Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Sodium Zirconium Cyclosilicate
ASTRAZENECA SDN. BHD.
Sodium Zirconium Cyclosilicate
30 Sachets; 3 Sachets
: AndersonBrecon Inc.
NOT APPLICABLE Baca dokumen lengkap
1 LOKELMA ® 5 G & 10 G POWDER FOR ORAL SUSPENSION SODIUM ZIRCONIUM CYCLOSILICATE 1. NAME OF THE MEDICINAL PRODUCT Lokelma 5 g powder for oral suspension Lokelma 10 g powder for oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lokelma 5 g powder for oral suspension: Each sachet contains 5 g sodium zirconium cyclosilicate. Each 5 g sachet contains approximately 400 mg sodium. Lokelma 10 g powder for oral suspension: Each sachet contains 10 g sodium zirconium cyclosilicate. Each 10 g sachet contains approximately 800 mg sodium. 3. PHARMACEUTICAL FORM Powder for oral suspension. White to grey powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATION Lokelma is indicated for the treatment of hyperkalaemia in adult patients (see section 4.4 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Correction phase _ The recommended starting dose of Lokelma is 10 g, administered three times a day orally as a suspension in water. When normokalaemia is achieved, the maintenance regimen should be followed (see below). Typically, normokalaemia is achieved within 24 to 48 hours. If patients are still hyperkalaemic after 48 hours of treatment, the same regimen can be continued for an additional 24 hours. If normokalaemia is not achieved after 72 hours of treatment, other treatment approaches should be considered. _Maintenance phase _ 2 When normokalaemia has been achieved, the minimal effective dose of Lokelma to prevent recurrence of hyperkalaemia should be established. A starting dose of 5 g once daily is recommended, with possible titration up to 10 g once daily, or down to 5 g once every other day, as needed, to maintain a normal potassium level. No more than 10 g once daily should be used for maintenance therapy. Serum potassium levels should be monitored regularly during treatment (see section 4.4). _Missed dose _ If a patient misses a dose, they should be instructed to take the next usual dose at their normal time. _Special populations _ _Patients with renal impairment _ No changes from the normal dose Baca dokumen lengkap