U.S. Brand Names:

Zaditor™

Synonyms:

Ketotifen Fumarate

Generic Available:

No

Canadian Brand Names:

Apo-Ketotifen®; Novo-Ketotifen; Zaditen®; Zaditor™

Use:

Temporary prevention of eye itching due to allergic conjunctivitis

Pregnancy Risk Factor:

C

Pregnancy Implications:

Oral treatment administered to pregnant animals have resulted in retarded ossification of the sternebrae, slight increase in postnatal mortality, and a decrease in weight gain in the first 4 days of life. Topical ocular administration has not been studied.

Lactation:

Use caution

Contraindications:

Hypersensitivity to ketotifen or any component of the formulation (the preservative is benzalkonium chloride)

Warnings/Precautions:

For topical ophthalmic use only. Not to treat contact lens-related irritation. After ketotifen use, soft contact lens wearers should wait at least 10 minutes before putting their lenses in. Do not wear contact lenses if eyes are red. Do not contaminate dropper tip or solution when placing drops in eyes. Safety and efficacy in pediatric patients <3 years of age have not been established.

Adverse Reactions:

1% to 10%:

Ocular: Allergic reactions, burning or stinging, conjunctivitis, discharge, dry eyes, eye pain, eyelid disorder, itching, keratitis, lacrimation disorder, mydriasis, photophobia, rash

Respiratory: Pharyngitis

Miscellaneous: Flu syndrome

Overdosage/Toxicology:

No serious signs or symptoms seen after ingestion of up to 20 mg of ketotifen

Stability:

Stable at room temperature

Mechanism of Action:

Relatively selective, noncompetitive H1-receptor antagonist and mast cell stabilizer, inhibiting the release of mediators from cells involved in hypersensitivity reactions

Dosage:

Children 3 years and Adults: Ophthalmic: Instill 1 drop into the affected eye(s) twice daily, every 8-12 hours

Patient Education:

For use in eyes only. Do not let tip of applicator touch eye; do not contaminate tip of applicator (may cause eye infection, eye damage, or vision loss). Not to be used to treat contact lens-related irritation. Wait at least 10 minutes before putting soft contact lenses in. Do not wear contact lenses if eyes are red. Store at room temperature. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant or breast-feeding.

Dental Health: Effects on Dental Treatment:

Key adverse event(s) related to dental treatment: Pharyngitis.

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

None reported

Mental Health: Effects on Psychiatric Treatment:

May cause dry eyes which can be exacerbated by anticholinergic agents or psychotropics with significant anticholinergic activity

Dosage Forms:

Solution, ophthalmic, as fumarate: 0.025% (5 mL) [contains benzalkonium chloride]

International Brand Names:

Alertax® (DO); Alleal® (IT); Allerket® (IT); Apo-Ketotifen® (CA); Asdron® (BR); Asmafen® (NZ); Asmalergin® (BR); Asmanoc® (TH); Asmax® (BR); Asmen® (BR); Astafen® (TR); Asthafen® (RU); Asumalife YSP® (SG); Beatifen® (SG); Bentifen® (IT); Cetotifeno® (BR); Chetofen® (IT); Chetotifene Merck® (IT); Cipanfeno® (PT); Denerel® (RU, SG); Dhatifen® (SG); Difen® (CO); Dihalar® (HR, SI); Erliten® (SG); Frenasma® (RO); Fumarato de Cetotifeno® (BR); Fumast® (TR); H-Ketotifen® (RO); Ibis® (TH); Intifen® (ID); Kasmal® (MX); Katifen® (TH); Kelme® (AR); Kenaler® (CO); Kenefen® (TH); Ketarfen® (RO); Ketasma® (ES, IN); Keten® (TH); Ketifen® (BD, DO, TH); Ketocev® (AR); Ketof® (DE, LU, PL, RO, RU); Ketofen® (TH); Ketofex® (DE); Ketoftil® (IT); Keto-Gal® (RO); Ketohexal syrup® (ZA); Keto® (TH); Ketotifen beta® (DE); Ketotifen® (BG, CZ, PL, RO, YU); Ketotifen Heumann® (DE); Ketotifen LFM® (HU); Ketotifen Nordia® (SG); Ketotifen Nycomed® (AT); Ketotifeno® (EC); Ketotifeno Ecar® (CO); Ketotifeno Genfar® (EC); Ketotifeno MK® (CO, CR, DO, GT, HN, PA, SV); Ketotifen-ratiopharm® (DE, LU); Ketotifen Sanova® (AT); Ketotifen Stada® (DE); Ketotifen Temmler® (DE); Ketotifen Trom® (DE); Ketotiphar® (BE); Ketotisan® (AT); Ketotisin® (CL); Kofen® (BD); Licoften® (CY); Medkofen® (TH); Medotifen® (TH); Nemesil® (BR); Nortifen® (ID); Novo-Ketotifen (CA); P&auml;diatifen® (DE); Pehatifen® (ID); Politifen® (TH); Prevas® (ID); Profilar® (JO, RO); Profilas® (ID); Profilasmin-Ped® (BR); Profiten® (IL); Prosma® (BD); Quefeno® (PT); Repinox® (CL); Respimex® (AR); Scanditen® (ID); Sosefen® (IT); Stamifen® (IT); Sykofen® (TH); Tenerel® (CY, JO); Tifen® (BR, EC); Tofen® (BD); Totinal® (EG, JO, KW, LB, SY); Ventisol® (MX); Xidanef® (TH); Zadetin® (CL); Zadino® (TH); Zaditen® (AR, AT, BE, BR, CA, CH, CO, DE, DK, ES, FI, FR, GB, HK, HU, ID, IE, IL, IT, LU, MT, MX, NL, NO, PL, PT, RO, RU, SE, SG, TH, TR, ZA); Zaditor™ (CA); Zasten® (ES, NZ); Zatofug® (DE); Zetifen® (RU); Zidex® (CO); Zytofen® (TH)