Dosage/Direction for Use
Topical/Cutaneous Onychomycosis Adult: For cases caused by dermatophytes, yeasts, and moulds: As 5% medicated nail lacquer: Apply evenly onto the entire surface of the affected nail(s) once or twice weekly after filing and cleansing with the provided nail file and cleansing pads. Continue treatment until the nail has regenerated and the affected areas are cured. Therapy evaluation is recommended every 3 months. Treatment duration: Approx 6 months (fingernails); 9-12 months (toenails). Topical/Cutaneous Dermatomycoses Adult: For cases caused by dermatophytes: As 0.25% cream: Apply onto the affected area(s) once daily, preferrably in the evening. Continue treatment for 3-5 days after clinical cure is achieved. Treatment duration: 2-3 weeks (up to 6 weeks for foot mycoses). |
Contraindications
Hypersensitivity.
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Special Precautions
Pregnancy and lactation. Patient Counselling Avoid contact with the eyes, ears, and mucous membranes. Medicated nail lacquer: Avoid contact with the surrounding skin around the nails. Nail files used for affected nails should not be used for healthy nails. Avoid use of artificial nails during treatment. Wear impermeable gloves when working with organic solvents (e.g. thinners, white spirits).
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Adverse Reactions
Significant: Systemic or local hypersensitivity reaction, including contact dermatitis.
Skin and subcutaneous tissue disorders: Erythema, pruritus, urticaria, blister. Rarely, skin irritation; nail disorder or discolouration, onychoclasis, onychorrhexis, burning senation of skin around the nail.
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Action
Amorolfine is a broad spectrum morpholine derivative topical antimycotic agent. It alters the fungal cell membrane by interfering with sterol biosynthesis, resulting in the reduction of ergosterol and the accumulation of unusual sterically nonplanar sterols.
Absorption: Minimal systemic absorption. Distribution: Penetrates and diffuses through the nail plate. |
Storage
Topical/Cutaneous: Medicated nail lacquer: Store below 30°C. Protect from heat. Cream: Store below 25°C.
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CIMS Class
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ATC Classification
D01AE16 - amorolfine ; Belongs to the class of other antifungals for topical use.
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