HERPEVIR

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT HERPEVIRÒ (HERPEVIRÒ)

Composition:

Active substance: acyclovir;

1 g of ointment contains acyclovir equivalent to 100% substance 25 mg;

Excipients: propylene glycol, poloxamer 338, polyethylene oxide 400, emulsifier No. 1.

Pharmaceutical form. Ointment.

Main physicochemical properties: homogeneous white ointment with a slight specific odor.

Pharmacotherapeutic group. Antiviral agents. ATC code D06B B03.

Pharmacological Properties.

Pharmacodynamics.

Acyclovir is an antiviral agent that has high in vitro activity against herpes simplex virus types I and II. Its toxic effect on host organism cells is minimal. Upon entering cells infected with herpes virus, acyclovir is phosphorylated to form the active compound—acyclovir triphosphate. The first step of this process depends on the presence of virus-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.

Pharmacokinetics.

Systemic absorption of acyclovir after repeated topical application of Herpevir® ointment is minimal.

Clinical characteristics.

Indications.

Infections of the lips and face caused by herpes simplex virus (Herpes labialis).

Contraindications.

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

Interaction with other medicinal products and other forms of interaction. No interactions have been identified.

Special precautions for use.

The cream should be used only 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 suffering from 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 active lesions are present (e.g. wash hands before and after applying the cream). Use in immunocompromised individuals is not recommended. Such patients should consult a physician regarding treatment of any infection.

The product contains propylene glycol, which may cause skin irritation.

Use during pregnancy or breastfeeding. The product is recommended for use in pregnant women and women who are breastfeeding only when, in the opinion of a physician, the expected benefit outweighs the potential risk. However, it should be noted that systemic absorption of acyclovir after topical application of the cream is very low.

Clinical studies have shown that the use of acyclovir in any formulation does not lead to an increased risk of fetal developmental abnormalities.

Some clinical data indicate that acyclovir may pass into breast milk following systemic administration. However, the amount of acyclovir that could be transferred to an infant via breastfeeding after topical application of the cream is considered negligible.

Clinical studies have shown that oral administration of acyclovir does not have a clinically significant effect on male fertility. Data regarding the effect of acyclovir on female fertility are not available.

Ability to influence reaction speed when driving or operating machinery. Data are lacking.

Method of Administration and Dosage

The product is intended for topical use only.

For children aged 12 years and older, and adults: Herpevir® ointment should be applied 5 times daily at approximately 4-hour intervals, except during nighttime. It is important to start treatment as early as possible at the onset of infection, preferably during the prodromal stage or erythema phase. Treatment may also be initiated at later stages—papules or vesicles.

Treatment should last at least 4 days. If healing has not occurred, treatment may be continued for up to 10 days. If symptoms persist after 10 days of treatment, the patient should consult a physician. Hands should be washed before and after applying the ointment, and excessive rubbing or contact with a towel on affected areas should be avoided to prevent exacerbation or transmission of infection.

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

Overdose. Adverse effects are unlikely following accidental oral or topical application of the entire tube of ointment due to minimal systemic exposure. In case of suspected overdose, medical advice should be sought.

Side effects.

Skin and connective tissue disorders

Uncommon (≥ 1/1000; < 1/100): transient sharp or burning pain after ointment application, moderate skin dryness and desquamation, pruritus.

Rare (≥ 1/10000; < 1/1000): erythema, contact dermatitis after ointment application (sensitivity testing has shown that these cases were most frequently associated with components of the cream base rather than with acyclovir).

Immune system disorders

Very rare (< 1/10000): immediate hypersensitivity reactions, including angioneurotic edema and urticaria.

Shelf life. 5 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

5 g or 15 g in a tube, 1 tube in a carton.

Prescription status.

Prescription only for 15 g tube; over-the-counter for 5 g tube.

Manufacturer.

JSC "Kyivmedpreparat".

Manufacturer's address and place of business.

139 Saksaganсьkoho Street, Kyiv, 01032, Ukraine.