Composition:
Each One ml contains 0.345 mg ketotifen fumarate (equivalent to 0.25 mg ketotifen).
Each drop contains 8.5 microgram ketotifen fumarate
Excipients:
Benzalkonium chloride , Glycerol , Sodium hydroxide , Water for injections.
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.