Zovirax DUO-ACTIVE for colds on the lips, cream 5% 2g
A country
United Kingdom
Country of origin may vary by batch. Please check with the operator for detailed information when confirming your order.
Active substance
Acyclovir + Hydrocortisone
Description
Zovirax Duo-Active is a remedy for colds on the lips (herpes), which allows you to stop the development of the virus and prevent the formation of blisters at an early stage *.
Its unique dual-action formula** contains a combination of anti-inflammatory (hydrocortisone) and antiviral (acyclovir) substances*. Approved for use from 12 years of age.* * Instructions for medical use, RU No. LP-001674 dated April 26, 2012 ** GRLS, January 2019
Compound
Active ingredients: acyclovir 50 mg, hydrocortisone 10 mg. Excipients: liquid paraffin 56.5 mg, soft white paraffin 100.0 mg, isopropyl myristate 150.0 mg, sodium lauryl sulfate 8.0 mg, cetostearyl alcohol 67.5 mg, poloxamer 188 10.0 mg, propylene glycol 200.0 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 up to 1000.0 mg.
Product description
A homogeneous cream of white or white with a yellowish tint.
pharmachologic effect
Mechanism of action Acyclovir, an antiviral drug, is highly active in vitro against Herpes simplex virus (HSV) types 1 and 2.
The toxic effect on mammalian cells is minimal. After entering cells infected with the herpes virus, acyclovir is phosphorylated to the active compound acyclovir triphosphate. The first step of this process depends on the presence of the HSV-encoded thymidine kinase enzyme. Acyclovir triphosphate acts as an inhibitor and substrate of herpes-specific DNA polymerase, preventing further synthesis of viral DNA, without affecting normal cellular processes. Hydrocortisone is a weakly active glucocorticosteroid with various immunomodulatory effects. When used externally, the therapeutic activity of hydrocortisone is due to the control of various inflammatory skin disorders. The drug Zovirax Duo-Active, which combines the antiviral properties of acyclovir and the anti-inflammatory effect of hydrocortisone, reduces the frequency of progression of herpes on the lips to the appearance of ulcerative lesions, and also reduces their healing time. The exact mechanism of action is not completely known, but is thought to be related to clearance of the virus and suppression of the local inflammatory response in the lips, resulting in a reduction in signs and symptoms of infection. Pharmacokinetics Clinical pharmacokinetic studies of Zovirax Duo-Active have not been conducted. Absorption Due to limited absorption, the expected systemic exposure of acyclovir after topical application of Zovirax Duo-Active cream will be low. Glucocorticosteroids penetrate the stratum corneum of the epidermis and act on the deep layers of cells. Typically, only a small portion of the dose is absorbed, so changes in hormonal balance are unlikely. Systemic exposure to glucocorticosteroids is possible with increased absorption (for example, when applying the cream to large inflamed areas of the skin or to skin with damaged stratum corneum of the epidermis). Occlusive dressings also increase absorption.
Indications for use
Treatment of early manifestations of recurrent labial herpes in adults and children over 12 years of age with normal immune status.
Contraindications
Hypersensitivity to acyclovir, valacyclovir, hydrocortisone or any other component of the drug; - skin lesions caused by other viruses, fungal, bacterial skin diseases, as well as parasitic skin infections; - children under 12 years of age.
Use during pregnancy and lactation
Pregnancy Before using Zovirax Duo-Active, if you are pregnant, think you might be pregnant, or are planning a pregnancy, you should consult your doctor. The use of Zovirax Duo-Active during pregnancy is not recommended, unless prescribed by a doctor (if the expected benefit to the mother outweighs the potential risk to the fetus). The systemic exposure of acyclovir and hydrocortisone with topical application of the cream is very low. Breastfeeding period During breastfeeding, you should consult your doctor before using Zovirax Duo-Active. The use of Zovirax Duo-Active during breastfeeding is not recommended, unless prescribed by a doctor (if the expected benefit to the mother outweighs the potential risk to the child). Acyclovir and hydrocortisone are excreted in milk after systemic use. However, the dose received by the child through breast milk after the mother has taken Zovirax Duo-Active is insignificant. Fertility It is not possible to assess the effect of Zovirax Duo-Active on fertility due to a lack of human data.
Directions for use and doses
Use the drug only according to the indications, method of administration and in the doses indicated in the instructions. For external use only. Adults and children over 12 years old. Zovirax Duo-Active should be applied 5 times a day (approximately every 4 hours), except at night, for 5 days. The drug is applied to the affected and adjacent areas of the skin. With each application, apply enough cream to cover the affected area, including the outer edge of the ulcer. If you miss the application time, apply the cream next time as soon as you remember and continue according to the schedule. It is important to start treatment as early as possible, preferably when the first signs and symptoms appear (burning, tingling, feeling of skin tightness). Duration of treatment – 5 days. If symptoms persist for 10 days, you should consult your doctor. To prevent the condition from worsening and to prevent the transmission of infection, it is necessary to wash your hands before and after applying the drug, and do not rub or touch the affected areas of the skin with a towel.
