Tygacil (taigecycline) powder for solution for infusions 50 mg. vial №10

Description

Tygacil (taigecycline) powder for solution for infusions 50 mg. vial №10

Composition

active substance: taigecycline;

1 vial contains 50 mg of taigecycline;

excipients: lactose monohydrate; dilute hydrochloric acid; sodium hydroxide.

Dosage form

Powder for solution for infusion.

Main physical and chemical properties: lyophilisate in the form of a sticky mass or orange powder.

Pharmacotherapeutic group

Antibacterial agents for systemic use, tetracyclines.
ATX code J01A A12.

Pharmacological properties

It is an antibacterial agent of the glycylcycline series. The drug inhibits protein translation in bacterial cells by attaching to the 30S ribosomal subunit, blocking the entry of aminoacyl-tRNA into site A of the ribosome, preventing the incorporation of amino acid residues into peptide chains.

Indications

Tygacil is used for infectious and inflammatory diseases caused by microorganisms sensitive to tigecycline:

• with complicated infections of the skin, soft tissues, with the exception of infection of the diabetic foot;
• with complicated infections of the abdominal cavity.

Tigacil is used only in cases where the appointment of other antibacterial agents is unacceptable.

Contraindications

Tygacil is not applied:

• with an allergy to an active ingredient;
• with intolerance to auxiliary components;
• when breastfeeding.

Application during pregnancy and lactation

During pregnancy, it is possible to use it if the expected benefit of treatment for the mother outweighs the risk to the fetus. FDA category of action on the fetus – B.
The drug is excreted in breast milk, so breastfeeding is stopped during the treatment period.

Method of administration and dosage

Tygacil is administered by intravenous drip (for 30-60 minutes).
The standard initial dose for adults is 100 mg, then 50 mg is used every 12 hours for 5-14 days.
The duration of treatment depends on the location of the infection, the severity of the course, and the patient’s clinical response.
Patients with mild / moderate liver damage (Child-Pugh A, B) do not need dose adjustment, with severe hepatic impairment (Child-Pugh C) the dose is reduced to 25 mg every 12 hours; the initial loading dose is 100 mg.
The standard starting dose for children 8-12 years old is 1.2 mg / kg every 12 hours, the maximum dose is 50 mg every 12 hours for 5-14 days.
Children 12-18 years old – 50 mg every 12 hours for 5-14 days.

Overdose

• Symptoms: nausea, vomiting.
• Treatment: symptomatic, supportive therapy.

Side effects:

• Infections / invasions: abscesses, pneumonia, infections, sepsis, septic shock.
• Hematological disorders: prolongation of activated partial thromboplastin time, prothrombin time, increased INR, thrombocytopenia.
• Immune disorders: anaphylactic, anaphylactoid reactions.
• Metabolic disorders: hypoproteinemia, hypoglycemia.
• Neurological disorders: dizziness, headache.
• Cardiovascular disorders: phlebitis, thrombophlebitis.
• Digestive disorders: nausea, diarrhea, vomiting, abdominal pain, anorexia, dyspepsia, acute pancreatitis, increased levels of ASAT, ALT, hyperbilirubinemia, jaundice, cholestasis, liver damage, liver failure, pseudomembranous colitis.
• Dermatological disorders: itching, rash, Stevens-Johnson syndrome.
• Changes in laboratory data: an increase in the level of amylase, the level of urea nitrogen in the blood.
• General: impaired healing, inflammation, edema, pain, phlebitis at the injection site, superinfection, hypersensitivity to light, pseudotumor of the brain, pancreatitis, acidosis, hyperphosphatemia.