Zovirax IV 250mg, 500mg
GlaxoSmithKline UK Contact details
1. Name of the medicinal product
Zovirax® I.V. 250 mg
Zovirax® I.V. 500 mg
2. Qualitative and quantitative composition
250 mg aciclovir or 500 mg aciclovir in each vial
Excipients with known effect:
Sodium hydroxide
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Intravenous injection
4. Clinical particulars
4.1 Therapeutic indications
Zovirax I.V. is indicated for the treatment of Herpes simplex infections in immunocompromised patients and severe initial genital herpes in the non-immunocompromised.
Zovirax I.V. is indicated for the prophylaxis of Herpes simplex infections inimmunocompromised patients.
Zovirax I.V. is indicated for the treatment of Varicella zoster infections.
Zovirax I.V. is indicated for the treatment of herpes encephalitis.
Zovirax I.V. is indicated for the treatment of Herpes simplex infections in the neonate and infant up to 3 months of age.
4.2 Posology and method of administration
Route of administration: Slow intravenous infusion over 1 hour.
A course of treatment with Zovirax I.V. usually lasts 5 days, but this may be adjusted according to the patient's condition and response to therapy. Treatment for herpes encephalitis usually lasts 10 days. Treatment for neonatal herpes infections usually lasts 14 days for mucocutaneous (skin-eye-mouth) infections and 21 days for disseminated or central nervous system disease.
The duration of prophylactic administration of Zovirax I.V. is determined by the duration of the period at risk.
Dosage in adults:
Patients with Herpes simplex (except herpes encephalitis) or Varicella zoster infections should be given Zovirax I.V. in doses of 5 mg/kg body weight every 8 hours provided renal function is not impaired (see Dosage in renal impairment).
Immunocompromised patients with Varicella zoster infections or patients with herpes encephalitis should be given Zovirax I.V. in doses of 10 mg/kg body weight every 8 hours provided renal function is not impaired (see Dosage in renal impairment).
In obese patients dosed with intravenous aciclovir based on their actual body weight, higher plasma concentrations may be obtained (see 5.2 Pharmacokinetic properties). Consideration should therefore be given to dosage reduction in obese patients and especially in those with renal impairment or the elderly.
Dosage in infants and children: The dose of Zovirax I.V. for infants and children aged between 3 months and 12 years is calculated on the basis of body surface area.
Infants and children 3 months of age or older with Herpes simplex (except herpes encephalitis) or Varicella zoster infections should be given Zovirax I.V. in doses of 250 mg per square metre of body surface area every 8 hours if renal function is not impaired.
In immunocompromised children with Varicella zoster infections or children with herpes encephalitis, Zovirax I.V. should be given in doses of 500 mg per square metre body surface area every 8 hours if renal function is not impaired.
The dosage of Zovirax I.V. in neonates and infants up to 3 months of age is calculated on the basis of body weight.
The recommended regimen for infants treated for known or suspected neonatal herpes is acyclovir 20 mg/kg body weight IV every 8 hours for 21 days for disseminated and CNS disease, or for 14 days for disease limited to the skin and muco
