Tigecycline-Vista lyophilisate for infusions 50 mg No. 10

Tigecycline-Vistu is prescribed to adults and children aged 8 years and older for the treatment of:

Tigecycline should only be used when other antibiotics are not appropriate. Official guidance on the appropriate use of antibacterial agents should be consulted.

Composition

Active ingredient: tigecycline.

1 vial contains 50 mg of tigecycline.

Excipients: maltose monohydrate; hydrochloric acid, diluted; sodium hydroxide; water for injections.

Contraindication

Method of application

The initial recommended dose for adults is 100 mg, followed by 50 mg every 12 hours for 5–14 days.

The duration of treatment should be selected depending on the severity of the disease, the location of the infection and the patient's clinical response.

Children and adolescents (ages 8 to 17).

Tigecycline should be used to treat children aged 8 years and older only after consultation with a physician experienced in the treatment of infections.

Application features

Pregnant women

Tigecycline should not be used in pregnant women unless clinically indicated.

Children

The safety and effectiveness of tigecycline in children under 8 years of age have not been established.

Drivers

Dizziness may occur when using tigecycline, which may affect the ability to drive and use machines.

Overdose

There is no specific information on the treatment of overdose. After a single intravenous administration of 300 mg tigecycline over 60 minutes to healthy volunteers, an increased incidence of nausea and vomiting was observed.

Adverse reactions

A total of 2,393 patients with complicated skin and soft tissue infections and complicated intra-abdominal infections were treated during phase 3 and 4 clinical trials of tigecycline.

During clinical trials, the most common adverse reactions associated with the use of the drug were nausea (21%) and vomiting (13%). These reactions were in most cases mild or moderate in severity, usually developed at the beginning of treatment (after 1-2 days) and were reversible.

Interaction

Tigecycline is not extensively metabolized, and therefore active substances that are inhibitors or inducers of CYP450 isoforms are not expected to affect its clearance.

Storage conditions

Store in original packaging at a temperature not exceeding 25º C. Keep out of the reach of children.

Shelf life - 2 years.