Monograph

C03DA01 - Spironolactone

Porphyrinogenic

Rationale

Spironolactone has been associated with acute attacks of porphyria. Several references warn against its use. Spironolactone is known to induce CYP450. Sulfur metabolites of spironolactone are mechanism based inhibitors of CYP450 (degradation of prosthetic heme group). Two single observations of tolerance. Reported to have precipitated acute attacks.

Therapeutic characteristics

Mineralocorticoid antagonist, potassium saving diuretic.

Metabolism and pharmacokinetics

Extensively metabolized. The main metabolites7-alpha thiometyl-spironolactone and canrenone are excreted in urine and bile.

Preclinical data

The effect of spironolactone on the activity of delta-aminolevulinate synthase and on the formation of porphyrins and cytochrome P-450 were examined in the 18-day-old chick embryo liver in ovo(Anderson KE. Biochim Biophys Acta 1978). Spironolactone was found to induce delta-aminolevulinate synthase in this system. Spironolactone induces CYP activity. Sulfur metabolites inactivate CYP2C11 and 3A4 by degradation of the prosthetic heme group.

Personal communication

Thunell, patient report (n=1): tolerated. Andersson, patient report (n=1): tolerated.

Published experience

None

IPNet drug reports

Uneventful use reported in 2 patients with acute porphyria.

Similar drugs

Explore alternative drugs in similar therapeutic classes C03D / C03DA or go back.

References

#	Citation details	PMID
*	Other sources
1.	Temporary on NAPOS files porf

Citation details

PMID

Other sources

Temporary on NAPOS files porf

Tradenames

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Qaialdo 10 mg/ml orale suspensie · Spironolacton 100 mg, tabletten · Spironolacton 25 mg, tabletten · Spironolacton 50 mg, tabletten · Spironolacton Accord 100 mg filmomhulde tabletten · Spironolacton Accord 25 mg filmomhulde tabletten · Spironolacton Accord 50 mg filmomhulde tabletten · Spironolacton Aurobindo 100 mg, tabletten · Spironolacton Aurobindo 25 mg, tabletten · Spironolacton Aurobindo 50 mg, tabletten · Spironolacton Mylan 25 mg, tabletten · Spironolacton Mylan 50 mg, tabletten · Spironolacton Prolepha 100 mg, filmomhulde tabletten · Spironolacton Prolepha 12,5 mg, filmomhulde tabletten · Spironolacton Prolepha 25 mg, filmomhulde tabletten · Spironolacton Prolepha 50 mg, filmomhulde tabletten · Spironolacton Sandoz 100 mg, filmomhulde tabletten · Spironolacton Sandoz 25 mg, filmomhulde tabletten · Spironolacton Sandoz 50 mg, filmomhulde tabletten

Aldactone 100 mg compr. pellic. · Aldactone 25 mg compr. pellic. · Aldactone 50 mg compr. pellic. · Qaialdo 10 mg/ml susp. buv. · Spironolactone EG 100 mg comp. · Spironolactone EG 25 mg comp.

ALDACTONE 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA · ALDACTONE 25 mg COMPRIMIDOS RECUBIERTOS CON PELICULA · Espironolactona · Espironolactona Accord 100 mg Comprimidos Recubiertos con Pelicula efg · Espironolactona Accord 25 mg Comprimidos Recubiertos con Pelicula efg · ESPIRONOLACTONA ALTER 100 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG · ESPIRONOLACTONA ALTER 25 mg COMPRIMIDOS RECUBIERTOS EFG · Espironolactona Orion 100 mg Comprimidos efg · Espironolactona Orion 50 mg Comprimidos efg

Aldactone · Spirolang · Uractone

ALSPIRON 25 mg · ALSPIRON 50 mg · SPIRONOLACTONA LPH 25 mg · SPIRONOLACTONA ARENA 25 mg · SPIRONOLACTONA ARENA 50 mg · SPIRONOLACTONA BIOEEL 25 mg · Spironolactona Gemax Pharma · SPIRONOLACTONA TERAPIA 25 mg · Verospiron