Dioxydin - instructions for use, doses, side effects, contraindications

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Dosage form: & nbspSolution for intravenous administration, topical and topical application.

Composition:

Active substance: hydroxymethylquinoxaline dioxide (Dioxydin) - 5 mg.

Excipient: water for injection - up to 1 ml.

Description:

Transparent greenish-yellow liquid.

Note. In the case of the precipitation of crystals of dioxidine in ampoules during storage, they are dissolved by heating the ampoules in a boiling water bath with shaking until the crystals are completely dissolved (clear solution). If the crystals do not fall again upon cooling to 36-38 ° C, the preparation is usable.

Pharmacotherapeutic group:antimicrobial agent - quinoxaline

Pharmacodynamics:Dioxydin is a broad-spectrum antimicrobial agent from the group of quinoxaline derivatives. It is active against Proteus vulgaris, Pseudomonas aeruginosa, Klebsiella pneumoniae, Esherichia coli, Shigella dysenteria, Shigella flexneri, Shigella boydii, Shigella sonnei, Salmonella spp., Staphylococcus spp., Streptococcus spp., Pathogenic anaerobes (Clostridium perfringens). It acts on strains of bacteria resistant to other antibacterial drugs, including antibiotics. Does not have a local irritant effect. The development of drug resistance of bacteria is possible. Treatment of burns and purulent necrotic wounds promotes faster cleaning of the wound surface, stimulates reparative regeneration and marginal epithelization and favorably influences the course of the wound process.

Pharmacokinetics:After intravenous administration, the therapeutic concentration of the drug in the blood is maintained for 4-6 hours, the maximum concentration in the blood is 1 -2 hours after a single injection. The drug penetrates well and quickly into all organs and tissues, it is well absorbed from wound surfaces when applied topically. It is excreted by the kidneys. With repeated administration does not accumulate in the body.

Indications:

Treatment of various forms of purulent bacterial infection caused by sensitive microflora when other chemotherapeutic agents are ineffective or poorly tolerated.

Intravenous administration solution is shown only for severe septic conditions (including patients with burn disease), purulent meningitis, severe purulent inflammatory processes with symptoms of infection generalization.

External, local application - wound and burn infection (superficial and deep wounds of different localization, long-term healing wounds and trophic ulcers, phlegmon soft tissues, infected burns, purulent wounds in osteomyelitis).

Contraindications:Hypersensitivity, adrenal insufficiency (including in the anamnesis), pregnancy,the period of breastfeeding, children's age (up to 18 years).

Carefully:Renal failure.

Pregnancy and lactation:During pregnancy and during breastfeeding, the drug is contraindicated. In experimental studies it was shown that Dioxydin has a teratogenic and embryotoxic effect, has mutagenic properties. The use of Dioxydinum during lactation is possible only after the transfer of the child to artificial feeding.

Dosing and Administration:

Intravenous administration. Slowly drip.

Enter a solution of 5 mg / ml, which is previously diluted in a 5% solution of dextrose or in a 0.9% solution of sodium chloride to a concentration of 1-2 mg / ml. The daily dose of the drug is administered once or in 3-4 divided doses. The drug is administered at a rate of 60-80 drops / min for 30 minutes.

In severe septic states, the maximum single dose is 300 mg, the daily dose is 600 mg of dioxidine (ie, 120 ml of a solution of 5 mg / ml).

With purulent meningitis, the daily dose is 600 mg of dioxidine (that is, 120 ml of a solution of 5 mg / ml).

In chronic purulent processes in the lungs in the acute stage with signs of generalization, the daily dose is 500-600 mg of dioxidine (ie, 100-120 ml of a solution of 5 mg / ml).

In the treatment of severe purulent urinary tract infection, a daily dose of 200-400 mg of dioxidine (ie 40-80 ml of a solution of 5 mg / ml).

External, local application. To treat superficial purulent wounds on the wound surface, previously cleaned from purulent necrotic masses, apply a cloth wetted with a solution of dioxygen 5 mg / ml. Bandages are changed daily or every other day, depending on the condition of the burn wound and the course of the wound process.

Deep wounds after treatment are plugged or irrigation is carried out with a solution of 5 mg / ml. Dressings are done once a day. The maximum daily dose is 2.5 g. The duration of treatment is up to 3 weeks.

To treat deep purulent wounds in osteomyelitis (bruises of the hand, feet), apply the solution of the drug 5 mg / ml in the form of trays, followed by the application of dressings moistened with the drug.

For a long-term washing of wounds, a solution of 1 mg / ml is used (draining the wound with a thin catheter, rinsing with a few drops for 3-4 hours once or twice a day, but no more than 400-500 ml of solution for rinsing). To obtain solutions with a concentration of 1 -2 mg / ml, ampoule solutions of the drug are diluted to the desired concentration with a sterile 0.9% solution of sodium chloride or water for injection.

Dioxydin in the form of solutions 1-2 mg / ml are also used to prevent infection after surgery.

Side effects:

With intravenous administration, headache, chills, fever, convulsive muscle contraction, allergic reactions, photosensitizing effect (the appearance of pigmented spots on the body when exposed to sunlight), nausea, vomiting, and diarrhea are possible.

With external application: itching, peroronevoy dermatitis.

Overdose:With an overdose of Dioxydin, there are possible side effects associated with impaired synthesis of glucocorticoids (adrenal toxicity), which requires immediate withdrawal of the drug and appropriate hormone replacement therapy.

Interaction:For the prevention of adverse reactions it is recommended to be used simultaneously with antihistamines or calcium preparations.

Special instructions:

Apply under strict medical supervision. Assign only in severe forms of infectious diseases or in the ineffectiveness of other antibacterial drugs, including cephalosporins II-IV generation, fluoroquinolones, carbapenems.

At intravenous introduction the preparation is characterized by a narrow therapeutic breadth (strict control over observance of recommended doses is necessary). To prevent adverse reactions, it is recommended to use in combination with antihistamines and calcium preparations. If adverse reactions occur, reduce the dose, prescribe antihistamines, and if necessary, cancel the drug. With renal failure, the dose is reduced.

Effect on the ability to drive transp. cf. and fur:

During the treatment period, care should be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:Solution for intravenous administration, topical and topical application 5 mg / ml.

Packaging:

5 ml or 10 ml in ampoules.

For 5 ampoules of 5 ml or 10 ml in a planar cell pack of a polyvinyl chloride film. 2 contour squares are placed in a pack of cardboard.

10 ampoules of 10 ml each in a cardboard box.

Each instruction pack or box is supplied with instructions for use, an ampoule knife or a scarifier.At packing of ampoules with a ring of a break, points and notches the knife ampullum or skarifikator do not put.

Storage conditions:

In the dark place at a temperature of 18 to 25 ° C.

Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N002534 / 03

Date of registration:10.04.2008 / 11.08.2014

The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia

Manufacturer: & nbsp

BIOSINTEZ, PAO Russia

Information update date: & nbsp23.12.2015

Illustrated instructions

Instructions

Dioxydin® (Dioxydin)