Potassium citrate

Description

Potassium Citrate Extended-Release Tablets USP are a citrate salt of potassium, with an empirical formula of K₃C₆H₅O₇ • H₂O. These tablets are formulated as off-white to yellow, oral wax-matrix tablets, containing 10 mEq (1080 mg) of potassium citrate and 15 mEq (1620 mg) of potassium citrate per tablet. Inactive ingredients include carnauba wax and magnesium stearate. Potassium Citrate Extended-Release Tablets USP comply with USP Dissolution Test 4.

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 to be taken 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.

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 signs of gastrointestinal complications. If a patient experiences 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, although specific laboratory tests were not detailed in the provided information. Prompt recognition and management of any adverse effects are critical to ensuring patient safety during treatment with potassium citrate.

Side Effects

Common adverse reactions observed in patients include minor gastrointestinal complaints such as abdominal discomfort, vomiting, diarrhea, loose bowel movements, and nausea.

Serious adverse reactions may occur, including hyperkalemia, particularly in patients with impaired mechanisms for excreting potassium. The administration of potassium citrate can lead to hyperkalemia and potentially cardiac arrest. It is important to note that hyperkalemia can develop rapidly and may be asymptomatic, posing a significant risk to patients. Additionally, gastrointestinal lesions may arise; if patients experience severe vomiting, abdominal pain, or gastrointestinal bleeding, potassium citrate extended-release tablets should be discontinued immediately, and the possibility of bowel perforation or obstruction should be investigated.

Patients with pre-existing 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, are at increased risk. Furthermore, patients who may experience delays in tablet passage through the gastrointestinal tract, including those with delayed gastric emptying, esophageal compression, intestinal obstruction, or stricture, should be closely monitored. Other at-risk populations 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, including anticholinergics, may exacerbate gastrointestinal irritation when used with potassium salts. Caution is advised when these medications are prescribed concurrently.

For patients receiving renin-angiotensin-aldosterone inhibitors, it is essential to monitor serum potassium levels regularly, as there is an increased risk of hyperkalemia associated with their use.

Nonsteroidal anti-inflammatory drugs (NSAIDs) also warrant careful monitoring for hyperkalemia when administered with potassium salts. Regular assessment of potassium levels is recommended to mitigate the risk of this adverse effect.

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 exhibit reduced kidney function and increased sensitivity to side effects, which necessitates careful monitoring and potential dosage adjustments. Although there are no specific dosage adjustments or recommendations for geriatric patients outlined in the prescribing information, it is crucial for healthcare providers to remain vigilant.

Close monitoring of serum electrolytes, serum creatinine, and complete blood counts is advised every four months, particularly in elderly patients with underlying conditions such as cardiac disease, renal disease, or acidosis, which may be more prevalent in this population. This proactive approach can help mitigate risks and ensure the safe use of the medication in geriatric patients.

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 affect reproductive capacity. Potassium citrate extended-release tablets should be given to a pregnant woman only if clearly needed, weighing the potential benefits against any unknown risks to the fetus. Healthcare professionals are advised to exercise caution and consider alternative treatments when managing pregnant patients.

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. Potassium citrate extended-release tablets should be administered to lactating mothers only if clearly needed, taking into consideration the potential risks and benefits for both the mother and the breastfed infant.

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 extended-release tablets 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 advanced cases, late manifestations may present as muscle paralysis and cardiovascular collapse due to cardiac arrest.

Management of Hyperkalemia

In the event of hyperkalemia, several treatment measures should be implemented:

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

2. 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.

3. 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.

4. Calcium Administration: If the patient is at low risk for digitalis toxicity, intravenous calcium gluconate may be administered.

5. 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.

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

7. Dialysis: Hemodialysis or peritoneal dialysis may be necessary for severe cases.

8. Use of Exchange Resins: While exchange resins can 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, necessitating careful management of potassium levels during treatment.

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 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 concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Advise patients to take each dose of the medication without crushing, chewing, or sucking the tablet to ensure proper absorption and effectiveness. It is important to instruct patients to take this medicine only as directed, particularly if they are also using diuretics and digitalis preparations, as this can affect their treatment regimen.

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

Finally, remind patients that their doctor will conduct regular blood tests and electrocardiograms to monitor their safety while on this medication. This ongoing assessment is crucial for ensuring the patient's well-being during treatment.

Storage and Handling

The product is supplied in a tight container to ensure its integrity. 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.

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 REMEDYREPACK INC.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)