Potassium citrate

Description

Potassium Citrate extended-release tablets, USP are a citrate salt of potassium with the chemical formula K₃C₆H₅O₇ • H₂O and a molecular weight of 324.41. These tablets are presented as tan to yellowish, oral wax-matrix formulations. Each tablet contains 5 mEq (540 mg), 10 mEq (1080 mg), or 15 mEq (1620 mg) of potassium citrate, USP. Inactive ingredients include carnauba wax and magnesium stearate. The product meets the USP Dissolution Test 2 standards.

Uses and Indications

Potassium Citrate extended-release tablets are indicated for the management of renal tubular acidosis (RTA) associated with calcium stones, hypocitraturic calcium oxalate nephrolithiasis of any etiology, and uric acid lithiasis, with or without the presence of calcium stones.

There are no teratogenic or nonteratogenic effects associated with the use of this medication.

Dosage and Administration

For patients with severe hypocitraturia (urinary citrate < 150 mg/day), therapy should be initiated at a dosage of 60 mEq per day. This can be administered as 30 mEq two times per day or 20 mEq three times per day. Doses should be taken with meals, within 30 minutes after meals, or at bedtime snack to optimize absorption.

In cases of mild to moderate hypocitraturia (urinary citrate > 150 mg/day), therapy should commence at a dosage of 30 mEq per day. This may be given as 15 mEq two times per day or 10 mEq three times per day, also with meals, within 30 minutes after meals, or at bedtime snack.

It is essential to adhere to these dosing schedules to ensure effective management of hypocitraturia.

Contraindications

Use is contraindicated in patients with hyperkalemia or conditions predisposing them to hyperkalemia, including chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, and extensive tissue breakdown.

Additionally, use is contraindicated in patients with gastrointestinal conditions that may cause arrest or delay in tablet passage, such as delayed gastric emptying, esophageal compression, intestinal obstruction, or stricture.

Patients with peptic ulcer disease and those with active urinary tract infections should also not use this product. Furthermore, it is contraindicated in patients with renal insufficiency, specifically those with a glomerular filtration rate of less than 0.7 mL/kg/min.

Warnings and Precautions

Patients receiving potassium citrate should be closely monitored for the development of hyperkalemia, particularly in those with compromised renal function or conditions that impair potassium excretion. Hyperkalemia can lead to serious complications, including cardiac arrest, and may occur rapidly and without symptoms. Therefore, the use of potassium citrate is contraindicated in individuals with chronic renal failure or severe myocardial damage, as well as in those with heart failure.

In addition, the presence of gastrointestinal symptoms such as severe vomiting, abdominal pain, or gastrointestinal bleeding necessitates the immediate discontinuation of potassium citrate. These symptoms may indicate serious underlying conditions, including bowel perforation or obstruction, which require prompt medical evaluation.

Healthcare professionals should remain vigilant for these potential adverse effects and ensure appropriate monitoring and intervention as necessary.

Side Effects

Patients may experience a range of adverse reactions associated with potassium citrate administration. Common adverse reactions include minor gastrointestinal complaints such as abdominal discomfort, vomiting, diarrhea, loose bowel movements, and nausea.

Serious adverse reactions have been reported, including hyperkalemia, particularly in patients with impaired mechanisms for excreting potassium. This condition can lead to cardiac arrest and may develop rapidly and asymptomatically. Therefore, the use of potassium citrate is contraindicated in patients with chronic renal failure or other conditions that impair potassium excretion, such as severe myocardial damage or heart failure. Additionally, gastrointestinal lesions may occur; if patients experience severe vomiting, abdominal pain, or gastrointestinal bleeding, potassium citrate should be discontinued immediately, and an investigation for potential bowel perforation or obstruction should be conducted.

Further considerations include patients with pre-existing hyperkalemia or conditions that predispose them to hyperkalemia, such as chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, or extensive tissue breakdown. Caution is also advised for patients who may experience delays in tablet passage through the gastrointestinal tract, including those with delayed gastric emptying, esophageal compression, intestinal obstruction, or stricture. Additionally, potassium citrate should be used with caution in patients with peptic ulcer disease, active urinary tract infections, or renal insufficiency, particularly in those with a glomerular filtration rate of less than 0.7 mL/kg/min.

Drug Interactions

Concomitant administration of potassium-sparing diuretics is contraindicated due to the potential for severe hyperkalemia. The use of these agents alongside potassium supplements or potassium-containing medications should be avoided to prevent this serious adverse effect.

Drugs that slow gastrointestinal transit time, including anticholinergics, may exacerbate gastrointestinal irritation when used with potassium salts. Caution is advised when these medications are prescribed concurrently, as the risk of irritation may increase.

For patients receiving renin-angiotensin-aldosterone inhibitors, it is essential to monitor serum potassium levels regularly to detect any signs of hyperkalemia. This monitoring is crucial to ensure patient safety and to adjust therapy as needed.

Nonsteroidal anti-inflammatory drugs (NSAIDs) also warrant careful monitoring for hyperkalemia when used in conjunction with potassium supplements or potassium-sparing agents. Regular assessment of potassium levels is recommended to mitigate the risk of elevated serum potassium.

Packaging & NDC

The table below lists all NDC Code configurations of Potassium Citrate, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Therefore, the use of this medication in children is not recommended until further data are available to support its use in this population.

