Potassium citrate with potassium bicarbonate oral prolonged release
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Prolonged release oral formulations of potassium citrate with potassium bicarbonate.
Renal tubular acidosis
Treatment of distal renal tubular acidosis in adults and children aged one year and older.
The total daily dose should be taken in two divided doses, usually twelve hours apart. For each patient, the closest dose to the target dose should be fixed by combining whole sachets of the two available strengths.
Maximum daily dose for all ages is 10mEq/kg/day or 336mEq, whichever is lower.
When switching to potassium citrate with potassium bicarbonate from another alkalising therapy, treatment should be initiated at the target dose of the previous therapy (in mEq/kg/day) and titrated to the target dose of potassium citrate with potassium bicarbonate.
Initial dose is 1mEq/kg/day. Doses thereafter may be increased or decreased by 0.5mEq/kg/day to optimal dose that provides adequate metabolic acidosis control.
Children aged 12 to 18 years
Initial dose is 1mEq/kg/day. Doses thereafter may be increased or decreased by 1mEq/kg/day to optimal dose that provides adequate metabolic acidosis control.
Children aged 4 to 12 years
Initial dose is 2mEq/kg/day. Doses thereafter may be increased or decreased by 1.5mEq/kg/day to optimal dose that provides adequate metabolic acidosis control.
Children aged 1 to 4 years
Initial dose is 4mEq/kg/day. Doses thereafter may be increased or decreased by 1.5mEq/kg/day to optimal dose that provides adequate metabolic acidosis control.
Patients with Renal Impairment
GFR 45 to 59ml/minute/1.73m sq with normal plasma potassium levels: Regular monitoring of renal function and blood potassium levels recommended at initiation, after a dose increase or any decrease in GFR, at least twice yearly.
GFR 45 to 59ml/minute/1.73m sq with raised plasma potassium levels: Contraindicated.
GFR below 45ml/minute/1.73m sq: Contraindicated.
Children under 1 year
Renal impairment - GFR below 45 ml/minute/1.73 m squared
Precautions and Warnings
Delayed gastric emptying
Renal impairment - GFR 45 to 59ml/minute/1.73m squared
For use only under medical supervision
Monitor serum potassium regularly
Advise patient that granules matrix can be excreted in the stools
Take another dose if vomiting occurs within 2 hours
In patients at risk after initial close monitoring of plasma potassium the frequency of potassium tests should be adjusted to the patient condition but not less than twice a year.
Pregnancy and Lactation
Use potassium citrate with potassium bicarbonate with caution during pregnancy.
The manufacturer advises caution if potassium citrate with potassium bicarbonate is used during pregnancy. Available reports indicate no increased risk of teratogenic or developmental effects. The manufacturer notes that potassium citrate with potassium bicarbonate should only be used during pregnancy if the benefit to the mother outweighs the risk to the foetus due to the increased risk of developing hyperkalaemia.
Potassium citrate with potassium bicarbonate is considered safe for use during breastfeeding.
The manufacturer states potassium citrate with potassium bicarbonate may be used safely when breastfeeding. Potassium is naturally present in human breast milk therefore use of potassium citrate with potassium bicarbonate by lactating mothers would have no adverse effect on a nursing infant (Briggs, 2015).
Advise patient that granules must be swallowed with a large glass of water.
Advise patient to take with food.
Advise patient not to take with hot food, hot liquids or alcohol.
Advise patient not to crush and chew granules.
Potassium citrate with potassium bicarbonate granules may be mixed with small amounts of soft food (e.g. yoghurt, fruit puree) and swallowed without chewing for patients who are unable to swallow granules with water.
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: October 2022
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Sibnayal 8mEq prolonged-release granules. Advicenne S.A. Revised June 2021.
Summary of Product Characteristics: Sibnayal 24mEq prolonged-release granules. Advicenne S.A. Revised June 2021.
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