The recommended dosage regimen for adults for tigecycline is an initial dose of 100 mg, followed by 50 mg every 12 hours. Intravenous (IV) infusions of tigecycline should be administered over approximately 30 to 60 minutes every 12 hours.
The recommended duration of treatment with tigecycline for cSSSI or for cIAI is 5 to 14 days. The recommended duration of treatment with tigecycline for CAP 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.
Use in patients with renal impairment: No dosage adjustment of tigecycline is necessary in patients with renal impairment or in patients undergoing hemodialysis (see Pharmacology: Pharmacokinetics under Actions).
Use in patients with hepatic impairment: No dosage adjustment is necessary in patients (including pediatrics) with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B). Based on the pharmacokinetic profile of tigecycline in patients with severe hepatic impairment (Child Pugh C), the dose of tigecycline should be reduced by 50%. Adult dose should be altered to 100 mg followed by 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: Pharmacokinetics under Actions).
Use in children: Tigecycline is only to be used to treat patients aged 8 years and older after consultation with a physician with appropriate experience in the management of infectious diseases. Tigecycline should not be used in children under 8 years of age due to the lack of data on safety and efficacy in this age group and because of teeth discoloration (see Precautions).
Pediatric patients aged 8 to 11 years should receive 1.2 mg/kg of tigecycline every 12 hours intravenously to a maximum dose of 50 mg of tigecycline every 12 hours.
Pediatric patients aged 12 to 17 years should receive 50 mg of tigecycline every 12 hours.
Intravenous (IV) infusions of tigecycline should be administered over approximately 30 to 60 minutes every 12 hours.
The proposed pediatric doses of tigecycline were chosen based on exposures observed in pharmacokinetic trials, which included small numbers of pediatric patients (see Pharmacology: Pharmacokinetics under Actions).
Use in elderly: In a pooled analysis of 3900 subjects who received tigecycline in Phase 3 and 4 clinical studies, 1026 were 65 years and over. Of these, 419 were 75 years and over. No unexpected overall differences in safety were observed between these subjects and younger subjects. No dosage adjustment is necessary in elderly patients.
Race and gender: No dosage adjustment is necessary based on race or gender (see Pharmacology: Pharmacokinetics under Actions).
Mode of administration: Intravenous infusion.
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