LOKELMA Powder for oral suspension Ref.[10414] Active ingredients: Sodium zirconium cyclosilicate

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

LOKELMA is a powder for oral suspension. The active ingredient in LOKELMA is sodium zirconium cyclosilicate, a potassium binder. Sodium zirconium cyclosilicate is a non-absorbed zirconium silicate that preferentially exchanges potassium for hydrogen and sodium. LOKELMA is a odorless, insoluble white to grey powder for oral suspension. It has a mean particle size of 20 ยตm and includes no more than 3% of particles with a diameter below 3 ยตm. Each 5 g of sodium zirconium cyclosilicate contains 400 mg of sodium.

The chemical formula of sodium zirconium cyclosilicate is Na~1.5H~0.5ZrSi3O9โ€ข2–3H2O.

Figure 1. Crystal Structure of Sodium Zirconium Cyclosilicate:

Dosage Forms and Strengths

For oral suspension: 5 g or 10 g of white to grey powder in a foil-lined packet.

How Supplied

LOKELMA (sodium zirconium cyclosilicate) for oral suspension is supplied as a white to grey powder in foil-lined packets as follows:

LOKELMA (grams) Single PacketBox of 11 PacketsBox of 30 Packets
5 NDC 0310-1105-01 NDC 0310-1105-39 NDC 0310-1105-30
10 NDC 0310-1110-01 NDC 0310-1110-39 NDC 0310-1110-30

Drugs

Drug Countries
LOKELMA Austria, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States

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