Potassium citrate

Description

Potassium Citrate Extended-Release Tablets USP are a citrate salt of potassium with the empirical formula K3C6H5O7 • H2O. These tablets are off-white to yellow, formulated as oral wax-matrix tablets. Each tablet contains 10 mEq (1080 mg) of potassium citrate and 15 mEq (1620 mg) of potassium citrate. Inactive ingredients include carnauba wax and magnesium stearate.

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 a bedtime snack to enhance 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 a bedtime snack.

It is essential for healthcare professionals to ensure that patients adhere to the specified timing of doses to optimize therapeutic outcomes.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with hyperkalemia or conditions predisposing to hyperkalemia, including chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, and extensive tissue breakdown, due to the risk of exacerbating elevated potassium levels.

Patients with gastrointestinal conditions that may cause arrest or delay in tablet passage, such as delayed gastric emptying, esophageal compression, intestinal obstruction, or stricture, as these conditions may hinder proper absorption.

Patients with peptic ulcer disease, as the product may exacerbate gastrointestinal irritation.

Patients with active urinary tract infections, due to the potential for worsening the infection or complicating treatment.

Patients with renal insufficiency, specifically those with a glomerular filtration rate of less than 0.7 mL/kg/min, as this may lead to accumulation of the product and increased risk of adverse effects.

Warnings and Precautions

Patients receiving potassium citrate extended-release tablets must be closely monitored for the development of hyperkalemia, particularly in those with compromised renal function or conditions that impair potassium excretion, such as severe myocardial damage or heart failure. Hyperkalemia can manifest rapidly and may be asymptomatic, leading to potentially fatal cardiac arrest. Therefore, the use of potassium citrate in these populations is contraindicated.

In addition, healthcare professionals should be vigilant for gastrointestinal complications. If patients experience severe vomiting, abdominal pain, or gastrointestinal bleeding, potassium citrate extended-release tablets should be discontinued immediately. It is essential to investigate the possibility of bowel perforation or obstruction in such cases to prevent serious complications.

Regular monitoring of potassium levels and renal function is advisable in patients at risk for hyperkalemia to ensure safe administration of potassium citrate.

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, posing a significant risk to affected individuals. In cases of severe vomiting, abdominal pain, or gastrointestinal bleeding, it is crucial to discontinue potassium citrate extended-release tablets immediately and investigate the possibility of gastrointestinal lesions, including bowel perforation or obstruction.

Additional considerations for adverse reactions include specific patient populations at increased risk. 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—should be closely monitored. Furthermore, patients with conditions that may cause arrest or delay in tablet passage through the gastrointestinal tract, including delayed gastric emptying, esophageal compression, intestinal obstruction, or stricture, are also at risk. Other at-risk groups include patients with peptic ulcer disease, active urinary tract infections, and those with renal insufficiency, specifically 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 salts should be avoided to prevent this serious adverse effect.

Drugs that slow gastrointestinal transit time, such as anticholinergics, may exacerbate gastrointestinal irritation associated with potassium salts. Caution is advised when these medications are used concurrently.

For patients receiving renin-angiotensin-aldosterone inhibitors, it is essential to monitor serum potassium levels regularly to detect any signs of hyperkalemia.

Similarly, when nonsteroidal anti-inflammatory drugs (NSAIDs) are prescribed, monitoring for hyperkalemia is recommended, as these agents may also contribute to elevated potassium levels.

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 is available to support its use in this population.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the effects of potassium citrate, particularly regarding the risk of hyperkalemia. Clinical studies of potassium citrate extended-release tablets have not included sufficient numbers of subjects aged 65 and older to ascertain whether their responses differ from those of younger subjects.

The risk of hyperkalemia in geriatric patients may be heightened due to age-related declines in renal function. Potassium citrate administration can lead to hyperkalemia and potentially cardiac arrest, especially in individuals with compromised mechanisms for potassium excretion. Therefore, it is crucial to closely monitor serum electrolytes, including potassium levels, in elderly patients receiving potassium citrate.

