Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: Codal-Synto Ltd, 21 Constantinoupoleos Street, 3011 Limassol, Cyprus
Treatment of herpes simplex infections: 200mg of aciclovir, five times a day, at approximately four hour intervals, omitting the night time dose. Treatment is usually for five days, in the case of severe initial infections this may need to be extended.
In patients with impaired gut absorption or severely immunοcompromised patients (e.g. after marrow transplant) the dose may be doubled to 400mg aciclovir (or the intravenous form may be used).
Therapy should be initiated as early as possible, preferably during the prodromal period or when lesions first appear in the case of recurrent episodes.
Suppression of herpes simplex infections in immune-compromised patients: 200mg, 4 times a day at approximately six-hour intervals. Dose of 400 mg two times a day at approximately twelve hour intervals is convenient for many patients.
In some cases, dosage titration down to 200mg three times a day at eight hour intervals, or 200 mg two times a day at twelve hour intervals, may be effective. Cases of breakthrough infection on total doses of 800 mg a day may occur in some patients. Every six to twelve months, therapy should be periodically interrupted to observe any possible changes in the disease.
Prophylaxis of herpes simplex infection in immune-compromised patients: 200mg four times a day at approximately six-hour intervals.
In patients with impaired gut absorption, or severely immune-compromised, dose may be doubled to 400mg (or the intravenous form may be used). Length of treatment for prophylaxis is determined by the period of risk.
Treatment of varicella and herpes zoster infections: 800mg five times a day at approximately four hour intervals, omitting the night time dose. Treatment should last seven days.
In patients with impaired gut absorption, or severely immunocompromised, use of intravenous administration should be considered.
Herpes zoster treatment gives better results if therapy initiation is as soon as possible after rash appearance, treatment of chickenpox in immunocompromised patients should be initiated within 24 hours of rash appearance.
Treatment of and prophylaxis in immune-compromised of herpes simplex infection: Children two years of age or older, as adult dosages.
Children under two years of age: half the adult dose.
Treatment of varicella infections: Treatment should last five days.
Age 6 years and over: 800mg, four times a day.
Age two to five years: 400mg, four times a day.
Age under two years: 200mg aciclovir, four times daily.
Dosing may be calculated more accurately as 20mg/kg bodyweight four times a day. Total daily dosage must not exceed 800 mg. No information is available on suppression of herpes simplex infections or the treatment of herpes zoster infections in immunocompromised children.
Together with creatinine clearance, total aciclovir body clearance declines. Adequate hydration of such patients must be maintained. Attention should be paid to the need for dosage reduction, especially in such patients with renal impairment.
Recommended doses for herpes simplex infection will not lead to accumulation of aciclovir above infusion levels in patients with impaired renal function. In severe renal impairment, creatinine clearance <10ml/minute, 200mg two times a day at approximately twelve hour intervals is recommended.
In treatment of Varicella and Herpes zoster infection, the following dosage adjustments are recommended:
Moderate renal impairment, creatinine clearance 10 ml-25 ml/min, 800 mg three times a day at approximately eight hour intervals.
Severe renal impairment, creatinine clearance <10ml/min, 800 mg two times a day at approximately twelve hour intervals.
Syntovir tablets should be swallowed whole with a little water.
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.
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. 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. Most of the clinical isolates with reduced sensitivity have been relatively deficient in viral TK, however strains with altered viral TK or viral DNA polymerase have also been reported. In vitro exposure of HSV isolates to aciclovir can also lead to the emergence of less sensitive strains. The relationship between the in vitro determined sensitivity of HSV isolates and clinical response to aciclovir therapy is not clear.
Sixty (60) months.
This medicinal product does not require any special storage conditions.
Combination of polyvinylchloride and aluminium blisters in a carton with the patient information leaflet. Cartons of 10 and 30 tablets are available. Syntovir 800mg tablets are also available in cartons of 35, 500 and 1000 tablets.
No special requirements.
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