Gervirax (Cream) Instructions for Use

Marketing Authorization Holder

Pharmaceutical Factory Of St. Petersburg, PJSC (Russia)

ATC Code

D06BB03 (Aciclovir)

Active Substance

Aciclovir (Rec.INN registered by WHO)

Dosage Form

Gervirax

Cream for external use 5%: tubes 2 g, 3 g, 4 g, 5 g, or 10 g

Dosage Form, Packaging, and Composition

Cream for external use is homogeneous, white in color.

Excipients: nipazol, nipagin, cremophor A6, cremophor A25, cetyl alcohol, propylene glycol, vaseline oil, purified water – up to 100 g.

2 g – aluminum tubes (1) – cardboard packs.
3 g – aluminum tubes (1) – cardboard packs.
4 g – aluminum tubes (1) – cardboard packs.
5 g – aluminum tubes (1) – cardboard packs.
10 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Antiviral drug for external use

Pharmacotherapeutic Group

Antiviral agent

Pharmacological Action

An antiviral agent for external use, a synthetic analogue of a purine nucleoside. Thymidine kinase of virus-infected cells actively converts Aciclovir through a series of consecutive reactions into acyclovir mono-, di-, and triphosphate.

The latter interacts with viral DNA polymerase and is incorporated into the DNA that is synthesized for new viruses.

Thus, “defective” viral DNA is formed, which leads to the suppression of the replication of new generations of viruses.

Aciclovir is active against Herpes simplex virus types 1 and 2, Varicella zoster virus, Epstein-Barr virus, and cytomegalovirus.

Pharmacokinetics

With external use, systemic absorption is minimal.

Indications

Skin infections caused by Herpes simplex virus types 1 and 2, including genital herpes and herpes labialis; herpes zoster; varicella.

ICD codes

Dosage Regimen

Externally. Apply 4-6 times/day (every 4 hours) in a thin layer to the affected areas of the skin and the areas bordering them.

The drug is applied either with a cotton swab or with clean hands to avoid additional infection of the affected areas.

Therapy should be continued until a crust forms on the vesicles, or until they are completely healed.

The duration of therapy is on average 5 days and should not exceed 10 days.

It is important to start treatment of a recurrent infection during the prodromal phase or at the very beginning of the manifestation of the infection.

The duration of treatment is at least 5 days.

In the absence of healing, treatment can be continued for up to 10 days.

If symptoms of the disease persist for more than 10 days, you should consult a doctor.

Adverse Reactions

Definition of the frequency of adverse reactions: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10 000, <1/1000) and very rare (<10 000), frequency unknown (the frequency of occurrence cannot be determined from the available data).

Local reactions uncommon – a burning sensation is possible at the application site, which passes with time, dry skin, itching; rare – erythema, contact dermatitis at the application site.

If it gets on the mucous membranes, inflammation is possible.

From the immune system very rare – anaphylactic reactions, including angioedema and urticaria.

Contraindications

Hypersensitivity to acyclovir and valacyclovir; children and adolescents under 18 years of age.

With caution: pregnancy; lactation period (breastfeeding); dehydration; renal failure.

Use in Pregnancy and Lactation

The use of acyclovir during pregnancy is possible in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to use it during lactation, the issue of stopping breastfeeding should be decided.

Use in Renal Impairment

Use is not recommended for severe renal impairment.

In renal failure, dosage adjustment is necessary.

It should be taken into account that when using acyclovir, acute renal failure may develop due to the formation of a precipitate from acyclovir crystals, which is especially likely with rapid intravenous administration, simultaneous use of nephrotoxic drugs, in patients with impaired renal function and with insufficient hydration.

When using acyclovir, it is necessary to monitor renal function (determination of the level of blood urea nitrogen and plasma creatinine).

Pediatric Use

Orally for children over 2 years old – 200-400 mg 3-5 times/day, if necessary – 20 mg/kg (up to 800 mg per dose) 4 times/day. For children under 2 years of age, use at a dose equal to half the adult dose. The duration of treatment is 5-10 days.

Geriatric Use

Treatment of elderly patients should be carried out with a sufficient increase in hydration and under medical supervision, because in this category of patients, the half-life of acyclovir is increased.

Special Precautions

Aciclovir in the form of medicines for external use should not be applied to the mucous membranes of the oral cavity, eyes, or vagina.

Drug Interactions

With the external use of acyclovir, no clinically significant drug interaction has been noted.

Immunostimulants – enhancement of the effect of acyclovir is possible.

Storage Conditions

Store at 8°C (46°F) to 15°C (59°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.