Urocit-K

Description

Urocit-K is a citrate salt of potassium with the empirical formula K3C6H5O7 • H2O. It is presented as yellowish to tan, oral wax-matrix tablets, available in three strengths: 5 mEq (540 mg) potassium citrate, 10 mEq (1080 mg) potassium citrate, and 15 mEq (1620 mg) potassium citrate. The inactive ingredients in Urocit-K include carnauba wax and magnesium stearate.

Uses and Indications

Urocit-K 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 the presence of calcium stones.

There are no teratogenic or nonteratogenic effects associated with Urocit-K.

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 as a snack.

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 as a snack.

It is essential to adhere to these dosing schedules to optimize therapeutic outcomes and ensure patient safety.

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

Urocit-K administration carries significant risks that necessitate careful monitoring and prompt action in certain clinical scenarios.

Hyperkalemia Patients with impaired mechanisms for potassium excretion are at an increased risk of developing hyperkalemia, which can lead to cardiac arrest. This condition may progress rapidly and can be asymptomatic, making it crucial for healthcare professionals to monitor potassium levels closely in these patients. Urocit-K should be avoided in individuals with chronic renal failure or other conditions that compromise potassium excretion, such as severe myocardial damage or heart failure.

Gastrointestinal Lesions In cases where patients experience severe vomiting, abdominal pain, or gastrointestinal bleeding, Urocit-K must be discontinued immediately. It is essential to investigate the potential for bowel perforation or obstruction in these situations to prevent further complications.

Healthcare professionals are advised to remain vigilant for these warnings and to take appropriate action if any concerning symptoms arise.

Side Effects

Patients may experience a range of adverse reactions while receiving Urocit-K. Common adverse reactions include minor gastrointestinal complaints such as abdominal discomfort, vomiting, diarrhea, loose bowel movements, and nausea.

Serious adverse reactions associated with Urocit-K include 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 Urocit-K is contraindicated in patients with chronic renal failure or any condition that impairs potassium excretion, such as severe myocardial damage or heart failure.

Additionally, gastrointestinal lesions may occur, necessitating the immediate discontinuation of Urocit-K if patients experience severe vomiting, abdominal pain, or gastrointestinal bleeding. In such cases, it is essential to investigate the possibility of bowel perforation or obstruction.

Patients with pre-existing 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, Urocit-K should be used with caution 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. It is also contraindicated in patients with peptic ulcer disease, active urinary tract infections, or renal insufficiency characterized by a glomerular filtration rate of less than 0.7 ml/kg/min.

Drug Interactions

Concomitant administration of potassium-sparing diuretics is contraindicated, as the simultaneous use of these agents can lead to severe hyperkalemia.

Pharmacodynamic interactions may occur with drugs that slow gastrointestinal transit time, such as anticholinergics. These agents can exacerbate gastrointestinal irritation associated with potassium salts, necessitating caution when co-administered.

For patients receiving renin-angiotensin-aldosterone inhibitors, it is advisable to monitor serum potassium levels regularly due to the risk of hyperkalemia.

Nonsteroidal anti-inflammatory drugs (NSAIDs) also warrant monitoring for hyperkalemia when used concurrently, as they may influence potassium levels.

Packaging & NDC

The table below lists all NDC Code configurations of Urocit-K (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

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments or safety concerns. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

Urocit-K has not been evaluated in animal reproduction studies, and there is a lack of data regarding its potential to cause fetal harm or impact reproductive capacity when administered to pregnant women. Therefore, Urocit-K should be prescribed to pregnant patients only if the benefits clearly outweigh the potential risks. Healthcare professionals are advised to consider the necessity of treatment in this population and to discuss the uncertainties regarding fetal outcomes with patients of childbearing potential.

Lactation

Urocit-K has not been studied in animal reproduction, and there is no available data regarding its excretion in human breast milk. Consequently, it is unknown whether Urocit-K can cause harm to a breastfed infant or affect lactation. Given the lack of information, Urocit-K should be administered to lactating mothers only if clearly needed, weighing the potential benefits against any unknown risks to the nursing infant.

Renal Impairment

Patients with renal impairment may experience significant risks associated with Urocit-K administration. In individuals with impaired mechanisms for excreting potassium, the use of Urocit-K can lead to hyperkalemia, which may progress rapidly and can be asymptomatic, potentially resulting in cardiac arrest. Therefore, Urocit-K 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. Monitoring of potassium levels is essential in these patients 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 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, hyperkalemia may develop rapidly, particularly in patients with compromised mechanisms for potassium excretion. This condition can be asymptomatic, yet it poses a significant risk of cardiac arrest.

Management of Hyperkalemia To effectively manage hyperkalemia, it is essential to implement close monitoring for arrhythmias and electrolyte imbalances. The immediate elimination of any medications containing potassium, as well as potassium-sparing agents, is critical. Additionally, dietary modifications should be made to exclude foods high in potassium to mitigate the risk of exacerbating hyperkalemia during an overdose situation.

Treatment Options In patients who are at low risk for digitalis toxicity, intravenous calcium gluconate may be administered as part of the treatment protocol. Another therapeutic approach involves the administration of a 10% dextrose solution, typically at a rate of 300-500 mL/hr, combined with 10-20 units of crystalline insulin per 1,000 mL.

If acidosis is present, correction with intravenous sodium bicarbonate is recommended. In severe cases of hyperkalemia, more invasive interventions such as hemodialysis or peritoneal dialysis may be necessary to restore normal potassium levels.

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

Nonclinical Toxicology

Animal reproduction studies have not been conducted for Urocit-K. Therefore, it is not known whether Urocit-K can cause fetal harm when administered to a pregnant woman or if it can affect reproductive capacity. Urocit-K should be administered to a pregnant woman only if clearly needed.

No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding 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 for 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 instructed 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, patients must be made aware of the importance of reporting any signs of gastrointestinal bleeding, such as tarry stools, to their doctor immediately.

Inform patients that their healthcare provider 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 and stability. It is essential to store the product in a manner that prevents exposure to moisture and contaminants. Specific temperature ranges for storage are not provided; however, maintaining a controlled environment is recommended to preserve the product's quality. Special handling requirements include ensuring that the container remains sealed until use to prevent degradation.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Urocit-K as submitted by Mission Pharmacal Company. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)