Lokelma Sodium Zirconium Cyclosilicate Powder

Brand Name: 利倍卓 ®(Lokelma®)
Generic Name: Sodium Zirconium Cyclosilicate
Strength: 10 g per sachet, 11 sachets per box
Manufacturer: AndersonBrecon, Inc.
Marketing Authorization Holder: AstraZeneca AB
Approval Date in China: August 29, 2019
Registration Number: 国药准字HJ20190073
Storage: No special temperature storage requirements. Store in the original package to protect from moisture, keep out of sight and reach of children. Refer to the full package insert for detailed storage specifications.

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1. Indications and Usage
Sodium zirconium cyclosilicate powder is indicated for the treatment of hyperkalememia in adults. It is not intended for the emergency treatment of life-threatening hyperkalemia.
2. Dosage and Administration
Correction Phase: The recommended starting dose is 10 g orally three times daily for up to 48 hours.
Maintenance Phase: After serum potassium levels have normalized, the minimum effective dose should be determined to prevent recurrence. The recommended starting maintenance dose is 5 g once daily. The dose may be titrated up to 10 g once daily or down to 5 g every other day.
Administration: The powder should be completely emptied into a glass containing approximately 45 mL of water and stirred well. The powder will not dissolve. The resulting opaque liquid should be taken immediately while still in suspension.
Dosing Intervals: Other orally administered medications should be given at least 2 hours before or 3 hours after taking sodium zirconium cyclosilicate to avoid potential interactions.
3. Mechanism of Action
Sodium zirconium cyclosilicate is an inorganic, insoluble compound with a unique cubic crystal structure. The average pore size of this structure matches the ionic radius of potassium. It selectively binds to potassium ions in the gastrointestinal tract in exchange for sodium and hydrogen ions, increasing fecal potassium excretion and lowering serum potassium levels.
4. Safety and Warnings
Hypokalemia: Hypokalemia may occur. Serum potassium levels should be monitored regularly, and the dose should be reduced or the medication discontinued if moderate to severe hypokalemia develops.
Edema: Edematous events have been reported. This medication should be used with caution in patients with heart failure or severe renal impairment.
Gastrointestinal Obstruction: Use with caution in patients with a history of gastrointestinal obstruction or severe constipation.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most common adverse reactions include hypokalemia and edema-related events.
Clinical Research: Clinical trials have demonstrated that sodium zirconium cyclosilicate effectively lowers serum potassium levels and maintains them within the normal range over the long term.
6. Drug Interactions
Oral Medications: Sodium zirconium cyclosilicate may affect the absorption of concurrently administered oral medications. Other orally administered medications should be separated by at least 2 hours before or 3 hours after taking sodium zirconium cyclosilicate.
7. Pharmaceutical Information
Composition: The active ingredient is sodium zirconium cyclosilicate.
Appearance: White to gray powder.
Storage: Store at controlled room temperature in the original packaging.

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