Components:
Docosanol
Method of action:
Antibiotics And Chemotherapeutics For Dermatological Use
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Name of the medicinal product

Abreva (Topical)

Qualitative and quantitative composition

Docosanol

Pharmaceutical form

Cream

Therapeutic indications

The information provided in Therapeutic indications of Abreva (Topical) is based on data of another medicine with exactly the same composition as the Abreva (Topical) of the medicine (Docosanol). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Abreva (Topical) directly from the package or from the pharmacist at the pharmacy.
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Treatment of early stages (prodrome or erythema phase) of recurrent labial herpes simplex infection (cold sores) in immunocompetent adults.

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Abreva (Topical) is based on data of another medicine with exactly the same composition as the Abreva (Topical) of the medicine (Docosanol). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Abreva (Topical) directly from the package or from the pharmacist at the pharmacy.
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Route of Administration: Cutaneous use

Posology

Adults and adolescents aged 12 years and over:

Apply a thin film carefully over the entire cold sore 5 times a day (approximately every 3 hours during waking hours).

Treatment must begin as soon as possible after the first cold sore symptoms or signs appear (pain, burning/itching/tingling or redness) as efficacy has not been demonstrated when the treatment is initiated at the stage of an already developed blister or ulcer.

Treatment should continue until healing has occurred, usually 4 to 6 days, or for a maximum of 10 days.

Elderly:

No special dose recommendation.

Paediatric population:

The safety and efficacy of Blistex Cold Sore Cream in children aged younger than 12 years have not been established.

Dosage in renal failure:

No dose adjustments necessary due to negligible topical absorption.

Contraindications

The information provided in Contraindications of Abreva (Topical) is based on data of another medicine with exactly the same composition as the Abreva (Topical) of the medicine (Docosanol). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Abreva (Topical) directly from the package or from the pharmacist at the pharmacy.
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Hypersensitivity to the active substance (docosanol) or to any of the excipients.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Abreva (Topical) is based on data of another medicine with exactly the same composition as the Abreva (Topical) of the medicine (Docosanol). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Abreva (Topical) directly from the package or from the pharmacist at the pharmacy.
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Avoid application close to or in the eyes.

Should only be used for cold sores on the mouth and face.

Must not be used to treat genital or ocular herpes infections

Avoid transmitting the virus, particularly when active lesions are present.

The cream should not be used in immuno compromised patients.

Treatment with the cream should not be initiated at the stage of an already developed blister or ulcer.

If the recurrent cold sore is particularly severe, consult doctor.

Immunocompromised patients should consult a pharmacist or doctor concerning treatment of any infection, including cold sores.

Paediatric population

There is no treatment experience available for the use in children below the age of 12 years and only limited experience in adolescent (aged 12-18 years). It is recommended that the cream should not be used in children under 12 years.

This formulation contains propylene glycol and may cause skin irritation.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Abreva (Topical) is based on data of another medicine with exactly the same composition as the Abreva (Topical) of the medicine (Docosanol). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Abreva (Topical) directly from the package or from the pharmacist at the pharmacy.
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Due to its negligible absorption docosanol has no influence on the ability to drive and use machines.

Undesirable effects

The information provided in Undesirable effects of Abreva (Topical) is based on data of another medicine with exactly the same composition as the Abreva (Topical) of the medicine (Docosanol). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Abreva (Topical) directly from the package or from the pharmacist at the pharmacy.
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Very common (≥1/10)

Common (≥1/100 to <1/10)

Uncommon (≥1,000 to <1/100)

Rare (≥1/10,000 to <1/1,000)

Very rare (<1/10,000)

Not known (cannot be estimated from the available data).

Results from clinical trials of the treatment of recurrent labial herpes simplex demonstrate no difference in the frequency or type of undesirable effects in patients treated with Blistex Cold Sore Cream or placebo.

Nervous system disorders

Very common: Headache (10.4% of docosanol-treated patients and 10.7% of placebo-treated patients).

General disorders and administration site conditions

Common: Application site adverse reactions which include dry skin, rashes and skin disorders (2.9% of docosanol-treated patients and 2.3% of placebo-treated patients).

Facial oedema has also been reported but these application site adverse reactions are consistent with normal facial reactions experienced with cold sores.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard.

