Aciclovir Cream 5% w / w (Pharmacia Limited)

1. Name Of The Medicinal Product

Aciclovir Cream 5% w/w

2. Qualitative And Quantitative Composition

5% w/w (50mg per g) Aciclovir Ph Eur.

3. Pharmaceutical Form

Cream

4. Clinical Particulars

4.1 Therapeutic Indications

Aciclovir Cream 5% w/w is indicated for the treatment of recurrent herpes labialis and herpes genitalis.

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 Aciclovir Cream 5% w/w is normally continued for five days. If the situation deteriorates or, if after ten days there is 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 Aciclovir Cream 5% w/w 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, dimethicone or propylene glycol.

4.4 Special Warnings And Precautions For Use

Aciclovir Cream 5% w/w should not be used on mucous membranes (e.g. oral cavity, eyes, vagina) since local reactions may occur.

Severely immunocompromised patients should consult their physician before starting treatment with Aciclovir Cream 5% w/w. For these patients, oral administration should be considered.

Because of possible infections of partners, patients with herpes genitalis should be advised to abstain from sexual contact if any lesions are visible.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interactions known.

4.6 Pregnancy And Lactation

Pregnancy:

Systemic administration of aciclovir in internationally accepted studies did not produce teratogenic effects in mice, rats or rabbits.

In one other study a teratogenic effect was seen, but only at high doses and the clinical relevance of these findings is uncertain.

No evidence of malformations was observed in a group of several hundred patients exposed to aciclovir during the first trimester of pregnancy.

No foetotoxic effect was observed after aciclovir administration during the second and third trimesters of 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.

Consequently, topical administration of aciclovir for the specified indications is acceptable.

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

Aciclovir Cream 5% w/w is unlikely to impair a patient´s ability to drive or to use machines.

4.8 Undesirable Effects

Transient burning and itching may occur after application of Aciclovir Cream 5% w/w.

Occasionally erythema, dryness, pruritus and desquamation of cutaneous sites have been observed.

Rarely, contact dermatitis has been reported after administration of Aciclovir Cream 5% w/w. 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 characterized by the occurrence of the cutaneous reactions as described above, with a widespread distribution.

4.9 Overdose

As only 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

Glycerin monostearate/polyoxyethylen-30-stearate (Arlatone 983S), Dimeticone Ph Eur, Cetyl Alcohol Ph Eur, Liquid Paraffin Ph Eur, White Soft Paraffin USP/DAB10, Propylene Glycol Ph Eur, Purified Water Ph Eur.

6.2 Incompatibilities

None.

6.3 Shelf Life

The proposed shelf life is thirty six months.

6.4 Special Precautions For Storage

Store below 25°C. Do not refrigerate.

6.5 Nature And Contents Of Container

Aluminium tube containing 2*, 5, 10* or 15g of Aciclovir Cream 5% w/w.

One tube is packed in a carton together with a patient information leaflet.

*These tubes only are available in the UK.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

TAD Pharma GmbH

Heinz-Lohmann-Strasse 5

27472 Cuxhaven

Germany

Tel: +49 (0)4721/606-0

Fax: +49 (0)4721/606-333

8. Marketing Authorisation Number(S)

United Kingdom: PL 04986/0008

9. Date Of First Authorisation/Renewal Of The Authorisation

21 November 1996

10. Date Of Revision Of The Text

November 1999

LEGAL CATEGORY

POM.