Coadministration of estradiol/drospirenone and indomethacin does not cause hyperkalemia in healthy postmenopausal women: a randomized open-label crossover study.
The effect of drospirenone on plasma potassium when coadministered with nonsteroidal anti-inflammatory drugs, such as indomethacin, is unknown. An open-label crossover study investigated the effects of estradiol/drospirenone and indomethacin coadministration on plasma potassium levels in 32 postmenopausal women. Each participant received 2 treatments in random order: indomethacin alone for 5 days and estradiol/drospirenone alone for 12 days, then estradiol/drospirenone plus indomethacin for 5 days. Plasma potassium profiles (24 hours) were measured on the first and last days of indomethacin administration. No difference was seen between treatments in the area under the curve or maximum concentration of plasma potassium. No participant experienced hyperkalemia (potassium >5.5 mmol/L). Twenty-seven participants had at least 1 potassium value above the upper limit of normal (4.4 mmol/L), but these occurred during both treatments. Coadministration of estradiol/drospirenone and a nonsteroidal anti-inflammatory drug such as indomethacin is not expected to result in increased plasma potassium or hyperkalemia in healthy postmenopausal women.
Schütt
Barbara
B
Clinical Pharmacology, Bayer Schering Pharma AG, D-13342 Berlin, Germany. barbara.schuett@bayerhealthcare.com
Kunz
Michael
M
Blode
Hartmut
H
D000368:Aged; D000736:Androstenes / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D018592:Cross-Over Studies; D004338:Drug Combinations; D004347:Drug Interactions; D004958:Estradiol / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics; D005260:Female; D006801:Humans; D006947:Hyperkalemia / Q000139:chemically induced*; D007213:Indomethacin / Q000009:adverse effects*; D008875:Middle Aged; D000451:Mineralocorticoid Receptor Antagonists / Q000008:administration & dosage / Q000009:adverse effects* / Q000493:pharmacokinetics; D017698:Postmenopause; D011188:Potassium / Q000097:blood
D000736:Androstenes; D000894:Anti-Inflammatory Agents, Non-Steroidal; D004338:Drug Combinations; D000451:Mineralocorticoid Receptor Antagonists; D004958:Estradiol; C035144:drospirenone; D011188:Potassium; D007213:Indomethacin