CYCLOVAX Tablet Ref.[28211] Active ingredients: Aciclovir

Ensure that patients on high doses of aciclovir are adequately hydrated.

Posology

Adults

Treatment of herpes simplex infections

200 mg aciclovir 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 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.

Suppression of herpes simplex in infections in immunocompetent patients

200 mg aciclovir should be taken four times daily at approximately six-hourly 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.

Prophylaxis of herpes simplex infections in immunocompromised patients

200 mg aciclovir 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 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.

Treatment of varicella and herpes zoster in infections

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.

Children

Treatment of herpes simplex infections, and for 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.

Treatment of varicella infection

6 years and over: 800 mg aciclovir four times daily.

2-6 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.

Elderly

The possibility of renal impairment in the elderly must be considered and the dosage should be adjusted accordingly (see Renal impairment below).

Adequate hydration should be maintained.

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 impaired renal function, the recommended oral doses will not lead to accumulation of aciclovir above levels that have been established 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 varicella and 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).

Method of administration

Oral administration.

Symptoms

Aciclovir is only partly absorbed in the gastrointestinal tract. Patients have ingested overdoses of up to 20 g 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.

5 years.

Store below 25˚C. Protect from light and moisture.

PVC/Aluminium blisters. Pack sizes of 30, 100 and 1000 tablets.

PP containers with PE closures. Pack sizes of 100, 500 and 1000 tablets.

Not all pack sizes may be marketed.

No special instructions.