Aciclovir 5% w/w Cream
Pinewood Healthcare Contact details
1. Name of the medicinal product
Aciclovir 5% w/w Cream

2. Qualitative and quantitative composition
Aciclovir 50 mg/g.

For full list of excipients, see section 6.1.

3. Pharmaceutical form
Cream.

White to off-white cream.

4. Clinical particulars
4.1 Therapeutic indications
For the treatment of herpes simplex virus infections of the lips and face (Herpes labialis).

4.2 Posology and method of administration
Adults and children

Treatment should be initiated as soon as possible after the start of the infection, ideally during the prodromal period or when lesions first appear.

A thin film of cream should be applied to the infected area and immediately adjacent skin areas 5 times daily at 4-hour intervals during the day.

Treatment should be continued for 5 days, followed by a further 5 days treatment if healing has not occurred.

Patients should wash their hands before and after applying the cream and avoid unnecessary rubbing of the lesions or touching with a towel, to avoid aggravating or transferring the infection.

Elderly

No special requirement

4.3 Contraindications
Hypersensitivity to aciclovir, valaciclovir, propylene glycol or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use
Only recommended for use on cold sores on the lips and face.

People with particularly severe Herpes labialis should be encouraged to seek medical advice.

Not to be applied to mucous membranes such as inside the mouth or vagina, or on the eye. Particular care should be taken to avoid contact with the eye.

Not for use for the treatment of genital herpes or ocular herpes infections.

Not recommended for use by patients who know they are immunocompromised e.g. by HIV infection, bone marrow transplant or cancer treatment, except on the advice of a doctor.

Cold sore sufferers should be advised to avoid transmitting the virus, particularly when active lesions are present.

The excipient propylene glycol can cause skin irritations and the excipient cetyl alcohol can cause local skin reactions (e.g. contact dermatitis).

4.5 Interaction with other medicinal products and other forms of interaction
Probenecid increases the mean half-life and area under the plasma concentration curve of systemically administered Aciclovir. Other drugs affecting renal physiology could potentially influence the pharmacokinetics of Aciclovir. However this is likely to be of little relevance to the cutaneous application of Aciclovir.

No interactions with other drugs have been described for topical Aciclovir.

4.6 Fertility, pregnancy and lactation
Pregnancy

No specific studies of topical Aciclovir have been carried out in pregnant women or nursing mothers.

So far, no relevant plasma levels have been measured and no systemic effects have been observed.

However, use of the cream should be considered only when the potential benefit outweighs the possibility of unknown risks.

In internationally accepted standard tests the systemic administration of Aciclovir did not produce embryotoxic or teratogenic effects in rabbits, rats or mice.

Foetal abnormalities were observed in non-standard tests in rats, but only following such high subcutaneous doses that maternal toxicity was produced. The clinical relevance of these findings is uncertain.