Erasaban (Cream) Instructions for Use

Marketing Authorization Holder

Delta Medical Promotions AG (Switzerland)

Manufactured By

Fleet Laboratories, Limited (United Kingdom)

ATC Code

D06BB11 (Docosanol)

Active Substance

Docosanol

Dosage Form

Erasaban

Cream for external use 10%: tube 2 g

Dosage Form, Packaging, and Composition

Cream for external use white or almost white, homogeneous.

Excipients: sucrose, almond oil, propylene glycol, benzyl alcohol, water.

2 g – aluminum tubes (1) – cardboard packs.
5 g – aluminum tubes (1) – cardboard packs.
10 g – aluminum tubes (1) – cardboard packs.
15 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Antiviral drug for external use

Pharmacotherapeutic Group

Antiviral agent

Pharmacological Action

Docosanol is an antiviral agent. The exact mechanism of antiviral action is unclear.

In vitro studies have shown that Docosanol affects the adhesion of the virus to the plasma membrane, which inhibits the penetration of the virus into the cell and its replication.

In vivo studies have shown that cells treated with docosanol are resistant to infection by enveloped viruses, such as Herpes simplex virus 1.

Docosanol is not effective against non-enveloped viruses.

Docosanol in the dosage form of 10% cream was studied in clinical trials compared to placebo (containing polyethylene glycol). A total of 737 patients were randomized.

The average time to complete healing was 4.1 days in the docosanol group and 4.8 days in the placebo group, with a difference of 17.5 hours (0.7 days).

Pharmacokinetics

Docosanol is intracellularly metabolized to docosanoic acid (the main metabolite).

Docosanol and its metabolite are endogenous components of human cell membranes, especially in erythrocytes, brain, lungs, and kidneys.

When the cream is applied to intact skin: absorption is minimal, not detected in the blood.

Affected skin: absorption is moderate. Excreted by the kidneys.

Indications

• Infections of the skin and mucous membranes caused by Herpes simplex virus type 1, including herpes labialis.

ICD codes

Dosage Regimen

Externally.

The preparation is recommended to be applied 5 times a day (approximately every 3 hours during the daytime) as early as possible after the onset of the infection, applied in a thin layer to the affected areas and adjacent skin areas.

It is important to start treatment of a recurrent infection during the prodromal phase or at the very beginning of the manifestation of the infection.

The duration of treatment is at least 5 days.

In the absence of healing, treatment can be continued for up to 10 days.

If symptoms persist for more than 10 days, a doctor should be consulted.

Dosage adjustment is not required in elderly patients and in patients with impaired renal function.

The cream is applied either with a cotton swab or with clean hands to avoid additional infection of the affected areas.

Adverse Reactions

The frequency of adverse reactions that may occur during therapy is presented as the following gradation: very common (≥1/10); common (from ≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (from ≥1/10,000 to <1/1000); very rare (<1/10,000), including isolated cases.

From the central nervous system very common – headache.

Local common — dry skin, skin itching, rash, short-term redness, soreness, peeling, burning or tingling at the application sites, vulvitis.

There are isolated reports of cases of angioedema with external use of the drug.

If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Contraindications

• Hypersensitivity to docosanol or any other component of the drug;
• Age under 12 years (no experience of use);
• Patients with rare diseases: fructose intolerance and glucose/galactose malabsorption syndrome or sucrase/isomaltase deficiency.

With caution — pregnancy and lactation period.

Use in Pregnancy and Lactation

Adequate and strictly controlled clinical studies of the safety of the drug during pregnancy have not been conducted.

Experimental studies have not revealed teratogenic and embryotoxic effects on the fetus.

The use of Erasaban is indicated only if the intended benefit to the mother outweighs the potential risk to the fetus and/or child.

If it is necessary to use Erasaban during lactation, breastfeeding should be discontinued.

Use in Renal Impairment

Dosage adjustment is not required in patients with impaired renal function.

Pediatric Use

Contraindicated in children under 12 years of age.

Geriatric Use

Dosage adjustment is not required in elderly patients.

Special Precautions

Avoid contact of the drug with the eyes, do not apply to the skin near the eyes.

To achieve the maximum therapeutic effect, the drug should be used at the first signs of the disease (burning, skin itching, tingling, sensation of tension and redness).

Patients with reduced immunity (with HIV/AIDS or after bone marrow transplantation) during therapy for any infectious diseases should follow the doctor’s recommendations.

Effect on ability to drive vehicles and operate machinery

No effect.

Overdose

Overdose with external use is unlikely (low percutaneous absorption). No reports of overdose have been received.

Drug Interactions

No interaction with other medicinal products has been identified with external use.

Enhancement of the effect is noted with the simultaneous administration of immunostimulants.

Storage Conditions

Store at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 3 years.

Dispensing Status

Without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.