Embedded Files
Pharmacologic Category
Histamine H1 Antagonist; Histamine H1 Antagonist, Second Generation; Mast Cell Stabilizer; Piperidine Derivative
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)
* See Dosage and Administration in AHFS Essentials for additional information.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Renal Impairment: Adult
There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.
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.
Dosing: Renal Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer's labeling; however, adjustment unlikely needed due to minimal systemic absorption.
Dosing: Hepatic Impairment: Pediatric
There are no dosage adjustments provided in the manufacturer's labeling; however, adjustment unlikely needed due to minimal systemic absorption.
Use: Labeled Indications
Allergic conjunctivitis: Temporary relief of eye itching due to allergic conjunctivitis
* See Uses in AHFS Essentials for additional information.
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
Administration: Pediatric
Ophthalmic: 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 (Urtti 1993; Zimmerman 1984). Remove contacts prior to administration; wait at least 10 minutes before reinserting after use. Administer other topical ophthalmic medications at least 5 minutes apart.
Storage/Stability
Store at 4°C to 25°C (39°F to 77°F).
Medication Patient Education with HCAHPS Considerations
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.
Medication Safety Issues
Sound-alike/look-alike issues:
Contraindications
Hypersensitivity to ketotifen or any component of the formulation
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.
* See Cautions in AHFS Essentials for additional information.
Geriatric Considerations
Instruct the patient on proper instillation of ophthalmic solution.
Pregnancy Considerations
Topical ocular administration has not been studied.
Breast-Feeding Considerations
It is not known whether detectable levels of ketotifen would appear in human breast milk following topical ocular administration.
Briggs' Drugs in Pregnancy & Lactation
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%)
* See Cautions in AHFS Essentials for additional information.
Allergy and Idiosyncratic Reactions
Toxicology
Metabolism/Transport Effects
None known.
Drug Interactions Open Interactions
There are no known significant interactions.
Dosage Forms: US
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)
Dosage Forms: Canada
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)
Anatomic Therapeutic Chemical (ATC) Classification
- S01GX08
Generic Available (US)
Yes
Pricing: US
Solution (Alaway Childrens Allergy Ophthalmic)
0.025% (per mL): $1.56
Solution (Alaway Ophthalmic)
0.025% (per mL): $1.04
Solution (Claritin Eye Ophthalmic)
0.025% (per mL): $2.34
Solution (Ketotifen Fumarate Ophthalmic)
0.025% (per mL): $2.44 - $2.70
Solution (TheraTears Allergy Ophthalmic)
0.025% (per mL): $0.84
Solution (Zaditor Ophthalmic)
0.025% (per mL): $1.95
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.
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.
Pharmacodynamics/Kinetics
Onset of action: Within minutes (Zaditor Canadian product monograph, 2012)
Duration: Up to 12 hours (Zaditor Canadian product monograph, 2012)
Absorption: Minimally systemic (Zaditor US prescribing information, 2002)
Local Anesthetic/Vasoconstrictor Precautions
No information available to require special precautions
Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Pharyngitis.
Effects on Bleeding
No information available to require special precautions
Index Terms
Ketotifen Fumarate
FDA Approval Date
July 02, 1999
References
Alaway Children's (ketotifen) [prescribing information]. Bridgewater, NJ: Bausch & Lomb.
Alaway (ketotifen) [prescribing information]. Bridgewater, NJ: Bausch & Lomb.
Alaway (ketotifen) [package labeling]. Rochester, NY: Bosch and Lomb; no date.
Brunton LL, Chabner BA, Knollman BC, eds. Goodman & Gilman's The Pharmacological Basis of Therapeutics. 12th ed. New York, NY: McGraw-Hill Medical; 2011.
Horak F, et al, “Onset and Duration of Action of Ketotifen 0.025% and Emedastine 0.05% in Seasonal Allergic Conjunctivitis,” Clin Drug Invest, 2003, 23(5): 329-37.[PubMed 17535045]
Thera Tears (ketotifen) [prescribing information]. Ann Arbor, MI: Advanced Vision Research; October 2012.
Urtti A, Salminen L. Minimizing systemic absorption of topically administered ophthalmic drugs. Surv Ophthalmol. 1993;37(6):435-456.[PubMed 8100087]
Woerly G, Loiseau S, Loyens M, et al, “Inhibitory Effects of Ketotifen on Eotaxin-Dependent Activation of Eosinophils: Consequences for Allergic Eye Diseases,” Allergy, 2003, 58(5): 397-406.[PubMed 12752326]
Zaditor (ketotifen) [prescribing information]. Duluth, GA: Novartis Ophthalmics; October 2002.
Zaditor (ketotifen) [product monograph]. Concord, Ontario, Canada: Aurium Pharma; February 2012.
Zimmerman TJ, Kooner KS, Kandarakis AS, Ziegler LP. Improving the therapeutic index of topically applied ocular drugs. Arch Ophthalmol. 1984;102(4):551-553.[PubMed 6704011]
Brand Names: International
Aljen (BD); Altriabak (BE); Bei Ka Ming (CN); Dihalar (HR); Edifen (KR); Grandotifen (EG); Kedrop (CR, DO, GT, HN, NI, PA, SV); Ketof (LU); Ketohexal (ZA); Ketoptic (VE); Ketotifen-ratiopharm (LU); Mastosytex (EG); Orpidix (GR); Privent DPS (IN); Prosma (BD); Stafen (BD); Tofen (LK); Totiswix (EG); Unitten (VN); Zabak (RO); Zadit (LK); Zaditen (AE, AR, AT, AU, BB, BF, BG, BH, BJ, BM, BR, BS, BZ, CH, CI, CL, CO, CY, CZ, DE, DK, EC, EE, EG, ES, ET, FI, FR, GB, GH, GM, GN, GY, HK, HU, IE, IQ, IR, IS, IT, JM, JO, KE, KW, LB, LR, LU, LY, MA, ML, MR, MT, MU, MW, MX, MY, NE, NG, NL, NO, NZ, OM, PE, PH, PL, PT, PY, QA, RO, RU, SA, SC, SD, SE, SG, SI, SK, SL, SN, SR, SY, TN, TR, TT, TW, TZ, UG, UY, VN, YE, ZM, ZW); Zaditen Ofta (CR, DO, GT, HN, NI, PA, SV); Zatofen (PK)
Last Updated 2/8/20
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