Version May 2024
Allergic conjunctivitis:
OTC labeling: Ophthalmic solution: Instill 1 drop into the affected eye(s) twice daily every 8 to 12 hours (maximum: do not exceed 2 applications/day).
Rx labeling: Drug-eluting contact lens with ketotifen: Insert 1 lens in each eye per day. Note: The prevention of itch has been demonstrated to last through 12 hours in clinical trials; however, the lens may be worn for longer than 12 hours in a single day. The maximum daily wearing time should be determined by the eye care professional based upon the patient's individual response to contact lenses.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption.
Refer to adult dosing.
(For additional information see "Ketotifen (ophthalmic): Pediatric drug information")
Allergic conjunctivitis:
Ophthalmic solution:
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.
Drug-eluting contact lens with ketotifen:
Children ≥11 years and Adolescents: Ophthalmic: Insert 1 lens in each eye per day. Note: The prevention of itch has been demonstrated to last through 12 hours in clinical trials; however, the lens may be worn for longer than 12 hours in a single day. The maximum daily wearing time should be determined by the eye care professional based upon the patient's individual response to contact lenses.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; however, adjustment unlikely needed due to minimal systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling; however, adjustment unlikely needed due to minimal systemic absorption.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%: Ophthalmic: Eye irritation (≥1%), eye pain (≥1%)
Drug-eluting contact lens with ketotifen: Ocular hyperemia; insertion into red or irritated eye(s); patients with decreased corneal sensation; corneal infection (bacterial, fungal, protozoal, or viral).
Ophthalmic solution: Hypersensitivity to ketotifen or any component of the formulation.
Special populations:
• Contact lens wearers: Ophthalmic solution is not intended 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.
Dosage-form specific issues:
• Drug-eluting contact lens with ketotifen: Do not use ophthalmic solutions containing benzalkonium chloride simultaneously with this product; wait 10 minutes after applying a benzalkonium chloride–containing solution before inserting or reinserting lenses. Refer to the manufacturer's product labeling for comprehensive warning information for the contact lenses.
Other warnings/precautions:
• Self-medication (OTC use): Ophthalmic solution: When used for self-medication (OTC), notify health care provider if symptoms worsen or do not improve within 3 days. Contact health care provider if change in vision, eye pain, or redness occur. Do not use if solution is cloudy or changes color.
Acuvue Theravision with Ketotifen: FDA approved February 2022; anticipated availability currently unknown.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Ophthalmic:
Generic: 0.025% (5 mL)
Solution, Ophthalmic, as fumarate:
Alaway: 0.035% (10 mL) [contains benzalkonium chloride]
Alaway Childrens Allergy: 0.035% (5 mL) [contains benzalkonium chloride]
Claritin Eye: 0.035% (5 mL [DSC]) [contains benzalkonium chloride]
Eye Itch Relief: 0.035% (5 mL) [contains benzalkonium chloride]
TheraTears Allergy: 0.035% (10 mL [DSC]) [contains benzalkonium chloride]
Zaditor: 0.035% (5 mL) [contains benzalkonium chloride]
Generic: 0.035% (5 mL)
Yes
Solution (Alaway Childrens Allergy Ophthalmic)
0.035% (per mL): $1.56
Solution (Alaway Ophthalmic)
0.035% (per mL): $1.04
Solution (Ketotifen Fumarate Ophthalmic)
0.025% (per mL): $2.70
0.035% (per mL): $2.70
Solution (Zaditor Ophthalmic)
0.035% (per mL): $2.03
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Ophthalmic:
Zaditor: 0.025% (1 mL, 5 mL) [contains benzalkonium chloride]
Generic: 0.025% (5 mL)
Drug-eluting contact lens with ketotifen: Insert daily as instructed by eye care professional; lenses should be removed prior to sleeping. Refer to the manufacturer's labeling for detailed administration instructions.
Ophthalmic solution: 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.
Ophthalmic solution: Instill into conjunctival sac avoiding contact of bottle tip with skin or eye; replace cap after each use. Apply gentle pressure to lacrimal sac during and immediately following instillation (1 minute) or instruct patient to gently close eyelid after administration, to decrease systemic absorption of ophthalmic drops (Ref). Remove contacts prior to administration; wait at least 10 minutes before reinserting after use. Administer other topical ophthalmic medications at least 5 minutes apart.
Drug-eluting contact lens with ketotifen: Insert daily as instructed by eye care professional; lenses should be removed prior to sleeping; contacts should be discarded after use; do not use lens cleaning or disinfectant solutions with these contacts. Wait 10 minutes after application of any ophthalmic solution that contains benzalkonium chloride before inserting contact lens. Refer to the manufacturer's labeling for detailed administration instructions.
Allergic conjunctivitis:
Drug-eluting contact lens with ketotifen (Acuvue Theravision): Product is a daily wear, daily disposable etafilcon A drug-eluting contact lens packaged with ketotifen. The ketotifen component is indicated for the prevention of ocular itch due to allergic conjunctivitis; the contact lens component is indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or phakic patients who do not have red eye(s), are suitable for contact lens wear, and do not have more than 1 D of astigmatism.
Ophthalmic solution: Temporary relief of eye itching due to allergic conjunctivitis.
Claritin Eye may be confused with Claritin (loratadine)
Ketotifen may be confused with ketoprofen
None known.
There are no known significant interactions.
Systemic absorption is not expected following ocular administration of the drug-eluting contact lens with ketotifen. If ophthalmic drops are needed during pregnancy, the minimum effective dose should be used in combination with punctal occlusion to decrease potential exposure to the fetus (Samples 1988).
It is not known whether detectable levels of ketotifen would appear in human breast milk following topical ocular administration.
Systemic absorption is not expected following ocular administration of the drug-eluting contact lens with ketotifen. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
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.
Onset of action: Within minutes (Zaditor Canadian product monograph).
Duration: Up to 12 hours (Zaditor Canadian product monograph).
Absorption: Minimally systemic (Zaditor US prescribing information).
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