Zovirax Cream 0.05g / 1g Cream

    Zovirax Cream 0.05g / 1g Cream

    S4
    PDF Leaflet Revision Date: 23 July 2010

    API: Aciclovir | Company: Gsk

    Clinical Summary

    Quick overview from the medicine insert

    Indication

    Treatment of herpes simplex virus infections.

    Dosage (summary)

    Apply five times daily for 4-10 days depending on the condition.

    Special Populations

    • Severely immune compromised patients

    Pregnancy & Breastfeeding

    Safety in pregnancy and lactation not established; acyclovir passes into breast milk.

    Key Drug Interactions

    • Probenecid increases acyclovir half-life

    Contraindications

    • Hypersensitivity to acyclovir or excipients

    Common side effects

    • Burning or stinging
    • Drying or flaking of skin
    • Itching

    Counselling Points

    • Apply as soon as possible
    • Continue treatment for full duration
    • Consult physician if no healing occurs

    Serious warnings

    • Not recommended for mucous membranes
    • Avoid eye contact
    Important Disclaimer

    The Zovirax Cream 0.05g / 1g Cream professional information leaflet below is the property of Gsk and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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    Clinical Particulars

    Section 4 of the official insert — extracted exactly as issued, no alterations

    4.1 Therapeutic indications

    ZOVIRAX CREAM is indicated for the treatment of herpes simplex virus infections of the skin, lips or genitalia in the initial and recurrent situation.

    4.2 Posology and method of administration

    Adults and Children
    ZOVIRAX CREAM should be applied five times daily at approximately four hourly intervals. ZOVIRAX CREAM should be applied to the lesions or impending lesions as soon as possible, preferably during the earliest stages (prodroma or erythema). Treatment can also be started during the later (papule or blister) stages. Treatment should be continued for at least four 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.

    4.3 Contraindications

    ZOVIRAX CREAM is contra-indicated in patients known to be hypersensitive to acyclovir, valacyclovir or propylene glycol, or any of the excipients of ZOVIRAX CREAM.

    4.4 Special warnings and precautions for use

    In severely immune compromised patients (e.g. AIDS patients or bone marrow transplant recipients) topical ZOVIRAX may be inappropriate. Such patients should be encouraged to consult a physician concerning treatment of any infection. ZOVIRAX CREAM is not recommended for application to mucous membranes, such as in the mouth, eye or vagina, as it may be irritant. Particular care should be taken to avoid accidental introduction into the eye.

    4.5 Interactions with other medicines

    Probenecid increases the acyclovir mean half life and area under the plasma concentration curve. Other drugs affecting renal physiology could potentially influence the pharmacokinetics of acyclovir. However, clinical experience has not identified other drug interactions with acyclovir. No clinically significant interactions have been identified. Dilution: ZOVIRAX CREAM contains a specially formulated base and should not be diluted or used as a base for incorporation of other medicaments.

    4.6 Fertility, pregnancy and lactation

    The safety of ZOVIRAX CREAM in pregnancy and lactation has not been established. Limited human data show that acyclovir does pass into breast milk. There is no information on the effect of ZOVIRAX CREAM on human female fertility. In a study of 20 male patients with normal sperm count, oral acyclovir administered at doses of up to 1 g per day for up to six months has been shown to have no clinically significant effect on sperm count, motility or morphology.

    4.7 Effects on ability to drive and use machines

    No specific information provided.

    4.8 Undesirable effects

    The following convention has been used for the classification of undesirable effects in terms of frequency: Very common u2265 1/10, common u2265 1/100 and < 1/10, uncommon u2265 1/1 000 and < 1/100, rare u2265 1/10 000 and < 1/1 000, very rare < 1/10 000.
    Skin and subcutaneous tissue disorders:
    Uncommon
    u25cf Transient burning or stinging following application of ZOVIRAX CREAM
    u25cf Mild drying or flaking of the skin
    u25cf Itching
    Rare
    u25cf Erythema
    u25cf Contact dermatitis following application. Where sensitivity tests have been conducted, the reactive substances have most often been shown to be components of the cream rather than acyclovir.
    Immune System disorders:
    Very rare
    u25cf Immediate hypersensitivity reactions including angioedema.

    4.9 Overdose

    No untoward effects would be expected if the entire contents of a ZOVIRAX CREAM 10 g tube containing 500 mg of acyclovir were ingested orally. Acyclovir is dialysable.

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