Docosanol

Class: Antivirals
ATC Class: D06BB11
VA Class: DE103
Chemical Name: 1-Docosanol
Molecular Formula: C22H46O
CAS Number: 661-19-8
Brands: Abreva

Introduction

Saturated aliphatic alcohol with antiviral activity against various Herpesviridae, including herpes simplex virus type 1 (HSV-1).2 3 5 7 11 13

Uses for Docosanol

Herpes Labialis

Topical treatment of recurrent herpes labialis (perioral herpes, cold sores, fever blisters).1 6 10

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

Available for self-medication (OTC use).1 5 10

Safety and efficacy in immunocompromised individuals not established.5

Docosanol Dosage and Administration

Administration

Topical Administration

Apply topically to affected areas of the lips and surrounding skin as a 10% cream.1 5

Do not apply in or near the eyes or inside the mouth.1 5

Supplied as a smooth, odorless, tasteless white cream that dries clear.10 When applying, rub in gently and completely.1

Wash hands before and after application process.1 10

For best results, remove any cosmetics from affected areas prior to applying or reapplying the 10% cream.1 10

Cosmetics may be applied to lips or skin after application of the 10% cream.1 10 Avoid spreading the HSV infection by using a separate applicator (e.g., cotton swab) to apply cosmetics or sunscreen over unhealed lesions.1 10

Dosage

Pediatric Patients

Herpes Labialis
Topical

Children≥12 years of age: Apply to affected areas 5 times daily until healed (maximum 10 days).1 5 Use sufficient quantity to adequately cover lesions and symptomatic area (e.g., area with tingling).1 5

Initiate at earliest sign or symptom (i.e., tingling, pruritus, redness, presence of a bump) of herpes labialis.1

Adults

Herpes Labialis
Topical

Apply to affected areas 5 times daily until healed (maximum 10 days).1 5 Use sufficient quantity to adequately cover lesions and symptomatic area (e.g., area with tingling).1 5

Initiate at earliest sign or symptom (i.e., tingling, pruritus, redness, presence of a bump) of herpes labialis.1

Prescribing Limits

Maximum 10 days of treatment.1

Special Populations

No special population recommendations at this time.5

Cautions for Docosanol

Contraindications

Known hypersensitivity to docosanol or any ingredient in the formulation.1

Warnings/Precautions

General Precautions

Use only for symptomatic treatment of herpes labialis lesions.1 10 Not indicated for preventive therapy.10

Not indicated for treatment of localized herpes zoster (shingles, zoster) or any other cutaneous or mucocutaneous diseases or conditions (e.g., canker sores inside the mouth, cracks forming at corners of mouth).10

Safety and efficacy in immunocompromised individuals not established.5

Discontinue if herpes labialis lesions are not healed after 10 days of treatment.10 An updated diagnosis and additional treatment may be indicated.10

Secondary bacterial infection may be present if lesions do not heal within 7–10 days.10

Specific Populations

Pregnancy

Studies have not been conducted; consult clinician before use.10

Lactation

Studies have not been conducted; consult clinician before use.10

Pediatric Use

Safety and efficacy not established in children <12 years of age.1 5

Geriatric Use

No specific recommendations.5

Common Adverse Effects

Headache,6 application site reaction (e.g., burning, stinging), 5 6 herpes simplex outside of treatment area.6

Docosanol Pharmacokinetics

Absorption

Bioavailability

Not appreciably absorbed into systemic circulation following topical application to healthy skin or herpes labialis lesions.13

In vitro studies using cadaver skin indicate dermal penetration following topical application is minimal and appears to be limited to the dermis and stratum corneum.13

Elimination

Metabolism

Metabolic fate of topically applied docosanol not fully determined.11 13 Metabolized to n-docosanoic acid and incorporated into cellular lipids and phospholipids.11 13

Stability

20–25°C.1 Do not freeze.1

Actions and Spectrum

  • Naturally occurring 22-carbon saturated aliphatic alcohol.2 3 5 7

  • In vitro activity against Herpes simplex virus types 1 and 2 (HSV-1 and HSV-2), cytomegalovirus (CMV), respiratory syncytial virus (RSV), varicella zoster virus (VZV), and human immunodeficiency virus type 1 (HIV-1).2 3 7 12 13

  • Mechanism of action in treatment of herpes labialis lesions does not involve direct virucidal activity against HSV.10 11 12 13 Appears to interfere with fusion of the HSV envelope and host cell membranes, thereby preventing HSV entry into host cells and subsequent viral replication.2 3 5 7 10 11 12 13

Advice to Patients

  • Importance of applying docosanol 10% cream at first sign or symptom of herpes labialis lesion as indicated by tingling, pruritus, redness, or presence of a bump.1 10

  • Importance of discontinuing the drug and contacting clinician if lesion does not heal within 10 days of initiating treatment or if condition worsens.1 10

  • Importance of not sharing docosanol cream with others since this may spread the infection.1 10

  • Importance of keeping docosanol cream out of reach of children and of contacting a poison control center immediately if the drug is swallowed.1 5

  • Importance of avoiding contact with eyes or inside of mouth.1 For external use only.1 5

  • If a dose is missed, apply as soon as it is remembered; apply the next dose on schedule.10 If a dose is accidentally wiped off while blowing the nose or wiping the mouth, reapply the dose as soon as possible.10

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Docosanol

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

10%

Abreva

GlaxoSmithKline

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions May 1, 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. GlaxoSmithKline Consumer Healthcare. Abreva product information. Moon Township, PA. 2006.

2. Alrabiah FA, Sacks S. New antiherpesvirus agents. Drugs. 1996; 11: 17-32.

3. Pope LE, Marcelletti JF, Katz LR et al. The anti-herpes simplex virus activity of n-docosanol includes inhibition of the viral entry process. Antiviral Res. 1998; 40:85-94. [PubMed 9864049]

4. Anon. Docosanol cream (abreva) for recurrent herpes labialis. Med Lett Drugs Ther. 2000; 42:108. [PubMed 11077469]

5. GlaxoSmithKline Consumer Healthcare, Pittsburgh, PA and Weybridge, Surrey, United Kingdom. Personal communication.

6. 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; 45:222-30. [IDIS 467497] [PubMed 11464183]

7. Katz DH, Marcelletti JF, Pope LE et al. N-docosanol: broad spectrum anti-viral activity against lipid-enveloped viruses. Ann NY Acad Sci. 1994; 724:472-88. [PubMed 8030975]

8. Novartis. Denavir– (penciclovir cream 1%) prescribing information. East Hanover, NJ; 2001 Jan.

9. Spruance SL. The natural history of recurrent oral-facial herpes simplex virus infections. Semin Dermatol. 1992; 11:200-6. [PubMed 1390034]

10. GlaxoSmithKline Consumer Healthcare. Frequently asked questions about Abreva. From website ().

11. Pope LE, Marcelletti JF, Katz LR et al. Antiherpes simplex virus activity of n-docosanol correlates with intracellular metabolic conversion of the drug. J Lipid Res. 1996; 37:2167-78. [PubMed 8906594]

12. Katz DH, Marcelletti JF, Khalil MH et al. Antiviral activity of 1-docosanol, an inhibitor of lipid-enveloped viruses including herpes simplex. Proc Natl Acad Sci. 1991; 88:10825-9. [PubMed 1660151]

13. Center for Drug Evaluation and Research. New drug application for docosanol (NDA 20-941). From Drugs@FDA website ().

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