Tigecycline

What it is and how it works

Mechanism of Action Tigecycline is a tetracycline class antibacterial .

Indications

Tigecycline for Injection is a tetracycline class antibacterial indicated in patients 18 years of age and older for: Complicated skin and skin structure infections Complicated intra-abdominal infections Community-acquired bacterial pneumonia Limitations of Use : Tigecycline for Injection is not indicated for treatment of diabetic foot infection or hospital-acquired pneumonia, including ventilator-associated pneumonia. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tigecycline for Injection and other antibacterial drugs, Tigecycline for Injection should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

Dosage and administration (summary)

Initial dose of 100 mg followed by 50 mg every 12 hours administered intravenously over approximately 30 to 60 minutes. Severe hepatic impairment (Child Pugh C): Initial dose of 100 mg followed by 25 mg every 12 hours. Obtain baseline blood coagulation parameters, including fibrinogen, and continue to monitor regularly during treatment with tigecycline for injection. ( 2.4 , 5.6 ) Recommended Adult Dosage The recommended dosage regimen for tigecycline for injection is an initial dose of 100 mg, followed by 50 mg every 12 hours. Intravenous infusions of tigecycline for injection should be administered over approximately 30 to 60 minutes every 12 hours.

Contraindications

Tigecycline is contraindicated for use in patients who have known hypersensitivity to tigecycline or to any of the excipients. Reactions have included anaphylactic reactions . Known hypersensitivity to tigecycline.

Warnings and precautions

All-Cause Mortality : A meta-analysis of Phase 3 and 4 clinical trials demonstrated an increase in all-cause mortality in tigecycline-treated patients compared to controls with a risk difference of 0.6% (95% CI 0.1, 1.2). The cause of this increase has not been established. An increase was also seen in a meta-analysis limited to the approved indications [0.6% (95% CI 0.0, 1.2)]. The greatest difference in mortality was seen in tigecycline-treated patients with ventilator-associated pneumonia.

Pregnancy

Pregnancy Risk Summary Tigecycline, like other tetracycline class antibacterial drugs, may cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy .

Storage and supply

Prior to reconstitution, Tigecycline for Injection, USP should be stored at 20° to 25°C (68° to 77°F). The reconstituted solution of Tigecycline for Injection, USP may be stored at room temperature (not to exceed 25°C/77°F) for up to 24 hours (up to 6 hours in the vial and the remaining time in the intravenous bag) .

Source: Tigecycline (Tigecycline) — US FDA prescribing information, 2025-09-02, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.