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Ketotifen (ophthalmic): Drug information

Ketotifen (ophthalmic): Drug information
2024© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Ketotifen (ophthalmic): Patient drug information" and "Ketotifen (ophthalmic): Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Alaway Childrens Allergy [OTC];
  • Alaway [OTC];
  • Claritin Eye [OTC] [DSC];
  • Eye Itch Relief [OTC];
  • TheraTears Allergy [OTC] [DSC];
  • Zaditor [OTC]
Brand Names: Canada
  • Zaditor
Pharmacologic Category
  • Histamine H1 Antagonist;
  • Histamine H1 Antagonist, Second Generation;
  • Mast Cell Stabilizer;
  • Piperidine Derivative
Dosing: Adult
Allergic conjunctivitis

Allergic conjunctivitis: Ophthalmic: Instill 1 drop into the affected eye(s) twice daily (spaced 8 to 12 hours apart) (maximum: do not exceed 2 applications/day).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney 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: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Ketotifen (ophthalmic): Pediatric drug information")

Allergic conjunctivitis

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.

Dosing: Kidney 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.

Adverse Reactions

There are no adverse reactions listed in the manufacturer’s labeling.

Contraindications

Hypersensitivity to ketotifen or any component of the formulation.

Warnings/Precautions

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.

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.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

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)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (Alaway Childrens Allergy Ophthalmic)

0.035% (per mL): $1.56

Solution (Alaway Ophthalmic)

0.035% (per mL): $1.04

Solution (Ketotifen Fumarate Ophthalmic)

0.035% (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.

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)

Administration: Adult

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.

Administration: Pediatric

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.

Use: Labeled Indications

Allergic conjunctivitis: Temporary relief of eye itching due to allergic conjunctivitis.

Medication Safety Issues
Sound-alike/look-alike issues:

Claritin Eye may be confused with Claritin (loratadine)

Ketotifen may be confused with ketoprofen

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

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).

Breastfeeding Considerations

It is not known whether detectable levels of ketotifen would appear in human breast milk following topical ocular administration.

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.

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 (Adult Data Unless Noted)

