Docosanol

Kathryn Dzintars, Pharm.D., BCPS, Paul G. Auwaerter, M.D.

INDICATIONS

INDICATIONS

INDICATIONS

FDA

FDA

FDA

  • Herpes labialis

FORMS

FORMS

FORMS

brand name

preparation

manufacturer

route

form

dosage^

cost*

Abreva

Docosanol

GlaxoSmithKline

topical

cream

10% (2g)

$16.05

*Prices represent cost per unit specified, are representative of "Average Wholesale Price" (AWP).
^Dosage is indicated in mg unless otherwise noted.

USUAL ADULT DOSING

USUAL ADULT DOSING

USUAL ADULT DOSING

  • Apply topically 5 times per day as soon as possible during HSV prodromal stage.
    • Prodromal stage: pain, burning, itching, or tingling at the site where the blisters will form.
    • Later application may not be effective; use should be limited to 10 days.
    • Do not apply directly inside the mouth or to the eyes.
  • Available over the counter in the U.S.

PEDIATRIC DOSING

PEDIATRIC DOSING

PEDIATRIC DOSING

USUAL PEDIATRIC DOSING

USUAL PEDIATRIC DOSING

USUAL PEDIATRIC DOSING

  • Children ≥12 years: apply to the affected area 5x per day as soon as possible during the prodromal stage and until lesions healed (but for no more than 10 days).
  • Children < 12 years: dose not established

Pediatric Dosing Author: George K Siberry, MD, MPH

RENAL DOSING

RENAL DOSING

RENAL DOSING

DOSING FOR GLOMERULAR FILTRATION OF 50-80

DOSING FOR GLOMERULAR FILTRATION OF 50-80

DOSING FOR GLOMERULAR FILTRATION OF 50-80

Usual dose.

DOSING FOR GLOMERULAR FILTRATION OF 10-50

DOSING FOR GLOMERULAR FILTRATION OF 10-50

DOSING FOR GLOMERULAR FILTRATION OF 10-50

Usual dose.

DOSING FOR GLOMERULAR FILTRATION OF < 10 ML/MIN

DOSING FOR GLOMERULAR FILTRATION OF < 10 ML/MIN

DOSING FOR GLOMERULAR FILTRATION OF < 10 ML/MIN

Usual dose.

DOSING IN HEMODIALYSIS

DOSING IN HEMODIALYSIS

DOSING IN HEMODIALYSIS

Usual dose.

DOSING IN PERITONEAL DIALYSIS

DOSING IN PERITONEAL DIALYSIS

DOSING IN PERITONEAL DIALYSIS

Usual dose.

DOSING IN HEMOFILTRATION

DOSING IN HEMOFILTRATION

DOSING IN HEMOFILTRATION

Usual dose.

ADVERSE DRUG REACTIONS

ADVERSE DRUG REACTIONS

ADVERSE DRUG REACTIONS

OCCASIONAL

OCCASIONAL

OCCASIONAL

  • Burning/stinging with topical application

RARE

RARE

RARE

  • Pruritis
  • Rash

DRUG INTERACTIONS

DRUG INTERACTIONS

DRUG INTERACTIONS

None

SPECTRUM

SPECTRUM

SPECTRUM

HSV

PHARMACOLOGY

PHARMACOLOGY

PHARMACOLOGY

MECHANISM

MECHANISM

MECHANISM

Docosanol is a long-chain, 22-carbon primary alcohol that can interfere with a wide range of enveloped viruses. It inhibits fusion between the plasma membrane and the viral envelope phospholipids, preventing the entry of the virus into the cell.

PHARMACOKINETIC PARAMETERS

PHARMACOKINETIC PARAMETERS

PHARMACOKINETIC PARAMETERS

Absorption

Absorption

Absorption

No systemic absorption after topical administration.

Metabolism and Excretion

Metabolism and Excretion

Metabolism and Excretion

N/A

Protein Binding

Protein Binding

Protein Binding

N/A

Cmax, Cmin, and AUC

Cmax, Cmin, and AUC

Cmax, Cmin, and AUC

N/A

T1/2

T1/2

T1/2

N/A

Distribution

Distribution

Distribution

N/A

DOSING FOR DECREASED HEPATIC FUNCTION

DOSING FOR DECREASED HEPATIC FUNCTION

DOSING FOR DECREASED HEPATIC FUNCTION

Usual dose.

PREGNANCY RISK

PREGNANCY RISK

PREGNANCY RISK

No data. Probably compatible since systemic absorption is negligible.

BREAST FEEDING COMPATIBILITY

BREAST FEEDING COMPATIBILITY

BREAST FEEDING COMPATIBILITY

No data. Probably compatible since systemic absorption is negligible.

COMMENTS

COMMENTS

COMMENTS

  • Used against labial herpes, not genital outbreaks.
  • Has activity against acyclovir-resistant HSV.
  • Topical docosanol may improve healing time by about 1 day if applied during the prodromal stage, but an experimental animal study did not show a benefit[4].
  • The inconvenience of 5x per day administration, cost, and minimal benefit probably should limit the use of this over-the-counter (OTC) product.

References

References

References

  1. Sadowski LA, Upadhyay R, Greeley ZW, et al. Current Drugs to Treat Infections with Herpes Simplex Viruses-1 and -2. Viruses. 2021;13(7).  [PMID:34202050]

    Comment: This article focuses on the mechanism of action of docosanol. A note is made that as a primary alcohol, it has activity against acyclovir-resistant HSV.

  2. McCarthy JP, Browning WD, Teerlink C, et al. Treatment of herpes labialis: comparison of two OTC drugs and untreated controls. J Esthet Restor Dent. 2012;24(2):103-9.  [PMID:22524716]

    Comment: The study that relied upon a patient survey instrument suggested a 4d reduction in time to healing compared to a placebo.

  3. Treister NS, Woo SB. Topical n-docosanol for management of recurrent herpes labialis. Expert Opin Pharmacother. 2010;11(5):853-60.  [PMID:20210688]

    Comment: A review of the available literature speaks to the safety of this topical compound and given the mechanism of action--little chance for the development of resistance.

  4. McKeough MB, Spruance SL. Comparison of new topical treatments for herpes labialis: efficacy of penciclovir cream, acyclovir cream, and n-docosanol cream against experimental cutaneous herpes simplex virus type 1 infection. Arch Dermatol. 2001;137(9):1153-8.  [PMID:11559210]

    Comment: The authors compared three topical treatments (penciclovir cream, acyclovir cream, and docosanol cream) in a guinea pig model of HSV infection. Penciclovir was superior to acyclovir cream in reducing the number of lesions (19% vs. 0%), area involved (38% vs. 21%) and virus titer (88% vs. 75%). The n-docosanol cream failed to show any differences compared to controls. The authors conclude that penciclovir cream is superior to the other two topical preparations in this animal model and presumably in people as well.

  5. Sacks SL, Thisted RA, Jones TM, et al. Clinical efficacy of topical docosanol 10% cream for herpes simplex labialis: A multicenter, randomized, placebo-controlled trial. J Am Acad Dermatol. 2001;45(2):222-30.  [PMID:11464183]

    Comment: RCT suggests ~ 18h improvement compared to placebo regarding median time to healing. Only mild adverse reactions were seen.

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