Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Medovir is indicated for:
Medovir 800 mg tablets are indicated for the treatment of varicella (chickenpox) and herpes zoster (shingles) infections (excluding neonatal HSV and severe HSV infections in immunocompromised children).
Medovir 800 mg tablets is recommended in children over the age of 6.
200 mg of aciclovir should be taken five times daily, at approximately four hour 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 400 mg aciclovir 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.
200 mg aciclovir should be taken four times daily at approximately six-hour intervals.
Many patients may be conveniently managed on a regimen of 400 mg aciclovir twice daily at approximately twelve-hourly intervals.
Dosage titration down to 200 mg aciclovir 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 800 mg aciclovir.
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.
200 mg aciclovir should be taken four times daily at approximately six-hour 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 400 mg aciclovir, or alternatively, intravenous dosing could be considered.
The duration of prophylactic administration is determined by the duration of the period at risk.
800 mg aciclovir 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.
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 on neonatal herpes virus infections, intravenous aciclovir is recommended.
6 years and over: 800 mg aciclovir, four times daily.
2-5 years: 400 mg aciclovir, four times daily.
Under 2 years: 200 mg aciclovir, four times daily.
Treatment should continue for five days.
Dosing may be more accurately calculated as 20 mg/kg bodyweight (not to exceed 800 mg) aciclovir 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.
The possibility of renal impairment in the elderly must be considered and the dosage should be adjusted accordingly (see Renal impairment below).
Adequate hydration of elderly patients taking high oral doses of aciclovir should be maintained.
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 impaired renal function, the recommended oral doses will not lead to accumulation of aciclovir above levels that have been established safe by intravenous infusion. However for 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 herpes zoster infections it is recommended to adjust the dosage to 800 mg aciclovir twice daily at approximately twelve-hourly intervals for patients with severe renal impairment (creatinine clearance less than 10 ml/minute), and to 800 mg aciclovir three times daily at intervals of approximately eight hours for patients with moderate renal impairment (creatinine clearance in the range 10–25 ml/minute).
Medovir tablets should be swallowed whole with a little water. Ensure that patients on high doses of aciclovir are adequately hydrated.
Oral.
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.
60 months.
This medicine does not require any special storage conditions.
Combination of polyvinylchloride and aluminium blisters in a carton with the patient information leaflet. Cartons of 10, 30, 35, 40 100, 500 and 1000 tablets are available.
Medovir 400 mg tablets have additional carton pack with 70 tablets.
Not all pack sizes may be marketed.
For oral administration, swallow whole with a little water if required.
No special requirements for disposal.
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