were immunocompromised, patients with decubitus ulcer infections, or patients that had infections requiring longer than 14 days of treatment (for example, necrotizing fasciitis), were not enrolled. A limited number of patients were enrolled with co-morbid factors such as diabetes (20 %), peripheral vascular disease (7 %), intravenous drug abuse (2 %), and HIV-positive infection (1 %). Limited experience is also available in treating patients with concurrent bacteraemia (3 %). Therefore, caution is advised when treating such patients. The results in a large study in patients with diabetic foot infection, showed that tigecycline was less effective than comparator, therefore, tigecycline is not recommended for use in these patients (see section 4.1).
In clinical trials in complicated intra-abdominal infections, the most common type of infection in tigecycline treated-patients was complicated appendicitis (51 %), followed by other diagnoses less commonly reported such as complicated cholecystitis (14 %), intra-abdominal abscess (10 %), perforation of intestine (10 %) and gastric or duodenal ulcer perforation less than 24 hours (5 %). Of these patients, 76 % had associated diffuse peritonitis (surgically-apparent peritonitis). There were a limited number of patients with severe underlying disease such as immunocompromised patients, patients with APACHE II scores > 15 (4 %), or with surgically apparent multiple intra-abdominal abscesses (10 %). Limited experience is also available in treating patients with concurrent bacteraemia (6 %). Therefore, caution is advised when treating such patients.
Consideration should be given to the use of combination antibacterial therapy whenever tigecycline is to be administered to severely ill patients with complicated intra-abdominal infections (cIAI) secondary to clinically apparent intestinal perforation or patients with incipient sepsis or septic shock (see section 4.8).
The effect of cholestasis in the pharmacokinetics of tigecycline has not been properly established. Biliary excretion accounts for approximately 50 % of the total tigecycline excretion. Therefore, patients presenting with cholestasis should be closely monitored.
Prothrombin time or other suitable anticoagulation test should be used to monitor patients if tigecycline is administered with anticoagulants (see section 4.5).
Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of any antibacterial agent (see section 4.8).
The use of tigecycline may result in overgrowth of non-susceptible organisms, including fungi. Patients should be carefully monitored during therapy. If super infection occurs, appropriate measures should be taken (see section 4.8).
Results of studies in rats with tigecycline have shown bone discolouration. Tigecycline may be associated with permanent tooth discolouration in humans if used during tooth development (see section 4.8).
Paediatric population
Tygacil should not be used in children under 8 years of age because of teeth discolouration, and is not recommended in adolescents below 18 years due to the lack of data on safety and efficacy (see sections 4.2 and 4.8).
4.5 Interaction with other medicinal products and other forms of interaction
Interaction studies have o |
