Adults: 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. Safety and efficacy of Tigecycline have not been established in paediatric patients and the drug should not be used in patients younger than 18 years of age unless no alternative anti-infectives are available.
Children and adolescents (8 to 17 years of age): BACTICIL 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.
Children aged 8 to <12 years: 1.2 mg/kg of tigecycline every 12 hours intravenously to a maximum dose of 50 mg every 12 hours for 5 to 14 days.
Adolescents aged 12 to <18 years: 50 mg of tigecycline every 12 hours for 5 to 14 days.
Elderly: No dosage adjustment is necessary in elderly patients.
Renal impairment: No dosage adjustment is necessary in patients with renal impairment or in patients undergoing haemodialysis.
Hepatic impairment: No dosage adjustment is warranted in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B).
In patients (including paediatrics) with severe hepatic impairment (Child Pugh C), the dose of tigecycline should be reduced by 50 %. Adult dose 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.
Paediatric population: The safety and efficacy of BACTICIL in children under 8 years of age have not been established. No data are available. BACTICIL should not be used in children aged under 8 years because of teeth discolouration.
Method of administration: Tigecycline is administered only by intravenous infusion over 30 to 60 minutes. Tigecycline should be preferably administered over a 60-minute length of infusion in paediatric patients.
For instructions on reconstitution & dilution of the medicinal product before administration, see Cautions for Usage.