1. Name Of The Medicinal Product
Icthaband.
2. Qualitative And Quantitative Composition
Zinc Oxide BP 15% w/w; Ichthammol BP 2% w/w.
3. Pharmaceutical Form
Open wove bleached cotton bandage impregnated with the paste formulation.
4. Clinical Particulars
4.1 Therapeutic Indications
Icthaband may be used for the following conditions: subacute eczematous conditions; chronic eczema, where tar is not tolerated; subacute gravitational eczema and all other forms of leg eczema; varicose and gravitational ulcers, in conjunction with a compression bandage, when a protective barrier to thin and fragile skin is required.
4.2 Posology And Method Of Administration
For topical use. Adults, the elderly, and children: Frequency of dressing changes is at the discretion of the responsible physician. There are no differences in use between adults, children and the elderly.
4.3 Contraindications
Hypersensitivity to any ingredient of the paste, and acute eczematous lesions.
4.4 Special Warnings And Precautions For Use
Avoid use on grossly macerated skin. The skin of leg ulcers is easily sensitised to topical medicaments including preservatives. Sensitisation should be suspected in patients particularly where there is deterioration of the ulcer or surrounding skin. Such patients should be referred for special diagnosis including patch testing. One of the functions of occlusive bandages is to increase absorption. Care should be taken, therefore, if it is decided to apply topical steroid preparations under these bandages as their absorption may be significantly increased.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None stated.
4.6 Pregnancy And Lactation
No special precautions required.
4.7 Effects On Ability To Drive And Use Machines
Not applicable.
4.8 Undesirable Effects
Not applicable.
4.9 Overdose
Not applicable.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
The product is a paste bandage with the active constituent presented in a glycerine, modified starch and castor oil based paste spread onto a cotton bandage. Zinc Oxide as a zinc salt has astringent properties and has been shown to play a role in wound healing. Ichthammol has an antipruritic action and has slight bacteriostatic properties. These substances are well established in use, but only the subject of brief references in recent literature and pharmacopoeias (e.g. Martindale). Much of the therapeutic action of paste bandages is attributable to the bandaging technique, the physical support and protection provided and to the maintenance of moist wound healing conditions.
5.2 Pharmacokinetic Properties
The pharmacokinetics of the active ingredient are those relevant to topical application of the substances through whole or broken skin. Contemporary literature describes the biochemical properties but with the exception of the zinc salts does directly relate these properties to the disease states being treated. Zinc compounds are the subject of current re-appraisal for their role in wound healing.
5.3 Preclinical Safety Data
None stated.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Glycerol
Castor oil
Tapioca starch
Citric acid
Propylhydroxybenzoate
Water purified
Open weaved cotton bandage
6.2 Incompatibilities
None stated.
6.3 Shelf Life
Thirty months.
6.4 Special Precautions For Storage
Store in a dry place not exceeding 25oC.
6.5 Nature And Contents Of Container
Bandages are wrapped individually in waxed paper or polythene film and then placed in a nylon/foil/polythene laminate bag in a cardboard carton, or a sealed polythene bag in a cardboard carton. 12 cartons are packed per corrugated cardboard outer.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
Medlock Medical Ltd., Tubiton House, Oldham, OL1 3HS.
8. Marketing Authorisation Number(S)
PL 21248/0018
9. Date Of First Authorisation/Renewal Of The Authorisation
29th June 2007.
10. Date Of Revision Of The Text
29th June 2007.
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