Geriatric Use

Elderly patients may be prescribed Potassium Citrate extended-release tablets; however, the prescribing information does not provide specific recommendations for geriatric use, including dosage adjustments or safety concerns. Additionally, there are no special precautions outlined for this population.

Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering individual patient factors and potential comorbidities that may influence treatment outcomes. Regular monitoring may be warranted to ensure safety and efficacy in this demographic.

Pregnancy

Animal reproduction studies have not been conducted with potassium citrate. Therefore, it is not known whether potassium citrate can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. Given the lack of data, potassium citrate should be administered to pregnant patients only if clearly needed, weighing the potential benefits against any unknown risks to fetal outcomes. Healthcare professionals are advised to exercise caution and consider alternative treatments when appropriate.

Lactation

The normal potassium ion content of human milk is approximately 13 mEq/L. It is currently unknown whether potassium citrate affects this potassium content in breast milk. Therefore, potassium citrate should be administered to lactating mothers only if clearly needed.

Renal Impairment

Patients with impaired mechanisms for excreting potassium are at an increased risk of hyperkalemia when administered potassium citrate. This condition can lead to cardiac arrest and may develop rapidly, often without symptoms. Therefore, the use of potassium citrate is contraindicated in patients with chronic renal failure or any other conditions that significantly impair potassium excretion, such as severe myocardial damage or heart failure. Careful consideration and monitoring are essential in this patient population to prevent potentially fatal complications.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In cases of overdosage, the administration of potassium salts to individuals without predisposing conditions for hyperkalemia is unlikely to result in serious hyperkalemia at recommended dosages. It is crucial to note that hyperkalemia is often asymptomatic, typically identified only through elevated serum potassium levels and specific electrocardiographic changes, including T-wave peaking, loss of P-wave, S-T segment depression, and QT interval prolongation. Late-stage manifestations may include muscle paralysis and cardiovascular collapse due to cardiac arrest.

Management of Hyperkalemia

Management strategies for hyperkalemia should include the following actions:

1. Monitoring: Patients should be closely monitored for arrhythmias and electrolyte imbalances.

2. Medication Review: Discontinue any medications containing potassium or those with potassium-sparing properties. This includes potassium-sparing diuretics, angiotensin receptor blockers (ARBs), angiotensin-converting enzyme (ACE) inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), and certain nutritional supplements.

3. Dietary Restrictions: Eliminate foods high in potassium from the patient's diet. Common high-potassium foods include almonds, apricots, bananas, lima beans, pinto beans, cantaloupe, canned carrot juice, figs, grapefruit juice, halibut, milk, oat bran, potatoes (with skin), salmon, spinach, and tuna.

4. Calcium Administration: Administer intravenous calcium gluconate if the patient is at low or no risk of developing digitalis toxicity.

5. Insulin and Dextrose: Administer 300 to 500 mL/hr of a 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL to help lower potassium levels.

6. Acidosis Correction: If acidosis is present, correct it with intravenous sodium bicarbonate.

7. Dialysis: Consider hemodialysis or peritoneal dialysis for severe cases.

8. Use of Exchange Resins: While exchange resins may be utilized, they should not be relied upon as the sole treatment for acute hyperkalemia.

It is important to exercise caution when lowering potassium levels in patients taking digitalis, as rapid reductions can precipitate digitalis toxicity. Additionally, in patients with impaired potassium excretion mechanisms, such as those with chronic renal failure or severe myocardial damage, the administration of potassium citrate can lead to hyperkalemia and potentially fatal cardiac arrest. Therefore, the use of potassium citrate in these populations should be avoided.

Nonclinical Toxicology

Animal reproduction studies have not been conducted to evaluate the teratogenic effects of potassium citrate. Consequently, it remains unknown whether potassium citrate can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. Therefore, potassium citrate should be administered to a pregnant woman only if clearly needed.

Regarding non-teratogenic effects, the normal potassium ion content of human milk is approximately 13 mEq/L. However, it is not known if potassium citrate influences this content. As such, potassium citrate should be given to a breastfeeding woman only if clearly needed.

No specific details are available concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Patients should be advised to take each dose of the medication without crushing, chewing, or sucking the tablet to ensure proper absorption and effectiveness. It is crucial for patients to take this medicine only as directed, particularly if they are also using diuretics and digitalis preparations, as this can affect the medication's efficacy and safety.

Patients should be encouraged to communicate with their healthcare provider if they experience any difficulty swallowing the tablets or if they feel that the tablet is sticking in their throat. Additionally, patients must be instructed to seek immediate medical attention if they notice tarry stools or any other signs of gastrointestinal bleeding, as these may indicate serious side effects.

Healthcare providers should inform patients that regular blood tests and electrocardiograms will be performed by their doctor to monitor their safety while on this medication. This ongoing assessment is essential to ensure that the treatment remains appropriate and effective.

Storage and Handling

The product is supplied in a tight container to ensure integrity and stability. It should be stored at a temperature range of 20º to 25ºC (68º to 77ºF), in accordance with USP Controlled Room Temperature guidelines. Proper storage conditions are essential to maintain the quality and efficacy of the product.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Potassium Citrate as submitted by Actavis Pharma, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)