LOKELMA

Država: Indonezija

Jezik: indonezijski

Izvor: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Preuzimanje Svojstava lijeka (SPC)
31-03-2023

Dostupno od:

ASTRAZENECA INDONESIA - Indonesia -

Doziranje:

5 G

Farmaceutski oblik:

SERBUK

Sastav:

SODIUM ZIRCONIUM CYCLOSILICATE

Jedinice u paketu:

DUS, 30 SACHETS @ 5 G

Razred:

Obat

Proizveden od:

ANDERSONBRECON INCORPORATED - United States of America

Status autorizacije:

Berlakus/d 31-03-2028

Datum autorizacije:

2023-03-31

Svojstava lijeka

                                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_
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.
Monitoring frequency will
depend upon a variety of factors including other medications,
progression of chronic kidney disease and
dietary potassium intake.
If severe hypokalaemia should occur, Lokelma should be discontinued
and the patient re-evaluated.
_Patients on chronic haemodialysis_
For patients on dialysis Lokelma should only be dosed on non-dialysis
days. The recommended starting
dose is 5 g once daily. To establish normokalaemia (4.0-5.0 mmol/L),
the dose may be titrated up or
down weekly based on the pre-dialysis serum potassium value after the
long inter-dialytic interval (LIDI).
The dose could be adjusted at intervals of one week in increments of 5
g up to 15 g once daily on non-
dialysis days. It is recommended to monitor serum potassium weekly
while the dose is adjusted; once
normokalaemia is established, potassium should be monitored regularly
(e.g., monthly, or more
frequently based on clinical judgement including changes in dietary
potassium or medication affecting
serum potassium).
_Missed dose_
If a patient misses a dose, they shoul
                                
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