Tigecycline is indicated 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 group (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 group (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.

The duration of therapy should be guided by the severity and site of the infection, as well as the patient's clinical and bacteriological progress. The recommended duration of treatment with Tigecycline is:
Complicated skin and skin structure infections or complicated intra-abdominal infections: 5 to 14 days
Community-acquired bacterial pneumonia: 7 to 14 days
The recommended daily dose is as follows:
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 elderly and younger patients.

Each vial of Tigecycline should be reconstituted with 5 mL of Sodium Chloride 0.9% Solution 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 it 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 the 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 fluids:
0.9% Sodium Chloride Injection
5% Dextrose Injection
Lactated Ringer’s Injection

Tigecycline is contraindicated in patients with known hypersensitivity to any components of this product.

Tegalon®: Each pack contains:
1 vial of Tigecycline USP 50 mg as lyophilized powder
1 ampoule of 5 mL Sodium Chloride 0.9% Solution BP
1 sterile 5 mL disposable syringe with a needle
