Agiderilin (Cream) Instructions for Use

Marketing Authorization Holder

Agio Pharmaceuticals, Ltd. (India)

ATC Code

D01AE22 (Naftifine)

Active Substance

Naftifine (Rec.INN registered by WHO)

Dosage Form

Agiderilin

Cream for external use 1%: tubes 15 g, 20 g or 30 g

Dosage Form, Packaging, and Composition

Cream for external use homogeneous, from white to almost white color, with a characteristic odor.

Excipients : sodium hydroxide – 1.5 mg, benzyl alcohol – 10 mg, sorbitan monostearate – 19 mg, cetyl palmitate – 20 mg, cetyl alcohol – 40 mg, stearyl alcohol – 40 mg, polysorbate 60 – 61 mg, isopropyl myristate – 80 mg, purified water – up to 1 g.

15 g – aluminum tubes (1) – cardboard packs.
20 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Indications

• Agiderilin (Naftifine) cream is indicated for the topical treatment of fungal infections of the skin caused by susceptible dermatophytes, yeasts, and molds.
• It is specifically effective for tinea pedis (athlete’s foot), tinea cruris (jock itch), and tinea corporis (ringworm).
• The cream formulation is also indicated for the treatment of cutaneous candidiasis.
• It may be used for the management of pityriasis versicolor, a common fungal infection caused by Malassezia species.

The decision to use Agiderilin should be based on the physician’s clinical judgment and, where possible, confirmed by microscopic examination and culture of skin scrapings to identify the causative organism.

Dosage Regimen

Agiderilin cream is for external use only. The affected area and immediately surrounding skin should be cleaned and dried thoroughly before application.

The standard adult and pediatric (12 years and older) dosage is to apply a thin layer of the cream once daily. Sufficient cream should be applied to cover the entire affected area and approximately one centimeter of the surrounding healthy skin.

Duration of treatment is critical for efficacy and to prevent recurrence. For tinea corporis and tinea cruris, treatment typically lasts for 2 weeks. For tinea pedis, a 4-week treatment course is generally recommended. For pityriasis versicolor, a 2-week course is usually sufficient. Continue using the medication for the full prescribed time, even if symptoms improve, unless otherwise directed by a physician.

If no clinical improvement is observed after the recommended treatment period, the diagnosis should be re-evaluated. Do not use occlusive dressings unless specifically directed by a healthcare professional. Wash hands thoroughly before and after application, unless the hands are the treated area.

Contraindications

• Hypersensitivity to Naftifine or to any of the excipients listed in the composition of the cream constitutes an absolute contraindication.
• Known allergic reactions to other allylamine antifungal agents are a contraindication for use.
• The cream should not be applied to severely broken or ulcerated skin, or to open wounds, due to the potential for increased systemic absorption and local irritation.
• Use in the eyes or on the mucous membranes is strictly contraindicated. If accidental contact occurs, rinse thoroughly with copious amounts of water.

Before initiating treatment, a careful patient history should be taken to rule out any previous hypersensitivity reactions to topical antifungal products.

Adverse Reactions

During clinical trials and post-marketing surveillance, the following adverse reactions have been reported. Most local reactions are mild to moderate in intensity and often resolve even with continued treatment.

Common (≥1/100 to <1/10): Local skin reactions at the site of application, including burning sensation, dryness, itching (pruritus), erythema (redness), and skin irritation.

Uncommon (≥1/1,000 to <1/100): Less frequently, patients may experience contact dermatitis, scaling, blistering, pain, or worsening of the existing condition.

Rare (<1/1,000): Isolated cases of allergic contact dermatitis have been reported. Systemic reactions are extremely rare due to low percutaneous absorption but cannot be entirely excluded, especially if applied to large areas or compromised skin barriers.

If signs of severe irritation, hypersensitivity, or a systemic allergic reaction (such as widespread rash, swelling, or difficulty breathing) develop, discontinue use immediately and seek medical attention.

Drug Interactions

Formal studies of drug interactions with topically applied naftifine are limited. Due to the low systemic absorption after topical administration, clinically significant pharmacokinetic interactions with systemically administered medicinal products are not anticipated.

However, the potential for pharmacodynamic interactions exists. Concomitant use of other topical preparations (e.g., corticosteroids, antimicrobials, abrasive or desquamating agents) on the same skin area is not recommended, as they may cause incompatibility, irritation, or dilution of Agiderilin, potentially reducing its efficacy.

If combination therapy with another topical agent is deemed medically necessary, the products should be applied at different times of the day, with a sufficient interval between applications. Always inform your healthcare provider about all other medications you are using, including prescription, over-the-counter, and herbal products.

Overdose

Acute overdose following topical application is unlikely due to the localized nature of treatment. However, accidental ingestion of the cream may occur.

Symptoms of ingestion may include gastrointestinal irritation such as nausea, vomiting, and abdominal pain. Given the low bioavailability and the small amount of active substance in a full tube, serious systemic toxicity is not expected, but medical advice should be sought.

In case of excessive topical application, the primary risk is local skin reactions, including intensified adverse effects like severe redness, burning, or irritation. The affected area should be washed thoroughly with mild soap and water to remove any excess cream. Symptomatic and supportive care is recommended.

There is no specific antidote for naftifine overdose. Treatment should be directed at managing symptoms. For ingestion, consider gastric lavage or administration of activated charcoal if a very large quantity has been consumed and the patient presents shortly after the event.

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.