Zovirax duo

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT ZOVIRAX DUO (ZOVIRAX DUO)

Composition:

Active substances: acyclovir, hydrocortisone;

1 g of cream contains acyclovir 50 mg, hydrocortisone 10 mg;

Excipients: propylene glycol; white soft paraffin; mineral oil; cetylstearyl alcohol; isopropyl myristate; poloxamer; sodium lauryl sulfate; citric acid monohydrate; sodium hydroxide; hydrochloric acid concentrated; purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: homogeneous white cream in an aluminum tube.

Pharmacotherapeutic group. Drugs for treatment of skin disorders. Antibiotics and chemotherapeutic agents for treatment of skin diseases. Chemotherapeutic agents for topical use. Antiviral agents. Acyclovir in combination with other agents. ATC code D06B B53.

Pharmacological Properties.

Pharmacodynamics.

Acyclovir is an antiviral agent with high in vitro activity against herpes simplex virus types I and II. Its toxic effect on host cells is minimal. Once inside cells infected with the herpes virus, acyclovir is phosphorylated to form the active compound, acyclovir triphosphate. The first step in this process depends on the presence of virally encoded thymidine kinase. Acyclovir triphosphate acts as both an inhibitor and a substrate for viral DNA polymerase, thereby preventing further viral DNA synthesis without affecting normal cellular processes.

Hydrocortisone is a weak corticosteroid that exhibits several immunomodulatory effects. When applied topically, its primary role is to control various inflammatory skin conditions.

The cream containing acyclovir and hydrocortisone combines the antiviral action of acyclovir with the anti-inflammatory action of hydrocortisone, reducing the progression of herpes labialis episodes to the stage of ulcerative lesion formation.

The precise mechanism is not fully understood, but it is believed to be mediated by viral clearance and reduction of the local inflammatory response on the lips, resulting in decreased signs and symptoms of recurrent herpes.

Pharmacokinetics.

No clinical pharmacokinetic studies have been conducted with the acyclovir and hydrocortisone cream.

Clinical characteristics.

Indications.

Treatment of early signs and symptoms of recurrent labial herpes (cold sores) to reduce progression of herpes blister episodes to the ulcerative stage in immunocompetent adults and children aged 12 years and older.

Contraindications.

Hypersensitivity to acyclovir, valacyclovir, propylene glycol, or to any other components of the cream.

Use for treatment of skin lesions caused by any virus other than herpes simplex, or for treatment of fungal, bacterial, or parasitic skin infections.

Interaction with other medicinal products and other forms of interaction.

No interactions identified.

Special precautions for use.

The cream should only be used for the treatment of herpes of the lips and face. It is not recommended to apply the cream to mucous membranes of the oral cavity or eyes, or to use it for the treatment of genital herpes. Accidental contact of the cream with the eyes should be avoided.

Patients with particularly severe or recurrent episodes of Herpes labialis should consult a physician. Patients with herpes should be advised to avoid transmitting the virus to others, especially when open lesions are present (in particular, hands should be washed before and after using the cream). Use in immunocompromised individuals is not recommended due to the possibility of opportunistic infections or resistant viral strains, which may require systemic antiviral therapy. Such patients should consult a physician regarding treatment of any infection.

The cream should not be used with occlusive dressings such as plasters or special films/plasters.

Prolonged continuous use should be avoided. Treatment duration should be during and no longer than 5 days. The use of the cream in patients with concomitant dermatitis of other etiologies has not been studied.

The product contains cetylstearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis), and propylene glycol, which may cause skin irritation.

Contains sodium lauryl sulfate, which may cause local skin reactions (e.g., stinging or burning sensation) or exacerbate skin reactions caused by other products applied to the same area.

Use of systemic and topical corticosteroids may lead to visual disturbances. If a patient experiences symptoms such as blurred vision or other ocular disorders, the patient should be referred to an ophthalmologist for evaluation of possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, which have been observed following the use of systemic and topical corticosteroids.

Use during pregnancy or breastfeeding.

The product is recommended for use in pregnant and breastfeeding women only when, in the opinion of the physician, the expected benefit outweighs the potential risk. Systemic exposure to acyclovir and hydrocortisone following topical application of the cream is very low.

During use in pregnant women, no increased incidence of fetal malformations has been observed. Clinical data on hydrocortisone do not indicate an increased risk of teratogenicity. In animal studies, embryofetal toxicity was observed following administration at low doses. Acyclovir and hydrocortisone pass into breast milk following systemic administration; however, the amount transferred into breast milk does not reach clinically significant levels. Nevertheless, the product should not be used during breastfeeding unless absolutely necessary.

Effect on ability to drive or operate machinery.

Zovirax Duo has no or negligible effect on the ability to drive or operate machinery.

Method of Administration and Dosage

The product is intended for external use only.

For adults and children aged 12 years and older: apply the cream 5 times daily at approximately 4-hour intervals, excluding nighttime. Treatment should begin as early as possible, preferably immediately after the first signs or symptoms appear.

Each time, apply a sufficient amount of cream to cover the affected area, including the outer edge of the lesion, if present.

Treatment duration should not exceed 5 days. Hands should be washed before and after using the cream. Avoid excessive rubbing or touching the affected areas with a towel to prevent aggravation or transmission of infection.

Children.

There is insufficient data on the safety of using the product in children under 12 years of age; therefore, use is recommended only for children aged 12 years and older.

Overdose.

No adverse effects have been reported following oral or topical application of an entire tube of cream due to minimal systemic exposure. In case of suspected overdose, seek medical help immediately.

Side effects.

Skin and subcutaneous tissue disorders:

Common (≥ 1/100, <1/10): skin dryness and desquamation.

Uncommon (≥ 1/1000, <1/100): transient burning or stinging sensation, prickling (after application of the product), pruritus.

Rare (≥ 1/10000, <1/1000): erythema, pigmentation changes. In skin safety studies, contact dermatitis was observed after application of the cream under an occlusive dressing. In sensitivity testing, the reactive substance was either hydrocortisone or a component of the cream base. Local reactions at the application site were observed, including signs and symptoms of inflammation.

Immune system disorders:

Very rare (<1/1000): immediate hypersensitivity reactions, including angioneurotic edema.

Eye disorders:

Not known: blurred vision.

In sensitivity testing, these cases were more frequently associated with components of the cream base rather than with acyclovir. There have been isolated reports of immediate hypersensitivity reactions, including angioneurotic edema, following topical application of acyclovir.

Shelf life.

2 years.

Storage conditions.

Store below 25°C in a place inaccessible to children. Do not freeze.

Packaging.

2 g of cream in a tube. 1 tube per cardboard box.

Prescription status.

Over-the-counter (without prescription).

Manufacturer.

1. Glaxo Operations UK Ltd, United Kingdom
   (Manufacturing of the medicinal product, primary and secondary packaging, quality control, batch release)

2. Haleon CH S.a.r.l., Switzerland
   (Primary and secondary packaging, quality control, batch release)

Manufacturer's address and location of operations.

1. Harmire Road, Barnard Castle, DL12 8DT, United Kingdom
2. Route de l’Etraz 2, Nyon, 1260, Switzerland