty foods and use of extra table salt

» Checking with physician at once if black, tarry stools or other signs of gastrointestinal bleeding are observed

Not being alarmed at appearance of ``whole'' tablet in stools; checking with physician


Side/adverse effects
Signs of potential side effects, especially:

For potassium citrate– or sodium citrate–containing—Metabolic alkalosis or diarrhea or loose bowel movements

For potassium citrate–containing only—Hyperkalemia

For potassium citrate tablets only—Bowel perforation or obstruction, or contact irritation resulting from improper release from wax matrix of tablets

For sodium citrate–containing only—Hypernatremia


General Dosing Information
For patients on sodium-restricted diets, potassium citrate preparations may be preferable as urinary alkalizers; conversely, sodium citrate may be used when potassium citrate is contraindicated.

The goal of therapy with potassium citrate tablets or potassium citrate and citric acid solution is to increase the urinary citrate to normal (greater than 320 mg a day) and as close to the normal mean (640 mg a day) as possible, and to increase urinary pH to 6.0 to 7.0. {31}

The rise in urinary citrate is directly dependent on the dosage of potassium citrate tablets or potassium citrate and citric acid oral solution. After long-term treatment, a dosage of 6.5 grams of potassium citrate (60 mEq of potassium ion) a day raises urinary citrate by approximately 400 mg a day and increases urinary pH by approximately 0.7 units. {31} When treatment is withdrawn, urinary citrate begins to fall toward the pretreatment level of the first day.

Potassium citrate tablets and potassium citrate and citric acid oral solution are equally efficacious in raising urinary pH and citrate excretion. {19} {29} {30}

Diet/Nutrition
Each dose should be taken immediately after a meal or within 30 minutes after a meal or bedtime snack, to lessen gastrointestinal pain or the saline laxative effect. {32}

High fluid intake (at least 3 liters a day) is important to prevent supersaturation of urine and to assure a minimum urine volume of 2.5 liters a day.

Low-salt milk may contain up to 60 mEq of potassium per liter, and salt substitutes may contain substantial amounts of potassium. Both should be avoided if a patient is taking a potassium citrate–containing product, to prevent hyperkalemia. {11} {45}

For treatment of adverse effects
For hyperkalemia
Treatment includes:

   • Discontinuing foods and medications containing potassium, including salt substitutes, ACE inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), heparin, cyclosporine, and potassium-sparing diuretics. {33} {49}
   • Administering 10% dextrose injection containing 10 to 20 units of insulin per liter at a rate of 300 to 500 mL of solution per hour. Monitoring for serial EKG and serum potassium concentration is recommended. {33} {36}
   • Correcting acidosis with intravenous sodium bicarbonate.
   • Using exchange resins, hemodialysis, or peritoneal dialysis. {33}
   • Observing caution when treating hyperkalemia in digitalized patients, since rapid reduction of serum potassium concentrations may induce digitalis toxicity. {33}
For hypernatremia
Treatment includes:

   • Discontinuing foods and medications containing sodium.
   • If acute hypernatremia, administering hypotonic {39} or isotonic saline solution intravenously to maintain fluid volume. In infants, to avoid a too rapid fall in serum sodium concentrations, use of a saline solution containing less than 70 mEq per liter is not recommended. Serum osmolality should be corrected over a 24- to 48-hour period. {37} {50}

For metabolic alkalosis
Treatment includes:

   • Controlling symptoms by having patient rebreathe expired air into a paper bag or mask.
   • Administering calcium gluconate injection if alkalosis is severe, to control tetany.


POTASSIUM CITRATE

Summary of Differences
Indications: Also used to prevent or treat hypocitraturia in patients with calcium renal calculi.

Precautions: Medical considerations/contraindications—May increase risk of gastrointestinal lesions in peptic ulcer disease; may increase risk of gastrointestinal irritation in delayed gastric emptying, esophageal compression, or intestinal obstruction.

Side/adverse effects: Tablets may cause severe abdominal or stomach pain; black, tarry stools; or severe vomiting, sometimes with blood.


Additional Dosing Information
May be used as a urinary alkalizer when sodium citrate is contraindicated.


