Treatment of early signs and symptoms of recurrent cold sores on the lips (cold sores) to reduce the progression of episodes of cold sores to ulcers and reduce the healing time of lesions in immunocompetent adults and children 12 yEars and Nose of age.
COMPOSITION active ingredients: 1 g of cream contains 50 mg acyclovir, 10 mg hydrocortisone Excipients: propylene glycol, white soft paraffin, mineral oil, cetostearyl alcohol, isopropyl myristate, poloxamer, sodium lauryl sulfate, citric acid monohydrate, sodium hydroxide, purified hydrochloric acid.
DOSAGE FORM Cream.
MAIN PHYSICAL AND CHEMICAL PROPERTIES: white homogeneous cream in an aluminum tube.
PHARMACOLOGICAL GROUP Antiviral drugs. ATX code D06B B03.
Pharmacological. Acyclovir is an antiviral drug that has high in vitro activity against herpes simplex virus types I and II. The toxic effect on the host cells is minimal. Once in cells infected with the herpes virus, acyclovir is phosphorylated to form the active compound, acyclovir triphosphate. The first stage of this process depends on the presence of virus-coded and thymidine kinase. Acyclovir triphosphate acts as an inhibitor and substrate for viral DNA polymerase, preventing further viral DNA synthesis without affecting normal cellular processes. Hydrocortisone is a weak GCS that exhibits a number of immunomodulatory effects. When applied topically, its main role is to control various inflammatory skin lesions. Cream with acyclovir and hydrocortisone, which combines the antiviral action of acyclovir and the anti-inflammatory action of hydrocortisone, reduces the progression of herpetic vesicles to ulceration and also reduces the healing time of the lesions. The exact mechanism is not well understood, but it is thought to be mediated by viral clearance and a decrease in the local inflammatory response on the lips, resulting in a decrease in the signs and symptoms of recurrent herpes. Pharmacokinetics. No clinical pharmacokinetic studies have been conducted for acyclovir-hydrocortisone cream. INDICATIONS Treatment of early signs and symptoms of recurrent lip herpes (herpes blisters) to reduce the progression of herpes sores to ulceration and shorten the healing time of lesions in immunocompetent adults and children over 12 years of age.
Hypersensitivity to acyclovir, valacyclovir, propylene glycol or other components of the cream. Use in skin lesions caused by any virus other than herpes simplex, or to treat fungal, bacterial or parasitic skin infections. SPECIAL PRECAUTIONS The cream should only be used to treat herpes on the lips and face. It is not recommended to apply the cream to the mucous membranes of the mouth, eyes and to use it to treat genital herpes. Avoid accidental contact with the eyes. Patients with particularly severe and recurrent manifestations of Herpes labialis require medical advice. Herpes patients should be warned against contact transmission of the virus to other people, especially in the presence of open lesions (in particular, hands should be washed before and after using the cream). Not recommended for people with immunodeficiency. Such patients need the advice of a physician to treat any infection. INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER KINDS OF INTERACTIONS No interaction has been identified. FEATURES OF APPLICATION Application during pregnancy or lactation. For pregnant and breastfeeding women, the drug is recommended to be used only when the benefit, in the opinion of the doctor, outweighs the risk. ABILITY TO INFLUENCE THE RATE OF RESPONSE WHEN DRIVING MOTOR VEHICLES OR OTHER MECHANISMS No data available. DOSAGE AND METHOD OF APPLICATION The preparation is intended for external use. For adults and children over 12 years of age, apply the cream 5 times a day at approximately 4-hour intervals, excluding at night. Treatment should be started as early as possible, preferably immediately after the first manifestations or symptoms appear. A sufficient amount of cream must be applied each time to cover the affected area, including the outer edges of the lesion, if present. Treatment lasts at least 5 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 avoid excessive rubbing or touching the affected area with a towel to prevent exacerbation or transmission of infection.