Aciclovir (Ointment, Cream) Instructions for Use

ATC Code

D06BB03 (Aciclovir)

Active Substance

Aciclovir (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antiviral drug for external use

Pharmacotherapeutic Group

Antibiotics and antimicrobial agents used in dermatology; antimicrobial preparations for topical use; antiviral preparations

Pharmacological Action

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 sequential reactions into acyclovir mono-, di-, and triphosphate.

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

Thus, a “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

Ointment, Cream

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 blisters, 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 (frequency 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; childhood and adolescence 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 during lactation, the issue of stopping breastfeeding should be decided.

Use in Renal Impairment

Use is not recommended in severe renal impairment.

In renal failure, adjustment of the dosage regimen is necessary.

It should be borne in mind that when using acyclovir, the development of acute renal failure is possible 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 water load.

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 water load and under medical supervision, because in this category of patients, the half-life of acyclovir is increased.

Special Precautions

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

Drug Interactions

With external use of acyclovir, clinically significant drug interactions have not been noted.

Immunostimulants – enhancement of the effect of acyclovir is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°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.