Dosage adjustments may be warranted for elderly patients, particularly those with reduced kidney function or other comorbidities that could impair potassium excretion. Additionally, elderly patients may demonstrate increased sensitivity to side effects, necessitating a careful evaluation of the risks versus benefits of potassium citrate therapy in this demographic.

Caution should be exercised when administering potassium citrate to elderly patients, especially those with chronic renal failure or other conditions that affect potassium excretion. These considerations underscore the importance of individualized treatment and vigilant monitoring for geriatric patients receiving potassium citrate.

Pregnancy

Potassium citrate has not been studied in animal reproduction studies, and there is a lack of data regarding its potential to cause fetal harm or impact reproductive capacity in humans. Therefore, potassium citrate extended-release tablets should be administered to pregnant patients only if the benefits clearly outweigh the risks. Healthcare professionals are advised to carefully consider the necessity of treatment with potassium citrate in this population.

Lactation

Lactating mothers should be aware that 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 extended-release tablets should be administered to breastfeeding women only if clearly needed, taking into consideration the potential implications for breastfed infants.

Renal Impairment

Patients with renal impairment may experience significant risks associated with potassium citrate administration. In individuals with impaired mechanisms for excreting potassium, the use of potassium citrate can lead to hyperkalemia, which may progress rapidly and can be asymptomatic, potentially resulting in cardiac arrest. Therefore, potassium citrate extended-release tablets should be avoided in patients with chronic renal failure or any other conditions that impair potassium excretion, such as severe myocardial damage or heart failure. Careful monitoring of potassium levels is essential in this patient population to prevent serious 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 indicated 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

The administration of potassium salts, even at recommended dosages, can infrequently lead to serious hyperkalemia. This condition may be asymptomatic initially, with increased serum potassium concentrations and electrocardiographic changes serving as the primary indicators.

Symptoms and Late Manifestations

As hyperkalemia progresses, late manifestations may include muscle paralysis and cardiovascular collapse, potentially resulting in cardiac arrest. It is essential for healthcare professionals to remain vigilant for these symptoms, particularly in patients with risk factors for hyperkalemia.

Management Procedures

Management of hyperkalemia necessitates close monitoring for arrhythmias and electrolyte changes. Immediate actions include the elimination of any medications containing potassium, as well as potassium-sparing agents. Additionally, dietary modifications are critical; foods high in potassium, such as bananas, apricots, and spinach, should be removed from the patient's diet.

In cases where the patient is at low risk for digitalis toxicity, intravenous calcium gluconate may be administered to stabilize cardiac membranes. Furthermore, a 10% dextrose solution combined with 10 to 20 units of crystalline insulin per 1,000 mL can be given intravenously at a rate of 300 to 500 mL/hr to facilitate the cellular uptake of potassium.

If acidosis is present, correction with intravenous sodium bicarbonate is recommended. For severe cases of hyperkalemia, hemodialysis or peritoneal dialysis may be necessary to effectively lower potassium levels. It is important to note that in patients taking digitalis, potassium levels should not be lowered too rapidly, as this may precipitate digitalis toxicity.

Healthcare professionals are advised to implement these management strategies promptly to mitigate the risks associated with hyperkalemia.

Nonclinical Toxicology

Animal reproduction studies have not been conducted to evaluate the teratogenic potential 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 extended-release tablets should be prescribed to pregnant women only if clearly needed.

Regarding non-teratogenic effects, the normal potassium ion concentration in human milk is approximately 13 mEq/L. However, it is not established whether potassium citrate influences this concentration. As such, potassium citrate extended-release tablets should be administered to breastfeeding women only if clearly needed.

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

Postmarketing Experience

No postmarketing experience details are available in the provided text.

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 their doctor will conduct regular blood tests and electrocardiograms to monitor their health and ensure the safety of the treatment. This ongoing assessment is essential for managing any potential risks associated with the medication.

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 20° to 25°C (68° to 77°F), with permissible excursions between 15° to 30°C (59° to 86°F) as defined by USP Controlled Room Temperature guidelines. Proper storage conditions are essential to maintain the product's efficacy and safety.

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 ANI Pharmaceuticals, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)