Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Ophthalmic:
Alaway: 0.025% (10 mL) [contains benzalkonium chloride]
Alaway Childrens Allergy: 0.025% (5 mL) [contains benzalkonium chloride]
Claritin Eye: 0.025% (5 mL) [contains benzalkonium chloride]
Eye Itch Relief: 0.025% (5 mL [DSC]) [contains benzalkonium chloride]
GoodSense Itchy Eye: 0.025% (5 mL) [contains benzalkonium chloride]
TheraTears Allergy: 0.025% (10 mL) [contains benzalkonium chloride]
Zaditor: 0.025% (5 mL) [contains benzalkonium chloride]
Generic: 0.025% (5 mL)
Pharmacology
Mechanism of Action
Exhibits noncompetitive H1-receptor antagonist and mast cell stabilizer properties. Efficacy in conjunctivitis likely results from a combination of anti-inflammatory and antihistaminergic actions including interference with chemokine-induced migration of eosinophils into inflamed conjunctiva.
Pharmacokinetics/Pharmacodynamics
Absorption
Minimally systemic (Zaditor US prescribing information, 2002)
Onset of Action
Within minutes (Zaditor Canadian product monograph, 2012)
Duration of Action
Up to 12 hours (Zaditor Canadian product monograph, 2012)
Use: Labeled Indications
Allergic conjunctivitis: Temporary relief of eye itching due to allergic conjunctivitis
Contraindications
Hypersensitivity to ketotifen or any component of the formulation
Dosage and Administration
Dosing: Adult
Allergic conjunctivitis: OTC labeling: Ophthalmic: Instill 1 drop into the affected eye(s) twice daily every 8 to 12 hours (maximum: do not exceed 2 applications/day)
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Allergic conjunctivitis: Children ≥3 years and Adolescents: Ophthalmic: Instill 1 drop into lower conjunctival sac of affected eye(s) twice daily (spaced 8 to 12 hours apart). Note: Do not exceed 2 applications per day.
Administration
Ophthalmic: For use in eyes only. Wash hands before use. Do not let tip of applicator touch eye; do not contaminate tip of applicator. Remove soft contact lenses prior to administration. Wait 10 minutes before reinserting lenses if using products containing benzalkonium chloride. Do not wear contact lenses if eyes are red. Allow at least 5 minutes between applications of other eye drops.
Storage
Store at 4°C to 25°C (39°F to 77°F).
Drug Interactions
There are no known significant interactions.
Adverse Reactions
Reactions are generally mild, transient, and local as systemic exposure following topical ocular administration is minimal.
>10%:
Central nervous system: Headache (≤10% to ≤25%)
Ophthalmic: Conjunctival injection (≤10% to ≤25%)
Respiratory: Rhinitis (≤10% to ≤25%)
1% to 10%:
Hypersensitivity: Hypersensitivity reaction (ophthalmic; <5%)
Ophthalmic: Circumocular rash (<5%), conjunctivitis (<5%), disease of the lacrimal apparatus (<5%), eye pain (<5%), keratitis (<5%), mydriasis (<5%), photophobia (<5%), burning sensation of eyes (<3%), eye discharge (<3%), eyelid disease (<3%), eye pruritus (<3%), stinging of eyes (<3%), xerophthalmia (<3%)
Respiratory: Flu-like symptoms (<5%), pharyngitis (<5%)
Warnings/Precautions
Special populations:
- Contact lens wearers: Not to treat contact lens-related irritation. Solution contains benzalkonium chloride; soft contact lens wearers should remove them prior to administration and wait at least 10 minutes after administration before reinserting them. Do not wear contact lenses if eyes are red. Do not contaminate dropper tip or solution when placing drops in eyes.
- Self-medication (OTC use): When used for self-medication (OTC), notify healthcare provider if symptoms worsen or do not improve within 3 days. Contact healthcare provider if change in vision, eye pain, or redness occur. Do not use if solution is cloudy or changes color.
Concurrent drug therapy issues:
- Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Pregnancy
Pregnancy Considerations
Topical ocular administration has not been studied.
Patient Education
What is this drug used for?
- It is used to treat eye irritation.
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Vision changes
- Eye pain
- Severe eye irritation
- Eye redness
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
