Tygacil(TM) (Tigecycline) Injection 50mg

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

**4.2 Posology and method of administration** **Posology** The recommended dose for adults is an initial dose of 100 mg followed by 50 mg every 12 hours for 5 to 14 days. The duration of therapy should be guided by the severity, site of the infection, and the patient’s clinical response. _**Hepatic insufficiency**_ 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 dose of Tygacil should be reduced to 25 mg every 12 hours following the 100 mg loading dose. Patients with severe hepatic impairment (Child Pugh C) should be treated with caution and monitored for treatment response (see sections 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **_Renal insufficiency_** No dosage adjustment is necessary in patients with renal impairment or in patients undergoing haemodialysis (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**Elderly patients**_ 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 (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _**Paediatric patients**_ Tygacil is not recommended for use in children and adolescents below 18 years due to the lack of data on safety and efficacy (see sections 5.2 and 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Method of administration** Tygacil is administered only by intravenous infusion over 30 to 60 minutes (see section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).