Eclaran (Gel) Instructions for Use

ATC Code

D10AE01 (Benzoyl peroxide)

Active Substance

Benzoyl peroxide (USAN adopted for use in the USA)

Clinical-Pharmacological Group

Acne treatment drug

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

Antimicrobial agent for external use. It has an antimicrobial effect. It is active against gram-positive bacteria: Propionibacterium, Staphylococcus epidermidis.

It has a keratolytic effect, improves tissue oxygenation, and the process of granulation of lower limb ulcers. It reduces the formation of fat by the sebaceous glands of the skin.

Pharmacokinetics

When applied externally, it is practically not absorbed. A small amount is absorbed through the skin. It is metabolized to form benzoic acid. It is excreted by the kidneys in the form of benzoate.

Indications

• Acne vulgaris, including the conglobate form as a component of a comprehensive therapeutic regimen.

• Lower leg ulcers of diverse etiology, encompassing trophic ulcers resulting from venous insufficiency or other underlying pathologies.

ICD codes

Dosage Regimen

Apply the gel topically to cleansed and dried affected skin areas. For acne vulgaris, initiate therapy with the 5% gel formulation once daily for a duration of two to three weeks.

Subsequently, transition to the 10% gel strength, continuing application until complete resolution of cutaneous lesions is achieved. For the management of lower leg ulcers, utilize the 10% gel under an occlusive dressing, applied twice daily for a period of two to three weeks.

Adverse Reactions

Common adverse effects are predominantly localized to the site of application. These include skin erythema, a pronounced dryness and peeling of the epidermis, and a local irritant effect characterized by a burning or stinging sensation.

Less frequently, allergic contact dermatitis may manifest. Systemic reactions are exceedingly rare due to minimal percutaneous absorption of the active pharmaceutical ingredient.

Drug Interactions

Concomitant use with other topical acne medications, especially those containing tretinoin or its derivatives, may result in a significant increase in skin irritation and erythema. Exercise caution when applying other topical preparations to the same anatomical site.

Avoid concurrent use with abrasive or highly desiccating cleansers, astringents, and products with high concentrations of alcohol, as these may exacerbate the drying and irritant effects of the therapy.

Contraindications

• Hypersensitivity to benzoyl peroxide, any of the excipients in the formulation, or other peroxide compounds, which may present as contact dermatitis or more severe allergic responses.

• Application to skin with significant abrasions, eczematous eruptions, or sunburn, as the irritant properties of the drug may exacerbate these conditions and impede the natural healing process.

Overdose

Acute overdose from topical application is unlikely. Excessive use may lead to severe skin reactions, including intense erythema, scaling, pruritus, and a painful burning sensation.

In case of accidental ingestion, seek immediate medical attention. Symptoms may include gastrointestinal irritation, nausea, and vomiting. Treatment is supportive and directed at alleviating the presenting symptoms.

Use in Pregnancy and Lactation

Use with caution during pregnancy and lactation (breastfeeding).

Pediatric Use

Use with caution in children under 12 years of age.

Special Precautions

Use with caution in children under 12 years of age.

Avoid contact with eyes and mucous membranes.

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.