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Dioxydin ungventum 5% (Ointment) Instructions for Use

ATC Code

D08AH (Quinoline derivatives)

Active Substance

Hydroxymethylquinoxalindioxide (Grouping Name)

Clinical-Pharmacological Group

Antibacterial drug, a derivative of quinoxaline

Pharmacotherapeutic Group

Antimicrobial agent, quinoxaline

Pharmacological Action

Broad-spectrum antimicrobial agent, a derivative of quinoxaline. Acts bactericidally.

Active against Proteus vulgaris, Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli, Shigella dysenteria, Shigella flexneri, Shigella boydii, Shigella sonnei, Salmonella spp., Staphylococcus spp., Streptococcus spp., pathogenic anaerobes (Clostridium perfringens). It acts on bacterial strains resistant to other antimicrobial drugs, including antibiotics. Does not have a local irritant effect. The development of bacterial drug resistance is possible.

When administered intravenously, it is characterized by a narrow therapeutic index, which necessitates strict adherence to the recommended doses.

Treatment of burn and purulent-necrotic wounds promotes faster cleansing of the wound surface, stimulates reparative regeneration and marginal epithelialization, and has a beneficial effect on the course of the wound process.

Experimental studies have demonstrated the presence of teratogenic, embryotoxic, and mutagenic effects.

Indications

Wound and burn infection (superficial and deep purulent wounds of various locations, long-term non-healing wounds and trophic ulcers, soft tissue phlegmons, infected burns, purulent wounds in osteomyelitis); wounds with deep purulent cavities (lung abscess, soft tissue abscesses, pelvic cellulitis, postoperative wounds of the urinary and biliary tracts, purulent mastitis); pustular skin diseases.

ICD codes

ICD-10 code Indication
J85 Abscess of lung and mediastinum
L01 Impetigo
L02 Cutaneous abscess, furuncle and carbuncle
L03 Cellulitis
L08.0 Pyoderma
L08.8 Other specified local infections of skin and subcutaneous tissue
L98.4 Chronic skin ulcer, not elsewhere classified
M86 Osteomyelitis
O91 Infections of the breast associated with childbirth
T30 Burns and corrosions of unspecified body region
T79.3 Posttraumatic wound infection, not elsewhere classified
ICD-11 code Indication
1B70.1 Streptococcal cellulitis of the skin
1B70.2 Staphylococcal cellulitis of the skin
1B70.Z Bacterial cellulitis or lymphangitis caused by unspecified bacterium
1B72.0 Bullous impetigo
1B72.1 Nonbullous impetigo
1B72.Z Impetigo, unspecified
1B75.0 Furuncle
1B75.1 Carbuncle
1B75.2 Furunculosis
1B75.3 Pyogenic skin abscess
1B7Y Other specified pyogenic bacterial infections of skin or subcutaneous tissue
1C44 Non-pyogenic bacterial infections of skin
CA43.Z Abscess of lung or mediastinum, unspecified
EA40 Tropical phagedenic ulcer
EA50.3 Staphylococcal scarlet fever
EB21 Pyoderma gangrenosum
EF60 Ischemic ulceration of the skin
EM0Z Unspecified skin disorder
FB84.Z Osteomyelitis or osteitis, unspecified
JB45.Z Infections of the breast associated with childbirth, unspecified
ME60.2 Ulcerative skin lesion of unspecified nature
NE11 Burn of unspecified body region
NF0A.3 Posttraumatic wound infection, not elsewhere classified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Apply the ointment externally to the affected area after thorough cleansing of the wound from purulent and necrotic tissues.

Use a thin layer of the 5% ointment for superficial infections, including pustular skin diseases, superficial burns, and infected wounds.

For deep wounds, abscess cavities, or trophic ulcers, perform tamponade using gauze swabs saturated with the ointment.

Administer the drug once daily or every other day, depending on the severity of the infection and the rate of wound healing.

Do not exceed the maximum daily dose of 2.5 grams of ointment.

Limit the duration of treatment to a maximum of three weeks to prevent the development of bacterial resistance.

Discontinue application immediately if signs of a local allergic reaction or periwound dermatitis occur.

Reserve use for cases where other antimicrobial agents have proven ineffective, due to the drug’s narrow therapeutic index and potential for resistance.

Adverse Reactions

Possible: allergic reactions.

Local reactions periwound dermatitis.

Contraindications

Adrenal insufficiency (including history); pregnancy; lactation period (breastfeeding); children under 18 years of age; hypersensitivity to the active substance.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Renal Impairment

Use with caution in patients with renal failure.

Pediatric Use

The drug is contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

Use with caution in patients with renal failure.

Prescribed only when other antimicrobial drugs are ineffective.

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

Rx Only

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Biokhimik, JSC (Russia)

Dosage Form

Bottle Rx Icon Dioxydin ungventum 5% Ointment for external use 5%: jars 30 g, 60 g or 100 g

Dosage Form, Packaging, and Composition

Ointment for external use 5% 1 g
Hydroxymethylquinoxalindioxide 50 mg

30 g – dark glass jars (1) – cardboard packs.
60 g – dark glass jars (1) – cardboard packs.
100 g – dark glass jars (1) – cardboard packs.

Marketing Authorization Holder

Trading House KhiMoptorg CJSC (Russia)

Dosage Form

Bottle Rx Icon Dioxydin ungventum 5% Ointment for external use 5%: jars 30 g, 60 g or 100 g

Dosage Form, Packaging, and Composition

Ointment for external use 5% 1 g
Hydroxymethylquinoxalindioxide 50 mg

30 g – dark glass jars (1) – cardboard packs.
60 g – dark glass jars (1) – cardboard packs.
100 g – dark glass jars (1) – cardboard packs.

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle Rx Icon Dioxydin ungventum 5% Ointment for external use 5%: jars 30 g, 60 g or 100 g

Dosage Form, Packaging, and Composition

Ointment for external use 5% 1 g
Hydroxymethylquinoxalindioxide 50 mg

30 g – dark glass jars (1) – cardboard packs.
60 g – dark glass jars (1) – cardboard packs.
100 g – dark glass jars (1) – cardboard packs.

Marketing Authorization Holder

Central European Pharmaceutical Company CJS (Russia)

Dosage Form

Bottle Rx Icon Dioxydin ungventum 5% Ointment for external use 5%: jars 30 g, 60 g or 100 g

Dosage Form, Packaging, and Composition

Ointment for external use 5% 1 g
Hydroxymethylquinoxalindioxide 50 mg

30 g – dark glass jars (1) – cardboard packs.
60 g – dark glass jars (1) – cardboard packs.
100 g – dark glass jars (1) – cardboard packs.

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