Urilizer

 (1500 mg+250 mg)/5 ml Oral Solution
Kumudini Pharma Ltd.
200 ml bottle: ৳ 200.00
Indications
  • Prevention and treatment of kidney stones (urolithiasis):
    Particularly effective for calcium oxalate and uric acid stones by increasing urinary citrate and alkalinizing urine to reduce stone formation and recurrence.
  • Renal tubular acidosis (Type I, distal):
    Used to correct metabolic acidosis and associated hypokalemia by replenishing potassium and raising urinary pH.
  • Urinary alkalinization:
    Employed in conditions such as gout and cystinuria to increase urinary pH, improving solubility of crystals and preventing stone formation.
  • Chronic metabolic acidosis:
    As an alkalinizing agent in disorders requiring correction of acid-base imbalance with potassium supplementation.
Dosage & Administration
  • Adults:
    Oral administration of 10–30 mEq of potassium citrate 2 to 4 times daily, typically with meals and at bedtime. Total daily doses usually range from 30 to 100 mEq. Dose adjusted to maintain urinary pH between 6.0 and 7.0.
  • Pediatrics:
    1–3 mEq/kg/day in divided doses, adjusted by clinical response and urinary pH target.
  • Elderly:
    Start with lower doses; monitor renal function and serum potassium closely.
  • Renal or hepatic impairment:
    Use with caution. Dose adjustment and frequent monitoring of serum potassium, bicarbonate, and renal function are required.
  • Administration instructions:
    Oral only. Tablets should be swallowed whole with water; do not crush or chew. Solutions should be measured accurately and taken with food or shortly after meals.
Mechanism of Action (MOA)

Potassium citrate is metabolized to bicarbonate, which alkalinizes blood and urine. The increased urinary pH enhances solubility and decreases precipitation of uric acid and cystine crystals. Citrate binds calcium ions in urine, reducing calcium salt crystallization and the risk of stone formation. Citric acid supports urinary citrate levels. Potassium replenishes intracellular potassium, correcting hypokalemia common in renal tubular acidosis and metabolic acidosis.

Pharmacokinetics
  • Absorption: Rapid and nearly complete absorption from the gastrointestinal tract.
  • Distribution: Potassium and citrate are distributed primarily in extracellular fluid.
  • Metabolism: Citrate is converted mainly to bicarbonate in the liver.
  • Elimination: Potassium is excreted primarily via the kidneys; citrate is filtered and partially reabsorbed in the renal tubules.
  • Onset of action: Urinary alkalinization begins within 30 to 60 minutes.
  • Half-life: Not clearly defined; dependent on renal clearance and acid-base balance.
Pregnancy Category & Lactation
  • Pregnancy:
    Classified as FDA Pregnancy Category C. Use only if clearly needed, with close monitoring of maternal serum potassium and acid-base status.
  • Lactation:
    Considered safe; potassium and citrate occur naturally in breast milk. Monitor infant for adverse effects.
  • Caution advised in conditions involving pregnancy-associated electrolyte or renal disturbances.
Therapeutic Class
  • Electrolyte supplement
  • Urinary alkalinizer
  • Urolithiasis prevention agent
Contraindications
  • Hypersensitivity to potassium citrate, citric acid, or excipients
  • Hyperkalemia or predisposition to hyperkalemia
  • Severe renal impairment or anuria
  • Metabolic alkalosis
  • Active gastrointestinal ulcers or obstruction
  • Use of potassium-sparing diuretics without monitoring
  • Delayed gastric emptying or motility disorders
Warnings & Precautions
  • Risk of hyperkalemia; monitor serum potassium regularly, especially in renal impairment or when combined with potassium-elevating drugs.
  • Oral tablets may cause gastrointestinal irritation or ulceration; do not crush or chew tablets.
  • Excessive urinary alkalinization can increase risk of calcium phosphate stones.
  • Use cautiously in patients with cardiac, hepatic, or renal diseases.
  • Pediatric use requires close monitoring of acid-base balance and electrolytes.
Side Effects
  • Common: Nausea, vomiting, abdominal pain, diarrhea, flatulence.
  • Serious (rare): Hyperkalemia with symptoms like muscle weakness and arrhythmias; gastrointestinal ulceration or obstruction.
  • Side effects often appear early; hyperkalemia risk depends on renal function and dose.
Drug Interactions
  • Increased hyperkalemia risk with ACE inhibitors, ARBs, potassium-sparing diuretics, NSAIDs, heparin, cyclosporine, and tacrolimus.
  • Aluminum-containing antacids may increase aluminum absorption.
  • Potassium-containing salt substitutes or supplements add to hyperkalemia risk.
  • No significant CYP450 enzyme involvement.
Recent Updates or Guidelines
  • Potassium citrate + citric acid remains first-line for prevention of calcium oxalate and uric acid stones.
  • Updated warnings emphasize correct administration to minimize gastrointestinal adverse effects.
  • Guidelines highlight maintaining urinary pH in target range to prevent alternate stone formation.
Storage Conditions
  • Store tablets and solutions at 20°C to 25°C (68°F to 77°F).
  • Protect from moisture and light.
  • Keep containers tightly closed.
  • Shake oral solutions well before use.
  • Avoid freezing or refrigeration unless specified by manufacturer.
Available Brand Names