1, Recommended Adult Dosage
The recommended dosage regimen for this product is an initial dose of 100 mg (2 vials), followed by 50 mg (1 vial) every 12 hours. Intravenous infusions of this product should be administered over approximately 30 minutes to 60 minutes every 12 hours.
The recommended duration of treatment with this product for complicated intra-abdominal infections is 5 days 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.
2, 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 this product should be 100 mg (2 vials) followed by a reduced maintenance dose of 25 mg (half vial) every 12 hours. Patients with severe hepatic impairment (Child Pugh C) should be treated with caution and monitored for treatment response.
3. Dosage in Patients with Renal Impairment or in Patients Undergoing Haemodialysis
No dosage adjustment is necessary in patients with renal impairment or in patients undergoing haemodialysis.
4. No dosage adjustment based on the age, sex or ethnicity is warranted in patients 18 years of age and older.
Preparation and Administration
Reconstitution and Dilution: Each vial of this product should be reconstituted with 5.3 mL of 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or Lactated Ringer’s Injection, 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. Withdraw 5 mL of the reconstituted solution from the vial and add to a 100 mL intravenous bag for infusion or other suitable infusion container (such as a glass bottle) (for a 100 mg dose, reconstitute two vials; for a 50 mg dose, reconstitute one vial). The maximum concentration in the intravenous bag or other suitable infusion container (such as a glass bottle) should be 1 mg/mL. The reconstituted solution should be yellow to orange in color; if not, the solution should be discarded.
Storage of Reconstituted Solution: Parenteral drug products should be inspected visually for particulate matter and discoloration (e.g., green or black) prior to administration. Once reconstituted, this product may be stored at room temperature for up to 24 hours (up to 6 hours in the vial and the remaining time up to 18 hours in the intravenous bag). Alternatively, this product mixed with 0.9% Sodium Chloride Injection, or 5% Dextrose Injection, may be stored refrigerated at 2°C to 8°C for up to 48 hours following immediate transfer of the reconstituted solution into the intravenous bag or other suitable infusion container (such as a glass bottle).
Administration of the Diluted Solution: This product 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 this product with 0.9% Sodium Chloride Injection or 5% Dextrose Injection. Injection should be made with an infusion solution compatible with Tigecycline and with any other drug(s) administered via this common line.
Compatible intravenous solutions include 0.9% Sodium Chloride Injection, 5% Dextrose Injection, and Lactated Ringer's Injection (USP).
When administered through a Y-tube, this product is compatible with the following drugs or diluents when used with 0.9% Sodium Chloride Injection or 5% Dextrose Injection: amikacin, dobutamine, dopamine HCl, gentamicin, haloperidol, Lactated Ringer's, lidocaine HCl, metoclopramide, morphine, norepinephrine, piperacillin/tazobactam (EDTA formulation), potassium chloride, propofol, ranitidine HCl, theophylline, and tobramycin.
The following drugs should not be administered simultaneously through the same Y-site as this prodcut: amphotericin B, amphotericin B lipid complex, diazepam, esomeprazole and omeprazole