Tigecycline

The recommended dosage regimen for tigecycline injection is an initial dose of 100 mg, followed by 50 mg every 12 hours. The intravenous infusions of tigecycline should be administered over about 30-60 minutes every 12 hours. The recommended duration of therapy with tigecycline for complicated skin and skin structure infections or for complicated intra-abdominal infections is 5-14 days. The recommended duration of therapy with tigecycline for the community-acquired bacterial pneumonia is 7-14 days. Duration of therapy must be guided through the severity & site of the infection and the patient’s clinical as well as bacteriological progress.

Commonly reported side effects are incidence >5% in patients treated with tigecycline 50 mg injection include:

• Nausea
• Vomiting
• Diarrhea
• Abdominal pain
• Headache
• Increased SGPT

• Use of tigecycline 50 mg injection is contraindicated in patients with known hypersensitivity to this drug.
• Patients with tigecycline and who established abnormal liver function tests should be assessed for evidence of worsening hepatic function and evaluated for the risk or benefit of continuing tigecycline therapy.
• Administration tigecycline 50 mg injection may cause fetal harm to pregnant women. In case the patient becomes pregnant while on therapy, the patient must be apprised of the potential risk to the fetus.
• The use of tigecycline during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may be responsible for causing permanent discoloration of the teeth (yellow-gray-brown).
• Caution should be imposed if using tigecycline 50 mg monotherapy in recipients with complicated intra abdominal infections secondary to the clinically apparent intestinal perforation.
• As with certain other antibacterial agents, tigecycline injection uses may cause excess growth of non-susceptible organisms, including fungi. Patients must be precisely evaluated while on therapy. In case superinfection occurs, apt measures must be considered.

Prior to reconstitution, Tigecycline should be stored at 20°C to 25°C (68°F to 77°F). The excursions permitted 15°C-30°C (59°F-86°F). Following the reconstitution, it could be stored at room temperature for up to 1-day/24-hours (up to six hours in the vial and the rest time in the intravenous bag). Alternatively, Tigecycline is mixed with 0.9% Sodium Cl Injection, USP or 5% Dextrose Injection, USP can be stored in refrigerator at 2°C to 8°C (36°F to 46°F) for up to 48 hours after immediate transfer of the reconstituted solution into the intravenous bag. The reconstituted solution must be transferred and further diluted for intravenous infusion.

• Prothrombin time or other suitable anticoagulation test should be monitored in case tigecycline is administered along with warfarin.
• Administration of antibacterial drugs along with oral contraceptives may render oral contraceptives less effective.