Stellanin^®-PEG (Ointment) Instructions for Use

Marketing Authorization Holder

Pharmpreparat, LLC (Russia)

ATC Code

D08AG (Iodine preparations)

Dosage Form

Stellanin®-PEG

Ointment for external use 3%: tube 20 g

Dosage Form, Packaging, and Composition

20 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with antimicrobial, anti-inflammatory, and tissue regeneration-improving action for external use

Pharmacotherapeutic Group

Tissue regeneration stimulant

Pharmacological Action

The mechanism of the drug’s pharmacological activity lies in the antibacterial action of 1,3-diethylbenzimidazolium.

The active iodine, which is part of 1,3-diethylbenzimidazolium triiodide, inactivates bacterial cell wall proteins and enzymatic proteins of bacteria, thereby exerting a bactericidal effect on microorganisms.

The pronounced antimicrobial action of the drug prevents wound infection.

Along with antibacterial and anti-inflammatory effects, the ointment has a high osmotic potential, which is especially important in the treatment of purulent wounds, as it promotes the evacuation of purulent discharge from the wound defect.

Pharmacokinetics

Systemic absorption of the active substance is absent even with damaged skin; nevertheless, therapeutic concentrations of the drug are present in the wound.

Indications

• Treatment of acute purulent processes (wounds) of the skin and soft tissues (furuncles, carbuncles, hidradenitis, phlegmons, abscesses);
• Additional treatment of purulent complications of postoperative wounds (after excision, coagulation, episiotomy, for the treatment of skin cracks, wounds, and sutures);
• Thermal lesions of the skin and soft tissues of I-III degrees, complicated by an infectious process;
• Trophic ulcers, bedsores, complicated by an infectious process;
• Abrasions, cuts, scratches, cracks, excoriations.

ICD codes

Dosage Regimen

The ointment is applied in a thin layer of about 1.5-2 mm directly onto the wound surface, after which a sterile gauze bandage is applied, or the drug is applied to the dressing material and then to the wound.

The layer of ointment should exceed the dimensions of the wound in circumference by at least 5 mm.

Cavities of purulent wounds after their surgical treatment are loosely filled with tampons soaked in the ointment, and gauze turundas with the drug are inserted into fistula tracts.

If the wound is located in an area inconvenient for bandaging, the use of an adhesive plaster or glue bandage is permissible.

Dressings are changed 1-2 times a day.

The daily dose should not exceed 10 g. The duration of treatment averages 5 – 15 days.

For minor skin injuries (abrasions, cuts, scratches, cracks, excoriations), the drug is applied in a thin layer to the affected surface 2 times a day.

Adverse Reactions

In rare cases, skin allergic reactions (itching, skin hyperemia) are possible, upon the appearance of which the use of the drug should be discontinued.

Contraindications

• Hypersensitivity to the components of the drug;
• Thyrotoxicosis;
• Thyroid adenoma;
• Severe renal failure;
• Concurrent therapy with radioactive iodine;
• Children under 18 years of age;
• First trimester of pregnancy.

With caution: chronic renal failure, second and third trimesters of pregnancy, lactation period.

Use in Pregnancy and Lactation

It is prohibited to use the drug in the first trimester of pregnancy.

Use with caution in the second and third trimesters of pregnancy and during lactation.

Use in Renal Impairment

Contraindicated in severe renal failure.

With caution: chronic renal failure.

Pediatric Use

Contraindicated in children under 18 years of age.

Special Precautions

Avoid getting the ointment into the eyes. If the drug gets into the eyes, rinse with warm water.

Overdose

Cases of overdose have not been described. In case of accidental ingestion of the drug, nausea and vomiting may occur.

Gastric lavage is necessary and a doctor should be consulted; if necessary, symptomatic treatment is carried out.

Drug Interactions

The drug should not be used in combination with other antiseptic agents containing mercury, oxidizing agents, alkalis, and cationic surfactants.

Alkaline or acidic environment, the presence of fat, pus, and blood weaken the antiseptic activity.

Storage Conditions

The drug should be stored in a dry place, protected from light, at a temperature of 0-25°C (32-77°F).

Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is dispensed by prescription.

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.