Potassium citrate

Description

Potassium citrate is a citrate salt of potassium with the molecular formula K₃C₆H₅O₇ • H₂O. It is presented as transparent crystals or a white, granular powder. Potassium citrate is freely soluble in water and slightly soluble in alcohol. The extended-release tablets, intended for oral administration, are available in three strengths: 5 mEq (540 mg), 10 mEq (1,080 mg), and 15 mEq (1,620 mg) of potassium citrate, USP as monohydrate. Each tablet also contains inactive ingredients, including carnauba wax and magnesium stearate. Potassium citrate meets the USP Dissolution Test 2.

Uses and Indications

Potassium citrate extended-release tablet is 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 calcium stones.

There are no teratogenic or nonteratogenic effects associated with 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 and efficacy.

In cases of mild to moderate hypocitraturia (urinary citrate > 150 mg/day), therapy should commence at a dosage of 30 mEq per day. This can 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 for healthcare professionals to ensure that patients adhere to the specified timing of doses to achieve the desired 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 and efficacy.

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

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

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 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, if patients experience severe vomiting, abdominal pain, or gastrointestinal bleeding, potassium citrate should be discontinued immediately. These symptoms may indicate serious underlying conditions such as bowel perforation or obstruction, which require prompt medical evaluation.

Healthcare professionals are advised to remain vigilant for these potential adverse effects and to ensure appropriate monitoring of patients at risk.

Side Effects

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

Serious adverse reactions can occur, particularly in patients with impaired mechanisms for excreting potassium. Hyperkalemia is a significant concern, as it can lead to cardiac arrest. This condition may develop rapidly and can be asymptomatic, making it crucial to monitor potassium levels in patients with chronic renal failure or other conditions that impair potassium excretion, such as severe myocardial damage or heart failure. The use of potassium citrate in these populations should be avoided.

Additionally, gastrointestinal lesions may arise, particularly if patients experience severe vomiting, abdominal pain, or gastrointestinal bleeding. In such cases, potassium citrate should be discontinued immediately, and the possibility of bowel perforation or obstruction should be investigated.

Other important considerations include the risk of hyperkalemia in patients with conditions such as uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, or extensive tissue breakdown. Patients with delayed gastric emptying, esophageal compression, intestinal obstruction, or stricture may also be at risk, as well as those with peptic ulcer disease, active urinary tract infections, or renal insufficiency (with a glomerular filtration rate of less than 0.7 ml/kg/min).

In cases of overdosage, hyperkalemia is typically asymptomatic but may be indicated by increased serum potassium concentrations and characteristic electrocardiographic changes, including peaking of the T-wave, loss of the P-wave, depression of the S-T segment, and prolongation of the QT interval. Late manifestations can include muscle paralysis and cardiovascular collapse due to cardiac arrest.

Drug Interactions

Concomitant administration of potassium-sparing diuretics is contraindicated due to the potential for severe hyperkalemia. It is advised that these agents be avoided in patients receiving treatment.

Drugs that slow gastrointestinal transit time, including anticholinergics, may exacerbate gastrointestinal irritation associated with potassium salts. Caution is recommended when these agents are used concurrently.

For patients taking renin-angiotensin-aldosterone inhibitors, monitoring for hyperkalemia is essential. Regular assessment of serum potassium levels is advised to prevent complications.

Nonsteroidal anti-inflammatory drugs (NSAIDs) may also increase the risk of hyperkalemia. Patients should be monitored closely for elevated potassium levels when these medications are used in conjunction.

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 not have specific information regarding the use of this medication, including dosage adjustments or safety concerns. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be aware that 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 prescribed to pregnant women 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

Potassium citrate is excreted in human milk; however, it is not known if it affects the normal potassium ion content of breast milk, which is approximately 13 mEq/L.

Potassium citrate should be administered to lactating mothers only if clearly needed, taking into consideration the potential effects on breastfed infants.

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 outcomes.

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

The administration of potassium salts in individuals without predisposing conditions for hyperkalemia is unlikely to result in serious hyperkalemia when dosages are kept within recommended limits. However, it is crucial to recognize that hyperkalemia is often asymptomatic and may only be indicated by elevated serum potassium levels and specific electrocardiographic changes. These changes can include T-wave peaking, loss of the P-wave, S-T segment depression, and QT interval prolongation.

In more severe cases, late manifestations of hyperkalemia may present as muscle paralysis and cardiovascular collapse due to cardiac arrest.

Recommended Actions for Management of Hyperkalemia

Management of hyperkalemia requires vigilant monitoring and a multifaceted approach:

• Monitoring: Patients should be closely observed for arrhythmias and fluctuations in electrolyte levels.

• Medication Review: It is essential to discontinue any medications that contain potassium or possess 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.

• Dietary Restrictions: Patients should avoid foods high in potassium, such as almonds, apricots, bananas, various beans (lima, pinto, white), cantaloupe, canned carrot juice, figs, grapefruit juice, halibut, milk, oat bran, potatoes (with skin), salmon, spinach, and tuna.

• Calcium Administration: For patients at low or no risk of developing digitalis toxicity, intravenous calcium gluconate may be administered.

• Insulin and Dextrose: An intravenous infusion of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL should be given at a rate of 300 to 500 mL/hr.

• Correction of Acidosis: If acidosis is present, intravenous sodium bicarbonate should be utilized to correct the condition.

• Dialysis: In cases of severe hyperkalemia, hemodialysis or peritoneal dialysis may be necessary.

• Use of Exchange Resins: While exchange resins can be employed, they should not be relied upon as the sole treatment for acute hyperkalemia.

It is important to note that lowering potassium levels too rapidly in patients who are taking digitalis can precipitate digitalis toxicity, necessitating careful management of potassium levels during treatment.

Nonclinical Toxicology

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

Regarding non-teratogenic effects, the normal potassium ion concentration in human milk is approximately 13 mEq/L. The impact of potassium citrate on this concentration is not established. Consequently, potassium citrate should be given to breastfeeding women only if clearly needed.

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

Postmarketing Experience

Reports of side effects have been received through voluntary submissions and surveillance programs. Patients are encouraged to consult their healthcare provider for medical advice regarding any adverse effects experienced. Additionally, side effects can be reported to the FDA at 1-800-FDA-1088.

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 consult their doctor if they experience any difficulty swallowing the tablets or if they notice that the tablet seems to stick in their throat. Additionally, they must be informed to seek immediate medical attention if they observe tarry stools or any other signs of gastrointestinal bleeding, as these may indicate serious side effects.

Healthcare providers should explain that regular blood tests and electrocardiograms will be performed by their doctor to monitor the patient's safety while on this medication. Patients should also be instructed to contact their doctor for medical advice regarding any side effects they may experience. Furthermore, they can report side effects to the FDA at 1-800-FDA-1088.

Storage and Handling

The product is supplied in a tight container as defined by the United States Pharmacopeia (USP). It should be stored at a temperature range of 20° to 25°C (68° to 77°F), in accordance with USP Controlled Room Temperature guidelines. Proper adherence to these storage conditions is essential to maintain the integrity 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 Zydus Lifesciences Limited. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)