Side effect
Side effects are listed below depending on the class of organ systems and frequency of occurrence. The frequency of occurrence was divided as follows: very often (≥1/10), often (from ≥1/100 to Disorders of the skin and subcutaneous tissues Dryness or flaking of the skin - Common Brief burning or tingling sensation in the areas where the drug was applied, Itching - Uncommon Redness skin Changes in skin pigmentation Contact dermatitis after application under occlusive dressing, identified in safety studies (hydrocortisone or a component of the cream base was the reagent in sensitization tests) Application site reactions, including signs and symptoms of inflammation - Rare Immune system disorders Immediate hypersensitivity reactions, including angioedema - Very rare Children aged 12 - 17 years The safety profile in children aged 12 - 17 years corresponds to the safety profile in adults If you experience the side effects indicated in the instructions or they are aggravated, or you If you notice any other side effects not listed in the instructions, tell your doctor
Overdose
When taken orally or applied externally, the entire contents of a tube of Zovirax Duo-Active cream (2 g) are not expected to cause undesirable effects due to minimal systemic exposure. In case of suspected overdose, symptomatic treatment is carried out.
Interaction with other drugs
Interaction studies with Zovirax Duo-Active have not been conducted.
special instructions
Do not apply to mucous membranes (eg eyes, mouth, nose or genitals). Do not use for the treatment of genital herpes. Avoid getting the cream into your eyes. If the cream accidentally gets into your eyes, rinse your eyes thoroughly with warm water. Consult your doctor if you experience any discomfort. If there are severe manifestations of a herpetic infection of the skin of the lips, you should consult a doctor. Do not apply occlusive dressings, such as regular or special patches for the treatment of herpes. It is not recommended for use in immunocompromised patients, as opportunistic infection or resistant strains requiring systemic antiviral therapy cannot be excluded. Treatment of patients with concomitant dermatitis of other origins has not been studied. Patients with herpes labialis should avoid transmitting the virus, especially if active lesions are present (wash hands before and after applying the cream). Long-term continuous use should be avoided. The drug should not be used for more than 5 days. This medicine contains cetyl alcohol, which may cause local skin reactions such as contact dermatitis, and propylene glycol, which may cause skin irritation. If you miss the application time, apply the cream next time as soon as you remember and continue according to the schedule. Before using this drug, tell your doctor if you regularly use any prescription or over-the-counter medicine.
Release form
Cream for external use 5% + 1%. 2 g of cream in an aluminum tube with a screw-on plastic cap. The aluminum tube along with instructions for use is placed in a cardboard box
Storage conditions
Store at a temperature not exceeding 25 C. Do not store in the refrigerator. Do not freeze. Keep out of the reach of children.
Best before date
2 years. Shelf life after first opening the tube is 3 months. Do not use after the expiration date stated on the packaging.
Zovirax Duo-active
Zovirax Duo-active is a local combined antiviral drug. Contains the purine nucleoside analogue deoxyguanosine acyclovir and the glucocorticosteroid hydrocortisone. Acyclovir acts on herpes simplex viruses types 1, 2 and 4 (Epstein-Barr) types, chickenpox, cytomegaloviruses. Thymidine kinase of cells affected by the virus phosphorylates acyclovir to form mono-, di- and triphosphorus salts. Acyclovir monophosphate interacts with viral DNA polymerase and is incorporated into viral DNA, making new viral particles defective and incapable of replication. Hydrocortisone is a weakly active glucocorticosteroid. When applied to the skin and mucous membranes, the therapeutic activity of the drug is due to its ability to reduce and prevent further development of the inflammatory process, suppress itching, inhibit allergic reactions, and prevent the effusion of exudate into the interstitial space (due to its vasoconstrictor effect). As a result of the combination of the antiviral effect of acyclovir and the anti-inflammatory effect of hydrocortisone, the drug prevents the appearance of vesicular rashes on the skin (when used during the period of the disease, which occurs between the incubation period and the disease itself), and also promotes the healing of existing vesicular formations. Blocking the reproduction of the virus while simultaneously suppressing the inflammatory process in areas of the skin in the affected area leads to a reduction in the clinical manifestations of the infection. When applied externally, acyclovir is practically not absorbed into the systemic circulation. Hydrocortisone is absorbed in small quantities through the stratum corneum of the skin, reaching the deep layers of the epidermis. Zovirax Duo-active is prescribed for recurrent herpesvirus infection. In pediatric practice, the drug is used after the patient reaches 12 years of age. The frequency of use in patients of all age categories is five times a day with a four-hour interval between applications (night time is not taken into account).
Application area - affected areas and areas adjacent to them. The effectiveness of treatment will be higher if you start using the drug at the first appearance of nonspecific symptoms of herpesvirus infection (irritating local sensation of heat, slight stabbing pain, feeling of skin tightness). The duration of the medication course is five days. If after this time there is no improvement or a worsening of the clinical situation is observed, it is necessary to seek medical advice to adjust treatment. To avoid the spread of infection, you should thoroughly wash your hands before and after applying the medicine and avoid touching the infected areas of the skin with a towel. Undesirable side reactions when using Zovirax Duo-active are local in nature and occur at the sites where the drug is applied. Possible allergic reactions, local dehydration and peeling of the skin, a feeling of painful tickling irritation of the skin, causing the need to scratch the irritated area, burning, tingling, hyperemia. Hydrocortisone can cause allergic dermatitis. In rare cases, a local inflammatory reaction may develop, accompanied by pain, swelling, hyperemia and a local increase in temperature. Zovirax Duo-active is not used in case of individual intolerance to any active or auxiliary components, skin lesions caused by viruses insensitive to acyclovir, bacterial, fungal, parasitic lesions of the skin, skin tumors, rosacea and vulgar acne, dermatitis of the perioral area. For severe herpesvirus infections, self-medication is not recommended: in such situations you should consult a doctor. Zovirax Duo-active is not intended for the treatment of genital herpes.
