amorolfine cream

Action and Spectrum

Actions and Spectrum  

Actions: 

• Inhibition of Ergosterol Synthesis: Amorolfine inhibits the enzyme squalene epoxidase, which is involved in synthesizing ergosterol, a key component of fungal cell membranes. Amorolfine weakens the cell membrane’s integrity by disrupting ergosterol synthesis, leading to cell leakage and cell death. 
• Antifungal Activity: Amorolfine has broad-spectrum antifungal activity against various fungi, including dermatophytes (e.g., Trichophyton, Microsporum), yeasts (e.g., Candida), and molds. It is effective against both superficial and deep-seated fungal infections. 

Spectrum: 

• Dermatophytes: These fungi commonly cause nail and skin infections, including athlete’s foot and nail. 
• Yeasts: Amorolfine is effective against some yeast species, such as Candida, which can cause various types of infections, including oral thrush and vaginal yeast infections. 
• Molds: While amorolfine is not the first-line treatment for mold infections, it may have some activity against certain mold species. 

Drug Interaction

Adverse Reaction

 None reported 

Black Box Warning

Black Box Warning: 

None 

Contraindication / Caution

Contraindication/Caution: 

Contraindications: 

• Known allergy 

Cautions: 

• Pregnancy  
• Breastfeeding 
• Children 
• Skin sensitivity 
• Drug interactions 
• Contact with eye membranes 

Pregnancy / Lactation

Pregnancy consideration:  

Not indicated during pregnancy. 

Breastfeeding warnings:  

The excretion of the drug in breast milk is unknown.  

Pregnancy category: 

Category A: well-controlled and satisfactory studies show no risk to the fetus in the first or later trimester. 

<b>Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: No data is available for the drug under this category. 

Pharmacology

Pharmacology:  

amorolfine belongs to the class of drugs known as allylamines. Its antifungal activity is attributed to its ability to inhibit squalene epoxidase, a key enzyme in synthesizing ergosterol, an essential component of fungal cell membranes. amorolfine weakens the fungal cell membrane by disrupting ergosterol synthesis, leading to cell death and eliminating the fungal infection. 

Antioxidant Activity: Some catechins, particularly epigallocatechin gallate (EGCG), have antioxidant properties. Antioxidants can help reduce cell oxidative stress, which is relevant to HPV-infected tissue. 

Pharmacodynamics: amorolfine binds to the enzyme squalene epoxidase, which is involved in ergosterol biosynthesis. This binding prevents the conversion of squalene to lanosterol, a critical step in ergosterol synthesis. As a result, ergosterol levels in the fungal cell membrane decrease, compromising its integrity. 

• Fungal Cell Damage: 

The disruption of ergosterol synthesis leads to increased membrane permeability and decreased membrane fluidity. This, in turn, causes cellular contents and ions to leak, disrupting essential cellular processes. The fungal cell becomes more susceptible to external stressors, resulting in cell death. 

Pharmacokinetics: 

Absorption 

When applied to the nails, amorolfine can penetrate the nail plate and reach the nail bed and surrounding skin. However, systemic absorption is limited. 

Distribution 

Distribution of amorolfine is primarily confined to the treated nails and the immediate surrounding area. It does not extensively distribute throughout the body. 

Metabolism 

Information regarding the metabolism of amorolfine is limited, but it’s expected that any absorbed amorolfine may undergo metabolic processes similar to other topical agents. 

Elimination and Excretion 

Any absorbed amorolfine is likely eliminated from the body through various routes, including metabolism in the liver and excretion through urine and bile. 

Adminstartion

Administration: 

• Clean the Area: Wash and gently dry the affected area before applying the cream. Make sure the area is clean and free from any residue. 
• Apply a Thin Layer: Take a small amount of the cream and apply a thin layer to the affected skin. Use a gentle, even motion to spread the cream over the area. 
• Massage Gently: Gently massage the cream into the skin until it’s absorbed. Be sure to cover the entire affected area. 
• Frequency of Application: Follow the instructions provided by your healthcare professional or the product label for the recommended frequency of application. This could range from once a day to several times a day. 
• Wash Hands: After applying the cream, wash your hands thoroughly to prevent accidentally transferring the cream to other areas. 
• Avoid Contact with Eyes and Mouth: Avoid getting the cream in your eyes, mouth, or other mucous membranes. If accidental contact occurs, rinse with water. 
• Follow Complete Course: Using the cream consistently throughout the treatment course is essential, even if you start to see improvement. Complete the entire treatment course as recommended. 
• Consult a Healthcare Professional: If you have any questions or concerns or experience adverse reactions while using amorolfine cream, consult a healthcare professional or pharmacist for guidance. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: amorolfine cream 

Pronounced as: am-o-rol-fin 

Why do we use amorolfine cream? 

amorolfine is primarily used to treat fungal infections of the nails caused by various fungal species, including dermatophytes, yeasts, and molds. Fungal nail infections can lead to discoloration, thickening, brittleness, and deformation of the nails. Applying amorolfine directly to the nails can penetrate the nail plate and reach the nail bed to target and eliminate the fungal infection.