LIPSTER

INSTRUCTIONS for medical use of the medicinal product LIPSTER® (LIPSTER)

Composition:

Active substance: aciclovir;

1 g of cream contains micronized acyclovir, calculated as 100% dry substance, 50 mg;

Excipients: white soft paraffin, liquid paraffin, emulsifying cetostearyl alcohol (type A), propylene glycol, poloxamer, dimethicone, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: cream of white or almost white color.

Pharmacotherapeutic group.

Antiviral agents. ATC code D06B B03.

Pharmacological Properties

Pharmacodynamics

Lipster® 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. 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.

Pharmacokinetics

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

Clinical characteristics.

Indications.

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

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

No interactions have been 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 it to the mucous membranes of the mouth, eyes, or 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 lesions are open (for example, by washing hands before and after applying the cream). The product is not recommended for immunocompromised individuals. Such patients should consult a physician regarding treatment of any infection.

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

Use during pregnancy or breastfeeding

This medicinal product is recommended for use in pregnant and breastfeeding women only if the expected benefit outweighs the potential risk, as judged by the physician. However, it should be noted that systemic absorption of acyclovir following topical application of the cream is very low.

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

Limited clinical data indicate that acyclovir is excreted into human milk following intravenous administration. However, the amount of acyclovir that could be ingested by infants through breastfeeding after topical application of this product as a cream is expected to be negligible.

Fertility
Clinical studies have shown that acyclovir administered orally has no clinically significant effect on male fertility. Data on the effect of acyclovir on female fertility are not available.

Ability to influence the reaction rate while driving or operating machinery
No data available.

Method of Administration and Dosage

The product is intended for topical use.

For adults and children aged 12 years and older: apply the cream five 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 blisters.

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 cream, and excessive rubbing or contact with towels on affected areas should be avoided 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, its use is not recommended in this age group.

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, medical advice should be sought.

Side effects.

The adverse reactions listed below are classified by system and organ, and by frequency of occurrence. Frequency categories: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000).

Immune system:

very rare: immediate hypersensitivity reactions, including angioneurotic edema and urticaria.

Skin and subcutaneous tissue:

uncommon: transient, short-lived acute or burning pain, mild drying and desquamation of the skin, pruritus;

rare: erythema, contact dermatitis; in sensitivity testing, these cases were more frequently associated with components of the cream base rather than with acyclovir.

Shelf life.

3 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

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

Packaging.

5 g in a tube. 1 tube per carton.

Classification. Over-the-counter (without prescription).

Manufacturer: JSC "Farmak".

Manufacturer's address and place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.