Amorolfine: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Indonesia prescribing information.

Generic Medicine Info

Indications and Dosage

Topical/Cutaneous
Dermatomycoses

Adult: For cases caused by dermatophytes: As 0.25% cream: Apply onto the affected area(s) once daily, preferably 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).

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).

Contraindications

Hypersensitivity.

Special Precautions

Pregnancy and lactation.

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.

Patient Counseling Information

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).

Action

Description:
Mechanism of 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.
Pharmacokinetics:
Absorption: Minimal systemic absorption.
Distribution: Penetrates and diffuses through the nail plate.

Chemical Structure

Storage

Medicated nail lacquer: Store below 30°C. Protect from heat. Cream: Store below 25°C.

MIMS Class

Topical Antifungals & Antiparasites

ATC Classification

D01AE16 - amorolfine ; Belongs to the class of other antifungals for topical use.

References

Anon. Amorolfine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/04/2022.

Buckingham R (ed). Amorolfine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/04/2022.

Healthcare Logistics. Loceryl Nail Lacquer 5% data sheet 30 May 2019. Medsafe. http://www.medsafe.govt.nz. Accessed 01/04/2022.

Joint Formulary Committee. Amorolfine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/04/2022.

Loceryl 0.25% w/w Cream (Galderma [UK] Limited). MHRA. https://products.mhra.gov.uk. Accessed 01/04/2022.

Loceryl 5% w/v Medicated Nail Lacquer (Galderma [UK] Limited). MHRA. https://products.mhra.gov.uk. Accessed 01/04/2022.

Mycofine 5% w/v Nail Lacquer (Pahang Pharmacy Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 01/04/2022.

Disclaimer: This information is independently developed by MIMS based on Amorolfine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com