s
After penetrating into a cell infected by herpes simplex virus, aciclovir converts to aciclovir triphosphate. Viral replication is selectively inhibited by viral DNA polymerase.
Aciclovir does not eradicate latent virus.
5.2 Pharmacokinetic properties
Concentrations in the plasma are minimal so that there should be no systemic effect.
5.3 Preclinical safety data
Local effects:
Aciclovir cream was applied to guinea pig and rabbit skin (damaged and normal) once a day for 21 days. A mild irritation occurred after repeated application.
Since the amount of active ingredient absorbed from the cream does not lead to significant plasma levels (see paragraph 5.2 on pharmacokinetics) there were no further studies on this form of administration.
6. Pharmaceutical particulars
6.1 List of excipients
Self-emulsifying glyceryl monostearate (Arlatone 983S), Dimeticone, Cetyl Alcohol, Liquid Paraffin, White Soft Paraffin, Propylene Glycol, Purified Water.
6.2 Incompatibilities
None.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
Do not store above 30°C.
Do not refrigerate.
6.5 Nature and contents of container
Aluminium tube containing 2g of Virasorb Cold Sore Cream.
One tube is packed in a carton together with a patient information leaflet.
6.6 Special precautions for disposal and other handling
No special requirements.
7. Marketing authorisation holder
Thornton & Ross Limited
Linthwaite Laboratories
Huddersfield
HD7 5QH
United Kingdom
8. Marketing authorisation number(s)
PL 00240/0136
9. Date of first authorisation/renewal of the authorisation
21/11/2006
10. Date of revision of the text
26/11/2014
