Finasteride Missed-Dose Protocol: What to Do When You Skip a Pill

At a glance

  • Labeled dose, Propecia / 1 mg once daily, with or without meals [1]
  • Labeled dose, Proscar / 5 mg once daily, with or without meals [2]
  • Plasma half-life / About 5 to 6 hours in men 18 to 60; about 8 hours over 70 [1]
  • DHT after one 1 mg tablet / 65% suppression of serum DHT within 24 hours [1]
  • Type II enzyme turnover / Half-life about 30 days [1]
  • Time to benefit / Three months or more of daily use [1]
  • If treatment stops / Reversal of effect within 12 months [1]
  • Studied hair-loss regimen / 1 mg daily; 107 and 138 more hairs than placebo at 1 and 2 years [3]

What the two labels say

The Propecia dosing section is short: one tablet (1 mg) once daily, with or without meals; daily use for three months or more is usually necessary before benefit is observed; and continued use is recommended to sustain benefit, with withdrawal of treatment leading to reversal of effect within 12 months [1]. The Proscar section is shorter still: one tablet (5 mg) taken once a day, with or without meals [2]. The Propecia patient information adds that if you forget a tablet, you should not take an extra tablet and should just take the next one as usual, and that taking it more than once a day will not work faster or better [1]. The dosing sections themselves give no separate missed-dose rule [1][2].

Why plasma half-life and DHT effect differ

Finasteride is a competitive, specific inhibitor of type II 5-alpha-reductase, the enzyme that converts testosterone to dihydrotestosterone; type II accounts for about two-thirds of circulating DHT, and finasteride is roughly 100-fold selective for it over type I [1]. A 1 mg tablet produces 65% suppression of serum DHT within 24 hours [1]. In a 24-week randomized trial of 399 men with benign prostatic hyperplasia (randomized across dutasteride doses, finasteride 5 mg and placebo), the finasteride 5 mg arm had a 70.8% mean decrease in serum DHT [4].

The drug clears faster than the enzyme effect does. Mean terminal half-life is about 5 to 6 hours in men aged 18 to 60 and about 8 hours in men over 70, with peak levels at 1 to 2 hours and bioavailability of about 65%, unaffected by food [1]. The label attributes the persistence of DHT suppression to slow turnover of the enzyme complex: a half-life of about 30 days for type II and 14 days for type I [1].

The hair-loss data come from daily dosing

Two 1-year placebo-controlled trials enrolled 1,553 men aged 18 to 41 with male pattern hair loss who took finasteride 1 mg daily or placebo, and 1,215 of them continued into blinded second-year extensions [3]. Hair count in a 1-inch (5.1 cm2) circle of vertex scalp was 107 hairs higher than placebo at 1 year and 138 higher at 2 years (P<0.001), while the placebo group kept losing hair [3].

Missing a tablet and stopping treatment

Propecia's label recommends continued use to sustain benefit and states that withdrawal of treatment leads to reversal of effect within 12 months [1]. That statement is about withdrawal of treatment, not about a single missed tablet.

PSA results and consistency of dosing

The labels tie one laboratory value to consistent dosing. The Propecia label reports mean serum PSA falling from 0.7 ng/mL to 0.5 ng/mL at month 12 in men aged 18 to 41 [1]. Proscar lowers PSA by approximately 50% within six months; its label says a new PSA baseline should be established at least six months after starting, that any confirmed increase from the lowest PSA value on treatment should be evaluated for prostate cancer, and that an isolated PSA value in a man treated for six months or more should be doubled for comparison with normal ranges in untreated men [2]. Percent free PSA is unchanged, so no adjustment to it appears necessary [2]. Both labels note that non-compliance with therapy may affect PSA test results [1][2].

Frequently asked questions

What should I do if I forget a finasteride tablet?
The Propecia patient information says not to take an extra tablet and to take the next tablet as usual [1]. The regimen in both labels is one tablet a day, 1 mg for Propecia and 5 mg for Proscar, each taken with or without meals [1][2].
Can I take two tablets the next day to catch up?
The Propecia patient information says not to take an extra tablet if you forget one, and that taking it more than once a day will not work faster or better [1].
Does missing a finasteride dose affect the hair-loss benefit?
The Propecia label recommends continued use to sustain benefit and says withdrawal of treatment leads to reversal of effect within 12 months [1]. The hair-count results, 107 more hairs than placebo at 1 year and 138 more at 2 years (P<0.001), come from men taking 1 mg daily [3].
Does a missed dose affect a PSA test?
Both labels note that non-compliance with therapy may affect PSA results [1][2]. Proscar lowers PSA by about 50% within six months, and its label says to double an isolated value in men treated six months or more [2].
Does finasteride have to be taken with food?
No. Both labels allow dosing with or without meals, and food does not affect absorption of the 1 mg tablet [1][2].
What does the label say happens if finasteride is stopped?
The Propecia label states that withdrawal of treatment leads to reversal of effect within 12 months [1].

References

  1. U.S. National Library of Medicine, DailyMed. Propecia (finasteride 1 mg) tablets, Organon prescribing information. Propecia (finasteride 1 mg) tablets, Organon label
  2. U.S. National Library of Medicine, DailyMed. Proscar (finasteride 5 mg) tablets, Organon prescribing information. Proscar (finasteride 5 mg) tablets, Organon label
  3. Kaufman KD, Olsen EA, Whiting D, Savin R, DeVillez R, Bergfeld W, et al. Finasteride in the treatment of men with androgenetic alopecia. Finasteride Male Pattern Hair Loss Study Group. J Am Acad Dermatol. 1998;39(4 Pt 1):578-89. Finasteride in the treatment of men with androgenetic alopecia. Finasteride Male Pattern Hair Loss Study Group
  4. Clark RV, Hermann DJ, Cunningham GR, Wilson TH, Morrill BB, Hobbs S. Marked suppression of dihydrotestosterone in men with benign prostatic hyperplasia by dutasteride, a dual 5alpha-reductase inhibitor. J Clin Endocrinol Metab. 2004;89(5):2179-84. Marked suppression of dihydrotestosterone in men with benign prostatic hyperplasia by dutasteride, a dual 5alpha-reductase inhibitor
  5. McConnell JD, Bruskewitz R, Walsh P, Andriole G, Lieber M, Holtgrewe HL, et al. The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. Finasteride Long-Term Efficacy and Safety Study Group. N Engl J Med. 1998;338(9):557-63. The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. Finasteride Long-Term Efficacy and Safety Study Group
  6. McConnell JD, Roehrborn CG, Bautista OM, Andriole GL, Dixon CM, Kusek JW, et al. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med. 2003;349(25):2387-98. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia
Evidence overview for finasteride: Finasteride Missed-Dose Protocol: What to Do When You Skip a Pill