Potassium citrate

Description

Potassium Citrate extended release tablets are a citrate salt of potassium, with an empirical formula of K₃C₆H₅O₇ • H₂O. These tablets are presented as off-white to tan yellowish, oral wax-matrix formulations. Each tablet contains 5 mEq (540 mg), 10 mEq (1080 mg), or 15 mEq (1620 mg) of potassium citrate. Inactive ingredients include carnauba wax, silicon dioxide, and magnesium stearate. The FDA-approved dissolution test specifications for these tablets differ from those established by the USP.

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.

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.

It is essential to adhere to these dosing schedules 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 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 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 should 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 lead to serious complications, including cardiac arrest, and may progress rapidly without warning signs. Therefore, the use of Potassium citrate is contraindicated in patients with chronic renal failure or similar conditions.

In addition, healthcare professionals should be vigilant for gastrointestinal complications. If a patient experiences severe vomiting, abdominal pain, or gastrointestinal bleeding, Potassium citrate must be discontinued immediately. It is essential to investigate the potential for bowel perforation or obstruction in such cases to prevent further complications.

Regular monitoring of potassium levels and renal function is advisable to ensure patient safety during treatment with Potassium citrate.

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 potentially fatal. Therefore, the use of Potassium citrate is contraindicated in patients with chronic renal failure or any other conditions that impair potassium excretion, such as severe myocardial damage or heart failure.

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.

Patients with pre-existing hyperkalemia or conditions that predispose them to hyperkalemia, including 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, caution is advised in patients who may experience delays in tablet passage through the gastrointestinal tract, such as those with delayed gastric emptying, esophageal compression, intestinal obstruction, or stricture. Patients with peptic ulcer disease, active urinary tract infections, or renal insufficiency (with a glomerular filtration rate of less than 0.7 ml/kg/min) are also at increased risk for adverse reactions and should be managed accordingly.

Drug Interactions

Concomitant administration of potassium-sparing diuretics with this medication should be avoided due to the risk of severe hyperkalemia. Monitoring of potassium levels is recommended if these agents are used together.

Additionally, the use of drugs that slow gastrointestinal transit time, such as anticholinergics, may exacerbate gastrointestinal irritation associated with potassium salts. Caution is advised when these agents are co-administered, and monitoring for increased gastrointestinal discomfort should be considered.

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 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

Pregnancy Category C. Animal reproduction studies have not been conducted with potassium citrate. It is not known whether potassium citrate can cause fetal harm when administered to a pregnant woman or affect reproductive capacity. Therefore, potassium citrate should be given to a pregnant woman only if clearly needed. Healthcare professionals are advised to weigh the potential benefits against the risks when considering the use of potassium citrate in pregnant patients.

Lactation

Potassium citrate is not known to affect the normal potassium ion content of human milk, which is approximately 13 mEq/L. Due to the lack of data on its excretion in breast milk and potential effects on breastfed infants, potassium citrate should be administered to lactating mothers only if clearly needed.

Renal Impairment

Patients with renal impairment may experience significant risks associated with potassium management. Administration of potassium citrate in these individuals can lead to hyperkalemia, which may progress rapidly and can be asymptomatic, potentially resulting in cardiac arrest. Therefore, the use of potassium citrate is contraindicated in patients with chronic renal failure or any condition that impairs potassium excretion, such as severe myocardial damage or heart failure. Careful consideration and monitoring are essential when treating patients with reduced kidney function to prevent serious complications related to potassium levels.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful evaluation and monitoring based on individual patient circumstances.

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 include T-wave peaking, loss of the P-wave, S-T segment depression, and QT interval prolongation. In advanced cases, symptoms may progress to muscle paralysis and cardiovascular collapse due to cardiac arrest.

Recommended Actions for Management of Hyperkalemia

In the event of suspected hyperkalemia, the following management strategies should be implemented:

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

2. Medication Review: 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.

3. Dietary Restrictions: Advise patients to eliminate foods high in potassium from their diet. Common high-potassium foods include almonds, apricots, bananas, various beans (such as lima, pinto, and white), 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 an intravenous solution of 10% dextrose containing 10-20 units of crystalline insulin per 1,000 mL at a rate of 300-500 mL/hr.

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 note that lowering potassium levels too rapidly in patients who are taking digitalis can lead to 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

Pregnancy Category C; animal reproduction studies have not been conducted. It is 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.

The normal potassium ion content of human milk is approximately 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 breastfeeding only if clearly needed.

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 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 stability and integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F). Temporary excursions are permitted between 15°C to 30°C (59°F to 86°F) to accommodate handling and transportation needs.

Additional Clinical Information

Clinicians should closely monitor patients for signs of hyperkalemia through periodic blood tests and ECGs. This vigilance is essential to ensure patient safety and effective management during treatment. No further information is available regarding abuse potential, administration routes, patient counseling, or postmarketing experiences.

FDA Insert (PDF)

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

View full prescribing information (PDF)