ASK DIS: 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

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.

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:

ASK DIS