1. Name Of The Medicinal Product
Virasorb Cold Sore Cream
2. Qualitative And Quantitative Composition
5% w/w Aciclovir
For excipients, see 6.1
3. Pharmaceutical Form
Cream
White to off-white, smooth cream without agglomerates, coarse lumps or contaminations and with characteristic odour.
4. Clinical Particulars
4.1 Therapeutic Indications
Virasorb Cold Sore Cream is indicated for the treatment of herpes labialis.
4.2 Posology And Method Of Administration
Dose:
Unless otherwise instructed, apply a thin layer of cream over the site of infection every four hours, five times a day.
Length of Treatment:
The cream should be applied to the lesion or developing lesion as soon as possible after the start of the infection. Treatment with Virasorb Cold Sore Cream is normally continued for five days. If there is no clinical benefit after 5 days, treatment should continue for up to another 5 days. If after ten days there is still no clinical benefit (crusted vesicles, healing of lesions), treatment should be discontinued and patients should consult their physician.
Method of Administration:
A cotton bud should be used to apply a sufficient quantity of Virasorb Cold Sore Cream to cover all lesions. The cream should be applied to visibly infected sites (vesicles, swelling, erythema) and the adjoining areas. If hands are used to apply the cream, they should be thoroughly washed before and after application to prevent further infection of the lesions by bacteria and to prevent autoinoculation of the virus to other mucous membrane and cutaneous sites not yet infected.
4.3 Contraindications
Hypersensitivity to aciclovir, polyoxyethylene fatty acid esters, cetyl alcohol, dimeticone or propylene glycol.
4.4 Special Warnings And Precautions For Use
Cold Sore sufferers should be advised to avoid transmitting the virus by direct contact, particularly when active lesions are present.
Virasorb Cold Sore Cream should not be used on mucous membranes (eg. oral cavity, eye, vagina) since local reactions may occur.
Patients with severe Herpes Labialis should seek medical advice.
Severely immunocompromised patients should consult their physician before starting treatment with Virasorb Cold Sore Cream. Immunocompromised patients may require oral dosing.
Virasorb Cold Sore Cream must not be used for treatment of ocular herpes infections or for the treatment of genital herpes.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No interactions known.
4.6 Pregnancy And Lactation
Pregnancy:
Only about 0.1% of the aciclovir applied to the skin is detectable in the plasma. Concentrations are minimal so that no systemic effect should occur.
Lactation:
As there is only minimal systemic absorption of aciclovir, adverse effects on the infant during lactation are unlikely.
4.7 Effects On Ability To Drive And Use Machines
Virasorb Cold Sore Cream is unlikely to impair a patient's ability to drive or to use machines.
4.8 Undesirable Effects
Transient burning and itching or stinging may occur after application of Virasorb Cold Sore Cream.
Occasionally erythema, dryness, pruritus and desquamation of cutaneous sites have been observed.
Rarely, contact dermatitis has been reported after administration of Virasorb Cold Sore Cream. Examination showed that in most cases the contact dermatitis was caused by one of the excipients rather than by the active ingredient aciclovir. The contact dermatitis is characterised by the occurrence of the cutaneous reactions as described above, with a widespread distribution.
There have been very rare reports of immediate hypersensitivity reactions including angioedema with topical aciclovir.
4.9 Overdose
As only about 0.1% of the aciclovir applied to the skin is detectable in the plasma, overdose is unlikely.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
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 Petrolatum, 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
24th March 2004
10. Date Of Revision Of The Text
21/11/06
11 DOSIMETRY (IF APPLICABLE)
Not Applicable
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS (IF APPLICABLE)
Not Applicable
No comments:
Post a Comment