AGERP

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT AGERP (AHERP)

Composition:

Active substance: acyclovir;

1 g of cream contains 50 mg of acyclovir;

Excipients: white soft paraffin, cetostearyl alcohol, propylene glycol, mineral oil, arlacel 165, poloxamer, sodium lauryl sulfate, dimethicone, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: cream of white or almost white color, of uniform consistency.

Pharmacotherapeutic group. Antiviral agents.

ATC code D06B B03.

Pharmacological Properties.

Pharmacodynamics.

Agerp belongs to antiviral agents that are highly effective against herpesviruses, particularly herpes simplex virus types I and II, as well as varicella-zoster virus. After entering a herpes virus-infected cell, acyclovir is converted into active acyclovir triphosphate. Its activity is associated with inhibition of viral DNA synthesis in human cells due to suppression of viral DNA polymerase function. Acyclovir does not affect other cellular processes unrelated to viral DNA synthesis.

Pharmacokinetics.

The pharmacokinetics of the drug have not been studied, but according to literature data, acyclovir in cream form has very low systemic absorption, even upon repeated application.

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to acyclovir, other components of the medicinal product, or valacyclovir.

Interaction with other medicinal products and other forms of interaction.

Not established.

Special precautions for use.

Avoid accidental contact of the cream with the eyes. In the presence of open lesions on the lips, keep in mind that herpes simplex virus can be transmitted to other individuals via direct contact. Agerp cream should be used only for herpes lesions affecting the mucous membranes of the lips and facial skin. The medicinal product should not be applied to mucous membranes of the oral cavity, eyes, or genital organs. In cases of particularly severe symptoms, medical advice should be sought. In general, patients with herpes lesions and immunodeficient conditions require systemic antiviral therapy; therefore, Agerp should not be used without prior consultation with a physician in such cases.

Use during pregnancy or breastfeeding.

Agerp may be used in pregnant or breastfeeding women only if the expected benefit to the patient outweighs the potential risk to the fetus or infant.

Ability to influence reaction rate when driving or operating machinery.

Studies have not been conducted.

Method of Administration and Dosage.

For children aged 12 years and older, and adults: apply Agerp cream to affected areas 5 times daily at 4-hour intervals, except during nighttime. It is important to start treatment as early as possible after the first symptoms appear. The minimum duration of treatment is 4 days. If healing has not occurred by this time, treatment should be continued for up to 10 days. If no improvement is observed within 10 days, consult a physician.

Children.

Agerp is not recommended for children under 12 years of age due to insufficient clinical data.

Overdose.

Literature data indicate no toxic effects following accidental topical or oral ingestion of an entire package of the medication.

Side effects.

The drug is generally well tolerated, but in some cases, temporary burning or stinging pain at the site of application may occur. Rarely, mild skin dryness, peeling, erythema, and itching may be observed. Very rarely, contact dermatitis may develop, and in isolated cases – angioneurotic edema following local application of acyclovir cream.

Shelf life.

3 years.

Do not use the drug after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

2 g in a tube, 1 tube in a box, 1 box in a cardboard pack; or 10 g in a tube, 1 tube in a cardboard pack.

Prescription status.

Over-the-counter (without prescription).

Manufacturer.

Ukrainian-Spanish joint venture "Sperco Ukraine".

Manufacturer’s address.

21027, Vinnytsia, Ukraine, 600-richchya St., 25.

Tel.: + 38(0432)52-30-36. E-mail: [email protected]

www.sperco.com.ua