Acnederil (Powder) Instructions for Use

Marketing Authorization Holder

Ivanovo Pharmaceutical Factory PJSC (Russia)

ATC Code

D10AF52 (Erythromycin in combination with other drugs)

Active Substances

Erythromycin (Rec.INN registered by WHO)

Zinc acetate, basic (Rec.INN registered by WHO)

Dosage Form

Acnederil

Powder for topical solution 12 mg+40 mg/ml: bottle 1 pc. with solvent and applicator

Dosage Form, Packaging, and Composition

Powder for preparation of topical solution white, crystalline; solvent – colorless, transparent.

Excipients : diisopropanolamine – 250 mg, ethanol (absolute ethanol) – 99.5%.

Vial with solvent:
Excipients: diisopropanolamine – 7810 mg, ethanol (absolute ethanol) 99.5% – 17100 mg.

1 pc. – vials (1) + 1 vial with solvent – cardboard packs.

Clinical-Pharmacological Group

A drug with antibacterial and comedolytic action for the treatment of acne

Pharmacotherapeutic Group

Drugs for the treatment of acne; drugs for the treatment of acne for topical use; antimicrobial agents for the treatment of acne

Pharmacological Action

Erythromycin-zinc complex. It has anti-inflammatory, antimicrobial, and comedolytic action.

Erythromycin acts bacteriostatically on microorganisms causing acne: Propionibacterium acnes and Streptococcus epidermidis. Zinc reduces the production of sebum and has an astringent effect.

Pharmacokinetics

The complex binding of active substances ensures their good penetration into the skin.

Zinc mainly binds to the follicular epithelium and is not absorbed into the systemic circulation.

A small part of erythromycin undergoes systemic distribution and is subsequently eliminated from the body.

Indications

• Treatment of acne vulgaris.

Apply the prepared solution topically to the affected skin areas twice daily, in the morning and evening, after thoroughly cleansing and drying the skin.

Shake the bottle well before each use. Use the applicator provided to apply a thin, even layer. Allow the solution to dry completely. Wash hands after application.

ICD codes

Dosage Regimen

Prepare the topical solution by transferring the entire volume of the supplied solvent into the vial containing the powder. Close the vial tightly and shake vigorously until the powder is completely dissolved and a clear solution is obtained.

Apply the solution to the affected skin areas twice daily, in the morning and evening. Prior to application, cleanse and dry the skin thoroughly. Shake the vial well before each use.

Use the applicator to apply a thin layer. Avoid contact with eyes, mouth, nostrils, and other mucous membranes. Wash hands immediately after application.

Adverse Reactions

The following adverse reactions are primarily local and mild in nature. A sensation of burning, skin irritation, dryness, peeling, or erythema may occur at the application site.

These reactions are usually transient and often resolve with continued use. Discontinuation of therapy is rarely required. In case of severe or persistent local reactions, discontinue use and consult a physician.

Drug Interactions

Consider the potential for cross-resistance to other antibiotics, including macrolides, lincomycin, and clindamycin.

Concomitant use with other topical acne medications, especially those with a drying or abrasive effect (e.g., products containing benzoyl peroxide, salicylic acid, or tretinoin), may increase the potential for cumulative skin irritation.

Avoid simultaneous application with other topical preparations on the same treatment area.

Contraindications

• Hypersensitivity to erythromycin, any other macrolide antibiotic, or any component of the formulation.

• Known hypersensitivity to zinc or its compounds.

Do not use on broken, sunburned, or eczematous skin. Avoid application to mucous membranes.

Overdose

Acute overdose from topical application is unlikely due to minimal systemic absorption. Excessive application may lead to severe local skin reactions, including pronounced erythema, peeling, and irritation.

In case of accidental ingestion, seek immediate medical attention. Treatment is symptomatic and supportive. There is no specific antidote.

Use in Pregnancy and Lactation

It is currently established that the use of the drug during pregnancy and lactation is possible according to indications in recommended doses.

Special Precautions

When using, the possibility of cross-resistance to other antibiotics of the macrolide group, lincomycin, clindamycin should be considered.

Avoid getting the drug into the eyes or on the mucous membrane of the oral and nasal cavities, as this may cause irritation and burns.

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.