HEXOMEDINE TRANSCUTANEOUS 1,5 PER THOUSAND topical solution, bottle/45 mL

VIDAL
Medicines
Update of 30/12/2020

HEXOMEDINE^® transcutaneous
hexamidine

Forms and presentations

Solution at 1,5 ‰ for topical application:  Bottle of 45 ml.

Composition

	p bottle
Hexamidine (INN) diisethionate	67,50 mg

Excipients: propylene glycol, methylal, nonoxynol, ethyl alcohol at 96,5°, purified water.

Indications

Adjunctive treatment of skin conditions that are primarily bacterial or likely to become superinfected.

Dosage and administration

Cutaneous use.

Use undiluted 2 times daily as swabs or local baths.

In nail and periungual infections, transcutaneous Hexomedine may be used:

• either as a short-duration wet dressing (30 to 45 minutes),
  
• or as a bath for 1 to 3 minutes (the wide-neck bottle is intended for this use; in this case, the solution must neither be used for another antiseptic purpose, nor the bottle kept after use).
  

Rinsing after application is unnecessary.

Close the bottle tightly.

Duration of use after opening:

• 15 days if use is carried out under hygienic conditions (the product is placed on a sterile compress before application to the area to be treated).
  
• 5 days maximum, if the area to be treated is immersed in the bottle (local baths for a nail condition).
  

Contraindications

• Hypersensitivity to hexamidine or to the chemical class of diamidines, or to any of the components of the solution.
  
• This preparation must not be used for:
  
  • antisepsis before sampling (puncture and/or injection),
    
  • any invasive procedure requiring surgical-type antisepsis (lumbar puncture, central venous access, etc.),
    
  • the disinfection of medico-surgical equipment.
    

Do not use on mucous membranes or on open wounds.

Warnings and precautions

• Although transcutaneous absorption is very low, the risk of systemic effects cannot be ruled out. Systemic effects are all the more to be feared when the antiseptic is used over a large area, under an occlusive dressing, on damaged skin (in particular burned skin), a mucous membrane, or the skin of a premature infant or a newborn (due to the surface-area-to-weight ratio and the occlusive effect of nappies in the diaper area).
  
• As soon as the packaging of an antiseptic preparation is opened, microbial contamination is possible.
  
• Risk of sensitisation to hexamidine.
  
• This medicine contains propylene glycol and may cause skin irritation.
  

Interactions

Drug interactions
Given the possible interferences (antagonism, inactivation...), simultaneous or successive use of antiseptics should be avoided.

Fertility, pregnancy and breastfeeding

Use with caution in pregnant or breastfeeding women, due to a lack of usable clinical data.

Adverse effects

• This medicine may cause sensitisation.
  The frequency of sensitisation to hexamidine varies with the pharmaceutical form and the degree of epidermal alteration: the hydroalcoholic solution, frequently applied to eroded or damaged epidermis, is more often responsible than other pharmaceutical forms.
  Contact dermatitis to hexamidine presents certain features suggestive of an Arthus phenomenon and suggesting humoral immunological mechanisms.
  Its clinical appearance usually differs from classic contact eczema: the eruption is most often infiltrated, made up of isolated or grouped hemispherical papular or papulo-vesicular lesions. More numerous and coalescing at the site of application of the antiseptic, they spread as isolated elements. Regression is often slow.
  
• Mild manifestations of local intolerance may be encountered: tingling, itching, burning, dry skin. They only exceptionally lead to discontinuation of treatment.
  

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres. Website: www.signalement-sante.gouv.fr.

Pharmacodynamics

Pharmacotherapeutic class: Antiseptic (D: dermatology).

Hexamidine belongs to the diamidine family. It behaves as a cationic antibacterial agent and has surfactant properties.

Bactericidal and fungicidal activity against yeasts.

The bactericidal activity is not inhibited by a standard exudate that reproduces in vitro the conditions observed on contact with pus, serum and organic debris.

Pharmacokinetics

Transcutaneous absorption of hexamidine through healthy skin is very low.

STORAGE CONDITIONS

Store at a temperature not exceeding 25 °C.

After opening: 15 days after 1^re opening (5 days if used as local baths for a nail infection).

HANDLING/DISPOSAL INSTRUCTIONS

Close the bottle tightly after use.

Prescription, supply and reimbursement

Marketing authorisation (AMM)

3400930495674 (1955/96, SmPC rev 27.07.2018).

Not reimbursed by Social Security. Collect.

COOPER
Coopération Pharmaceutique Française
Place Lucien-Auvert. 77020 Melun cdx
Tel: 01 64 87 20 00