Tigecare Dosage/Direction for Use

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.
The recommended duration of treatment with Tigecycline for Injection for complicated skin and skin structure infections or for complicated intra-abdominal infections is 5 to 14 days. The recommended duration of treatment with Tigecycline for Injection for community-acquired bacterial pneumonia is 7 to 14 days. The duration of therapy should be guided by the severity and site of the infection and the patient's clinical and bacteriological progress.
Dosage in Patients with Hepatic Impairment: No dosage adjustment is warranted in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B). In patients with severe hepatic impairment (Child Pugh C), the initial dose of Tigecycline for Injection should be 100 mg followed by a reduced maintenance dose of 25 mg every 12 hours. Patients with severe hepatic impairment (Child Pugh C) should be treated with caution and monitored for treatment response [see Pharmacology under Actions].
Dosage in Pediatric Patients: The safety and efficacy of the proposed pediatric dosing regimens have not been evaluated due to the observed increase in mortality associated with Tigecycline in adult patients. Avoid use of Tigecycline in pediatric patients unless no alternative antibacterial drugs are available. Under these circumstances, the following doses are suggested: Pediatric patients aged 8 to 11 years should receive 1.2 mg/kg of Tigecycline for Injection every 12 hours intravenously to a maximum dose of 50 mg of Tigecycline for Injection every 12 hours.
Pediatric patients aged 12 to 17 years should receive 50 mg of Tigecycline for Injection every 12 hours.
The proposed pediatric doses of Tigecycline for Injection were chosen based on exposures observed in pharmacokinetic trials, which included small numbers of pediatric patients [see Pharmacology: Specific Populations under Actions].
There are no data to provide dosing recommendations in pediatric patients with hepatic impairment.
Preparation and Administration: Each vial of Tigecycline for Injection should be reconstituted with 5.3 mL of 0.9% Sodium Chloride Injection, USP, 5% Dextrose Injection, USP, or Lactated Ringer's Injection, USP to achieve a concentration of 10 mg/mL of tigecycline. (Note: Each vial contains a 6% overage. Thus, 5 mL of reconstituted solution is equivalent to 50 mg of the drug.) The vial should be gently swirled until the drug dissolves. Reconstituted solution must be transferred and further diluted for intravenous infusion. Withdraw 5 mL of the reconstituted solution from the vial and add to a 100 mL intravenous bag for infusion (for a 100 mg dose, reconstitute two vials; for a 50 mg dose, reconstitute one vial). The maximum concentration in the intravenous bag should be 1 mg/mL. The reconstituted solution should be yellow to orange in color; if not, the solution should be discarded.
Parenteral drug products should be inspected visually for particulate matter and discoloration (e.g., green or black) prior to administration. Once reconstituted, Tigecycline for Injection 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). If the storage conditions exceed 25°C (77°F) after reconstitution, tigecycline should be used immediately. Alternatively, Tigecycline for Injection mixed with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP may be stored refrigerated at 2° to 8°C (36° to 46°F) for up to 48 hours following immediate transfer of the reconstituted solution into the intravenous bag.
Tigecycline for Injection may be administered intravenously through a dedicated line or through a Y-site.
If the same intravenous line is used for sequential infusion of several drugs, the line should be flushed before and after infusion of Tigecycline for Injection with 0.9% Sodium Chloride Injection, USP, 5% Dextrose Injection, USP or Lactated Ringer's Injection, USP. Injection should be made with an infusion solution compatible with tigecycline and with any other drug(s) administered via this common line.