Zineriderm (Powder) Instructions for Use

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (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

Zineriderm

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 95% – 550 mg.

Vial with solvent:
Excipients: diisopropanolamine – 7810 mg, ethanol 95% – 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 sebaceous gland secretion 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.

ICD codes

Dosage Regimen

For external use only. Prepare the solution immediately before first use by transferring the entire volume of the supplied solvent into the vial with powder; shake vigorously until the powder is completely dissolved.

Apply a thin layer of the prepared solution to the entire affected skin area twice daily, in the morning and evening, using the supplied applicator. Wash and dry skin thoroughly before application.

The duration of therapy is determined by the physician; clinical improvement is usually observed after 6-8 weeks of use.

Adverse Reactions

Adverse reactions are typically local and mild in nature, occurring at the site of application.

The most frequently reported reactions include a transient burning sensation, skin irritation, erythema, peeling, and dryness.

These effects usually diminish with continued treatment and rarely necessitate discontinuation of therapy. Hypersensitivity reactions, including contact dermatitis, occur infrequently.

Drug Interactions

Concomitant topical use with clindamycin may antagonize the antibacterial effects of both agents; avoid concurrent application.

No other clinically significant drug interactions for topical use have been reported. The potential for cross-resistance with systemic macrolides, lincomycin, and clindamycin exists.

Contraindications

• Hypersensitivity to erythromycin, other macrolide antibiotics, or any component of the formulation.
• Known hypersensitivity to zinc or its compounds.

Overdose

Overdose from topical application is unlikely due to minimal systemic absorption. Accidental ingestion may cause gastrointestinal disturbances consistent with erythromycin toxicity, such as nausea, vomiting, and diarrhea.

In case of accidental ingestion, seek medical attention; treatment is symptomatic and supportive. For topical over-application, wash the affected area thoroughly with water.

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.

It is necessary to avoid getting the drug into the eyes or on the mucous membrane of the oral and nasal cavity, as this may cause irritation and burn.

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.