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  • Zovirax Suspension
    / GSK


    Active Ingredient
    Aciclovir 200 mg / 5 ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Suspension

    125 ml X 200 mg/5 ml

    partial basket chart 20743 26057

    Dosage

    Dosage in Adults: Treatment of herpes simplex infections: 200mg Zovirax should be taken five times daily at approximately four hourly intervals omitting the night time dose. Treatment should continue for 5 days, but in severe initial infections this may have to be extended.
    In severely immunocompromised patients (e.g. after marrow transplant) or in
    patients with impaired absorption from the gut the dose can be doubled to 400mg Zovirax or alternatively intravenous dosing could be considered.
    Dosing should begin as early as possible after the start of an infection; for recurrent episodes this should preferably be during the prodromal period or when lesions first appear.
    Suppression of herpes simplex infections in immunocompetent patients:
    200mg Zovirax should be taken four times daily at approximately six‐hourly
    intervals.
    Many patients may be conveniently managed on a regimen of 400mg Zovirax twice daily at approximately twelve‐hourly intervals.
    Dosage titration down to 200mg Zovirax taken thrice daily at approximately eight‐ hourly intervals or even twice daily at approximately twelve‐hourly intervals, may prove effective.
    Some patients may experience break‐through infection on total daily doses of
    800mg Zovirax.
    Therapy should be interrupted periodically at intervals of six to twelve months, in order to observe possible changes in the natural history of the disease.
    Prophylaxis of herpes simplex infections in immunocompromised patients:
    200mg Zovirax should be taken four times daily at approximately six hourly intervals.
    In severely immunocompromised patients (e.g. after marrow transplant) or in
    patients with impaired absorption from the gut, the dose can be doubled to 400mg Zovirax or, alternatively, intravenous dosing could be considered.
    The duration of prophylactic administration is determined by the duration of the
    period at risk.
    Treatment of varicella and herpes zoster infections: 800mg Zovirax should be taken five times daily at approximately four‐hourly intervals, omitting the night time dose. Treatment should continue for seven days.
    In severely immunocompromised patients (e.g. after marrow transplant) or in
    patients with impaired absorption from the gut, consideration should be given to
    intravenous dosing.
    Dosing should begin as early as possible after the start of an infection: treatment of herpes zoster yields better results if initiated as soon as possible after the onset of the rash. Treatment of chickenpox in immunocompetent patients should begin within 24 hours after onset of the rash.
    Dosage in Children: Treatment of herpes simplex infections, and prophylaxis of herpes simplex infections in the immunocompromised: Children aged two years and over should be given adult dosages and children below the age of two years should be given half the adult dose.
    For treatment of neonatal herpes virus infections, intravenous aciclovir is
    recommended.
    Treatment of varicella infections:
    6 years and over: 800mg Zovirax four times daily.
    2 to 5 years: 400mg Zovirax four times daily.
    Under 2 years: 200mg Zovirax four times daily.
    Treatment should continue for five days.
    Dosing may be more accurately calculated as 20mg/kg body weight (not to exceed 800mg) Zovirax four times daily. No specific data are available on the suppression of herpes simplex infections or the treatment of herpes zoster infections in immunocompetent children.
    Dosage in the Elderly: The possibility of renal impairment in the elderly must be considered and the dosage should be adjusted accordingly (see Dosage in Renal Impairment below). Adequate hydration of elderly patients taking high oral doses of aciclovir should be maintained.
    Dosage in Renal Impairment: Caution is advised when administering aciclovir to patients with impaired renal function. Adequate hydration should be maintained.
    In the management of herpes simplex infections in patients with severe renal
    impairment (creatinine clearance less than 10 ml/minute) an adjustment of dosage to 200 mg aciclovir twice daily at approximately twelve‐hourly intervals is recommended.
    In the treatment of varicella and herpes zoster infections it is recommended to
    adjust the dosage to 800mg aciclovir twice daily at approximately twelve‐hourly
    intervals for patients with severe renal impairment (creatinine clearance less than 10ml/minute), and to 800mg aciclovir three times daily at intervals of approximately eight hours for patients with moderate renal impairment (creatinine clearance in the range 10 to 25ml/minute).


