Oflomil Derma (Cream) Instructions for Use

Marketing Authorization Holder

Glenmark Pharmaceuticals, Ltd. (India)

ATC Code

D01AE16 (Amorolfine)

Active Substance

Amorolfine (Rec.INN registered by WHO)

Dosage Form

Oflomil Derma

External use cream 0.25%

Dosage Form, Packaging, and Composition

Cream for external use

15 g – tubes – cardboard packs – Over-the-Counter
30 g – tubes – cardboard packs – Over-the-Counter

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agents used in dermatology; external antifungal agents; other external antifungal agents

Pharmacological Action

Antifungal agent for external use. It has fungistatic and fungicidal action.

It damages the fungal cell membrane, mainly by disrupting sterol synthesis. It reduces ergosterol content and causes the accumulation of abnormal non-planar sterol stereoisomers.

It is active against yeast fungi of the genus Candida spp., Pityrosporum spp., Malassezia spp., Cryptococcus spp., dermatophytes (Trichophyton spp., Microsporum spp., Epidermophyton spp.), molds (Alternaria, Hendersonula, Scopulariopsis), Dematiaceae fungi (Cladosporium, Fonsecaea, Wangiella), dimorphic fungi (Coccidioides, Histoplasma spp., Sporothrix) and actinomycetes.

Pharmacokinetics

When applied externally in appropriate dosage forms, systemic absorption is negligible.

Indications

• Treat onychomycosis caused by dermatophytes, yeasts, and molds. Use only when no more than 2/3 of the nail plate is affected.
• Apply for the prevention of fungal nail infections in patients with a history of such conditions or who are at high risk.

ICD codes

Dosage Regimen

Apply the cream once or twice daily to the affected skin areas and the surrounding skin. The duration of treatment depends on the indication and the severity of the infection.

For skin mycoses, treatment typically continues for several weeks until clinical cure. For onychomycosis, apply to the affected nail and surrounding skin; treatment is long-term and continues until the nail has completely regrown and is clinically healthy.

Ensure the affected area is clean and dry before each application. Wash hands thoroughly before and after use.

Adverse Reactions

Adverse reactions are typically local and mild in nature. The most commonly reported reactions include a burning sensation, erythema (redness), and pruritus (itching) at the application site.

In rare instances, local skin irritation, peeling, or contact dermatitis may occur. Discontinuation of therapy is usually sufficient if these reactions become troublesome. Systemic absorption is negligible; therefore, systemic adverse effects are not expected.

Contraindications

• Do not use in patients with a known hypersensitivity to amorolfine, any other morpholine derivatives, or to any of the excipients in the cream formulation.
• Contraindicated during pregnancy due to the lack of sufficient safety data. Avoid use in lactating women unless the potential benefit justifies the potential risk to the infant.
• Do not administer to neonates and infants in the early childhood period. The safety and efficacy in this pediatric population have not been established.

Use in Pregnancy and Lactation

Contraindicated: pregnancy, lactation period.

Pediatric Use

Contraindicated: neonatal period and early childhood.

Special Precautions

During treatment, it is not recommended to use cosmetic nail polish or artificial nails.

When working with organic solvents, impermeable gloves should be worn.

Nail files used to treat affected nails should not be used on healthy nails.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.