tigecycline: clinical use

Prescribing considerations

• Reserve for licensed complicated infections when alternative antibacterial agents are unsuitable; obtain cultures and review susceptibility and source control.
• A numerical excess in mortality versus comparators has been observed; poorer efficacy or safety cannot be excluded.
• Avoid use for diabetic foot infection; efficacy was inferior to the comparator in a large study.
• Clinical experience is limited in severe underlying disease, concurrent bacteraemia and paediatric patients.
• Review promptly if superinfection, especially hospital-acquired pneumonia, develops.
• Use caution in severe hepatic impairment and assess clinical response closely.

Contraindications and cautions

• Hypersensitivity to tigecycline or any product excipient
• Possible cross-hypersensitivity in patients allergic to tetracycline-class antibiotics
• Do not use in children under 8 years because safety and efficacy are unestablished and permanent tooth discolouration may occur

Monitoring

• Liver function, full blood count, coagulation parameters including fibrinogen, amylase and lipase
• Clinical response, infection focus, cultures and emergence of non-susceptible organisms or fungal overgrowth
• Symptoms of pancreatitis, hepatic injury, severe diarrhoea, hypersensitivity and impaired wound healing
• Tacrolimus or ciclosporin trough concentrations when co-administered
• Hydration in children experiencing nausea or vomiting

Clinical pharmacology

Tigecycline is principally bacteriostatic and distributes extensively into tissues. It undergoes limited metabolism and is eliminated mainly through biliary and faecal routes. Activity is limited against Proteus, Providencia and Morganella species and is unreliable against Pseudomonas aeruginosa.

Formulation and product differences

• The selected product is a single-use orange to orange-red lyophilised powder for intravenous infusion.
• It may be reconstituted and diluted with sodium chloride 0.9% or glucose 5%; it is incompatible with Ringer lactate solution.
• The selected formulation contains L-arginine, hydrochloric acid and sodium hydroxide.
• Use a dedicated intravenous line or confirm Y-site compatibility and flush the line when necessary.

Solution for infusion

Route: Intravenous

Strengths: 50 mg