TIGECCORD TIGECYCLINE FOR INJECTION USP 50 MG/VIAL [SIN16104P]

Product Info

TIGECCORD TIGECYCLINE FOR INJECTION USP 50 MG/VIAL

[SIN16104P]

4.1 Therapeutic indications

Tigeccord is indicated in 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), excluding diabetic foot infections (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information);

• Complicated intra-abdominal infections (cIAI).

Tigeccord 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).

Tigeccord should be used only in situations where other alternative antibiotics are not suitable (see sections 4.4, 4.8 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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

4.2 Posology and method of administration

Posology

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.

Elderly
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).

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 (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 impairment
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).

Paediatric population
Tigecycline is not recommended for use in children and adolescents below 18 years due to the lack of data on safety and efficacy.

Method of administration:

Tigecycline is administered only by intravenous infusion over 30 to 60 minutes (see sections 4.4 and 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

For instructions on reconstitution & dilution of the medicinal product before administration, 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.