Potassium citrate: Difference between revisions
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Revision as of 17:24, 16 January 2015
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]
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Overview
Potassium citrate is an urinary alkalinizer that is FDA approved for the treatment of nephrolithiasis. Common adverse reactions include abdominal discomfort, vomiting, diarrhea, loose bowel movements or nausea..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indicactions
- Renal tubular acidosis (RTA) with calcium stones
- Hypocitraturic calcium oxalate nephrolithiasis of any etiology
- Uric acid lithiasis with or without calcium stones
Dosage
Severe Hypocitraturia (urinary citrate < 150 mg/day)
- Therapy should be initiated at 60 mEq per day; a dose of 30 mEq two times per day or 20 mEq three times per day with meals or within 30 minutes after meals or bedtime snack.
Mild to Moderate Hypocitraturia (urinary citrate > 150 mg/day)
- Therapy should be initiated at 30 mEq per day; a dose of 15 mEq two times per day or 10 mEq three times per day with meals or within 30 minutes after meals or bedtime snack.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Potassium citrate in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Potassium citrate in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Safety and efficacy not established in pediatric patients
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Potassium citrate in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Potassium citrate in pediatric patients.
Contraindications
Potassium Citrate is contraindicated:
- In patients with hyperkalemia (or who have conditions pre-disposing them to hyperkalemia), as a further rise in serum potassium concentration may produce cardiac arrest. Such conditions include: chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown or the administration of a potassium-sparing agent (such as triamterene, spironolactone or amiloride).
- In patients in whom there is cause for arrest or delay in tablet passage through the gastrointestinal tract, such as those suffering from delayed gastric emptying, esophageal compression, intestinal obstruction or stricture, or those taking anticholinergic medication.
- In patients with peptic ulcer disease because of its ulcerogenic potential.
- In patients with active urinary tract infection (with either urea-splitting or other organisms, in association with either calcium or struvite stones). The ability of Potassium Citrate to increase urinary citrate may be attenuated by bacterial enzymatic degradation of citrate. Moreover, the rise in urinary pH resulting from Potassium Citrate therapy might promote further bacterial growth.
- In patients with renal insufficiency (glomerular filtration rate of less than 0.7 ml/kg/min), because of the danger of soft tissue calcification and increased risk for the development of hyperkalemia.
Warnings
Hyperkalemia
- In patients with impaired mechanisms for excreting potassium, Potassium Citrate administration can produce hyperkalemia and cardiac arrest.
- Potentially fatal hyperkalemia can develop rapidly and be asymptomatic.
- The use of Potassium Citrate in patients with chronic renal failure, or any other condition which impairs potassium excretion such as severe myocardial damage or heart failure, should be avoided.
- Closely monitor for signs of hyperkalemia with periodic blood tests and ECGs.
Gastrointestinal Lesions
- Because of reports of upper gastrointestinal mucosal lesions following administration of potassium chloride (wax-matrix), an endoscopic examination of the upper gastrointestinal mucosa was performed in 30 normal volunteers after they had taken glycopyrrolate 2 mg p.o. t.i.d., Potassium Citrate 95 mEq/day, wax-matrix potassium chloride 96 mEq/day or wax-matrix placebo, in thrice daily schedule in the fasting state for one week. Potassium Citrate and the wax-matrix formulation of potassium chloride were indistinguishable but both were significantly more irritating than the wax-matrix placebo. In a subsequent, similar study, lesions were less severe when glycopyrrolate was omitted.
- Solid dosage forms of potassium chlorides have produced stenotic and/or ulcerative lesions of the small bowel and deaths. These lesions are caused by a high local concentration of potassium ions in the region of the dissolving tablets, which injured the bowel. In addition, perhaps because wax-matrix preparations are not enteric-coated and release some of their potassium content in the stomach, there have been reports of upper gastrointestinal bleeding associated with these products. The frequency of gastrointestinal lesions with wax-matrix potassium chloride products is estimated at one per 100,000 patient-years. Experience with Potassium Citrate is limited, but a similar frequency of gastrointestinal lesions should be anticipated.
- If there is severe vomiting, abdominal pain or gastrointestinal bleeding, Potassium Citrate should be discontinued immediately and the possibility of bowel perforation or obstruction investigated.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Potassium citrate Clinical Trials Experience in the drug label.
Postmarketing Experience
Some patients may develop minor gastrointestinal complaints during Potassium Citrate therapy, such as abdominal discomfort, vomiting, diarrhea, loose bowel movements or nausea. These symptoms are due to the irritation of the gastrointestinal tract, and may be alleviated by taking the dose with meals or snacks, or by reducing the dosage. Patients may find intact matrices in their feces.
Drug Interactions
Potential Effects of Potassium Citrate on Other Drugs
- Potassium-sparing Diuretics
- Concomitant administration of Potassium Citrate and a potassium-sparing diuretic (such as triamterene, spironolactone or amiloride) should be avoided since the simultaneous administration of these agents can produce severe hyperkalemia.
Potential Effects of Other Drugs on Potassium Citrate
- Drugs that slow gastrointestinal transit time
- These agents (such as anticholinergics) can be expected to increase the gastrointestinal irritation produced by potassium salts.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA): C
Animal reproduction studies have not been conducted. It is also not known whether Potassium Citrate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium Citrate should be given to a pregnant woman only if clearly needed.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Potassium citrate in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Potassium citrate during labor and delivery.
