Ecodax^® (Cream) Instructions for Use

Marketing Authorization Holder

J&JTL, LLC (Russia)

Manufactured By

Unique Pharmaceutical Laboratories (India)

Contact Information

J&JTL LLC (Russia)

ATC Code

D01AC03 (Econazole)

Active Substance

Econazole (Rec.INN registered by WHO)

Dosage Form

Ecodax®

Cream for external use 1%: tubes 10 g or 20 g

Dosage Form, Packaging, and Composition

Cream for external use 1% from white to yellowish-white, homogeneous, practically odorless.

Excipients: sodium hydroxide – 0.9 mg, sodium dihydrogen phosphate dihydrate – 3.65 mg, phosphoric acid – 0.02 mg, chlorocresol – 1 mg, cetomacrogol 1000 – 50 mg, cetearyl alcohol (cetyl alcohol 60%, stearyl alcohol 40%) – 70 mg, white soft paraffin – 150 mg, liquid paraffin – 60 mg, purified water – q.s. to 1 g.

10 g – aluminum tubes (1) – cardboard packs.
20 g – aluminum tubes (1) – cardboard packs.
10 g – laminated plastic tubes (1) – cardboard packs.
20 g – laminated plastic tubes (1) – cardboard packs.

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Econazole is an imidazole derivative, a broad-spectrum antifungal drug for topical application. It has fungicidal and bactericidal action.

It inhibits the synthesis of ergosterol, which regulates the permeability of the cell wall of microorganisms. It is active against dermatophytes, yeast and mold fungi: Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, Candida albicans, Torulopsis, Rhodotorula, Malassezia furfur (Pityrosporum orbiculare), which causes pityriasis versicolor, Corynebacterium, Epidermophyton floccosum, Aspergillus, Cladosporium, Scopulariopsis brevicautus and some gram-positive bacteria (streptococci, staphylococci and Nocardia minutissima).

It is effective against fungi resistant to treatment with other drugs. With topical application, it causes the death of fungi within 3 days, promotes rapid regression of burning and itching of the skin.

Pharmacokinetics

When applied externally, the drug penetrates into all layers of the skin and the nail plate. Therapeutic concentrations are created in the stratum corneum and other layers of the epidermis, as well as in the dermis.

When applied to the skin, systemic absorption is minimal and practically insignificant. Less than 1% of the applied dose is excreted in feces via the intestines, and by the kidneys.

Indications

• Dermatomycoses of the scalp skin caused by dermatophytes, yeasts, mold fungi, including those complicated by superinfection with gram-positive bacteria;
• Erythrasma;
• Pityriasis versicolor;
• Skin infections caused by gram-positive microorganisms.

ICD codes

Dosage Regimen

Apply externally only.

Use in adults and children over 18 years.

Apply the cream to the affected area of skin in a thin, even layer.

Rub in gently until the cream is completely absorbed.

Apply the cream twice daily, in the morning and in the evening.

The standard duration of treatment is 2 weeks.

For infections of highly keratinized skin, such as the soles of the feet, continue treatment for up to 1.5 months.

Continue application for the full prescribed duration, even if symptoms improve earlier.

Wash hands before and after each application.

Avoid contact with eyes, mucous membranes, and open wounds.

If no clinical improvement is observed within the recommended treatment period, verify the diagnosis.

Discontinue use immediately and consult a physician if signs of hypersensitivity or severe local irritation occur.

Adverse Reactions

Individual intolerance to econazole and other components included in the drug.

Local reactions in the form of burning, itching, irritation and hyperemia of the skin, urticaria, dryness, hypopigmentation, skin atrophy are possible.

Contraindications

• Hypersensitivity to econazole and other components included in the drug;
• Children under 18 years of age.

Do not apply the drug to areas with damaged skin.

Use in Pregnancy and Lactation

During pregnancy (I-II trimester) it is used only if the intended benefit to the mother outweighs the potential risk to the fetus.

When prescribing the drug during lactation, breastfeeding should be discontinued.

Pediatric Use

Contraindicated in children under 18 years of age.

Special Precautions

In patients with eczema, anti-eczema therapy should be carried out before starting treatment. If there is no effect from the therapy within the recommended time frames, it is necessary to verify the diagnosis. If the first symptoms of hypersensitivity appear, the drug should be discontinued.

Avoid getting the drug into the eyes, on mucous membranes, on open wounds. If any side effects occur during the use of the drug, its further use should be discontinued and a doctor should be consulted.

Information on the possible effect of the medicinal product on the ability to drive vehicles, mechanisms

The drug does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

If the cream is accidentally ingested, nausea, vomiting, and diarrhea are possible.

Treatment: gastric lavage, oral administration of activated charcoal, symptomatic therapy.

Drug Interactions

No data available.

Storage Conditions

Store at a temperature not exceeding 30°C (86°F). Do not freeze. Keep out of reach of children.

Shelf Life

Shelf life – 3 years.

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.