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Safety profile

In clinical studies in complicated skin and soft tissue infections (cSSTI), complicated intra-abdominal infections (cIAI), diabetic foot infections, nosocomial pneumonia and studies in resistant pathogens, a numerically higher mortality rate among tigecycline treated patients has been observed as compared to the comparator treatment. The causes of these findings remain unknown, but poorer efficacy and safety than the study comparators cannot be ruled out.1

Tigecycline may prolong both prothrombin time and activated partial thromboplastin time therefore the relevant coagulation tests should be closely monitored when tigecycline is co-administered with anticoagulants1

Superinfection: In clinical trials in cIAI patients, impaired healing of the surgical wound has been associated with superinfection. A patient developing impaired healing should be monitored for the detection of superinfection.
Patients who develop superinfections, in particular nosocomial pneumonia, appear to be associated with poorer outcomes. Patients should be closely monitored for the development of superinfection. If a focus of infection other than cSSTI or cIAI is identified after initiation of tigecycline therapy consideration should be given to instituting alternative antibacterial therapy that has been demonstrated to be efficacious in the treatment of the specific type of infection(s) present.

Tygacil is not extensively metabolised.1
Based on in vitro studies, Tygacil is not expected to alter the metabolism of drugs metabolized by cytochrome P450 enzymes.1

Concurrent use of antibiotics with oral contraceptives may render oral contraceptives less effective. Based on an in vitro study tigecycline is a P-gp substrate. Co-administration of P-gp inhibitors (eg. ketoconazole or cyclosporine) or P-gp inducers (e.g., rifampicin) could affect the pharmacokinetics of tigecycline.

Common and very common side effects are listed below1:

 

System Organ Class Very Common ≥ 1/10 Common ≥ 1/1000 to < 1/10
Infections and infestations   Sepsis/septic shock, pneumonia, abscess, infections
Blood and lymphatic system disorders   Prolonged activated partial thromboplastin time (aPTT), prolonged prothrombin time (PT)
Metabolism and nutrition   Hypoglycaemia, hypoproteinemia
Nervous system disorders   Dizziness
Vascular disorders   Phlebitis
Gastrointestinal disorders Nausea, vomiting, diarrhoea Abdominal pain, dyspepsia, anorexia
Hepatobiliary disorders   Elevated aspartate aminotransferase (AST) in serum, and elevated alanine aminotransferase (ALT) in serum, hyperbilirubinemia
Skin and subcutaneous tissue disorders   Pruritus, rash
General disorders and administration site conditions   Impaired healing, injection site reaction, headache
Investigations   Elevated amylase in serum, increased blood urea nitrogen (BUN)

 

References
    1.     Tygacil Summary of Product Characteristics