Nursing Mothers
The normal potassium ion content of human milk is about 13 mEq/L. It is not known if Potassium Citrate has an effect on this content. Potassium Citrate should be given to a woman who is breast feeding only if clearly needed.
Pediatric Use
Safety and effectiveness in children have not been established.
Geriatic Use
There is no FDA guidance on the use of Potassium citrate in geriatric settings.
Gender
There is no FDA guidance on the use of Potassium citrate with respect to specific gender populations.
Race
There is no FDA guidance on the use of Potassium citrate with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Potassium citrate in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Potassium citrate in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Potassium citrate in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Potassium citrate in patients who are immunocompromised.
Patients taking digitalis
Lowering potassium levels too rapidly in patients taking digitalis can produce digitalis toxicity.
Administration and Monitoring
Administration
There is limited information regarding Potassium citrate Administration in the drug label.
Monitoring
Monitor serum electrolytes (sodium, potassium, chloride and carbon dioxide), serum creatinine and complete blood counts every four months and more frequently in patients with cardiac disease, renal disease or acidosis. Perform electrocardiograms periodically. Treatment should be discontinued if there is hyperkalemia, a significant rise in serum creatinine or a significant fall in blood hemocrit or hemoglobin.
IV Compatibility
There is limited information regarding the compatibility of Potassium citrate and IV administrations.
Overdosage
- The administration of potassium salts to persons without predisposing conditions for hyperkalemia rarely causes serious hyperkalemia at recommended dosages.
- It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration and characteristic electrocardiographic changes (peaking of T-wave, loss of P-wave, depression of S-T segment and prolongation of the QT interval).
- Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest.
- Treatment measures for hyperkalemia include the following:
- Patients should be closely monitored for arrhythmias and electrolyte changes.
- Elimination of medications containing potassium and of agents with potassium-sparing properties such as potassium-sparing diuretics, ARBs, ACE inhibitors, NSAIDs, certain nutritional supplements and many others.
- Elimination of foods containing high levels of potassium such as almonds, apricots, bananas, beans (lima, pinto, white), cantaloupe, carrot juice (canned), figs, grapefruit juice, halibut, milk, oat bran, potato (with skin), salmon, spinach, tuna and many others.
- Intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity.
- Intravenous administration of 300-500 mL/hr of 10% dextrose solution containing 10-20 units of crystalline insulin per 1,000 mL.
- Correction of acidosis, if present, with intravenous sodium bicarbonate.
- Hemodialysis or peritoneal dialysis.
- Exchange resins may be used. However, this measure alone is not sufficient for the acute treatment of hyperkalemia.
Pharmacology
There is limited information regarding Potassium citrate Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Potassium citrate Mechanism of Action in the drug label.
Structure
Its empirical formula is K3C6H507 • H20, and it has the following chemical structure:
Pharmacodynamics
There is limited information regarding Potassium citrate Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Potassium citrate Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Potassium citrate Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Potassium citrate Clinical Studies in the drug label.
How Supplied
There is limited information regarding Potassium citrate How Supplied in the drug label.
Storage
There is limited information regarding Potassium citrate Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
Administration of Drug
- Tell patients to take each dose without crushing, chewing or sucking the tablet.
- Tell patients to take this medicine only as directed. This is especially important if the patient is also taking both diuretics and digitalis preparations.
- Tell patients to check with the doctor if there is trouble swallowing tablets or if the tablet seems to stick in the throat.
- Tell patients to check with the doctor at once if tarry stools or other evidence of gastrointestinal bleeding is noticed.
- Tell patients that their doctor will perform regular blood tests and electrocardiograms to ensure safety.
Precautions with Alcohol
Alcohol-Potassium citrate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Potassium citrate Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Potassium citrate Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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|Label Page=Potassium citrate |Label Name=Potassium citrate 15 mEq.png
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Potassium citrate may be used to control Uric acid and Cystine kidney stones.
Chemical Formula: C6H5K3O7 + H2O
Appearance: A white, slightly hygroscopic crystalline powder. It is odorless with a saline taste.
Uses
Potassium citrate is rapidly absorbed when given by mouth and is excreted in the urine as the carbonate. It is, therefore, effective in reducing the pain and frequency of micturition when these are caused by highly acidic urine. It is used for this purpose in dogs and cats, but is chiefly employed as a non-irritating diuretic.
Potassium citrate is an effective way to treat/manage gout and arrhythmia, if the patient is hypokalemic. In common with other substances which render the urine alkaline, it may be used to reduce the danger of crystalluria during sulfonamide therapy.
It is widely used to treat urinary calculi (kidney stones), and is often used by patients with cystinuria.
It is also used in many soft drinks as a buffer.
Administration
Potassium citrate is usually administered by mouth in dilute aqueous solution.
The maximum amount of potassium citrate allowed by law in a tablet or capsule is only 99 mg[citation needed] (approximately 3% of the daily allowance). This is because of its somewhat caustic effect on the stomach lining, and the potential for other mild health hazards.
- (Only part of potassium citrate is potassium. There are pills sold in the USA with 258 mg of potassium citrate, only part of which is potassium.)