Name:
Zovirax. Release form Cream. MNNAciclovir. FTGAntiviral agent for topical use. Composition (per package, 2 g): Active substance – acyclovir 100 mg. Excipients – poloxamer 407, cetostearyl alcohol, sodium lauryl sulfate, white soft paraffin, liquid paraffin, dimethicone 20, propylene glycol, arlacel 165, purified water.
Description:
White or almost white cream, homogeneous, without graininess and lumps, without foreign matter and signs of separation. Pharmacotherapeutic groupAntiviral agent for local use. Acyclovir. ATX code: D06BB03. Zovirax is indicated for the treatment of infections of the lips and face caused by the Herpes simplex virus (recurrent herpes labialis). Use in immunocompromised patients: Immunocompromised patients should not be used and a physician should be consulted regarding the treatment of any infection. Method of application and dosage The drug is intended for topical use only. Adults (including the elderly): The drug is recommended to be applied 5 times a day (approximately every 4 hours), except at night. It is necessary to apply the drug as early as possible, preferably already at the first signs of the disease (in the prodromal period or with reddening of the skin). However, treatment can be initiated at a later stage (presence of a papule or vesicle). The duration of treatment is at least 4 days. In the absence of healing, treatment can be continued up to 10 days. If symptoms persist for more than 10 days, you should consult a doctor. To prevent deterioration of the condition and prevent transmission of infection, you must wash your hands before and after applying the drug, do not rub or touch the affected skin with a towel. Application in children. Due to the lack of adequate data, the use of the drug in children under 12 years of age is not recommended. Use in patients with renal / hepatic insufficiency. Despite the fact that acyclovir is excreted mainly through the kidneys, systemic absorption after topical application is negligible. Therefore, patients with renal or hepatic insufficiency do not require dose adjustment (see section “Pharmacokinetics”). Contraindications Hypersensitivity to acyclovir, valaciclovir, propylene glycol or any of the excipients of Zovirax cream. Special instructions and precautions for use The cream can only be used for herpes skin of the lips and face. The cream is not recommended to be applied to the mucous membranes of the mouth and eyes, and should not be used to treat genital herpes. Avoid accidental contact with eyes. With severe manifestations of herpes lips, it is recommended to consult a doctor. Persons with herpes on the lips (especially in the presence of open lesions) must strictly follow the precautions to prevent infection of other people (for example, wash hands before and after applying the drug, see section “Method of application and dosage”). This medicine contains cetyl alcohol, which can cause local skin reactions such as contact dermatitis, and propylene glycol, which can cause skin irritation. Interactions with other medicinal products No clinically significant interactions with other medicinal products have been identified. Use during pregnancy and breastfeeding Pregnancy. Application is indicated only in cases where the intended benefit to the mother outweighs the potential risk to the fetus. However, the systemic exposure of acyclovir after topical application is very low. In the post-registration registry of pregnancies with the use of acyclovir, data were recorded on the outcome of pregnancy in women taking acyclovir in different dosage forms. Analysis of registry data did not reveal an increase in the number of birth defects in children whose mothers took acyclovir during pregnancy, compared with the general population. The identified congenital defects did not differ in uniformity or regularity, allowing us to assume a common cause of their occurrence. The systemic exposure of acyclovir after topical application is very low. Breast-feeding. The limited data available on the use of acyclovir in women during breastfeeding show that when acyclovir is administered in systemic forms, the drug passes into breast milk. However, it is expected that the dose received by a breastfed child is small. Influence on the ability to drive a car and work with mechanisms Influence on the ability to drive a car and work with mechanisms when using acyclovir in the form of a cream is unlikely. Adverse reactions are indicated using the following system of classification of adverse effects by frequency: very often ≥ 1/10, often ≥ 1/100 and <1/10, infrequently ≥ 1/1000 and <1/100, rarely ≥ 1/10,000 and <1/1000, very rarely <1/10,000. Skin and subcutaneous tissue disorders: Uncommon • Transient burning or stinging after applying the cream. • Dry or flaky skin • Itching Rare • Erythema • Contact dermatitis at the site of application, more often associated with a reaction to excipients than to acyclovir Immune system disorders: Very rare • Immediate hypersensitivity reactions, including Quincke's edema. Overdose In case of accidental ingestion or topical application of the entire contents of a tube of Zovirax cream weighing 2 grams containing 100 mg of acyclovir, no adverse effect was identified due to minimal systemic exposure. If you suspect an overdose, you should seek medical help. Pharmacological properties Pharmacodynamics Acyclovir is an antiviral drug. In experimental in vitro studies, it demonstrates activity against the herpes simplex virus (herpes simplex) types 1 and 2. Toxicity to the host cell (human cell) is low. When it enters cells infected with the herpes virus, acyclovir is phosphorylated and converted to its active form - acyclovir triphosphate. The first step in this process depends on the presence of HSV-encoded thymidine kinase. Aciclovir triphosphate acts as an inhibitor and substrate for herpes-specific DNA polymerase, preventing further viral DNA synthesis without affecting normal cellular processes. PharmacokineticsAbsorption Pharmacological studies have shown that with repeated topical application of acyclovir cream, systemic absorption is minimal. Shelf life 3 years. Do not use after the expiration date. Storage conditions At a temperature not higher than 25 °C. Do not freeze. Keep out of the reach of children. Release formCream for external use 5%. 2 g of the drug in an aluminum tube with a screw cap. An aluminum tube is placed in a cardboard box along with instructions for use. Buy Zovirax cream 5% 2g №1 Price for Zovirax cream 5% 2g №1 Instructions for use for Zovirax cream 5% 2g №1
INN | ACYCLOVIR |
---|---|
The code | 135 955 |
Barcode | 4 870 223 140 281 |
Dosage | 5% 2g |
Active substance | Acyclovir |
Manufacturer | Glaxo Operations UK Limited, UK |
Importer | Republican unitary enterprise "Belpharmacy" Minsk, 220005, Republic of Belarus, Minsk, st. V. Khoruzhey, 11; Limited Liability Company "Farmiko", Minsk district, Senitsky s / s, Kolyadichi village, Lazurnaya st., 9; "VitPharmMarket" LLC Vitebsk, Republic of Belarus, 210004 Vitebsk, 5th Kooperativnaya st., 8; Commercial private unitary enterprise "Capsipharm", 223016 Minsk district, Novodvorsky s / s, 6-18; ALC "Dominantafarm", Minsk, 220140 Minsk, Dombrovskaya st., 15, room 10a, room 10a-41; ODO "TISHAS", Minsk, 220028 Belarus, Minsk, Mayakovsky st., 144, room 7; IOOO "Interfarmaks", Republic of Belarus, 223028, Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Zvezdnaya, 19A-5, pom. 5-2 |
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