A 23 y/o female patient presents to the pharmacy with a prescription from a dermatologist for spironolactone [Aldactone®] 50mg po every day. You’re not aware on any significant medical history for this patient. Her prescription profile only contains minocycline 100mg po BID. She has no allergies listed.

You explain to her the diuretic effects of this med, thinking it was for peri-menstrual swelling and fluid retention. Although strange coming from a dermatologist. She says ‘this isn’t what the doctor told her this drug was for’.

If not for it’s diuretic properties, why would a dermatologist write a prescription for spironolactone?

SELECT  here for discussion

Spironolactone, alone or in combination with other meds, can be used for treatment of acne vulgaris. The proposed mechanism of action is thought to be antagonism of excess hormones, specifically androgens.  This same antagonism may cause the drug’s other side effects such as menstrual irregularities, sexual dysfunction (men), gynecomastia, hypotension, hyperkalemia, CNS effects (lethargy, fatigue, dizziness, headache), etc. The incidence of side effects seems to correlate linearly with the dose. This therapy can be used alone or in combination with other medications used to control acne to include antibiotics, oral contraceptives, and tretinoin.

From MICROmedex:

Spironolactone in acne

1.    OVERVIEW:
    FDA APPROVAL: Adult, no; pediatric, no
    EFFICACY: Adult, possibly effective
    DOCUMENTATION: Adult, fair

2.    SUMMARY:

*    Oral and topical spironolactone are effective in the treatment of acne. (Topical spironolactone is NOT available commercially)

3.    ADULT:

       a.    GENERAL INFORMATION

             (1)    In open and controlled trials, oral spironolactone 50 to 200 milligrams daily has been effective in the treatment of acne vulgaris. The optimal dose appears to be between 150 to 200 mg daily. Clinical severity of acne (ie, number of lesions) and sebum excretion have decreased significantly following oral treatment with spironolactone (Vincenzi et al, 1993; Hughes & Cunliffe, 1988; Hatwal et al, 1988; Goodfellow et al, 1984).

       b.    CLINICAL STUDIES

             (1)    Low-dose SPIRONOLACTONE alone or combined with other therapeutic agents was well-tolerated and beneficial for the treatment of facial acne in 85 consecutive women, based on a retrospective chart review. Dosing of spironolactone was 50 to 100 milligrams/day; length of treatment varied from 2 to 24 months (mean 10 months). Enrolled patients had inflammatory papular or nodular acne that was considered moderate to severe; most (89%) had failed previous therapy (antibiotics, contraceptives, isotretinoin) and in 80%, the acne seemed to be hormone-related. Twenty percent of the cohort used spironolactone alone, 54% used it in combination with systemic antibiotics, 12% used it with oral contraceptives, and 14% used spironolactone plus antibiotics and oral contraceptives. Of 73 evaluable subjects, 33% found that spironolactone cleared their acne, and another 33% reported marked improvement. Partial improvement occurred in 27.4%, and no improvement in 5 patients. A majority of the group (57.5%) experienced no adverse effects. Menstrual irregularities occurred in 17.5%; central nervous system (CNS) effects (lethargy, fatigue, dizziness, headache) were reported in 16.3%. Five patients dropped out due to CNS effects. Blood pressure was measured in 19 patients; there was a mean reduction of 5 mmHg systolic and 2.6 mmHg diastolic. The authors noted that in other studies of spironolactone, higher doses of the drug (200 mg/day) were associated with higher rates of adverse effects, especially menstrual irregularities and breast tenderness (Shaw, 2001).

             (2)    In a study involving 30 patients, daily application of spironolactone 5% cream for 2 to 6 months produced excellent clinical results in 60% of cases and good results in 17%. However, the study was based on subjective criteria with no controls (Messina et al, 1985).

REFERENCES:

*    Vincenzi C, Trevisi P, Farina P et al: Facial contact dermatitis due to spironolactone in an anti-acne cream. Con Derm 1993; 29:277-278.

*    Hughes RB & Cunliffe WJ: Tolerance of spironolactone. Br J Derm 1988; 118:687-691

*    Goodfellow A, Alaghband-Zadeh J, Carter G et al: Oral spironolactone improves acne vulgaris and reduces sebum excretion. Br J Dermatol 1984; 3:209-214.

*    Hatwal A, Bhatt RP, Agrawal JK et al: Spironolactone and cimetidine in treatment of acne. Acta Derm Venereol (Stockh) 1988; 68:84-87.

*    Messina M, Manieri C, Rizzi G et al: Treating acne with antiandrogens: the confirmation of the validity of a percutaneous treatment with spironolactone. Curr Ther Res 1985; 38:269-282.

*    Shaw JC: Low-dose adjunctive spironolactone in the treatment of acne in women: a retrospective analysis of 85 consecutively treated patients.  J Am Acad Dermatol 2000; 43(3):498-502.

*    Shaw JC. White LE. Long-term safety of spironolactone in acne: results of an 8-year followup study. [Journal Article] Journal of Cutaneous Medicine & Surgery. 6(6):541-5, 2002 Nov-Dec.

This Pearl is meant for academic and educational purposes only. This Pearl is meant to raise important points regarding the safe and cost-effective pharmacotherapy of patients. It is not meant to be the definitive reference for the treatment or prophylaxis of various diseases. Although every effort is taken to ensure this Pearl is correct and factual, errors may occur. The Pharmacoeconomic Center assumes no liability for incorrect information or harm that may occur from the use of the information included in this Pearl.