Amorolfine Hydrochloride (Nail Lacquer)

This is indicated in onychomycosis caused by dermatophytes, yeasts and moulds.

Amorolfine is a topical antimycotic. It belongs to a new chemical class of Morpholine, Its fungistatic or fungicidal effect is based on an alteration of the fungal cell membrane targeted primarily on sterol biosynthesis. Amorolfine has a broad spectrum of action. Amorolfine is effective against Yeasts. Dermatophytes. Moulds, Dematiaceae and Dimorphic Fungi.

Amorolfine Nail Lacquer should be applied to the affected finger or toenails once or twice a week as directed by the doctor It is important to use Amorolfine until the infection has cleared and healthy nails have grown back usually takes 6 months for fingernails and 9 to 12 months for toenails.

Step 1: File the nail: First file down the infected areas of nail including the nail surface, as much as possible using the nail file provided. Do not use this all file on healthy nails, otherwise the infection will be spread out Discard the nail file after use.

Step 2: Clean the nail: Use one of the alcohol pads provided to clean the nail surface. Repeat steps 1 and 2 for each affected nail.

Step 3: Take some lacquer from the bottle: Use a nail brush to apply the nail lacquer. The lacquer must not be wiped off the edge of the bottle before it is applied. Do not use the brush on healthy nails and wash the brush with hot water after use

Step 4: Apply the lacquer: Apply the lacquer evenly over the entire surface of the nail. Repeat these steps for each affected nail. Let the treated nail(s) dry for approximately 3 minutes. Close the nail lacquer bottle tightly. Dispose of the alcohol pad.

• Before using the nail lacquer again, first remove the old lacquer from your nails using a swab, then file down the nails again if necessary.
• Re-apply the lacquer as previously described
• When dry, the nail lacquer is unaffected by soap and water. So you may wash your hands and feet as normal.

There are no known drug interactions.

Must not be reused by patients who have shown hypersensitivity to the treatment.

• Rare side-effects (occurring in less than 1 in 1000 people)- Nail may become discolored broken or brittle.
• Very rare side-effects (occurring in less than 1 in 10000 people)- A burning sensation or allergic skin reaction (contact dermatitis)
• Unknown frequency of occurrence-Skin redness, itching hives, blisters and allergic skin reaction (contact dermatitis).

No data available on the use of Amorolfine in pregnant women. There is no information on whether Amorolfine passes into human breast milk. There are no data on the use of Amorolfine in lactating women.

• Avoid the lacquer coming into contact with the eyes, ears or mucous membranes (eg. mouth and nostrils).
• Do not inhale
• Wear impermeable gloves when using organic solvents to stop the ball lacquer from being removed.

Other preparations

No information is available concerning over dosage in human.

Do not store above 30°C. Protect Clinell lacquer from heat. Keep the bottle tightly closed.