Zovirax^® Duo-Active (Cream) Instructions for Use

Marketing Authorization Holder

Cheleon Rus, JSC (Russia)

Manufactured By

Glaxo Wellcome Operations (United Kingdom)

Contact Information

CHELEON RUS JSC (Russia)

ATC Code

D06BB53 (Acyclovir in combination with other drugs)

Active Substances

Aciclovir (Rec.INN registered by WHO)

Hydrocortisone (Rec.INN registered by WHO)

Dosage Form

Zovirax® Duo-Active

Cream for external use 50 mg+10 mg/1 g: tube 2 g

Dosage Form, Packaging, and Composition

Cream for external use homogeneous, from white to yellowish in color.

Excipients: liquid paraffin, white soft paraffin, isopropyl myristate, sodium lauryl sulfate, ceto-stearyl alcohol, poloxamer 188, propylene glycol, citric acid monohydrate, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), purified water.

2 g – aluminum tubes (1) – cardboard packs.

The primary and secondary packaging may have a first-opening control feature.

Clinical-Pharmacological Group

Drug with antiviral and anti-inflammatory action for external use

Pharmacotherapeutic Group

Antibiotics and antimicrobial agents used in dermatology; antimicrobial agents for topical use; antiviral agents

Pharmacological Action

Acyclovir – an antiviral drug – is highly active in vitro against Herpes simplex virus (HSV) types 1 and 2. Its toxic effect on mammalian cells is minimal. After entering cells infected with the herpes virus, Acyclovir is phosphorylated to the active compound acyclovir triphosphate.

The first stage of this process depends on the presence of the HSV-encoded enzyme thymidine kinase. Acyclovir triphosphate acts as an inhibitor and substrate for the herpes-specific DNA polymerase, preventing further synthesis of viral DNA, while not affecting normal cellular processes.

Hydrocortisone belongs to weakly active glucocorticosteroids, which have various immunomodulatory actions. When applied externally, the therapeutic activity of hydrocortisone is due to the control of various inflammatory skin disorders.

The drug Zovirax^® Duo-Active, combining the antiviral properties of acyclovir and the anti-inflammatory action of hydrocortisone, reduces the frequency of progression of lip herpes to ulcerative lesions and also reduces their healing time.

The exact mechanism of action is not fully known, but it is presumably associated with the elimination of the virus and suppression of the local inflammatory reaction on the lips, which leads to a reduction in the signs and symptoms of infection.

Pharmacokinetics

Clinical pharmacokinetic studies of the drug Zovirax^® Duo-Active have not been conducted.

Absorption

Due to limited absorption, the expected systemic exposure of acyclovir after topical application of Zovirax^® Duo-Active cream will be low.

Glucocorticosteroids penetrate the stratum corneum of the epidermis and affect the deeper cell layers. Typically, only a small part of the dose is absorbed, so a change in hormonal balance is unlikely.

Systemic effects of glucocorticosteroids are possible with increased absorption (for example, when the cream is applied to extensive inflamed areas of the skin or to skin with a damaged stratum corneum). Occlusive dressings also increase absorption.

Indications

• In adults and children over 12 years of age with normal immune status for the treatment of early manifestations of recurrent labial herpes.

ICD codes

Dosage Regimen

For external use only.

It is important to start treatment as early as possible, preferably at the first signs and symptoms (burning, tingling, feeling of skin tightness).

To prevent worsening of the condition and prevent the spread of infection, it is necessary to wash hands before and after applying the drug, and not to rub or touch the affected skin areas with a towel.

Adults

The drug Zovirax^® Duo-Active should be applied 5 times a day (approximately every 4 hours), excluding nighttime, for 5 days. The drug is applied to the affected and adjacent skin areas. With each application, a sufficient amount of cream should be applied to cover the affected area, including the outer edge of the ulcer.

If the patient misses an application time, the cream should be applied as soon as remembered and then continue according to the schedule.

The duration of treatment is 5 days. If symptoms persist for 10 days, it is necessary to consult a doctor.

Children

The dosage regimen for children from 12 to 18 years does not differ from the dosage regimen for adults.

Efficacy and safety in children aged 0 to 12 years have not been established. Data are not available.

Adverse Reactions

Adverse reactions are listed below by system organ class and frequency of occurrence. Frequency is defined as follows: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥ 1/10000 and <1/1000) and very rare (<1/10000), also included are isolated reports.

The safety profile in children aged 12-18 years corresponds to the safety profile in adults.

Contraindications

• Hypersensitivity to acyclovir, valacyclovir, hydrocortisone or any of the excipients included in the drug;
• Skin lesions caused by other viruses, fungal, bacterial skin diseases, as well as parasitic skin infections;
• Children under 12 years of age.

Use in Pregnancy and Lactation

Pregnancy

The use of the drug Zovirax^® Duo-Active during pregnancy is not recommended, except when prescribed by a doctor (if the intended benefit to the mother outweighs the potential risk to the fetus). Systemic exposure to acyclovir and hydrocortisone with topical application of the cream is very low.

Breastfeeding period

The use of the drug Zovirax^® Duo-Active during breastfeeding is not recommended, except when prescribed by a doctor (if the intended benefit to the mother outweighs the potential risk to the child).

Acyclovir and Hydrocortisone are excreted in milk after systemic use. However, the dose received by the infant with breast milk after the mother uses Zovirax^® Duo-Active is negligible.

Pediatric Use

Contraindicated for use in children under 12 years of age (efficacy and safety have not been established).

Special Precautions

Do not apply to mucous membranes (for example, eyes, oral cavity, nose, or genitals).

Do not use for the treatment of genital herpes.

Avoid getting the cream into the eyes. If the cream accidentally gets into the eyes, rinse eyes thoroughly with warm water. It is recommended to consult a doctor if discomfort occurs.

In case of severe manifestations of herpes infection of the lip skin, a doctor should be consulted.

Do not apply occlusive dressings, such as regular or special patches for herpes treatment.

Not recommended for use in patients with weakened immune systems, as opportunistic infection or resistant strains requiring systemic antiviral therapy cannot be ruled out.

Treatment of patients with concomitant dermatitis of other origins has not been studied. Patients with lip herpes should avoid transmitting the virus, especially in the presence of active lesions (wash hands before and after applying the cream).

Avoid long-term continuous use. The drug should not be used for more than 5 days.

If the patient misses an application time, the cream should be applied as soon as remembered and then continue according to the schedule.

Before using the drug, it is necessary to inform the doctor if any prescription or over-the-counter medicine is regularly used.

Excipients

The drug contains ceto-stearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis), as well as propylene glycol, which may irritate the skin.

Effect on ability to drive vehicles, mechanisms

The drug Zovirax^® Duo-Active does not affect the ability to drive vehicles and work with mechanisms.

Overdose

If ingested or if the entire contents of the Zovirax^® Duo-Active cream tube (2 g) is applied externally, the occurrence of adverse effects is not expected due to minimal systemic exposure.

Treatment in case of suspected overdose is symptomatic therapy.

Drug Interactions

Interaction studies with the drug Zovirax^® Duo-Active have not been conducted.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F). Do not store in the refrigerator. Do not freeze.

Shelf Life

The shelf life is 2 years.

The shelf life after first opening the tube is 3 months.

Dispensing Status

The drug is available 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.