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Drug Details

ZADITEN eye drop

• Drug Class Description
  Anti-allergic agents (antihistamines / mast cell stabilisers).
• Generic Name
  Ketotifen - asthma
• Presentation
  Eye drops, solution. Clear, colourless to faintly yellow solution
• Description
  One ml contains 0.345 mg ketotifen fumarate corresponding to 0.25 mg ketotifen. Each drop contains 8.5 microgram ketotifen fumarate
• Indications
  Symptomatic treatment of seasonal allergic conjunctivitis
• Adult Dosage
  

  Adults, elderly and children (age 3 and older): one drop of ZADITEN into the conjunctival sac twice a day.

  The contents and dispenser remain sterile until the original closure is broken. To avoid contamination do not touch any surface with the dropper tip.

• Child Dosage
  Under 2 years, not recommended; over 2 years, 1 mg twice daily with food.
• Contra Indications
  

  Hypersensitivity to ketotifen or to any of the excipients.

• Special Precautions
  

  The formulation of ZADITEN eye drops contains benzalkonium chloride as a preservative, which may be deposited in soft contact lenses; therefore ZADITEN eye drops should not be instilled while the patient is wearing these lenses. The lenses should be removed before application of the drops and not reinserted earlier than 15 minutes after use.

  All eye drops preserved with benzalkonium chloride may possibly discolour soft contact lenses.

• Interactions
  

  If ZADITEN is used concomitantly with other eye medications there must be an interval of at least 5 minutes between the two medications.

  The use of oral dosage forms of ketotifen may potentiate the effect of CNS depressants, antihistamines and alcohol. Although this has not been observed with ZADITEN eye drops, the possibility of such effects cannot be excluded.

• Adverse Drug Reactions
  

  At the recommended dose, the following undesirable effects have been reported:

  Eye disorders

  Common effects: Eye irritation, eye pain, punctate keratitis.

  Uncommon effects: Vision blurred (during instillation), dry eye, eyelid disorder, conjunctivitis, photophobia, conjunctival haemorrhage.

  Nervous system disorders

  Uncommon effects: Headache

  General disorders and administration site conditions

  Uncommon effects: Somnolence

  Skin and subcutaneous tissue disorders

  Uncommon effects: Rash, eczema, urticaria

  Gastrointestinal disorders

  Uncommon effects: Dry mouth

  Immune system disorders

  Uncommon effects: Hypersensitivity