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Transcutaneous Hexomedine solution is an antiseptic that contains 0.015% hexamidine. This disinfectant is recommended for the antisepsis of small superficial wounds and local treatment of a possible secondary infection of the skin.
How to use Transcutaneous Hexomedine?
Transcutaneous hexomedine can be used pure twice a day in brushing or local baths.
For care concerning the nail or its periphery ( panaris ), there are 2 possibilities:
- By soaking a compress to make a moist dressing that will be left in place for 30 to 45 minutes. There is no need to rinse. In this case, the bottle will keep for 15 days after opening.
- By dipping your finger directly into the bottle for 1 to 3 minutes. Again, it is not necessary to rinse the product. The bottle, however, should not be used for any other purpose and should be discarded after a maximum of 5 days.
Composition of transcutaneous Hexomedine
Hexamidine diisetionate ... 0.15g.
Excipients: propylene glycol, methylal, nonoxynol, ethyl alcohol at 96.5°, purified water for 100 ml.
Precautions for use of transcutaneous Hexomedine
This medication should be used with caution and on medical advice during pregnancy or breastfeeding.
Transcutaneous hexomedine should not be used for antisepsis of healthy skin before sampling or injection. This antiseptic cannot be used for the disinfection of equipment.
Transcutaneous hexomedine should not be applied to a large surface, a wound, a mucous membrane, a burn, on the skin of an infant or premature baby or under an occlusive dressing: risk of passage into the general circulation.
This disinfectant should not be used simultaneously with other antiseptics.
Transcutaneous hexomedine is contraindicated in case of allergy to one of its constituents including excipients (propylene glycol, methylal, nonoxynol, ethyl alcohol at 96.5°, purified water). Its application can cause skin irritation.
In case of paronychia, after disinfecting, you can apply a pure drop of tea tree essential oil as a natural "antibiotic".
Capacity : 45ml
Please read the following full disclosure
PRODUCT CHARACTERISTICS SUMMARY
ANSM - Updated on: 27/07/2018
- NAME OF THE MEDICINE
HEXOMEDINE TRANSCUTANEOUS 1.5 PER THOUSAND, solution for local application
- QUALITATIVE AND QUANTITATIVE COMPOSITION
Di-iodohexamidine isethionate ............................................................................................................... 0.150 g
For 100 ml of solution for local application.
For the full list of excipients, see section 6.1.
- PHARMACEUTICAL FORM
Solution for local application.
- CLINICAL DATA
4.1. Therapeutic indications
Adjunctive treatment of skin disorders primarily bacterial or likely to become superinfected.
Note:
Antiseptic agents are not sterilizing. They temporarily reduce the number of microorganisms.
4.2. Dosage and method of administration
CUTANEOUS ROUTE.
Use pure twice a day in dressings or local baths.
In nail and perinail infections, Transcutaneous Hexomedine can be used:
· Either in a short-term wet dressing (30 to 45 minutes)
· Or in a 1 to 3 minute bath (The bottle with a wide neck is intended for this use. In this case, neither use the solution for another antiseptic use, nor keep the bottle after use).
Rinsing after application is unnecessary.
Close the bottle tightly.
Duration of use after opening:
15 days if used under hygienic conditions (the product is deposited on a sterile compress before application to the area to be treated).
A maximum of 5 days, if the area to be treated is immersed in the bottle (local baths for a nail disorder).
4.3. Contraindications
· Hypersensitivity to hexamidine, to the chemical class of diamidines, or to any of the components of the solution.
· This preparation should not be used:
o For antisepsis before sampling (puncture and injection).
o For any invasive procedure requiring surgical type antisepsis (lumbar puncture, central venous route etc.).
o For disinfection of medical-surgical equipment.
Do not use on mucous membranes and open wounds.
4.4. Special warnings and precautions for use
Special warnings
Although transcutaneous absorption is very low, the risk of systemic effects cannot be excluded.
Systemic effects are all the more to be feared as the antiseptic is used over a large area, under occlusive dressing, on damaged skin (especially burned), a mucous membrane, a premature or infant skin (due to the surface/weight ratio and the occlusion effect of diapers at the buttock level).
Upon opening the packaging of an antiseptic preparation, microbial contamination is possible.
Risk of sensitization to hexamidine.
This medicine contains propylene glycol and can cause skin irritation.
4.5. Interactions with other medicines and other forms of interaction
Given the possible interferences (antagonism, inactivation), the simultaneous or successive use of antiseptics should be avoided.
4.6. Pregnancy and breastfeeding
Use with caution in pregnant or breastfeeding women, due to lack of exploitable clinical data.
4.7. Effects on ability to drive and use machines
Not applicable.
4.8. Adverse effects
This medicine may cause sensitization.
The frequency of sensitization to hexamidine varies with the galenic form and the degree of epidermal alteration: the hydro-alcoholic solution, frequently applied on eroded or damaged epidermis, is more often responsible than the other galenic forms.
Hexamidine contact dermatitis has certain particularities reminiscent of an Arthus phenomenon and suggesting humoral mechanisms.
Its clinical aspect usually differs from the classic contact eczema: the rash is most often infiltrated, made up of isolated or grouped papular or papulo-vesicular hemispheric lesions. More numerous and coalescing at the point of application of the antiseptic, they diffuse into isolated elements. Regression is often slow.
Local intolerance manifestations may be encountered: tingling sensation, itching, burning, skin dryness. They only exceptionally lead to the discontinuation of treatment.
4.9. Overdose
Not applicable.
- PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic class:
ANTISEPTIC
(D. Dermatology)
Hexamidine belongs to the family of diamidines.
It behaves as a cationic antibacterial agent and has surfactant properties.
Bactericidal and fungicidal antiseptic activity on yeasts.
The bactericidal activity is not inhibited by a standard exudate that reproduces, in vitro, the conditions observed when in contact with pus, serum, organic debris.
5.2. Pharmacokinetic properties
The transcutaneous absorption of hexamidine by healthy skin is very low.
5.3. Preclinical safety data
Not reported.
- PHARMACEUTICAL DATA
6.1. List of excipients
Propylene glycol, methylal, nonoxynol, ethyl alcohol at 96.5°, purified water.
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
Before opening: 2 years.
15 days after 1st opening (5 days in case of use in local baths for a nail infection).
6.4. Special storage precautions
Store at a temperature not exceeding 25°C.
6.5. Nature and content of outer packaging
45 ml bottle (glass) with cap (PE).
6.6. Special precautions for disposal and handling
Close the bottle tightly after use.
- MARKETING AUTHORISATION HOLDER
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
- NUMBER(S) OF MARKETING AUTHORISATION
· 304 956-7: 45 ml in bottle (glass).
- DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
[to be completed by the holder]
- DATE OF REVISION OF THE TEXT
[to be completed by the holder]
- DOSIMETRY
Not applicable.
- INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
PRESCRIPTION AND SUPPLY CONDITIONS
Medicine not subject to medical prescription.
