Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION, POWDER, FOR SOLUTION
**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_.
INTRAVENOUS
Medical Information
**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.
**4.3 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.
J01AA12
tigecycline
Manufacturer Information
ACCORD HEALTHCARE PRIVATE LIMITED
Intas Pharmaceuticals Limited
INTAS PHARMACEUTICALS LIMITED
Active Ingredients
Documents
Package Inserts
TIGECCORD TIGECYCLINE FOR INJECTION USP PI.pdf
Approved: February 15, 2021