Ipadine 2% Forte

/ Floris

For dermal use. The amount of solution to use will depend on the type of invasive medical procedure being performed and the preference of the clinician.

To be use in subjects aged 2 months and above for the disinfection of the skin prior to invasive medical procedures to help reduce bacteria that can potentially cause skin infection.

Known hypersensitivity to chlorhexidine, isopropanol or any other ingredients, especially in those with a history of possible chlorhexidine related allergic reactions.

For external use only on intact skin.
The solution is flammable. Do not use electrocautery procedures or other ignition sources until the skin is completely dry.
Remove any soaked materials, drapes or gowns before proceeding with the intervention. Do not use excessive quantities and do not allow the solution to pool in skin folds or under the patient or drip on sheets or other material in direct contact with the patient. Where occlusive dressings are to be applied to areas previously exposed to Ipadine 2% Forte, care must be taken to ensure no excess product is present prior to application of the dressing.
Begin draping and/or using electrocautery only after solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair) and all wet materials are removed.
Keep out of eyes, ears and mouth. The solution may cause serious or permanent injury if it comes into contact with these areas. If contact occurs, rinse immediately and thoroughly with cold water.
The use of chlorhexidine solutions, both alcohol based and aqueous, for skin antisepsis prior to invasive procedures has been associated with chemical burns in neonates. Based on available case reports and the published literature, this risk appears to be higher in preterm infants, especially those born before 32 weeks of gestation and within the first 2 weeks of life. As the development of the epidermal barrier is a continuous process beyond the first months of life, Ipadine 2% Forte is not recommended in the age group less than 1 year old.
Do not use for lumbar puncture or in contact with the meninges. In addition, direct contact with neural tissue or the middle ear must be avoided.
Do not use on open skin wounds, broken or damaged skin or as a general skin cleaner. Please refer to the license holder for further details.

Common: application site rash, application site erythema, application site vesicles, application site pain and application site pruritus.
See prescribing information for full details.

The product is applied topically and the expected systemic activity is very low. No studies were performed to investigate its pharmacologic effects when used concomitantly with other medications.

There are no studies with this product in pregnant or lactating women.
Pregnancy: No effects during pregnancy are anticipated since systemic exposure to chlorhexidine gluconate and isopropanol is negligible. It may be used during pregnancy.
Lactation: No effects on the breastfed newborn / infant are anticipated since the systemic exposure of the breast-feeding woman to chlorhexidine gluconate and isopropanol is negligible. The product may be used during breast-feeding.
Fertility: The effects of chlorhexidine gluconate on human reproduction have not been studied. No effects on fertility are anticipated since systemic exposure to isopropanol is negligible.

This product is indicated for use as a preoperative surgical skin preparation and will be administered in a controlled environment by qualified personnel. In addition, the product is administered to a localised body region and is not absorbed through the skin in any significant amounts. Therefore, the potential for an overdose with this product is low.

After the initial opening of the bottle, it may be used for a period of 3 months, but no later than the expiry date of the preparation. Special precautions for storage
Store below 25°C in the original package to protect from light.
Keep away from fire.
Do not light a cigarette or expose yourself to an open flame until the product has completely dried.