Lokelma Sodium Zirconium Cyclosilicate Powder for Oral Suspension

1. Indications and Usage
Hyperkalemia:
Treatment of hyperkalemia in adult patients.
Note: It is not intended as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.
2. Dosage and Administration
Route of Administration:
For Oral Use ONLY.
Recommended Dosage:
Initial Dose: 10 g three times daily (TID) for up to 48 hours.
Maintenance Dose: 5 g once daily. The dose may be titrated based on serum potassium levels, ranging from 5 g every other day to 10 g once daily.
Critical Administration Instructions:
Preparation: Mix the contents of the single-dose packet with approximately 3 tablespoons (45 mL) of water. Stir well until a uniform suspension is formed and drink immediately. If any powder remains, add more water, stir, and drink.
Food: Can be taken with or without food.
Other Medications: Because it binds to potassium in the gastrointestinal tract, it may bind to other oral medications. Take other oral medications at least 2 hours before or 2 hours aftertaking sodium zirconium cyclosilicate.
3. Mechanism of Action
Cation Exchange:
Sodium zirconium cyclosilicate is a non-absorbed, highly selective cation exchange crystal.
Potassium Binding:
It selectively traps potassium ions (K⁺) in exchange for sodium (Na⁺) and hydrogen (H⁺) ions throughout the gastrointestinal tract.
Therapeutic Result: This increases fecal excretion of potassium, thereby reducing serum potassium levels. It does not contain calcium or magnesium and has minimal effect on other electrolytes.
4. Safety and Warnings
Edema:
Because each gram of the drug contains approximately 100 mg of sodium, it can cause fluid retention and edema, particularly in patients with heart failure or renal impairment. Monitor patients for signs of worsening edema.
Gastrointestinal Perforation/Obstruction:
Caution should be used in patients with underlying gastrointestinal disorders (e.g., strictures, severe constipation).
Contraindications:
Hypokalemia.
Bowel obstruction.
5.Adverse Reactions
Most Common:
Edema, hypomagnesemia, nausea, diarrhea, constipation, and dyspnea.
6.Drug Interactions
Absorption of Other Drugs:
May decrease the absorption of concomitantly administered oral medications. Administer other oral drugs at least 2 hours before or 2 hours after Lokelma.
RAAS Inhibitors & Diuretics:
No specific interaction studies have been conducted, but monitoring is advised when used with RAAS inhibitors, potassium-sparing diuretics, or NSAIDs.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Sodium Zirconium Cyclosilicate.
Appearance: White to off-white powder for oral suspension.
Packaging: Single-dose packets (5 g and 10 g).
Storage: Store at 20°C to 25°C (68°F to 77°F). Do not freeze.