Dioxysept^® (Solution, Ointment) Instructions for Use

ATC Codes

B05CA (Antimicrobial solutions)

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. It acts bactericidally.

Active against Proteus vulgaris, Pseudomonas aeruginosa, Friedlander’s bacillus, 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. It does not have a locally irritating 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.

Pharmacokinetics

After intravenous administration, the therapeutic concentration in the blood is maintained for 4-6 hours. The time to reach C_max 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

Dosage Regimen

Ointment

Externally, gauze pads soaked in a 1% solution are applied to the wound surface, previously cleaned of 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 tamponaded 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, gauze pads soaked in a 1% solution are applied to the wound surface, previously cleaned of 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 tamponaded 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 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.

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.