Instructions for Zovirax cream 5% tube 2 g
Composition
active ingredient: acyclovir; 1 g (g) of cream contains 50 mg (mg) of acyclovir;
Excipients: propylene glycol, white soft paraffin, mineral oil, cetostearyl alcohol, arlacel 165, poloxamer, sodium lauryl sulfate, dimethicone, purified water.
Dosage form
Cream.
Main physicochemical properties: cream from white to whitish in color, homogeneous, without grains, lumps and foreign inclusions, without signs of delamination.
Pharmacotherapeutic group
Antiviral agents. Acyclovir. ATX code D06B B03.
Pharmacological properties
Pharmacodynamics
Acyclovir is an antiviral drug that has high in vitro activity against herpes simplex virus types I and II. Toxicity to host cells is minimal. Once in cells infected with herpes virus, acyclovir is phosphorylated to form the active compound acyclovir triphosphate. The first stage of this process depends on the presence of virus-encoded thymidine kinase. Acyclovir triphosphate acts as an inhibitor and substrate for viral DNA polymerase, preventing further synthesis of viral DNA without affecting normal cellular processes.
Pharmacokinetics
Pharmacokinetic studies have shown minimal systemic absorption of acyclovir after repeated topical application of the cream.
Indication
Treatment of infections of the lips and face caused by the herpes simplex virus (Herpes labialis).
Contraindication
Hypersensitivity to acyclovir, valacyclovir, propylene glycol or other components of the cream.
Interaction with other medicinal products and other types of interactions
No interaction was detected.
Application features
The cream should only be used to treat herpes on the lips and face. It is not recommended to apply the cream to mucous membranes, for example, the mouth or eyes, and it should not be used to treat genital herpes. Accidental contact of the cream with the eyes should be avoided.
Persons suffering from particularly severe and recurrent Herpes labialis should seek medical advice. Persons with herpes should be advised to avoid contact with others, especially if there are open lesions (e.g. wash hands before and after using the cream). It is not recommended for use in immunocompromised persons. Such persons should seek medical advice regarding the treatment of any infection.
The medicinal product contains propylene glycol, which may cause skin irritation, and cetostearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis).
Ability to influence reaction speed when driving vehicles or other mechanisms
No data.
Use during pregnancy or breastfeeding
Pregnant and breastfeeding women are recommended to use the drug only if the benefit, in the opinion of the doctor, outweighs the risk. However, it should be understood that the systemic penetration of acyclovir after external application of the cream is very low.
Clinical studies have shown that the use of acyclovir in preparations of any composition does not lead to an increase in fetal developmental defects.
Some clinical data indicate that acyclovir passes into breast milk when administered orally. However, the amount of acyclovir that may enter the body of a breastfed infant after application of this drug in the form of a cream is insignificant.
Clinical studies have shown that acyclovir has no clinically significant effect on male fertility after oral administration. There are no data on the effect of acyclovir on female fertility.
Method of administration and doses
The drug is intended for external use.
Adults and children aged 12 and over
The cream should be applied 5 times a day at approximately 4-hour intervals, except at night. It is important to start treatment as early as possible at the onset of infection, best during the prodromal period or erythema stage. Treatment can also be started in the later stages of the disease, such as papules or blisters.
Treatment lasts at least 4 days. If healing has not occurred, treatment can be continued for up to 10 days. If the symptoms of the disease do not disappear after 10 days of treatment, the patient should consult a doctor. Hands should be washed before and after using the cream, and excessive rubbing or touching the affected areas with a towel should be avoided to prevent exacerbation or transmission of infection.
Children
There is insufficient data on the safety of the drug in children under 12 years of age, therefore it is recommended for use in children over 12 years of age.
Overdose
Adverse effects of the drug after oral or topical application of the entire contents of a tube of cream are not expected due to minimal systemic exposure. In case of suspected overdose, medical attention should be sought.
Adverse reactions
Skin and connective tissue disorders
Rare (≥ 1/10,000; < 1/1,000): erythema, contact dermatitis after applying the cream (sensitivity testing showed that these cases were most often associated with the components of the cream base, and not with acyclovir).
On the part of the immune system
Rare (< 1/10,000): immediate hypersensitivity reactions, including angioedema and urticaria.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ° C, out of the reach of children. Do not freeze.
Packaging
2 g (g) of cream in an aluminum foil tube with a plastic screw cap. 1 tube in a cardboard box.
Vacation category
Without a prescription.
Producer
Glaxo Operations UK Limited, UK.
Location of the manufacturer and its business address
Harmire Road, Barnard Castle, Durham, DL12 8DT, United Kingdom/ Harmire Road, Barnard Castle, Durham, DL12 8DT, UK.
