Composition, form of production and packaging
? Cream for external use white or white with a yellowish tinge.
1 g
Acyclovir 50 mg
hydrocortisone 10 mg
Auxiliary substances: paraffin liquid - 56.5 mg, paraffin soft white - 100 mg, isopropyl myristate - 150 mg, sodium lauryl sulfate - 8 mg, cetostearyl alcohol (cetyl alcohol - 60%, stearyl alcohol - 40%) - 67.5 mg, poloxamer 188 - 10 mg, propylene glycol 200 mg, citric acid monohydrate 1.4 mg, sodium hydroxide 0.6 mg qs until pH is reached, hydrochloric acid qs until pH is reached, purified water qs to 1000 mg.
2 g - aluminum tubes (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
The combined preparation contains acyclovir and hydrocortisone.
Acyclovir is active against Herpes simplex 1 and 2 types, the virus Varicella zoster, the Epstein-Barr virus and cytomegaloviruses. Thymidine kinase virus-infected cells through a series of consecutive reactions actively converts acyclovir into mono-, di- and triphosphate acyclovir. The latter interacts with the viral DNA polymerase and is embedded in DNA, which is synthesized for new viruses. Thus, "defective" viral DNA is formed, which leads to suppression of replication of new generations of viruses.
Hydrocortisone refers to weakly active glucocorticosteroids. With external and local application, the therapeutic activity of hydrocortisone is caused by anti-inflammatory, antipruritic, anti-allergic and antiexudative (due to vasoconstrictor effect) action.
As a result of the combination of the antiviral action exerted by acyclovir and the anti-inflammatory effect of hydrocortisone, Zovirax® Duo-Active prevents the formation of vesicular rash elements on the affected skin areas (when applied in the prodromal period), and shortens the healing time of the already formed elements of the rash. The mechanism of action is due to the blocking of viral replication and the inhibition of the development of an inflammatory reaction on the affected area of ​​the skin, which leads to a decrease in the severity of the symptoms of the infection.
PHARMACOKINETICS
Suction and distribution
With topical application of the drug, systemic absorption of acyclovir is minimal; Hydrocortisone can penetrate through the stratum corneum of the epidermis, reaching its lower layers, is absorbed in a small amount. When used in the recommended doses does not cause suppression of the hypothalamic-pituitary-adrenal system.
INDICATIONS
- a recurrent infection of the skin of the lips caused by the herpes simplex virus (Herpes simplex) in adults and children over 12 years of age.
DOSING MODE
For external use only.
Adults and children over 12 years of age
The drug should be applied 5 times a day (about every 4 hours), except at night. The drug is applied a thin layer on the affected and adjacent areas of the skin.
It is important to begin treatment of a recurring infection as soon as possible, best in the prodromal period, that is, when the nonspecific signs of infection first appear (burning, tingling, sensation of tightness of the skin).
Duration of treatment is not less than 5 days.
Do not apply the drug for more than 5 days. If symptoms persist after 5 days of use, consult a physician. To prevent deterioration and prevent transmission of infection, you must wash your hands before and after applying the drug, do not rub and do not touch the affected areas of the skin with a towel.
SIDE EFFECT
Adverse reactions were local in nature and occurred at the site of application.
Side effects are classified according to organ systems and frequency. The frequency of side effects is defined as follows: very often (? 1/10), often (? 1/100 and <1/10), infrequently (? 1/1000 and <1/100), rarely (? 1/10 000 and <1/1000) and very rarely (? 1/100 000 and <1/10 000).
Allergic reactions:
Very rarely - immediate reactions of increased sensitivity, including angioedema.
From the skin and subcutaneous tissues:
Often - dryness, peeling of the skin;
Infrequent - short-term burning, tingling in the areas of application of the drug; itching;
Rarely is the redness of the skin; change in skin pigmentation; allergic dermatitis, more often associated with a reaction to hydrocortisone or excipients.
Local reactions:
Rarely, the symptoms of an inflammatory reaction (pain, swelling, redness, local tissue temperature increase).
If any of these side effects occur, stop taking the medication and consult a doctor immediately.
CONTRAINDICATIONS
- Hypersensitivity to acyclovir, valaciclovir, hydrocortisone and other components of the drug;
- skin lesions caused by other viruses, fungal, bacterial skin diseases, as well as parasitic skin infections;
- skin tumors, rosacea, vulgar acne, perioral dermatitis;
- Children under 12 years old.
PREGNANCY AND LACTATION
The use of ZoviraxВ® Duo-Active during pregnancy and during breastfeeding is not recommended unless it is prescribed by a doctor (if the intended benefit for the mother exceeds the potential risk to the fetus and the baby).
APPLICATION FOR CHILDREN
Contraindicated for children under 12 years.
SPECIAL INSTRUCTIONS
To achieve the maximum therapeutic effect and prevent the formation of vesicles (vesicles) on the skin, it is necessary to start using the drug with the appearance of the first signs of the disease (burning, itching, tingling, a feeling of tightness).
If the manifestations of herpetic infection of the skin of the lips are severe, you should consult a doctor.
The cream can be used only with herpes skin of the lips. It is not recommended to apply the drug to the mucous membranes of the mouth and eyes, and also apply a cream to treat genital herpes.
Avoid contact with eyes.
Do not apply occlusive dressings, as well as patches or special antiherpetic masking patches to the place of application of the cream. Patients with immunodeficiency states in the treatment of any infectious diseases should follow the recommendations of the doctor. Since for these patients the risk of developing resistance to acyclovir
high, they should not use this drug.
The drug contains cetyl alcohol, which can cause local skin reactions, such as contact dermatitis, as well as propylene glycol, which can cause skin irritation.
Influence on ability to drive vehicles, mechanisms
The drug Zovirax В® Duo-Active does not affect the performance of potentially hazardous activities requiring special attention and quick reactions (driving and other vehicles, working with moving mechanisms, dispatcher and operator work, etc.).
OVERDOSE
In the event of accidental ingestion or one-time use of the entire contents of the package, no adverse effects were observed. If you suspect an overdose, seek medical help.
DRUG INTERACTION
When external application of interaction with other drugs is not revealed.
TERMS OF RELEASE FROM PHARMACY
Without recipe.
TERMS AND CONDITIONS OF STORAGE
Store at a temperature not exceeding 25 В° C. Do not store in the refrigerator. Do not freeze. Keep out of the reach of children. Shelf life - 2 years.