Oral Dosage Forms

POTASSIUM CITRATE TABLETS

Usual adult dose
Antiurolithic or
Alkalizer, urinary
Mild to moderate hypocitraturia (more than 150 mg of urinary citrate a day): Oral, initially 1.08 grams (10 mEq of potassium ion) three times a day with meals. {31}

Severe hypocitraturia (less than 150 mg of urinary citrate a day): Oral, initially, 2.16 grams (20 mEq of potassium ion) three times a day, with meals or within thirty minutes after a meal or bedtime snack; or 1.62 grams (15 mEq of potassium ion) four times a day, with meals or within thirty minutes after a meal or bedtime snack. {31}

Note: Dosage should be adjusted as determined by 24-hour fasting urinary citrate and/or urinary pH measurements. {31}



Usual adult prescribing limits
10.8 grams of potassium citrate (100 mEq of potassium ion) a day. {31}

Usual pediatric dose
Dosage has not been established.

Strength(s) usually available
U.S.—


540 mg (5 mEq of potassium ion) (Rx) [Urocit-K]


1080 mg (10 mEq of potassium ion) (Rx) [Urocit-K]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Swallow tablets whole
   • Take with a full glass of water.
   • Take with meals or snack.

Note: Dispense in original container.


Additional information:
Intact wax matrix may appear in the feces.


POTASSIUM CITRATE AND CITRIC ACID

Summary of Differences
Indications: Also used to prevent or treat hypocitraturia in patients with calcium renal calculi.


Additional Dosing Information
May be used as a urinary alkalizer when sodium citrate is contraindicated.


Oral Dosage Forms

POTASSIUM CITRATE AND CITRIC ACID ORAL SOLUTION USP

Usual adult dose
Antiurolithic or
Alkalizer, systemic or
Alkalizer, urinary
Oral, initially 10 to 15 mL (2.2 to 3.3 grams of potassium citrate [20 to 30 mEq of potassium ion]) four times a day, after meals and at bedtime, the dosage being adjusted as needed and tolerated. {33}

Note: Dosage should be adjusted as determined by 24-hour fasting urinary citrate and/or urinary pH measurements. {33}



Usual pediatric dose
Alkalizer, urinary—Oral, initially 5 to 15 mL (1.1 to 3.3 grams of potassium citrate [10 to 30 mEq of potassium ion]) four times a day, after meals and at bedtime, the dosage being adjusted as needed and tolerated. {33} {51} {52}

Strength(s) usually available
U.S.—


1.1 grams of potassium citrate (10 mEq of potassium ion) and 334 mg of citric acid per 5 mL (Rx) [Polycitra-K]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing and excessive heat.

Auxiliary labeling:
   • Dilute with water or juice.
   • Take with meals or snack.

Additional information:
Citric acid is present as a temporary buffer with only a transient effect on the systemic acid-base balance.


POTASSIUM CITRATE AND CITRIC ACID FOR ORAL SOLUTION

Usual adult dose
Antiurolithic or
Alkalizer, systemic or
Alkalizer, urinary
Oral, initially 3.3 grams of potassium citrate (30 mEq of potassium ion) four times a day, after meals and at bedtime, the dosage being adjusted as needed and tolerated. {34}

Note: Dosage should be adjusted as determined by 24-hour fasting urinary citrate and/or urinary pH measurements. {34}



Usual pediatric dose
Use is not recommended.

Note: Because of the difficulty of regulating dosage with this dosage form, the oral solution is not recommended for pediatric patients.


Size(s) usually available:
U.S.—


3.3 grams of potassium citrate (30 mEq of potassium ion) and 1 gram of citric acid (Rx) [Polycitra-K Crystals]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer.

Preparation of dosage form:
Add contents of one packet to at least 6 ounces of cool water or juice. Stir well to dissolve. {34}

Auxiliary labeling:
   • Dilute with water or juice.
   • Take with meals or snack.

Additional information:
Each packet provides the same amounts of potassium citrate and citric acid as 15 mL of potassium citrate and citric acid oral solution.

Citric acid is present as a temporary buffer with only a transient effect on the systemic acid-base balance.


POTASSIUM CITRATE AND SODIUM CITRATE

Summary of Differences
Indications: Used as a urinary alkalizing agent only, in patients with uric acid or cystine calculi.


Oral Dosage Forms

POTASSIUM CITRATE AND SODIUM CITRATE TABLETS

Usual adult dose
Antiurolithic or
Alkalizer, urinary
Oral, initially, 1 to 4 tablets (50 to 200 mg of potassium citrate [0.45 to 1.8 mEq of potassium ion] and 950 mg to 3.8 grams of sodium citrate [9.5 to 38 mEq of sodium ion]) after meals and at bedtime. {10}


Usual pediatric dose
Dosage has not been established.

