Zovirax 800mg Tablets
GlaxoSmithKline UK Contact details
1. Name of the medicinal product
Zovirax® Tablets BP 800mg
2. Qualitative and quantitative composition
Aciclovir 800mg BP
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Dispersible film coated tablet
4. Clinical particulars
4.1 Therapeutic indications
Zovirax tablets 800 mg are indicated for the treatment of varicella (chickenpox) and herpes zoster (shingles) infections (excluding neonatal HSV and severe HSV infections in immunocompromised children).
Zovirax 800mg tablets is recommended in children over the age of 6.
4.2 Posology and method of administration
Dosage in adults:
Treatment of varicella and herpes zoster infections: 800 mg 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 the onset of the rash.
Dosage in children:
Treatment of varicella infections:
6 years and over: 800 mg Zovirax four times daily.
Treatment should continue for five days.
No specific data are available on the treatment of herpes zoster infections in immunocompetent children.
For treatment of neonatal herpes virus infections, intravenous acyclovir is recommended.
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 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 of 10-25 ml/minute).
Administration
Zovirax tablets are for oral administration and may be dispersed in a minimum of 50 ml of water or swallowed whole with a little water. Ensure that patients on high doses of aciclovir are adequately hydrated.
4.3 Contraindications
Hypersensitivity to aciclovir or valaciclovir, or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
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. Bo
