ZOVIRAX (ACYCLOVIR) INSTRUCTIONS

INSTRUCTIONS

on medical use of the drug


Registration number:

LCP-001797 / 07-300707


International Nonproprietary Name

Acyclovir


Dosage form:

cream for external use of 5%


Chemical name:

9- (2-hydroxy) ztoxymethylguanine or 2-amino-1,9 dihydro-9- (2-hydroxy) ethoxymethyl-6H-purin-6-one.


Composition:

Active ingredient - acyclovir 5 g

Auxiliary substances - nipazol. nipagin, cremophor A6. Cremophor A25. cetyl alcohol, propylene glycol, vaseline oil, purified water.


Description:

Uniform cream of white color.


Pharmacotherapeutic group:

antiviral agent.


ATX Code:

D06BB03



Pharmacological properties:


Acyclovir is active against Herpes simplex type 1 and 2, Varicella zoster virus, Epstein Barr virus and cytomegalovirus. Thymidine kinase of virus-infected cells through a series of successive reactions activates convert acyclovir into mono-, di-, and acyclovir triphosphate. The latter interacts with viral DNA polymerase and is inserted 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.

Pharmacokinetics:

When local use is practically not absorbed through damaged skin, does not enter the systemic circulation.


Indications for use:

Infections of the skin and mucous membranes caused by the Herpes simplex virus types 1 and 2, genital herpes, shingles, chicken pox.


Contraindications:

Hypersensitivity to acyclovir and other components of the drug.

With care - pregnancy, lactation, dehydration, renal failure.


Pregnancy and lactation:

Adequate and controlled clinical studies of the safety of the drug during pregnancy was not conducted. Use is indicated only in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

During treatment, it is necessary to solve the issue of stopping breastfeeding.


Dosage and administration:


Outwardly. The drug is applied 5 times a day (every 4 hours) in a thin layer on the affected skin and bordering with them. The cream is applied either with a cotton swab or with clean hands to avoid additional infection of the affected areas. Therapy should be continued until the crust forms on the vesicles, or until they fully heal. The duration of therapy is an average of 5 days and should not exceed 10 days.


Side effect:


Hyperemia, dryness, peeling of the skin; burning, inflammation in contact with mucous membranes. Perhaps the development of atopic dermatitis.


Interaction with other drugs:


When external use is not revealed interaction with other drugs.


Special instructions:


To achieve the maximum therapeutic effect, it is necessary to start using the drug as early as possible after the start of infection (at the first signs of illness: burning, itching, tingling, feeling of tension and redness).

The cream is not recommended to be applied on the mucous membranes of the mouth and eyes, as it is possible the development of pronounced local inflammation. When treating genital herpes, you should avoid sexual intercourse or use condoms, since the use of acyclovir does not prevent transmission of the virus to partners.


Release form:


5% cream for external use in aluminum tubes of 3, 5, 10 g. Together with the instructions for use are placed in a pack of cardboard.


Storage conditions:


List B. At a temperature of 12 to 15 ° C. Keep out of the reach of children.


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