Aciclovir-Vertex, cream 5% 10 g

Indications

Treatment of viral infections caused by the Herpes simplex virus, lips and facial skin (recurrent herpes of the lips).

Pharmacological effect

Pharmacotherapeutic group
Antiviral agent.

ATX code

D06BB03

Pharmacological properties
Pharmacodynamics

Acyclovir is an antiviral drug. Highly active in vitro against Herpes simplex virus (HSV) types 1 and 2. Low toxicity to mammalian host cells. After entering cells infected with the herpes virus, acyclovir is phosphorylated to the active compound, acyclovir triphosphate. The first step of this process depends on the presence of the HSV-encoded thymidine kinase enzyme. Acyclovir triphosphate acts as an inhibitor and substrate of herpes-specific DNA polymerase, preventing further synthesis of viral DNA without affecting normal cellular processes.

Pharmacokinetics

Pharmacological studies have shown minimal systemic absorption with repeated external use of the cream.

Special instructions

The drug should be used exclusively for herpes of the skin of the lips and face. It is not recommended to apply to the mucous membranes of the mouth, eyes and vagina. Do not use for the treatment of genital herpes. Avoid getting the cream in your eyes.

In case of severe manifestations of recurrent herpes, it is recommended to consult a doctor.

Patients with herpes labialis should avoid transmitting the virus, especially if active lesions are present.

Patients with immunodeficiency conditions are not recommended to use the drug. Such patients should follow the doctor’s recommendations when treating any infectious diseases.

Patients with renal and liver failure

Despite the fact that acyclovir is mainly excreted by the kidneys, systemic absorption of acyclovir after external use is insignificant. Accordingly, there is no need to change the dose in patients with impaired renal or hepatic function.

Influence on the ability to drive vehicles and machinery

The drug does not affect the ability to drive or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Active ingredient

Acyclovir

Composition

1 g of cream contains:
active ingredient: acyclovir – 50.0 mg;
excipients: liquid paraffin (vaseline oil) – 120.0 mg; propylene glycol – 80.0 mg; cetyl alcohol – 60.0 mg; macrogol 6 cetostearyl ether – 15.0 mg; macrogol 25 cetostearyl ether – 15.0 mg; methyl parahydroxybenzoate (methylparaben) – 1.5 mg; propyl parahydroxybenzoate (propylparaben) – 0.5 mg; purified water – up to 1.0 g.

Pregnancy

Pregnancy

Use is only possible in cases where the expected benefit outweighs the potential and unknown risk, however, systemic exposure with topical application of the cream is very low.

As a result of post-registration experience with the use of acyclovir, data were obtained containing information on the results of pregnancy in women receiving acyclovir in any dosage form. Data do not demonstrate an increase in the incidence of congenital malformations among patients treated with acyclovir compared with the general population, and no birth defects have been reported that are unique or have a consistent pattern of features suggestive of a common cause.

Before use, if you are pregnant, or think you might be pregnant, or are planning a pregnancy, or while breastfeeding, you should consult your doctor.

Breastfeeding period

Limited data indicate that acyclovir passes into breast milk with regular use. However, the dose received by a breastfed infant will be negligible.

Contraindications

hypersensitivity to acyclovir, valacyclovir, propylene glycol or other components of the drug.

With caution

pregnancy;
breastfeeding period.

Side Effects

Classification of the incidence of side effects according to the recommendations of the World Health Organization (WHO):
very often ≥ 1/10;
often from ≥ 1/100 to < 1/10;
uncommon ≥ 1/1000 to < 1/100;
rarely from ≥ 1/10000 to < 1/1000;
very rare <1/10000, including individual reports;
frequency unknown – based on available data, it is not possible to determine the frequency of occurrence.

Immune system disorders:
very rarely – immediate hypersensitivity reactions, including angioedema, urticaria.
If you experience side effects listed in the instructions or they get worse, or you notice any other side effects not listed in the instructions, you should immediately inform your doctor.
Skin and subcutaneous tissue disorders:
infrequently – short-term burning, tingling in areas where the drug was applied, slight dryness or flaking of the skin, itching;
rarely – redness, contact dermatitis after application, more often associated with a reaction to excipients than to acyclovir.

Interaction

When used externally, no interactions with other drugs have been identified.

Overdose

Due to minimal systemic exposure, no adverse effects are expected to occur when taken orally or when applied topically to the entire contents of the consumer package of the drug. You should consult a doctor if you suspect an overdose.

Storage conditions

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

Shelf life

2 years.
Do not use after expiration date.

Manufacturer

Vertex, Russia