Urilit1080 mg

Established (FDA-approved) Uses

Urilit is an alkalinizing agent indicated for the management of:

• Renal tubular acidosis (RTA) with calcium stones
• Hypocitraturic calcium oxalate nephrolithiasis of any etiology (kidney stones associated with low urinary citrate)
• Uric acid lithiasis, with or without calcium stones, by raising urinary pH to reduce uric acid crystallization

Guideline-Supported / Adjunct Use

Urilit is also used more broadly as a urinary alkalinizing agent to raise urine pH and increase urinary citrate excretion, which helps prevent formation of certain calcium-containing and uric acid stones, often as an adjunct to increased fluid intake and dietary measures.

Urilit is not intended to dissolve existing large stones and does not replace surgical or urological management when indicated.

Each formulation contains Potassium Citrate as the active ingredient, supplied as extended-release tablets (commonly available in strengths equivalent to 5 mEq, 10 mEq, and 15 mEq of potassium) and, in some markets, as an oral solution or effervescent granules for reconstitution in water. The exact strength and dosage form should be confirmed on the product label.

Urilit is the potassium salt of citric acid. It works as a systemic and urinary alkalinizing agent: once absorbed, the citrate component is metabolized (mainly in the liver) to bicarbonate, which raises blood and urinary pH. This increases urinary citrate excretion and reduces the tendency for calcium salts and uric acid to crystallize in the urinary tract, thereby helping prevent kidney stone formation and correcting the acidosis seen in renal tubular acidosis.

Urilit belongs to the class of urinary alkalinizing agents / potassium and electrolyte replenishers.

Mechanism of Action

After oral absorption, Potassium Citrate is metabolized to potassium bicarbonate. The bicarbonate produced increases urinary pH and urinary citrate concentration. Citrate forms soluble complexes with calcium in the urine, reducing the availability of calcium to combine with oxalate or phosphate and form stones. The increase in urinary pH also reduces the saturation of undissociated uric acid, decreasing uric acid stone formation.

Pharmacokinetics

Potassium Citrate is well absorbed from the gastrointestinal tract. It is metabolized via the citric acid (Krebs) cycle to bicarbonate, which is primarily excreted by the kidneys, along with unmetabolized citrate and potassium.

Urilit extended-release tablets should be swallowed whole with a full glass of water, taken with or immediately after meals, and the patient should remain upright (not lie down) for at least 30 minutes afterward to minimize gastrointestinal irritation. Do not crush or chew the tablets.

Clinically Significant Interactions

• Potassium-sparing diuretics (e.g., spironolactone, amiloride, triamterene): concomitant use should generally be avoided as it can produce severe, potentially fatal hyperkalemia.
• ACE inhibitors, angiotensin receptor blockers (ARBs), and other drugs that raise serum potassium: increase the risk of hyperkalemia when combined with Urilit; require careful monitoring of serum potassium if co-administered.
• NSAIDs: may reduce renal potassium excretion and increase hyperkalemia risk; use with caution and monitor.
• Anticholinergic drugs: may increase gastrointestinal transit time, increasing the risk of contact with and irritation of the GI mucosa from potassium salts.
• Other potassium supplements or salt substitutes containing potassium: additive risk of hyperkalemia; avoid concurrent use unless directed by a physician.

Common

The most frequently reported adverse effects of Urilit are gastrointestinal, including nausea, vomiting, abdominal discomfort or pain, diarrhea, and loose stools. These often improve when the drug is taken with food or when the dose is reduced.

Serious (Less Common)

• Hyperkalemia (can be asymptomatic in early stages; see Precautions and Warnings)
• Gastrointestinal ulceration, bleeding, obstruction, or perforation with extended-release tablets, particularly if gastrointestinal transit is delayed

Pregnancy

Adequate and well-controlled animal reproduction studies with Urilit have not been conducted. Urilit should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; use only under medical supervision.

Lactation

Potassium is a normal constituent of human breast milk. Urilit should be used during breastfeeding only if clearly needed, with medical guidance, and the nursing infant should be monitored as advised by the physician.

Hyperkalemia

Potentially fatal hyperkalemia can develop with Urilit, particularly in patients with renal impairment, diabetes mellitus, adrenal insufficiency, or in those taking potassium-sparing diuretics, ACE inhibitors, or ARBs (see Contraindications and Interactions). Hyperkalemia may be asymptomatic and can present only as cardiac arrhythmia. Serum potassium and, where indicated, ECG monitoring should be performed periodically, especially early in therapy or after dose changes.

Gastrointestinal Lesions

Solid oral dosage forms of potassium salts, including Urilit extended-release tablets, have been associated with stenotic and ulcerative lesions of the small bowel. Therapy should be discontinued immediately if severe vomiting, abdominal pain, distension, or gastrointestinal bleeding occurs.

General Precautions

• Swallow tablets whole; do not crush or chew extended-release forms.
• Take with food and adequate fluid to reduce gastrointestinal irritation.
• Use with caution in patients with cardiac disease or conditions affecting potassium handling.

Overdose of Urilit can cause hyperkalemia, which may be life-threatening. Early signs can include paresthesia (tingling), muscle weakness or paralysis, and mental confusion; more severe overdose can cause cardiac arrhythmias, heart block, and cardiac arrest. Hyperkalemia can occur without obvious warning symptoms.

Suspected overdose is a medical emergency: seek immediate medical attention or contact a poison control center / emergency services right away. Do not attempt to treat a suspected overdose at home.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Renal Impairment

Urilit is contraindicated in patients with severe renal impairment because of an increased risk of hyperkalemia (see Contraindications). Use with caution and close monitoring in patients with any degree of renal insufficiency.

Hepatic Impairment

Specific dosage adjustment data in hepatic impairment are not well established; use with caution and monitor serum potassium.

Elderly

Elderly patients more often have reduced renal function and may be at higher risk of hyperkalemia; renal function and serum potassium should be monitored.

Pediatric Use

See Pediatric Uses section.

Urilit is typically used long-term for chronic conditions such as renal tubular acidosis and recurrent kidney stone prevention. Duration is individualized and periodically reassessed based on urinary citrate, urinary pH, and serum potassium monitoring, as directed by the treating physician.

Alkalinizing agents; potassium salts / electrolyte replenishers.

Potassium Citrate is converted in the body to bicarbonate, which raises urinary pH and urinary citrate excretion. Elevated urinary citrate binds calcium, reducing calcium oxalate and calcium phosphate crystallization, while the raised pH reduces uric acid crystallization, together lowering the risk of stone formation.

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Safety and effectiveness of Urilit in pediatric patients have not been established. Use in children should only be considered under specialist supervision when the potential benefit is judged to outweigh the risks, with close monitoring of serum potassium and renal function.