Docosanol (Monograph)

Brand name: Abreva
Drug class: Antivirals
ATC class: D06BB11
VA class: DE103
Chemical name: 1-Docosanol
Molecular formula: C₂₂H₄₆O
CAS number: 661-19-8

Introduction

Saturated aliphatic alcohol with antiviral activity against various Herpesviridae, including herpes simplex virus type 1 (HSV-1).

Uses for Docosanol

Herpes Labialis

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

Available for self-medication (OTC use).

Safety and efficacy in immunocompromised individuals not established.

Docosanol Dosage and Administration

Administration

Topical Administration

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

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

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

Wash hands before and after application process.

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

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

Dosage

Pediatric Patients

Herpes Labialis

Topical

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

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

Adults

Herpes Labialis

Topical

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

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

Prescribing Limits

Maximum 10 days of treatment.

Special Populations

No special population recommendations at this time.

Cautions for Docosanol

Contraindications

Known hypersensitivity to docosanol or any ingredient in the formulation.

Warnings/Precautions

General Precautions

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

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).

Safety and efficacy in immunocompromised individuals not established.

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

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

Specific Populations

Pregnancy

Studies have not been conducted; consult clinician before use.

Lactation

Studies have not been conducted; consult clinician before use.

Pediatric Use

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

Geriatric Use

No specific recommendations.

Common Adverse Effects

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

Docosanol Pharmacokinetics

Absorption

Bioavailability

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

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.

Elimination

Metabolism

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

Stability

20–25°C. Do not freeze.

Actions and Spectrum

• Naturally occurring 22-carbon saturated aliphatic alcohol.

• 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).

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

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.

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

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

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

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

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

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

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

Preparations

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

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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