By Gary M. White, MD
Note, this is a brief summary only and is meant to emphasize dermatologic aspects. More complete information, including the package insert and recent studies should be consulted before prescribing.
Spironolactone is heart-medication that is also effective in the treatment of acne in adult women. However, it not FDA-approved for the treatment of acne.
- Spironolactone has been documented to decrease sebum secretion from 50-80%.
- It also can decrease levels of male hormones including testosterone and DHEAS [JAAD 2015:73:856].
FDA-approval in 1960. Current FDA-approved indications:
- Primary hyperaldosteronism
- Edematous conditions, e.g. cirrhosis of the liver or nephrotic syndrome
- Congestive Heart Failure
- Essential hypertension
Spironolactone is not FDA-approved for acne.
Notes for Use in Acne
- Giving with OCP aids in the treatment of acne, reduces menstrual irregularity, and prevents pregnancy (spironolactone is not to be used in pregnancy).
- The typical dose for acne is 50-100 mg/day although one may go up to 200 mg/day.
- 3 months are needed to see an effect.
- Checking K+ is not routinely necessary, but may be in special circumstances.
- It should be taken with food (increases bioavailability by almost 100%).
- Aldosterone antagonist=> diuresis and lowering of blood pressure
- Antiandrogen=> improvement in acne and hirsutism
- Androgen receptor blocker
- Inhibits 5 α-reductase
- Decreases androgen production
- Routine potassium monitoring is unnecessary for healthy women taking spironolactone for acne [JAMA Derm 2015;151;941].
Researchers reviewed the records of 974 healthy women aged 18-45 who were prescribed spironolactone for acne [JAMA Dermatol. 2015;151;941]. Of 1802 serum potassium measurements over 14 years, 13 (0.72%) showed mild hyperkalemia (5.1-6.0 mEq/l) which was similar to the baseline rate (0.76%) in this population. Six were retested and all had normal values on subsequent test.
When to Measure the K+?
It seems reasonable to check the K+ in the following situations:
- Older age
- History of renal or cardiac disease
- History of impaired hepatic function (minor alterations of fluid and electrolyte balance may precipitate hepatic coma)
- Higher doses of spironolactone (200 mg/day)
- If on certain medications:
- ACE inhibitors
- Angiotensin II antagonists
- Aldosterone blockers
- NSAIDS (e.g., indomethacin)
- Salt substitutes
- K+ supplementation
- Muscle weakness
- Flaccid paralysis of extremities
- Diuretics increase renal clearance of lithium.
- Digoxin. Spironolactone increases the half life of digoxin and may increase toxicity.
Trimethoprim-sulfamethoxazole. Do not give spironolactone along with trimethoprim-sulfamethoxazole. That combination in one study was more than 12 times likelier than spironolactone/amoxicillin to cause hyperkalemia.
- In the elderly, giving trimethoprim-sulfamethoxazole to a patient on spironolactone puts them at risk for sudden death [CMAJ].
One study found the combination of spironolactone 100 mg/day and drospirenone/EE 30 ug efficacious, safe, and well-tolerated [JAAD 2008;58:60-2].
- Most dose-related
- Menstrual irregularities
- Breast tenderness and/or enlargement
- In those with baseline low blood pressure, lightheadedness and syncope.
- Some may note decreased facial oiliness
Women with baseline low blood pressure may have trouble with lightheadedness and even syncope. The blood pressure in these patients should be monitored at followup visits.
Pregnancy Category D
- Spironolactone should not be used in pregnancy.
Black Box Warning
Spironolactone has been shown to be a tumorigenic in chronic toxicity studies in rats. Spironolactone should be used only in those conditions described under Indications and Usage. Unnecessary use of this drug should be avoided.
Note: Dosages used in these rat studies were 25-100 times higher than those administered to humans.
With respect to breast, uterus, ovarian, and cervical cancer, there does not seem to be evidence of increased risk with spironolactone [Cancer Epidemiol 2013;37:870-5].
One study of 200 person-years of exposure to spironolactone and 506 person-years of followup over 8 years found no serious illnesses thought to be attributed to spironolactone [J Cutan Med Surg 2002;6:541-5].
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