    Indications

    – For the treatment of herpes simplex virus infections of the skin and mucous membranes including initial and recurrent genital herpes (excluding neonatal HSV and severe HSV infections in immunocompromised children).
    – For the suppression (prevention of recurrences) of recurrent herpes simplex infections in immunocompetent patients.
    – For the prophylaxis of herpes simplex infections in immunocompromised patients.
    – For the treatment of varicella (chickenpox) and herpes zoster (shingles) infections.


    Contra-Indications

    Hypersensitivity to aciclovir or valaciclovir, or to any of the excipients.


    Special Precautions

    Use in patients with renal impairment and in elderly patients: Aciclovir is eliminated by renal clearance, therefore the dose must be adjusted in patients with renal impairment (see 4.2 Posology and Method of Administration) Elderly patients are likely to have reduced renal function and therefore the need for dose adjustment must be considered in this group of patients. Both elderly patients and patients with renal impairment are at increased risk of developing neurological side effects and should be closely monitored for evidence of these effects. In the reported cases, these reactions were generally reversible on discontinuation of treatment. Prolonged or repeated courses of aciclovir
    in severely immune‐compromised individuals may result in the selection of virus
    strains with reduced sensitivity, which may not respond to continued aciclovir
    treatment.
    Hydration status: Care should be taken to maintain adequate hydration in patients receiving high oral doses of aciclovir.
    This risk of renal impairment is increased by use with other nephrotoxic drugs.
    The data currently available from clinical studies is not sufficient to conclude that treatment with aciclovir reduces the incidence of chickenpox‐associated
    complications in immunocompetent patients.
    Zovirax Suspension contains Methyl parahydroxybenzoate and Propyl
    parahydroxybenzoate which may cause allergic reactions (possibly delayed).
    Zovirax Suspension also contains sorbitol. Hence Patients with rare hereditary
    problems of fructose intolerance should not take this medicine.


    Side Effects

    Common: Headache, dizziness, nausea, vomiting, diarrhoea, abdominal pains, pruritus, rashes (including photosensitivity), fatigue, fever.
    See prescribing information for full details.


    Drug interactions

    Aciclovir is eliminated primarily unchanged in the urine via active renal tubular
    secretion. Any drugs administered concurrently that compete with this mechanism may increase aciclovir plasma concentrations. Probenecid and cimetidine increase the AUC of aciclovir by this mechanism, and reduce aciclovir renal clearance.
    Similarly increases in plasma AUCs of aciclovir and of the inactive metabolite of
    mycophenolate mofetil, an immunosuppressant agent used in transplant patients have been shown when the drugs are coadministered. However no dosage adjustment is necessary because of the wide therapeutic index of aciclovir.
    An experimental study on five male subjects indicates that concomitant therapy
    with aciclovir increases AUC of totally administered theophylline with approximately 50%. It is recommended to measure plasma concentrations during concomitant therapy with aciclovir.


    Pregnancy and Lactation

    Pregnancy: Caution should be exercised by balancing the potential benefits of treatment against any possible hazard.
    Breast‐feeding: Following oral administration of 200mg Zovirax five times a day, aciclovir has been detected in breast milk at concentrations ranging from 0.6 to 4.1 times the corresponding plasma levels. These levels would potentially expose nursing infants to aciclovir dosages of up to 0.3mg/kg/day. Caution is therefore advised if Zovirax is to be administered to a nursing woman.
    See prescribing information for full details.


    Overdose

    Symptoms & signs: Aciclovir is only partly absorbed in the gastrointestinal tract.
    Patients have ingested overdoses of up to 20g aciclovir on a single occasion, usually without toxic effects. Accidental, repeated overdoses of oral aciclovir over several days have been associated with gastrointestinal effects (such as nausea and vomiting) and neurological effects (headache and confusion).
    Overdosage of intravenous aciclovir has resulted in elevations of serum creatinine, blood urea nitrogen and subsequent renal failure. Neurological effects including confusion, hallucinations, agitation, seizures and coma have been described in association with intravenous overdosage.
    Management: Patients should be observed closely for signs of toxicity.
    Haemodialysis significantly enhances the removal of aciclovir from the blood and may, therefore, be considered a management option in the event of symptomatic overdose.


    Manufacturer
    Aspen Bad Oldesloe GmbH
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