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Ketotifen (Ophthalmic)

Pronunciation

(kee toe TYE fen)

Index Terms

  • Ketotifen Fumarate

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) [contains benzalkonium chloride]

Refresh Eye Itch Relief: 0.025% (5 mL [DSC]) [contains benzalkonium chloride]

TheraTears Allergy: 0.025% (10 mL) [contains benzalkonium chloride]

Zaditor: 0.025% (5 mL) [contains benzalkonium chloride]

ZyrTEC Itchy Eye: 0.025% (5 mL) [contains benzalkonium chloride]

Generic: 0.025% (5 mL)

Brand Names: U.S.

  • Alaway Childrens Allergy [OTC]
  • Alaway [OTC]
  • Claritin Eye [OTC]
  • Eye Itch Relief [OTC]
  • Refresh Eye Itch Relief [OTC] [DSC]
  • TheraTears Allergy [OTC]
  • Zaditor [OTC]
  • ZyrTEC Itchy Eye [OTC]

Pharmacologic Category

  • Histamine H1 Antagonist
  • Histamine H1 Antagonist, Second Generation
  • Mast Cell Stabilizer
  • Piperidine Derivative

Pharmacology

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.

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

Dosing: Adult

Allergic conjunctivitis:

US labeling (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)

Canadian labeling: Ophthalmic: Instill 1 drop into the affected eye(s) every 8 to 12 hours

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Allergic conjunctivitis: Children ≥3 years and Adolescents: Ophthalmic: Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

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 Considerations

Topical ocular administration has not been studied.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber vision changes, eye pain, severe eye irritation, or eye redness (HCAHPS).

• Educate patient about signs of a significant reaction (eg, 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. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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