Zinc acetate + Erythromycin (Powder) Instructions for Use

Marketing Authorization Holder

Patent-Pharm, JSC (Russia)

Manufactured By

Tyumen Chemical and Pharmaceutical Plant, JSC (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

Zinc acetate + Erythromycin

Powder for external solution preparation 12 mg+40 mg/1 ml: fl. 1.691 g in set with solvent (fl.) and applicator

Dosage Form, Packaging, and Composition

Powder for preparation of solution for external use white crystalline; solvent – transparent colorless liquid; ready solution – opaque white liquid, the presence of individual particles is allowed.

* 1 ml after mixing two bottles.

Excipients : diisopropyl sebacate – 7810 mg (250 mg/1 ml of ready solution), ethanol – 17100 mg (550 mg/1 ml of ready solution).

1.691 g – high-density polyethylene bottles in a set with solvent (fl. 24.91 g 1 pc.) and applicator – cardboard packs.

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Acne vulgaris treatment agent

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 bond of active substances ensures their good penetration into the skin.

Zinc mainly binds to the follicular epithelium and is not resorbed into the systemic bloodstream.

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

Indications

• Treatment of acne vulgaris.

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

Shake the bottle well before each use to ensure a uniform suspension.

Use the applicator provided for precise application, covering the entire affected area with a thin film.

Wash hands immediately after application to avoid accidental contact with eyes or mucous membranes.

ICD codes

Dosage Regimen

For external use only.

Apply a thin layer to the entire affected area twice daily, in the morning and evening, after the skin has been thoroughly cleansed and dried.

Shake the bottle vigorously before each use to resuspend the medication.

Use the applicator for precise application; wash hands immediately after use.

Treatment duration is determined by the physician based on clinical response; improvement is typically observed after 2-4 weeks of use.

Avoid contact with eyes, mouth, nostrils, and other mucous membranes.

Adverse Reactions

Local skin reactions are the most commonly reported adverse effects.

These may include a transient burning sensation, skin irritation, erythema, peeling, and dryness at the application site.

Such reactions are generally mild in intensity and often resolve with continued use; they rarely necessitate discontinuation of therapy.

Discontinue use and consult a physician if severe irritation, pruritus, or signs of a contact allergic reaction (e.g., rash, swelling) develop.

Drug Interactions

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

Separate application times by several hours or use on alternate days if combination therapy is required.

Be aware of potential cross-resistance with systemically administered macrolides, as well as with lincomycin and clindamycin.

No specific pharmacokinetic interactions with systemic drugs have been reported for topical application.

Contraindications

• Hypersensitivity to erythromycin, any other macrolide antibiotic, or any component of the formulation.
• Known allergy or hypersensitivity to zinc or any of the excipients, including diisopropyl sebacate and ethanol.
• Do not apply to broken skin, severe exudative lesions, or areas with active atopic dermatitis or eczema, as this may increase systemic absorption and the risk of adverse effects.

Overdose

Topical application makes systemic overdose unlikely.

Excessive or prolonged application to the skin may lead to severe local adverse reactions, including pronounced irritation, erythema, peeling, and discomfort.

In case of accidental ingestion, seek immediate medical attention; symptoms may include gastrointestinal distress such as nausea, vomiting, and abdominal pain.

Treatment for both topical and oral overdose is supportive and symptomatic; 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 taken into account.

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.