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DrugindexOnline2nd edition
All about: Ketotifen Fumarate

Class: Ophthalmic antihistamine
Trade Names:
Zaditor
- Solution 0.025%
Mechanism of Action
Pharmacology
Inhibits release of mediators from cells involved in hypersensitivity reactions.
Pharmacokinetics
Absorption
Little systemic exposure following topical ocular administration.
Indications and Usage
Temporary prevention of itching of eyes caused by allergic conjunctivitis.
Contraindications
Standard considerations.
Dosage and Administration
Adults and children 3 yr of age and olderOphthalmic 1 drop in affected eye(s) twice daily, every 8 to 12 h.
General Advice
- For topical ophthalmic use only. Not for use on the skin, in the ear, or for injection into eye.
- Ask patient to tilt head back and instill prescribed number of drops into affected eye(s) as ordered. Ask patient to close eye(s) for 2 to 3 min and apply light finger pressure to lacrimal sac for 1 to 2 min after installation. Do not touch top of dropper bottle to eye, fingers, or any other surface.
- If using other topical ophthalmic medications, separate each medication by at least 5 min. Instill ophthalmic ointment last.
Storage/Stability
Store ophthalmic solution between 39° and 77°F. Keep tightly capped.
Drug Interactions
None well documented.
Laboratory Test Interactions
None well documented.
Adverse Reactions
CNS
Headache (10% to 25%).
EENT
Conjunctival injection, rhinitis (10% to 25%); ocular allergic reactions, burning or stinging of eye, conjunctivitis, eye discharge, dry eye, eye pain, eyelid disorder, itching eye, keratitis, lacrimation disorder, mydriasis, photophobia, rash, pharyngitis (less than 5%).
Miscellaneous
Flu syndrome (less than 5%).
Precautions
Pregnancy
Category C .
Lactation
Undetermined.
Children
Safety and efficacy not established in children younger than 3 yr of age.
Patient Information
- Remind patient that eye drops are for use in the eye only.
- Teach patient proper technique for instilling eye drops: Wash hands; do not allow dropper to touch eye; tilt head back and look up; pull lower eyelid down; instill prescribed number of drops; close eye for 1 to 2 min and apply gentle pressure to bridge of nose for 1 to 3 min; do not rub eye.
- Caution patient not to touch top of dropper bottle to eye, fingers, or any other surface.
- Advise patient that if more than 1 topical ophthalmic medication is being used to separate each medication by at least 5 min apart. Instill ophthalmic ointment last.
- Inform patient that eye redness, headaches, and runny nose are the most common side effects and to contact health care provider if they occur and are bothersome.
- Advise patient to contact eye doctor if eye or eyelid inflammation is noted or if eye symptoms do not improve or worsen.
- Instruct patient wearing contact lenses to remove lenses when instilling eye drops and, if wearing soft contact lenses, to wait 10 min after instilling drops before inserting lenses.
- Caution patient wearing contact lenses not to wear lenses if eyes are red.
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