Aciclovir 400mg/5ml Oral Suspension
Rosemont Pharmaceuticals Limited Contact details
1. Name of the medicinal product
Aciclovir 400mg/5ml Oral Suspension
2. Qualitative and quantitative composition
Aciclovir 400mg/5ml
3. Pharmaceutical form
Oral Suspension
4. Clinical particulars
4.1 Therapeutic indications
Aciclovir Suspension is indicated for the following:

1. 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).

2. The suppression (prevention of recurrences) of recurrent herpes simplex infections in immunocompetent patients.

3. The prophylaxis of herpes simplex infections in immunocompromised patients.

4. The treatment of herpes zoster (shingles) and varicella (chickenpox) infections.
4.2 Posology and method of administration
For oral administration

Adults:

Treatment of herpes simplex infections:

200mg five times daily, at approximately 4 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.

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, four times daily (every six hours).

Many patients may be managed on a regimen of 400mg twice a day (every twelve hours).

Dosage titration down to 200mg three times daily (every eight hours) or even twice daily (every twelve hours), may prove effective.

Some patients may experience break-through infections on total daily doses of 800mg Aciclovir Suspension.

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 four times daily (every six hours)

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.

The duration of prophylactic administration is determined by the duration of the period at risk.

Treatment of herpes zoster and varicella infections:

800mg, five times daily (every four hours), 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:

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