Description

Tigecycline is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Complicated Skin and Skin structure Infections: Complicated skin and skin structure infections caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes, Enterobacter cloacae, Klebsiella pneumoniae and Bacteroides fragilis. Complicated Intra-Abdominal Infections: Complicated intra-abdominal infections caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros. Community-Acquired Bacterial Pneumonia: Community-acquired bacterial pneumonia caused by Streptococcus pneumoniae (penicillin-susceptible isolates), including cases with concurrent bacteremia, Haemophilus influenzae (beta-lactamase negative isolates), and Legionella pneumophila.

Drug interaction of Tigecycline with Digoxin and Warfarin is observed.

The most common treatment-emergent adverse events are nausea and vomiting which generally occurre during the first 1-2 days of therapy. The following drug-related adverse events are reported infrequently in patients receiving Tigecycline: Injection site inflammation & pain, septic shock, allergic reaction, chills, thrombophlebitis, bradycardia, tachycardia, vasodilatation, anorexia, dry mouth, hypoglycemia, hyponatremia, prolonged prothrombin time, eosinophilia, thrombocytopenia, vaginal moniliasis, vaginitis, leukorrhea.

Pregnancy: Tigecycline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactation: Caution should be exercised when Tigecycline is administered to a nursing woman.

Tigecycline is structurally similar to Tetracycline-class antibiotics and should be administered with caution in patients with known hypersensitivity to Tetracycline-class antibiotics

No specific information is available on the treatment of overdosage with Tigecycline. Intravenous administration of Tigecycline at a single dose of 300 mg over 60 minutes in healthy volunteers resulted in an increased incidence of nausea and vomiting.

Tetracycline group of drugs

Each vial of Tigecycline should be reconstituted with 5.3 ml of 0.9% Sodium Chloride Injection to achieve a concentration of 10 mg/ml of Tigecycline. The vial should be gently swirled until the drug dissolves. Withdraw 5 ml of the reconstituted solution from the vial and add to a 100 ml intravenous bag of 0.9% Sodium Chloride or 5% Dextrose for infusion (for a 100 mg dose, reconstitute two vials; for a 50 mg dose, reconstitute one vial). The maximum concentration of IV solution should be 1 mg/ml. If the same intravenous line is used for sequential infusion of several drugs, the line should be flushed before and after infusion of Tigecycline with either 0.9% Sodium Chloride Injection or 5% Dextrose Injection.  Tigecycline is compatible with the following IV fluid: 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Lactated Ringer’s Injection.