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Dixin (Solution, Ointment) Instructions for Use

ATC Code

J01XX (Other antibacterial drugs)

Active Substance

Hydroxymethylquinoxalindioxide (Grouping name)

Clinical-Pharmacological Group

Antibacterial drug, a derivative of quinoxaline

Pharmacotherapeutic Group

Systemic antibacterial agents; other antibacterial agents

Pharmacological Action

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

Active againstProteus vulgaris, Pseudomonas aeruginosa, Friedlander’s bacillus, Escherichia coli, Shigella dysenteriae, 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. It does not have a local irritant effect. The development of bacterial drug resistance is possible.

When administered intravenously, it is characterized by a low therapeutic range, 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.

Pharmacokinetics

After intravenous administration, the therapeutic concentration in the blood is maintained for 4-6 hours. The time to reach Cmax in the blood is 1-2 hours after a single administration. It penetrates well and quickly into all organs and tissues and is excreted by the kidneys. It does not accumulate upon repeated administration.

Indications

For intravenous administration septic conditions (including in patients with burn disease); purulent meningitis; purulent-inflammatory processes with symptoms of generalization.

For intracavitary administration purulent processes in the thoracic and abdominal cavities, including purulent pleurisy; pleural empyema; peritonitis; cystitis; gallbladder empyema; prevention of infectious complications after bladder catheterization.

For external, topical application 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 tissue phlegmons, postoperative wounds of the urinary and biliary tracts, purulent mastitis); pustular skin diseases.

ICD codes

ICD-10 code Indication
A40 Streptococcal sepsis
A41 Other sepsis
G00 Bacterial meningitis, not elsewhere classified
J85 Abscess of lung and mediastinum
J86 Pyothorax (pleural empyema)
K65.0 Acute peritonitis (including abscess)
K81.0 Acute cholecystitis
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
N30 Cystitis
N39.0 Infection of urinary tract, site not specified
N61 Inflammatory diseases of the breast
N73.5 Unspecified female pelvic peritonitis
O91 Infections of the breast associated with childbirth
T30 Burns and corrosions of unspecified body region
T79.3 Posttraumatic wound infection, not elsewhere classified
Z29.2 Other prophylactic chemotherapy (administration of antibiotics for prophylactic purposes)
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
1D01.0Z Bacterial meningitis, unspecified
1G40 Sepsis without septic shock
CA43.Z Abscess of lung or mediastinum, unspecified
CA44 Pyothorax
DC12.0Z Acute cholecystitis, unspecified
DC50.0 Primary peritonitis
DC50.2 Peritoneal abscess
DC50.Z Peritonitis, 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
GA05.2 Unspecified pelvic peritonitis in women
GB21.Z Inflammatory diseases of the breast, unspecified
GC00.Z Cystitis, unspecified
GC08.Z Urinary tract infection, site and agent not specified
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
QC05.Y Other specified prophylactic measures

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.

Ointment

Externally, apply gauze pads soaked in a 1% solution to the wound surface, pre-cleaned from purulent-necrotic masses, daily or every other day, depending on the condition of the burn wound and the course of the wound process. Deep wounds are tamponed or irrigated with a 0.5% solution. The maximum daily dose is 2.5 g. The duration of treatment is up to 3 weeks.

Solution

Intravenous drip. In severe septic conditions, the maximum single dose is 300 mg, the daily dose is 600 mg.

Intracavitary administration: 10-50 ml of a 1% solution is administered through a drainage tube, catheter, or syringe.

Externally, apply gauze pads soaked in a 1% solution to the wound surface, pre-cleaned from purulent-necrotic masses, daily or every other day, depending on the condition of the burn wound and the course of the wound process. Deep wounds are tamponed or irrigated with a 0.5% solution. The maximum daily dose is 2.5 g. The duration of treatment is up to 3 weeks.

Adverse Reactions

Possible: allergic reactions.

After intravenous and intracavitary administration – headache, chills, hyperthermia, nausea, vomiting, diarrhea, muscle twitching.

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 during the lactation period (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.

In chronic renal failure, the dose should be reduced. It is prescribed only when other antimicrobial drugs are ineffective.

Storage Conditions

Store at 15°C (59°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

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle Rx Icon Dixin Ointment for topical and external use 5%: 30 g tubes

Dosage Form, Packaging, and Composition

Ointment for topical and external use from light yellow to greenish-yellow, homogeneous.

100 g
Hydroxymethylquinoxalindioxide 5 g

Excipients: propylene glycol – 25 g, macrogol 1500 – 16.5 g, macrogol 4000 – 10.5 g, poloxamer – 5 g, macrogol 400 – up to 100 g.

30 g – tubes – cardboard packs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Bottle Rx Icon Dixin Solution for intracavitary and external use 10 mg/1 ml: amp. 5 ml or 10 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Solution for intracavitary and external use in the form of a transparent greenish-yellow liquid*.

1 ml
Hydroxymethylquinoxalindioxide 10 mg

Excipients: sodium hydroxide solution 0.1M – to pH 5.2-7.2, water for injection – up to 1 ml.

5 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
5 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
10 ml – ampoules (5) – contour cell packs (1) – cardboard packs.
10 ml – ampoules (5) – contour cell packs (2) – cardboard packs.

* During storage, the precipitation of hydroxymethylquinoxalindioxide crystals in the ampoules with the solution is allowed. In case of precipitation of hydroxymethylquinoxalindioxide crystals in the ampoules with the solution, they are dissolved by heating the ampoules with the solution in a boiling water bath with shaking until the crystals are completely dissolved (transparent solution). If, upon cooling to 36-38°C (96.8-100.4°F), the crystals do not precipitate again, the drug is suitable for use.

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