Docosanol (Topical)
 |
VA CLASSIFICATION
Primary: DE103
Commonly used brand name(s): Abreva.
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).
Category:
Antiviral (topical)—
Indications
General considerations
Docosanol produces its effect by modifying the host cell rather than acting directly on the virus. Therefore, it is very unlikely that HSV strains develop any type of resistance to the antiviral effects of docosanol.{01}
Docosanol exhibits antiviral activity in vitro against many lipid–enveloped viruses, including: HSV–1, HSV–2, VZV,CMV, HHV–6, RSV, influenza A, and HIV–1. HSV–1 and HSV–2 have been shown to be susceptible to antiviral activity in vivo{01}.
Accepted
Oral-facial herpes simplex (treatment)—Topical docosanol is indicated in the treatment of recurrent oral-facial herpes simplex (fever blisters or cold sores) in adults{01}.
Pharmacology/Pharmacokinetics
Physicochemical characteristics:
Molecular weight—
326.61{01}
Mechanism of action/Effect:
Docosanol reduces viral replication and activity by effectively inhibiting the fusion between the plasma membrane and the herpes simplex virus envelope.{01}
Absorption:
Absorption of docosanol has been shown to be minimal under conditions reflecting normal clinical use. Of 209 plasma samples taken from ten subjects 24 hours after a multi-day test, only one had a docosanol level above the quantitation limits (10 nanograms per mL).{01}
Precautions to Consider
Carcinogenicity
Carcinogenicity tests were not conducted with docosanol. However, carcinogenic effects are unlikely because the body is unable to absorb large quantities of docosanol and demonstrates a high rate of docosanol elimination{01}.
Mutagenicity
No increases in gene mutation were seen in adequate studies done on Salmonella typhimurium and Chinese hamster V79 cells.{01}
Pregnancy/Reproduction
Fertility—
No adverse effects on fertility were seen when rats and rabbits were dosed with either 1000 mg/kg/day or 2000 mg/kg/day, (2500 to 5000 times the expected human dose, respectively). Furthermore, rabbits did not exhibit any adverse effects on fertility following vaginal administration of docosanol{01}.
Pregnancy—
Adequate and well controlled studies have not been conducted in humans. Studies in which animals were administered several thousand times the recommended human dosage of docosanol have not shown that docosanol causes any adverse effects on the fetus.{01}
FDA Pregnancy Category B{01}
Breast-feeding
It is not known whether docosanol is distributed into breast milk. However, problems in humans have not been documented.{01}.
Pediatrics
Safety and efficacy have not been established.{01}
Adolescents
Appropriate studies on the relationship of age to the effects of docosanol have not been performed in the adolescent population. However, adolescent–specific problems that would limit the usefulness of this medicine in teenagers are not expected.{01}
Geriatrics
Appropriate studies performed to date have not demonstrated geriatrics–specific problems that would limit the usefulness of docosanol in the elderly.{01}
Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).
Except under special circumstances, this medication should not be used when the following medical problem exists:
Hypersensitivity to topical docosanol{01}
Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
Headache{02}
Incidence less frequent
Application site reaction{01} (burning, itching, redness, skin rash, swelling, or soreness at site of application)
Incidence rare
Skin manifestations, including:
acne{01}
dry skin{01}
pruritus {01} (itching), rash{01}
Overdose
For more information on the management of overdose or unintentional ingestion, contact a poison control center (see Poison Control Center Listing).
Treatment of overdose
Due to limited transcutaneous absorption and poor oral absorption of docosanol, the potential for an adverse reaction related to an overdose is extremely low.{01}Treatment is essentially symptomatic and supportive.{01}
Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.
Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Docosanol (Topical) .
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):
Before using this medication
» Conditions affecting use, especially:
Hypersensitivity to docosanol
Proper use of this medication
Reading patient information about herpes simplex infections {01}
» Avoiding contact with eyes or genitalia{01}
» Using medication as soon as possible after signs and symptoms of herpes begin to appear {01}
» Proper administration technique
To use
Applying medication to affected areas; rubbing in gently and completely.{01}
» Proper dosing
Proper storage
General Dosing Information
Topical docosanol is for oral-facial herpes only; it should not be used in the eyes or on the genitalia. {01}
Therapy should be initiated as soon as possible following the onset of signs and symptoms of herpes infection. {01}
Topical Dosage Forms
DOCOSANOL CREAM
Usual adult and adolescent dose
Antiviral
Topical, to the affected area, five times a day until the lesion is healed.{01} Apply a sufficient quantity to cover all lesions adequately. The cream should be rubbed in gently and completely.{01}
Usual Pediatric Dose
Antiviral
Children up to 12 years of age: Safety and efficacy have not been established.
Children 12 years of age and over: See Usual adult and adolescent dose.
Usual Geriatric Dose
See Usual adult and adolescent dose .
Strength(s) usually available
U.S.—
10% (0.1 gram per gram) (OTC) [Abreva{01} (benzyl alcohol NF) (light mineral oil NF) (propylene glycol USP) ( purified water USP) (sucrose distearate) (sucrose stearate)]
Packaging and storage:
Store at or below 25 °C (77 °F). Protect from freezing.{01}
Auxiliary labeling:
• For external use only.
• Do not use near the eyes{01}.
• Continue with medicine until lesion is healed{01}.
Revised: 12/22/2000
References
- Product Information: Abreva™, docosanol. Avanir Pharmaceuticals, San Diego, CA, (PI revised 08/2000) reviewed 10/2000.
- Reviewer's comments. 11/2000.
 |
Link to Page |  |
Print Page |  |
Email Page |
