Herpid

1. Name Of The Medicinal Product

Herpid.

2. Qualitative And Quantitative Composition

A clear, colourless solution containing idoxuridine BP 5% in dimethyl sulfoxide.

3. Pharmaceutical Form

Topical Solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Cutaneous herpes simplex and herpes zoster (shingles).

4.2 Posology And Method Of Administration

Administration: Herpid should be painted on the lesions and their erythematous bases four times daily for four days.

Adults and children over 12 years:

Treatment should start as soon as the condition has been diagnosed, ideally within two or three days after the rash appears. Good results are less likely if treatment is not started within seven days.

Children under 12 years:

The use of Herpid in children with malignant disease might be justified but, although not a contra-indication, its use in children under the age of 12 years is not recommended.

No specific information on the use of this product in the elderly is available. Clinical trials have included patients over 65 years and no adverse reactions specific to this age group have been reported.

4.3 Contraindications

Known hypersensitivity to either idoxuridine or dimethyl sulfoxide.

Dermographia.

4.4 Special Warnings And Precautions For Use

Herpid in the eye causes stinging: treat by washing out with water. The dimethyl sulfoxide in Herpid may be irritant to the skin.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Since the solvent in Herpid can increase the absorption of many substances it is important that no other topical medication be used on the same areas of skin treated with Herpid.

4.6 Pregnancy And Lactation

Animal studies have shown idoxuridine to be teratogenic. Consequently, Herpid should not be prescribed for women who are pregnant or at risk of becoming pregnant. In a small number of cases of women who used Herpid inadvertently in early pregnancy and who were followed to term, the infant was normal in each case.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Patients often experience stinging when applying Herpid and a distinctive taste during a course of treatment; both effects are transient.

Skin reactions have occasionally been reported.

Over-usage of the solution may lead to maceration of the skin.

4.9 Overdose

There is no clinical evidence of overdosage. Standard supportive measures should be adopted.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Idoxuridine is an antiviral agent which acts by blocking the uptake of thymidine into the deoxyribonucleic acid (DNA) of the virus and inhibits replication of viruses such as adenovirus, cytomegalovirus, herpes simplex (herpes virus hominus), varicella zoster or herpes zoster (herpes virus varicella) and vaccinia. It has no action against latent forms of the virus. It does not inhibit RNA viruses such as influenza virus or poliovirus.

5.2 Pharmacokinetic Properties

The idoxuridine is dissolved in dimethyl sulfoxide which penetrates the skin and carries the antiviral agent to the deeper levels of the epidermis where the virus is replicating.

Idoxuridine is rapidly metabolised in the body to iodouracil, uracil and iodine which are rapidly excreted in the urine.

5.3 Preclinical Safety Data

6. Pharmaceutical Particulars

6.1 List Of Excipients

Dimethyl sulfoxide.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

2 years.

6.4 Special Precautions For Storage

Herpid should be stored in its box below 25°C. Do not refrigerate as the contents of the bottle may solidify. If crystals do form, allow to re-dissolve before use by warming the bottle gently (in the palm of the hand) until the solution is clear. Because the solution is hygroscopic, any remaining after completion of treatment should be discarded.

6.5 Nature And Contents Of Container

5 ml bottle with brush (OP):

Bottle: Type III amber glass

Cap liner: high density natural polyethylene

Brush stem: low density natural polyethylene

6.6 Special Precautions For Disposal And Other Handling

Instructions for use:

1) Carefully unscrew the white cap and discard.

Replace it with the black cap and brush.

2) Apply the liquid sparingly with the brush 4 times a day to the affected area of skin.

It is important to treat only the affected areas.

3) Wash your hands thoroughly after using Herpid.

4) Do not continue a course of treatment on one area of the skin for more than four days.

5) Discard any solution remaining in the bottle as soon as the treatment period is complete.

Herpid can damage some synthetic materials (e.g. artificial silk and Terylene) and printed cotton fabrics. Contact between Herpid and these materials should therefore be avoided.

7. Marketing Authorisation Holder

Astellas Pharma Ltd

Lovett House

Lovett Road

Staines

TW18 3AZ

United Kingdom

8. Marketing Authorisation Number(S)

PL 00166/0177

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation 13.03.74

Date of latest renewal 15^th March 2007

10. Date Of Revision Of The Text

30 January 2008

11. LEGAL CATEGORY

POM