Serum electrolyte shifts following administration of sodium phosphates enema.
The misuse of sodium phosphates enemas has resulted in reports of potentially severe metabolic and hemodynamic disturbances. Despite their long availability, these products have not been fully characterized pharmacokinetically. This trial sought to evaluate changes in the metabolic and hemodynamic parameters following the administration of one of two standard sodium phosphates enemas. Enema Casen (250 ml) is available only in Spain, and Fleet Enema (133 ml) is available in 66 countries in six continents of the world. These changes were correlated with scientific literature reports of hyperphosphatemia following phosphate enema use. Forty-five adult participants aged 50 years or older enrolled in the trial. Twenty-five participants were given one Enema Casen, whereas 20 participants received one Fleet Enema. Blood pressure, pulse, and serum chemistries were evaluated at screening; baseline; and 10, 60, and 120 minutes after receiving the enema. Each participant had a bowel movement within 10 minutes of receiving his enema. Asymptomatic, transient hyperphosphatemia was associated with increase in retention time but not with increase in volume of sodium phosphates enemas. Increased serum phosphate concentration and increased area under the curve of serum phosphate were associated with increased enema retention time. The Enema Casen induced a greater mean AUC of serum sodium concentration than did the Fleet Enema. There were no drug-related adverse events. Transient hyperphosphatemia following the use of sodium phosphates enemas correlates with retention time but not with dose. A scientific literature review of serious adverse events revealed that overdose, concomitant use of oral and rectal sodium phosphates products, and use in a contraindicated patient were associated with sodium phosphates enema and hyperphosphatemia.
North Texas Colon and Rectal Associates, Dallas, Texas, USA.
Robert M
RM
Jacobson
Jessica
J
Peery
William O
WO
Thompson
Joseph A
JA
Kanapka
Michael
M
Caswell
D000285:Administration, Rectal; D000704:Analysis of Variance; D019540:Area Under Curve; D002400:Cathartics / Q000009:adverse effects* / Q000737:chemistry / Q000493:pharmacokinetics; D002626:Chemistry, Pharmaceutical; D004733:Enema; D005260:Female; D006801:Humans; D054559:Hyperphosphatemia / Q000097:blood / Q000139:chemically induced* / Q000175:diagnosis; D008297:Male; D008875:Middle Aged; D010710:Phosphates / Q000009:adverse effects* / Q000737:chemistry / Q000493:pharmacokinetics; D013030:Spain
D002400:Cathartics; D010710:Phosphates; C018279:sodium phosphate