Acyclovir Auxilto Cream 5% w/w appears as a smooth, white cream, with a characteristic odour, free from clumps, clots or foreign particles.
Active Substance: Each gram of cream contains 50 mg of acyclovir (5% of acyclovir, w/w).
Excipients/Inactive Ingredients: Cetostearyl alcohol, liquid paraffin, propylene glycol, sodium laurilsulfate, poloxamer 407, white soft paraffin and purified water.
Pharmacotherapeutic group: 13.1.4 - Medicines used to treat skin conditions. Anti-infective agents for topical application to the skin. Antiviral agents. ATC code: D06BB03.
Pharmacology: Pharmacodynamics: Acyclovir is an antiviral agent with high in vitro activity against the Herpes simplex (HSV) type I and II and Varicella-zoster viruses. Toxicity to mammalian host cells is low. After penetrating the cells infected by the Herpes simplex virus, acyclovir is phosphorylated to the active compound acyclovir triphosphate. The first step in this process is dependent on the presence of thymidine kinase, an enzyme encoded by the virus. Acyclovir triphosphate acts simultaneously as a substrate and an inhibitor of the viral DNA polymerase, preventing further synthesis of viral DNA without affecting normal cellular processes.
Acyclovir toxicity for non-infected mammalian host cells is low, since acyclovir cannot be used by mammalian thymidine kinase as a substrate.
Clinical studies with acyclovir cream have demonstrated statistically significant efficacy in healing of lesions and pain relief, compared to placebo. Healing time was 22% shorter in patients treated with acyclovir cream, compared to patients treated with placebo (average duration decreased by up to 0.5 days). Time to pain disappearance was reduced by approximately 20% (average duration decreased by up to 0.4 days). Approximately 60% of patients started treatment at an early stage (prodrome or erythema), with the remaining 40% starting treatment at a later stage (papular or vesicular stage).
Pharmacokinetics: Acyclovir absorption through the skin appears to be minimal following topical application to intact skin. The results of a study in several patients with localised infections by the Varicella-zoster virus have demonstrated that absorption through the skin is minimal when acyclovir cream is applied to the affected areas. Acyclovir distribution following topical application has not yet been determined. In vitro, acyclovir appears to be preferentially distributed to cells infected with the virus. Acyclovir metabolism following absorption through the skin has not been completely established. In a study involving topical application of acyclovir in patients with localised infections caused by the Varicella-zoster virus, 9.4% or less of the total daily dose of acyclovir was excreted unchanged in the urine.
Acyclovir Auxilto Cream 5% w/w is indicated for the treatment of herpes simplex virus infections of the skin including initial and recurrent genital herpes and herpes labialis.
Administration: For topical use.
Dosage: Adults and children: Acyclovir Auxilto Cream 5% w/w should be applied five times daily at approximately four hourly intervals omitting the night time application.
Acyclovir Auxilto Cream 5% w/w should be applied to the lesions or impending lesions as soon as possible, preferably during the earliest stages (prodrome or erythema). Treatment can also be started during the later (papule or blister) stages. Treatment should be continued for at least 4 days for herpes labialis and for 5 days for genital herpes. If healing has not occurred treatment may be continued for up to 10 days.
No adverse events would be expected if the entire contents of a Acyclovir Auxilto cream tube, containing 500 mg of acyclovir, were ingested orally. Oral doses of 800 mg of acyclovir were administered five times daily (4 grams daily), for 7 days, with no adverse events.
Accidental intravenous administration of doses up to 80 mg/kg has not caused adverse events.
Acyclovir is removed by dialysis.
Hypersensitivity to acyclovir or to any of the excipients.
Acyclovir Auxilto Cream 5% w/w should not be applied to mucous membranes, namely in the mouth, eyes or vagina, since it may be irritating.
Patients should take precautions in order to avoid transmitting the virus, particularly when active lesions are present.
Acyclovir Auxilto Cream 5% w/w contains propylene glycol, which may cause skin irritation.
Acyclovir Auxilto Cream 5% w/w contains cetostearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).
Effects on ability to drive and use machines: Not Applicable.
Pregnancy: No studies have been conducted concerning use of Acyclovir Auxilto Cream 5% w/w during pregnancy; however, records of use of acyclovir formulations during pregnancy have not revealed any increase in the number of malformations, compared to the general population. Additionally, the malformations observed showed no unique characteristics or consistent patterns suggestive of a common cause.
Although systemic exposure to acyclovir following topical application of Acyclovir Auxilto Cream 5% w/w is very low, Acyclovir Auxilto Cream 5% w/w use by pregnant women should only be considered when the potential benefits outweigh possible unknown risks.
Lactation: No studies have been conducted concerning use of Acyclovir Auxilto Cream 5% w/w during lactation; however, limited data in humans reveal that acyclovir is excreted in human milk following systemic administration. Although the dose received by a nursing infant following maternal use of Acyclovir Auxilto Cream 5% w/w would be negligible, Acyclovir Auxilto Cream 5% w/w use during lactation should only be considered when the potential benefits outweigh possible unknown risks.
A transient burning sensation may occur sporadically, following application of Acyclovir Auxilto cream. Some cases of mild drying and flaking of the skin have been reported following topical application of acyclovir. Erythema, pruritus and contact dermatitis may rarely occur.
No interactions with other medicinal products have been observed, with the exception of probenecid, which increases the half-life of acyclovir and the area under the plasma concentration curve, in case of systemic administration of acyclovir.
Must be kept in original package at room temperature under 30°C.
D06BB03 - aciclovir ; Belongs to the class of topical antivirals used in the treatment of dermatological diseases.
Acyclovir Auxilto Cream 5% w/w
10 g x 1's
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