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Respiratory Drug Data - A-Z (English)

Drug Class Description

Anti-allergic agents (antihistamines / mast cell stabilisers).

Generic Name

Ketotifen - asthma

Drug Description

One ml contains 0.345 mg ketotifen fumarate corresponding to 0.25 mg ketotifen. Each drop contains 8.5 microgram ketotifen fumarate

Presentation

Eye drops, solution. Clear, colourless to faintly yellow solution

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 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

Manufacturer

Novartis

Drug Availability

(POM)

Updated

16 June 2009

Drug Languages: en it fr de es no nl pt se

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ZADITEN eye drop