Anthisan(tm) Cream

Name of Medicine

Mepyramine maleate 2.0% w/w

Presentation

Cream

Uses

Actions

Mepyramine maleate is an antihistamine with antipruritic and local analgesic actions.

Pharmacokinetics

No pharmacokinetic data are available by any route of administration.

Indications

Symptomatic relief in insect stings and bites and nettle rash.

Dosage and Administration

Adults, Elderly and Children

Anthisan cream should be applied directly to the affected areas two or three times a day for up to three days. Early application is essential to obtain the optimum response.

Contraindications

Anthisan Cream should not be used in eczematous conditions or on extensively broken skin surfaces.

Warnings and Precautions

Repeated application of Anthisan Cream for periods longer than a few days is not recommended and treatment should be discontinued immediately if skin sensitisation occurs.

Pregnancy and Lactation

There is no evidence of the safety of mepyramine maleate in human pregnancy, but it has been widely used for many years without apparent ill consequence. Absorption of a significant amount after topical application is unlikely in the prescribed method of use, nevertheless, Anthisan Cream should not be used during pregnancy or lactation, unless considered essential.

Effects on Ability to Drive and Use Machines

May theoretically be extensively absorbed through the skin when applied over large areas and cause somnolence and mild disorientation.

Adverse Effects

Skin sensitisation has been reported on rare occasions.

Interactions

No significant interactions described.

Overdosage

A 25g tube of Anthisan Cream contains 500mg mepyramine maleate. If accidentally ingested this dose would constitute a dangerous overdose in young children. The chief symptom of overdosage is unconsciousness and there may be convulsions in the intervening periods. The stomach should be washed out. Stimuli liable to provoke convulsions should be avoided, but if this complication should occur, parenteral Diazepam should be given; sedatives which are liable to increase respiratory depression should be avoided. Other measures such as artificial respiration and oxygen may also be required and an antibiotic can be given as a prophylactic against pneumonia.

Pharmaceutical Precautions Instructions for Use/Handling

None

Incompatibilities

None

Shelf Life

Three years.

Special Precautions for Storage

Store below 25degC.

Medicine Classification

Pharmacy only medicine.

Package Quantities

One collapsible aluminium tube with extended nozzle and polythene cap containing 25g cream.

Further Information

The medicine also contains the following excipients: Castor oil Methyl hydroxybenzoate Ceto-stearyl alcohol Polyethylene glycol 600 monostearate Foin coupe Silicon antifoam Purified water

Name and Address

sanofi-aventis new zealand limited Level 8, James and Wells Tower 56 Cawley Street Ellerslie Auckland New Zealand Tel: (09) 580 1810

Date of Preparation

03 July 2007