Lyophilisate for Azithromycin solution is indicated for infections requiring initial infusion therapy caused by microorganisms sensitive to Azithromycin:

Active substance: azithromycin;

1 vial contains 500 mg of azithromycin (in the form of azithromycin dihydrate);

Excipients: citric acid monohydrate, sodium hydroxide.

Hypersensitivity to azithromycin, erythromycin or to any macrolide or ketolide antibiotic, or to any other component of the preparation.

Due to the theoretical possibility of ergotism, azithromycin should not be prescribed simultaneously with ergot derivatives.

The preparation should be used as an infusion for 3 hours with a concentration of 1 mg/ml and for 1 hour with a concentration of 2 mg/ml. The use of high concentrations should be avoided, as an infusion site reaction was observed in volunteers in studies who received infusions at concentrations higher than 2 mg/ml.

The duration of infusion of azithromycin should be at least 60 minutes.

Azithromycin cannot be used bolus or intramuscularly.

pregnant

Given the lack of data on the safety of azithromycin use, it is not recommended to prescribe the preparation during pregnancy and breastfeeding, except in cases where the expected positive effect for the mother exceeds the possible risk of using the preparation for the fetus or child, in the absence of adequate alternative preparations.

Children

The safety and efficacy of intravenous azithromycin for the treatment of infections in children have not been established.

Drivers

There is no evidence that azithromycin can impair the ability to drive vehicles or other mechanisms, but the possibility of developing adverse reactions, such as dizziness, drowsiness, and visual impairment, should be taken into account.

Typical symptoms of overdose: nausea, vomiting, diarrhea, abdominal pain and reversible hearing loss.

In case of overdose, if necessary, it is recommended to take activated charcoal and carry out symptomatic therapy aimed at supporting the body's vital functions.

When using azithromycin intravenously or orally for the treatment of pneumonia, the most frequently reported adverse events were diarrhea / loose stools, nausea, stomach pain, and vomiting. In case of administration of azithromycin, local inflammation/pain at the infusion site has been reported. The frequency and severity of these reactions were similar to those observed with an infusion of 500 mg of azithromycin over 1 hour (2 mg/ml as a 250 ml infusion) or 3 hours (1 mg/ml as a 500 ml infusion).

Diarrhea, nausea, vaginitis, stomach pain, anorexia, rash, and pruritus were frequently reported adverse events in adult women using intravenous or oral azithromycin in the treatment of pelvic inflammatory disease. With the simultaneous use of azithromycin and metronidazole in most women, such undesirable effects as nausea, stomach pain, vomiting, irritation at the infusion site, stomatitis, dizziness or shortness of breath were observed.

Azithromycin should be administered with caution to patients with other medications that may prolong the QT interval.

Store in the original packaging at a temperature not higher than 25 °C.

Keep out of the reach of children.

Shelf life - 3 years.