Strength(s) usually available
U.S.—


50 mg of potassium citrate (0.45 mEq of potassium ion) and 950 mg of sodium citrate (9.5 mEq of sodium ion) (Rx) [Citrolith]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Swallow tablets whole.
   • Take with a full glass of water.
   • Take with meals or snack.


SODIUM CITRATE AND CITRIC ACID

Summary of Differences
Indications: Also used to prevent acid-aspiration pneumonitis.


Additional Dosing Information
May be used when potassium citrate is contraindicated.


Oral Dosage Forms

SODIUM CITRATE AND CITRIC ACID ORAL SOLUTION USP

Usual adult dose
Antiurolithic or
Alkalizer, systemic or
Alkalizer, urinary
Oral, initially 10 to 30 mL (1 to 3 grams of sodium citrate [10 to 30 mEq of sodium ion]) four times a day, after meals and at bedtime, diluted in 30 to 90 mL of water, the dosage being adjusted as needed. {32}

Note: Dosage should be adjusted as determined by urinary pH measurements. {32}


Neutralizing buffer
Oral, 15 to 30 {29} mL (1.5 to 3 grams of sodium citrate [15 to 30 mEq of sodium ion]), as a single dose, or diluted in 15 to 30 mL of water.


Usual adult prescribing limits
Up to 150 mL (15 grams of sodium citrate [150 mEq of sodium ion]) a day. {32}

Usual pediatric dose
Alkalizer, systemic—Oral, initially 5 to 15 mL (500 mg to 1.5 grams of sodium citrate [5 to 15 mEq of sodium ion]) four times a day, after meals and at bedtime, diluted in 30 to 90 mL of water, the dosage being adjusted as needed. {18} {32}

Strength(s) usually available
U.S.—


490 mg of sodium citrate (5 mEq of sodium ion) and 640 mg of citric acid per 5 mL (Rx) [Oracit (not USP)]


500 mg of sodium citrate (5 mEq of sodium ion) and 334{29} mg of citric acid per 5 mL (Rx) [Bicitra]

Canada—


490 mg of sodium citrate (5 mEq of sodium ion) and 640 mg of citric acid per 5 mL (OTC) [Oracit{25}{38}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

Auxiliary labeling:
   • Dilute with water or juice.
   • Take with meals or snack.

Additional information:
Citric acid is a temporary buffer with only a transient effect on systemic acid-base balance. {32}


TRICITRATES

Summary of Differences
Indications: Also used to treat chronic metabolic acidosis and to prevent acid-aspiration pneumonitis.


Oral Dosage Forms

TRICITRATES ORAL SOLUTION USP

Usual adult dose
Antiurolithic or
Alkalizer, systemic or
Alkalizer, urinary
Oral, initially 15 to 30 mL (1.6 to 3.3 grams of potassium citrate [15 to 30 mEq of potassium ion] and 1.5 to 3 grams of sodium citrate [15 to 30 mEq of sodium ion]) four times a day after meals and at bedtime, the dosage being adjusted as needed. {35}

Note: Dosage should be adjusted as determined by urinary pH measurements. {35}


Neutralizing buffer
Oral, 15 mL (1.65 grams of potassium citrate [15 mEq of potassium ion] and 1.5 grams of sodium citrate [15 mEq of sodium ion]), as a single dose, diluted in 15 mL of water. {35}


Usual pediatric dose
Alkalizer, systemic or
Alkalizer, urinary
Oral, initially 5 to 10 mL (550 mg to 1.10 grams of potassium citrate [5 to 10 mEq of potassium ion] and 500 mg to 1 gram of sodium citrate [5 to 10 mEq of sodium ion]) four times a day after meals and at bedtime, the dosage being adjusted as needed. {35} {51} {52}


Strength(s) usually available
U.S.—


550 mg of potassium citrate (5 mEq of potassium ion), 500 mg of sodium citrate (5 mEq of sodium ion), and 334 mg of citric acid per 5 mL (Rx) [Polycitra-LC] [Polycitra Syrup (sucrose)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

Auxiliary labeling:
   • Dilute with water or juice.
   • Take with meals or snack.

Additional information:
Citric acid is a temporary buffer with only a transient effect on the systemic acid-base balance.



Revised: 08/29/1994



References
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