Table 3

Illustrative examples for each group of off label drug use

Proprietary nameConstituentNo. of off label prescriptionsOff label status originSummary of Product Characteristics
Ventoline 100 μgSalbutamol (MDI)25AgeNo advice for use in paediatric population
Rifamycine ChibretRifampicin (eye drops)18AgeNo advice for use in paediatric population
IsofraFramycetine3-150 (nasal drops)13AgeNo advice for use in neonates and infants
TridesonitDésonide3-151(cream)7AgeDisclaimer for use in infants
MucomystAcetylcysteine3-152 26IndicationRestricted to bronchitis
ClamoxylAmoxicillin10DoseDaily dose after 30 months: 25–50 mg/kg
HB VAX DNA 5 μgHepatitis B vaccine27RouteSubcutaneous use not indicated
  • 3-150 Aminoglycoside nasal drops used in purulent rhinitis.

  • 3-151 Corticosteroid cream used in atopic dermatitis.

  • 3-152 Mucolytic agent used in upper respiratory tract infections.