Lokelma 10g Powder for Oral Suspension

Страна: Малайзія

мова: англійська

Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Активний інгредієнт:

Sodium Zirconium Cyclosilicate

Доступна з:

ASTRAZENECA SDN. BHD.

ІПН (Міжнародна Ім'я):

Sodium Zirconium Cyclosilicate

Одиниць в упаковці:

30 Sachets; 3 Sachets

Виробник:

: AndersonBrecon Inc.

інформаційний буклет

NOT APPLICABLE

Характеристики продукта

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