Acyclostad®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT AСYCLOSTAD® (ACYCLOSTAD®)

Composition:

Active ingredient: acyclovir;

1 g of cream contains 50 mg of acyclovir;

Excipients: dimethicone, stearil macrogol glycerides, cetyl alcohol, mineral oil, white soft paraffin, propylene glycol, purified water.

Pharmaceutical form. Cream.

Main physicochemical characteristics: white or almost white homogeneous cream.

Pharmacotherapeutic group.

Antiviral agents. ATC code D06B B03.

Pharmacological properties.

Acyclovir is an antiviral agent that demonstrates high activity in vitro against herpes simplex virus types I and II. Its toxic effect on host cells is minimal. After entering virus-infected cells, acyclovir is phosphorylated to form the active compound, acyclovir triphosphate. The first step of 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.

Pharmacokinetic studies have shown minimal systemic absorption of acyclovir following repeated topical application of the cream.

Clinical characteristics.

Indications.

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

Contraindications.

The drug should not be administered to patients with known hypersensitivity to acyclovir, valacyclovir, propylene glycol, or any other components of the drug.

The drug should not be used for treatment of the eyes.

Interaction with other medicinal products and other forms of interactions.

Interaction with other medicinal products is unknown.

Special precautions for use

Apply the cream only for the treatment of herpes of the lips and face. The cream should not be applied to the mucous membranes of the oral cavity or eyes, and should not be used for the treatment of genital herpes, in order to avoid local irritation. Accidental contact of the cream with the eyes should be avoided.

Patients suffering from particularly severe manifestations of Herpes labialis require medical consultation. Patients with herpes labialis should be advised to avoid contact transmission of the virus to other people, especially when open lesions are present (e.g. hands should be washed before and after applying the cream).

The cream is not recommended for use in immunocompromised patients. Such patients require medical consultation regarding treatment of any infection.

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

Use during pregnancy or breastfeeding. During pregnancy or breastfeeding, the drug should be used 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 incidence of fetal developmental abnormalities.

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

Clinical studies have shown that orally administered acyclovir has no clinically significant effect on male fertility. Data regarding the effect of acyclovir on female fertility are lacking.

Ability to influence reaction rate while driving or operating machinery. There are no data on the effect of the drug on reaction rate while driving or operating machinery.

Method of Administration and Dosage

The medication is intended for topical use only.

Apply the cream in a thin layer to the affected area of the skin using a cotton swab, 5 times daily approximately every 4 hours, except during nighttime. The cream should be applied not only to the affected skin areas but also to the surrounding areas. If a cotton swab is not used when applying the cream, hands should be thoroughly washed immediately before and after application to prevent additional bacterial and/or viral contamination of the affected skin areas.

Treatment should last at least 4 days, but therapy should be individually adjusted and continued until the vesicle surface becomes firm or until complete healing occurs. The duration of treatment should not exceed 10 days. If symptoms of the disease do not resolve after 10 days of treatment, the patient should consult a physician.

Note: For optimal effect, the cream should be applied at the first signs of herpes infection (tingling, itching, tightness sensation, redness).

Treatment may also be initiated at later stages—papules or blisters. Antiviral therapy with acyclovir should be discontinued once a crust has formed on the affected skin area.

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

Overdose.

No cases of overdose have been reported. Since the medication is intended solely for topical use, the development of overdose symptoms is unlikely.

In case of suspected overdose, medical advice should be sought.

Adverse Reactions

Skin and connective tissue disorders

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

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

Immune system disorders

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

Shelf life. 3 years.

After opening the tube – no more than 1 year.

Do not use the medicinal product after the expiry date.

Storage conditions.

No special storage conditions required. Keep out of reach of children.

Packaging.

2 g of cream in an aluminum tube with a white screw cap; 1 tube per cardboard box.

Prescription status. Over-the-counter.

Manufacturer.

STADA Arzneimittel AG.

Manufacturer's address and place of business.

Stadashtrasse 2-18, 61118 Bad Vilbel, Germany.