Overdose

The information provided in Overdose of Abreva (Topical) is based on data of another medicine with exactly the same composition as the Abreva (Topical) of the medicine (Docosanol). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Abreva (Topical) directly from the package or from the pharmacist at the pharmacy.
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Adverse reactions related to overdose by topical application of Blistex Cold Sore Cream are unlikely because of negligible percutaneous absorption. Similarly, poor oral absorption makes the occurrence of adverse reactions unlikely following ingestion of docosanol.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Abreva (Topical) is based on data of another medicine with exactly the same composition as the Abreva (Topical) of the medicine (Docosanol). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Abreva (Topical) directly from the package or from the pharmacist at the pharmacy.
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Pharmacotherapeutic group: Chemotherapeutics for topical use, antivirals

ATC code: D06BB11

The exact mechanism of the antiviral activity of docosanol is unknown. In vitro studies indicate that docosanol affects the fusion between the virus and the plasma membrane, which inhibits intracellular uptake and replication of virus. In vitro studies demonstrate that docosanol-treated cells resist infection by lipid-enveloped viruses such as HSV-1. Docosanol has no effect against non-enveloped viruses. Docosanol 10 % was compared to placebo (containing polyethylene glycol) in two randomised, double-blind, controlled clinical trials. In one study, 370 adults were randomised. Subjects started with treatment in the prodrome or erythema phase of an acute recurrence of orofacial herpes. The ITT population consisted of 183 subjects for docosanol and 183 subjects for placebo. The median time to complete healing was 4.0 days in the docosanol group and 4.7 days in the placebo group a difference of 18.9 hours (p=0.0235; p=0.010 with covariate adjustment). In the second study, 373 adults were randomised. Subjects started with treatment in the prodrome or erythema phase of an acute recurrence of orofacial herpes. The ITT population consisted of 187 subjects for docosanol and 184 subjects for placebo. The median time to complete healing was 4.3 days in the docosanol group and 4.9 days in the placebo group a difference of 15.9 hours (p=0.1529; p=0,008 with covariate adjustment). In studies with treatment initiation at stages later than the prodromal or erythema stage, efficacy was not demonstrated.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Abreva (Topical) is based on data of another medicine with exactly the same composition as the Abreva (Topical) of the medicine (Docosanol). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Abreva (Topical) directly from the package or from the pharmacist at the pharmacy.
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Under conditions reflecting normal clinical use of Blistex Cold Sore Cream, docosanol could not be quantified (limit of quantification, LOQ = 10 ng/ml) in the plasma of treated patients. Ten women with active labial herpes simplex were treated with Blistex Cold Sore Cream. After a single dose on study day 1 and after multiple doses (five times daily, study days 2-3), blood samples were withdrawn up to 24 hours after treatment and analysed for docosanol. Of the 209 plasma samples analysed, the docosanol level was below the LOQ in 208 and exactly at the LOQ in one sample.

Docosanol is metabolized to docosanoic acid, its major metabolite. Both docosanol and docosanoic acid are endogenous components of cell membranes in man, particularly in erythrocytes, brain, nerve myelin sheath, lung, and kidney.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Abreva (Topical) is based on data of another medicine with exactly the same composition as the Abreva (Topical) of the medicine (Docosanol). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Abreva (Topical) directly from the package or from the pharmacist at the pharmacy.
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Chemotherapeutics for topical use, antivirals

Preclinical safety data

The information provided in Preclinical safety data of Abreva (Topical) is based on data of another medicine with exactly the same composition as the Abreva (Topical) of the medicine (Docosanol). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Abreva (Topical) directly from the package or from the pharmacist at the pharmacy.
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Preclinical data revealed no special hazard for humans based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.

Incompatibilities

The information provided in Incompatibilities of Abreva (Topical) is based on data of another medicine with exactly the same composition as the Abreva (Topical) of the medicine (Docosanol). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Abreva (Topical) directly from the package or from the pharmacist at the pharmacy.
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Not applicable.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Abreva (Topical) is based on data of another medicine with exactly the same composition as the Abreva (Topical) of the medicine (Docosanol). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Abreva (Topical) directly from the package or from the pharmacist at the pharmacy.
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No special requirements.