Indication for Fusafungine

Availability: Locabiotal 125 microgram/dose nasal and oromucosal spray, solution
(not available in Hospital Keningau)
Properties

• Fusafungine is a non-systemic, non-absorbed anti-inflammatory antibiotic. 
• It shows in vitro antibacterial activity and potential in vivo activity against the following microorganisms: group A streptococci, pneumococci, staphylococci, certain Neisseria strains, certain anaerobic bacteria, Candida albicans and Mycoplasma pneumoniae. 
• The product has a bacteriostatic effect
• Locabiotal is primarily absorbed via the oral cavity and via the nasal mucosa

Indication

• Indicated for the treatment of infections and inflammatory processes of the upper airways (rhinitis, rhinopharyngitis, laryngitis, tonsillitis, status after tonsillectomy, sinusitis). 
• Locabiotal is recommended for use in adults and adolescents aged 12 years and over

Posology 

• 4 puffs in the mouth and 2 puffs in each nostril 4 times daily. 
• Method of administration 
• Use the proper attachment piece for administration in the mouth and puffs in the nostrils. 

Duration of treatment: 

• The average treatment period should not exceed 10 days. After 10 days, treatment has to be reconsidered

Contraindications 

• Hypersensitivity to the active ingredient or to any of the excipients 
• In children under 12 years (there is a risk of laryngospasm) 
• Patients with allergic tendencies and bronchospasm

Pregnancy & Lactation

• No clinical data are available on the usage during pregnancy.
• Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development
• No clinical data are available to determine whether fusafungine is excreted in human breast milk. The excretion of fusafungine in milk has not been studied in animals either

Side Effects

• majority of paediatric reports of allergic reactions associated with fusafungine were reported in children less than 12 years and 42% (16/38) were assessed as serious, including one case with a fatal outcome. 
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Effectiveness

• percentage of responders (patients with nasal symptom score improvement from Day 0 to Day 4) was 61.5 ± 2.9% with fusafungine vs 46.8 ± 3.1% with placebo (p=0.009) with an odds ratio of 1.8 (p=0.01) in favour of fusafungine. 
• The nasal symptom score distribution at Day 4 showed an odds ratio of 1.56 (p=0.011) also in favour of fusafungine. 
• For patients treated early (onset of symptoms £1 day) the percentage of responders was 65.9 ± 4.1% with fusafungine vs 38.3 ± 4.0% with placebo (p=0.022) with an odds ratio of 3.08 (p=0.033) in favour of fusafungine.

References:

1. http://www.medicines.ie/medicine/2582/SPC/Locabiotal/
2. http://www.servier.com/sites/default/files/SPC-Locabiotal-EN-Aproved.pdf
3. http://www.medscape.com/viewarticle/446550