Tigacil: Each vial contains Tigecycline INN 50 mg as lyophilized powder.
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.
Adults: The recommended dosage regimen for Tigecycline is an initial dose of 100 mg, followed by 50 mg every 12 hours. Intravenous (IV) infusions of Tigecycline should be administered over approximately 30 to 60 minutes every 12 hours.
Pediatric use: Safety and effectiveness in pediatric patients below the age of 18 years have not been established.
Geriatric use: No unexpected overall differences in safety or effectiveness were observed between these subjects and younger subjects.
Method of reconstitution
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.
Compatible Infusion fluid
Tigecycline is compatible with the following IV fluid:
0.9% Sodium Chloride Injection
5% Dextrose Injection
Lactated Ringer’s Injection.
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.
Pharmaceutical precaution: Prior to reconstitution, Tigecycline should be stored at 20°C to 25°C. Once reconstituted, Tigecycline may be stored at room temperature for up to 24 hours (up to 6 hours in the vial and the remaining time in the intravenous bag). Reconstituted solution may be stored refrigerated at 2 °C to 8 °C for up to 48 hours following immediate transfer of reconstituted solution into the intravenous bag.
Lactation: Caution should be exercised when Tigecycline is administered to a nursing woman.