TYGACIL(TM) (TIGECYCLINE) INJECTION 50MG [SIN13282P]

Product Info

TYGACIL(TM) (TIGECYCLINE) INJECTION 50MG

[SIN13282P]

4.1 Therapeutic indications

Tygacil is indicated for the treatment of the following infections (see sections 4.4 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information):

➢ Complicated skin and soft tissue infections (cSSTI).

➢ Complicated intra-abdominal infections (cIAI).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Tigecycline is not indicated for the treatment of hospital-acquired or ventilator-associated pneumonia (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 hemodialysis (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).

Pediatric 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).

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. Patients hypersensitive to tetracycline class antibiotics may be hypersensitive to tigecycline.