Active Ingredient: Patiromer
Patiromer is indicated for the treatment of hyperkalaemia in adults and adolescents aged 12 to 17 years.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 8.4 grams patiromer, once daily, over the duration of 1 week. Afterwards, oral, between 8.4 grams patiromer and 25.2 grams patiromer, once daily. The maximum allowed total dose is 25.2 grams patiromer daily.
The onset of action of patiromer occurs 4–7 hours after administration. It should not replace emergency treatment for life threatening hyperkalaemia.
Patiromer is administrated once daily. The recommended starting dose of patiromer varies with age. Multiple sachets may be used to achieve the desired dose.
The daily dose may be adjusted in intervals of one week or longer, based on the serum potassium level and the desired target range. Serum potassium should be monitored when clinically indicated. The duration of treatment should be individualized by the treating physician based on the need of serum potassium management. If serum potassium falls below the desired range, the dose should be reduced or discontinued.
Administration of patiromer should be separated by 3 hours from other oral medicinal products.
The recommended starting dose is 8.4 g patiromer once daily. The daily dose may be increased or decreased by 8.4 g, as necessary to reach the desired target range, up to a maximum dose of 25.2 g daily.
If a dose is missed, the missed dose should be taken as soon as possible on the same day. The missed dose should not be taken with the next dose.
Patiromer should be mixed with water and stirred to a suspension of uniform consistency. The recommended total volumes for preparation of the suspension are dose dependent:
The suspension should be prepared according to the following steps:
The powder will not dissolve. More water may be added to the mixture as needed for desired consistency. However, larger volumes might lead to an accelerated sedimentation of the powder.
The mixture should be taken within 1 hour of initial suspension. If powder remains in the glass after drinking, more water should be added and the suspension stirred and taken immediately. This may be repeated as needed to ensure the entire dose is administered.
According to personal preferences, following liquids or soft foods can be used instead of water to prepare the mixture by following the same steps as described above: apple juice, cranberry juice, pineapple juice, orange juice, grape juice, pear juice, apricot nectar, peach nectar, yoghurt, milk, thickener (for example: cornstarch), apple sauce, vanilla and chocolate pudding.
The potassium content of liquids or soft foods used to prepare the mixture should be considered as part of the dietary recommendations on potassium intake for each individual patient. In general, cranberry juice intake should be limited to moderate amounts (for example less than 400 mL per day) due to its potential interaction with other medicinal products.
This medicine can be taken with or without meals. It should not be heated (e.g. microwaved) or added to heated foods or liquids. It should not be taken in its dry form.
For doses up to 8.4 g patiromer, the suspension should be prepared as described above in the section relating to the oral administration. For doses above 8.4 g and up to 16.8 g patiromer a total volume of 160 mL should be used and for doses above 16.8 g and up to 25.2 g patiromer a total volume of 240 mL. These volumes ensure that the suspension readily flows through the tubes.
Compatibility has been shown with tubes made from polyurethane, silicone, and polyvinyl chloride. The recommended diameter of the tubes is 2.17 mm (6.5 Fr) or larger. After administration the tube should be flushed with water.
For:
Oral, 4 grams patiromer, once daily, over the duration of 1 week. Afterwards, oral, between 4 grams patiromer and 25.2 grams patiromer, once daily.
The onset of action of patiromer occurs 4–7 hours after administration. It should not replace emergency treatment for life threatening hyperkalaemia.
Patiromer is administrated once daily. The recommended starting dose of patiromer varies with age. Multiple sachets may be used to achieve the desired dose.
The daily dose may be adjusted in intervals of one week or longer, based on the serum potassium level and the desired target range. Serum potassium should be monitored when clinically indicated. The duration of treatment should be individualized by the treating physician based on the need of serum potassium management. If serum potassium falls below the desired range, the dose should be reduced or discontinued.
Administration of patiromer should be separated by 3 hours from other oral medicinal products.
The recommended starting dose is 4 g patiromer once daily. Adjust the daily dose of patiromer based on the serum potassium level and the desired target range, up to a maximum dose of 25.2 g daily. It is recommended to switch to 8.4 g patiromer sachets if doses above 7 g are needed.
If a dose is missed, the missed dose should be taken as soon as possible on the same day. The missed dose should not be taken with the next dose.
Patiromer should be mixed with water and stirred to a suspension of uniform consistency. The recommended total volumes for preparation of the suspension are dose dependent:
The suspension should be prepared according to the following steps:
The powder will not dissolve. More water may be added to the mixture as needed for desired consistency. However, larger volumes might lead to an accelerated sedimentation of the powder.
The mixture should be taken within 1 hour of initial suspension. If powder remains in the glass after drinking, more water should be added and the suspension stirred and taken immediately. This may be repeated as needed to ensure the entire dose is administered.
According to personal preferences, following liquids or soft foods can be used instead of water to prepare the mixture by following the same steps as described above: apple juice, cranberry juice, pineapple juice, orange juice, grape juice, pear juice, apricot nectar, peach nectar, yoghurt, milk, thickener (for example: cornstarch), apple sauce, vanilla and chocolate pudding.
The potassium content of liquids or soft foods used to prepare the mixture should be considered as part of the dietary recommendations on potassium intake for each individual patient. In general, cranberry juice intake should be limited to moderate amounts (for example less than 400 mL per day) due to its potential interaction with other medicinal products.
This medicine can be taken with or without meals. It should not be heated (e.g. microwaved) or added to heated foods or liquids. It should not be taken in its dry form.
For doses up to 8.4 g patiromer, the suspension should be prepared as described above in the section relating to the oral administration. For doses above 8.4 g and up to 16.8 g patiromer a total volume of 160 mL should be used and for doses above 16.8 g and up to 25.2 g patiromer a total volume of 240 mL. These volumes ensure that the suspension readily flows through the tubes.
Compatibility has been shown with tubes made from polyurethane, silicone, and polyvinyl chloride. The recommended diameter of the tubes is 2.17 mm (6.5 Fr) or larger. After administration the tube should be flushed with water.
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