Drug products: Resonium
ATC code: V03AE01
Substances: sodium polystyrene sulfonate
Published controlled studies on differences between men and women regarding the efficacy, safety and pharmacokinetics of sodium polystyrene sulfonate are lacking.
Sodium polystyrene sulfonate was approved by the FDA in the 1950s and the required documentation regarding effect and safety, not to mention sex differences, at that time was limited .
No studies on sex differences in pharmacokinetic properties have been identified. The dosing of sodium polystyrene sulfonate is based on levels of elevated S-potassium.
Although participants of both sexes have been included in most studies on sodium polystyrene sulfonate [2, 3], few report sex divided results and we have not identified any studies providing sex divided analysis. Re-analysis of data reported from two retrospective studies do not indicate any obvious sex-differences [4, 5]. In a retrospective cohort study of successful treatment of lithium toxicity (6 men, 6 women) potassium and lithium were found to be lowered after administration of sodium polystyrene sulfonate in both the men and women included in the study. Potassium was lowered 0.8±0.6 and 0.4±0.6 mmol/L in men and women, respectively and percentage estimated total body lithium was lowered with 15.9±8.5% and 14.8±10.1% in men and women, respectively . In another retrospective cohort study of infants with hyperkalemia (10 boys, 3 girls) potassium was lowered with 1.4±0.5 mEq/L and 1.7±0.3 mEq/L in boys and girls, respectively .
In a systematic review of case series and case reports of possible severe gastrointestinal adverse events associated with sodium polystyrene sulfonate, with and without sorbitol use, 58 cases were identified (29 men, 29 women). The study found chronic dose and cardiovascular morbidity to be associated with an increased risk. No difference in risk of gastrointestinal adverse events between men and women was found .
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2016-12-16
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson