Composition:
Each One ml contains 0.345 mg ketotifen fumarate (equivalent to 0.25 mg ketotifen), each drop contains 8.5 microgram ketotifen fumarate
Mechanism of action:
Ketotifen is a histamine H1-receptor antagonist, studies suggest the additional activities of mast cell stabilisation and inhibition of infiltration, activation and degranulation of eosinophils.
Pharmacokinetics:
plasma levels of ketotifen afterrepeated ocular administration for 14 days were in most cases below the limit of quantitation (20 pg/ml).
About 1% of the substance is excreted unchanged in the urine within 48 hours and 60 to 70% as metabolites, the main metabolite is the practically inactive ketotifen-N-glucuronide
Indications:
Symptomatic treatment of seasonal allergic conjunctivitis.
Dosage and Administration:
- Adults, elderly and children (age 3 and older): one drop of the product into the conjunctival sac twice a day.
- The safety and efficacy of the product in children aged from birth to 3 years have not yet been established.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients.
Side effects:
Immune system disorders: Uncommon: Hypersensitivity
Nervous system disorders: Uncommon: Headache
Eye disorders:
Common: Eye irritation, eye pain, punctate keratitis, punctate corneal epithelial erosion.
Uncommon: Vision blurred (during instillation), dry eye, eyelid disorder, conjunctivitis, photophobia, conjunctival haemorrhage.
Gastrointestinal disorders: Uncommon: Dry mouth
Skin and subcutaneous tissue disorders: Uncommon: Rash, eczema, urticaria
General disorders: Uncommon: Somnolence
events have also been observed: hypersensitivity reactions including local allergic reaction
(mostly contact dermatitis, eye swelling, eyelid pruritis and oedema), systemic allergic reactions including facial swelling/oedema and exacerbation of pre-existing allergic conditions such as asthma and eczema.
Drugs Interactions:
• If the product 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 Zaditofen eye drops, the possibility of such effects cannot be excluded.
Warnings and Precautions:
- This medicine contains 2.6 micrograms benzalkonium chloride in each drop. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses, remove contact lenses prior to application and wait at least 15 minutes before reinsertion.
- Benzalkonium chloride may also cause eye irritation, especially in dry eyes or disorders of the cornea.
Pregnancy: There are no adequate data from the use of ketotifen eye drops in pregnant women, Systemic levels after ocular administration are much lower than after oral use
Lactation: Zaditofen eye drops can be used during lactation.
Effects on ability to drive and use machines:
Any patient who experiences blurred vision or somnolence should not drive or operate machines.
Overdose: No case of overdose has been reported.