Initial Dose: 100 mg followed by 50 mg every 12 hrs by IV route.
Tygacil is administered by IV infusion. The infusion time should be approximately 30-60 min (see Instructions for Use and Handling as follows).
The recommended duration of treatment with tigecycline for complicated skin and skin structure infections or for complicated intra-abdominal infections is 5-14 days. The recommended duration of treatment with tigecycline for community-acquired pneumonia is 7-14 days. The duration of therapy should be guided by the severity and site of the infection and the patient's clinical and bacteriological progress.
Hepatic Insufficiency: No dosage adjustment is necessary in patients with mild to moderate hepatic impairment (Child-Pugh A and B). Based on the pharmacokinetic profile of tigecycline in patients with severe hepatic impairment (Child-Pugh C), the dose of tigecycline should be altered to 100 mg followed by 25 mg every 12 hrs. Patients with severe hepatic impairment (Child-Pugh C) should be treated with caution and monitored for treatment response (see Pharmacokinetics under Actions).
Renal Insufficiency: No dosage adjustment is necessary in patients with renal impairment or in patients undergoing haemodialysis (see Pharmacokinetics under Actions).
Elderly: No dosage adjustment is necessary in elderly patients (see Pharmacokinetics under Actions).
Gender and Race: No dosage adjustment is necessary based on gender and race (see Pharmacokinetics under Actions).
Administration: Instructions for Use and Handling: The lyophilized powder should be reconstituted with 5.3 mL of 0.9% sodium chloride injection or 5% dextrose injection or Lactated Ringer's injection 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 to a 100-mL IV bag for infusion. For a 100-mg dose, reconstitute using 2 vials into a 100-mL IV bag. (Note: The vial contains a 6% overage. Thus, 5 mL of reconstituted solution is equivalent to 50 mg of the drug.) The reconstituted solution should be yellow to orange in colour; if not, the solution should be discarded. Tygacil may be administered IV through a dedicated line or through a Y-site. If the same IV line is used for sequential infusion of several drugs, the line should be flushed before and after infusion of Tygacil with either 0.9% sodium chloride injection or 5% dextrose injection. Injection should be made with an infusion solution compatible with tigecycline and any other medicinal product(s) via this common line (see Incompatibilities under Interactions).
Reconstituted solution must be transferred and further diluted for IV infusion.
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