Efinagud (Solution) Instructions for Use

Marketing Authorization Holder

Dr. Reddy’s Laboratories Ltd. (India)

Manufactured By

Encube Ethicals, Pvt. Ltd. (India)

ATC Code

D01AC19 (Efinaconazole)

Active Substance

Efinaconazole (Rec.INN registered by WHO)

Dosage Form

Efinagud

Solution for external use 100 mg/1 g: fl. 4 ml or 8 ml

Dosage Form, Packaging, and Composition

Solution for external use

4 ml – bottles – cardboard packs – By prescription
8 ml – bottles – cardboard packs – By prescription

Pharmacotherapeutic Group

Antifungal agents used in dermatology; external antifungal agents; imidazole and triazole derivatives

Pharmacological Action

Antifungal agent of the azole group. Efinaconazole inhibits lanosterol 14α-demethylase, which is involved in the biosynthesis of ergosterol, a component of the fungal cell membrane.

Efinaconazole is active against isolates of the following microorganisms both in vitro and in clinical practice. The minimum inhibitory concentrations (MIC) of efinaconazole are 0.06 µg/ml or less for the majority (≥ 90%) of isolates of the following microorganisms: Trichophyton rubrum, Trichophyton mentagrophytes.

Pharmacokinetics

Systemic absorption of efinaconazole after once-daily application for 28 days to toenails and 0.5 cm of adjacent skin. The plasma concentration of efinaconazole was determined at several time points over 24 hours on days 1, 14, and 28. The mean (± standard deviation) C_max of efinaconazole in plasma on day 28 was 0.67 ± 0.37 ng/ml, and the mean (± standard deviation) AUC was 12.15 ± 6.91 ng×h/ml. The steady-state plasma concentration-time profile was generally flat over the 24-hour dosing interval. The T_1/2 of efinaconazole from plasma after daily application to all 10 toenails for 7 days was 29.9 hours.

Indications

• Onychomycosis of toenails caused by Trichophyton rubrum and Trichophyton mentagrophytes.

Confirm diagnosis by appropriate laboratory testing prior to initiating therapy.

ICD codes

Dosage Regimen

Apply the solution once daily to the surface of the affected toenails.

Use an amount sufficient to completely cover the entire nail plate, nail folds, nail bed, hyponychium, and the underside of the nail plate.

Continue treatment for a total duration of 48 weeks to ensure complete eradication of the infection and healthy nail regrowth.

Adverse Reactions

Most adverse reactions are localized to the application site.

Common local reactions include ingrown toenail, application site dermatitis, application site vesicles, application site pain, erythema, and scaling.

Skin and subcutaneous tissue disorders of unknown frequency include onychomadesis and nail discoloration.

Drug Interactions

No specific drug interaction studies have been conducted with this topical formulation.

Given the minimal systemic absorption observed with topical application, clinically significant drug interactions are not anticipated.

Monitor for potential interactions if used concurrently with other topical medications applied to the same area.

Contraindications

• Hypersensitivity to efinaconazole or to any of the excipients in the formulation.
• Use in children under 6 years of age due to a lack of safety and efficacy data in this population.

Discontinue use immediately if signs of hypersensitivity or severe local irritation occur.

Overdose

Overdose from topical application is unlikely due to the limited systemic absorption.

In case of accidental ingestion, institute supportive measures and provide symptomatic treatment as required.

For topical over-application, remove excess solution by wiping the area and monitor for local skin reactions.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding only if the expected benefit to the mother outweighs the potential risk to the fetus and child.

Pediatric Use

Contraindicated for use in children under 6 years of age.

Geriatric Use

Dose adjustment is not required.

The possibility of increased sensitivity in older patients should not be ruled out.

Special Precautions

Efinaconazole is for external use on toenails and directly adjacent skin only. It is not intended for ophthalmic, oral, or intravaginal use.

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

Rx Only

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.