|
U.S. Brand
Names |
|
Zaditor™ |
|
|
Synonyms |
|
Ketotifen fumarate |
|
|
Pharmacological Index |
|
Antihistamine, H1 Blocker, Ophthalmic |
|
|
Use |
|
Temporary prevention of eye itching due to allergic
conjunctivitis |
|
|
Pregnancy Risk
Factor |
|
C |
|
|
Pregnancy/Breast-Feeding
Implications |
|
Oral treatment administered to pregnant animals has 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. Caution should be used when ketotifen is
administered to a nursing mother. |
|
|
Contraindications |
|
Known 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 not established in patients <3 years of
age. |
|
|
Adverse
Reactions |
|
1% to 10%:
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 |
|
|
Pharmacodynamics/Kinetics |
|
Absorption: Minimal systemic absorption
Onset: Within minutes
Duration: 8-12 hours |
|
|
Usual Dosage |
|
Adults: Ophthalmic: Instill 1 drop into the affected eye (s) every 8-12
hours |
|
|
Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
|
No information available to require special precautions |
|
|
Dental Health:
Effects on Dental Treatment |
|
No effects or complications reported |
|
|
Patient
Information |
|
For topical ophthalmic use only. Not to be used to treat contact lens-related
irritation. After ketotifen's use, soft contact lens wearers should wait at
least 10 minutes before putting their contact lenses in. Do not wear contact
lenses if eyes are red. Do not contaminate dropper tip or solution when placing
drops in eyes. Store at room temperature |
|
|
Dosage Forms |
|
Solution, ophthalmic: 0.025% (5
mL) |
|
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|