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).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Apizad | Zaditen;
  • (AR) Argentina: Antilerg | Bilozen | Farmoftal | Ketif | Zaditen col;
  • (AT) Austria: Zaditen ophta;
  • (AU) Australia: Apohealth allergy | Zaditen;
  • (BD) Bangladesh: Aljen | Fenat | Ketof | Ketorif | Kofen | Ocutifen | Prosma | Stafen | Tofen;
  • (BE) Belgium: Altriabak | Ketazed;
  • (BF) Burkina Faso: Orchazid;
  • (BG) Bulgaria: Zabak | Zaditen;
  • (BR) Brazil: Amistofeno | Asdron | Asmofen | Biatos | Fumarato de cetotifeno | Octifen | Uni cetotifen | Zaditen | Zetitec;
  • (CH) Switzerland: Zaditen Ophtha/- SDU;
  • (CI) Côte d'Ivoire: Orchazid | Privent | Zaditen ophta;
  • (CL) Chile: Nedrus | Oftaler | Zabak | Zaditen;
  • (CN) China: Bei ka ming | Ketotifen | Min fen | Zhan ru;
  • (CO) Colombia: Blasket | Difen | Kenaler | Ketofresh | Ketoftal | Ketotifeno | Konoftal max | Konoftal max soft | Wasserket | Zaditen;
  • (CZ) Czech Republic: Zaditen;
  • (DE) Germany: Ketotifen | Zaditen | Zaditen ophtha | Zaditen ophtha sine;
  • (DO) Dominican Republic: Fortifeno ocu | Ketotifran | Zaditen | Zaditen Ofta;
  • (EC) Ecuador: Oftaler | Oftaler forte | Zaditen;
  • (EG) Egypt: Mastosytex | Orchazid | Rednott | Zaditen | Zedotefen | Zoptic;
  • (ES) Spain: Bentifen | Ketisal | Ketotifeno farmalider | Okeye | Zaditen | Zalerg;
  • (ET) Ethiopia: Orchazid;
  • (FI) Finland: Zaditen;
  • (FR) France: Ketazed | Ketotifene thea | Zaditen | Zalerg;
  • (GB) United Kingdom: Zaditen | Zaditor;
  • (GR) Greece: Cleroptic | Dovidin | K | Meni-Drops | Noxtor | Orpidix | Urpem | Zaditen | Zaditor | Zethrinal;
  • (HK) Hong Kong: Zaditen;
  • (HU) Hungary: Zaditen;
  • (ID) Indonesia: Zaditen;
  • (IE) Ireland: Zaditen;
  • (IL) Israel: Zaditen;
  • (IN) India: Albalon | Ketorid | Privent | Zaditen;
  • (IT) Italy: Bentifen | Eustamyl | Ketazed | Ketoftil | Sosefen | Stamifen | Zabak | Zaditen | Zaditen oftabak;
  • (JO) Jordan: Apizad | Orchazid | Zaditen;
  • (JP) Japan: Allegy s menicon | Benanza | Drakern | Fumarton | Fumarufen | Fusachol | Ketoten | Ketotifen | Ketotifen kyorin | Ketotifen nitto | Ketotifen t alcon | Ketotifen t honso | Ketotifen towa | Magotiphen | Magotiphen merck hoei | Nichicard | Nichicard teika | Sadifen | Sekiton | Supdel | Xeblen | Zaditen | Zaditen al | Zaditoma | Zaltifen;
  • (KE) Kenya: Ketomar | Zaditen;
  • (KR) Korea, Republic of: Alercorn | Allefen | Allerfen | Atipen | Aukotifen | Cialen | Edifen | Eyetipen | Fotiten | Fotiten m | Fumarufen | Huons ketotifen fumarate | Hutofen | J tipen | Jeitipen | Kefran | Ketifen | Ketione | Ketoftil | Ketorin | Ketotifen t | Ketotwo | Ketovin | Preten | Ridifen | Uniten | Uniten-F | Unitifen | Vitofen | Zaditen | Zatopen;
  • (KW) Kuwait: Zaditen;
  • (LB) Lebanon: Cleroptic | Ketoftil | Zaditen | Zalerg;
  • (LT) Lithuania: Zaditen;
  • (LU) Luxembourg: Altriabak | Ketazed | Zaditen ophta;
  • (MA) Morocco: Viket | Zalerg;
  • (MX) Mexico: K azmacid | Kedrop | Zaditen | Zaditen Ofta;
  • (NG) Nigeria: Eyediten | Kaytifen;
  • (NL) Netherlands: Altriabak | Ketazed | Zaditen;
  • (NO) Norway: Zaditen;
  • (NZ) New Zealand: Ketotifen;
  • (PE) Peru: Kenaler | Oftaler | Uniteno | Zaditen;
  • (PH) Philippines: Ketotifen | Zadec | Zaditen;
  • (PK) Pakistan: Kartilerg | Ketof | Ketolerg | Medifen | Zaditen | Zaditor;
  • (PL) Poland: Zabak | Zaditen ophtha;
  • (PR) Puerto Rico: Alaway | Eye itch relief | Ketotifen | RRefresh Eye Itch Relief | TheraTears allergy eye itch relief | Zaditor;
  • (PT) Portugal: Zabak | Zaditen;
  • (PY) Paraguay: Citol aler | Ketotifeno dutriec | Oftaler forte;
  • (QA) Qatar: Apizad | Zaditen | Zaditen UD;
  • (RO) Romania: Ketazed;
  • (RU) Russian Federation: Daltifen | Zaditen;
  • (SA) Saudi Arabia: Histofen | Keta | Zaditen;
  • (SE) Sweden: Zaditen;
  • (SI) Slovenia: Zaditen;
  • (SK) Slovakia: Zaditen;
  • (TH) Thailand: Zaditen;
  • (TN) Tunisia: Zalerg;
  • (TR) Turkey: Conjiten | Detofen | Parvisten | Zaditen;
  • (TW) Taiwan: Kedifen | Kinzaten | Zaditen;
  • (UA) Ukraine: Ketotifen | Zaditen;
  • (UG) Uganda: Alarid;
  • (UY) Uruguay: Beyonas aler | Hyalcrom | Zaditen;
  • (VE) Venezuela, Bolivarian Republic of: Ketoptic | Konoftal max | Zaditen | Zaditen oftalmico;
  • (VN) Viet Nam: Datifen;
  • (ZA) South Africa: Ketotifen ipharma | Zaditen
  1. Acuvue Theravision (ketotifen) [prescribing information]. Jacksonville, FL: Johnson & Johnson Vision Care Inc; February 2022.
  2. Alaway (ketotifen) [prescribing information]. Bridgewater, NJ: Bausch & Lomb; January 2020.
  3. Eye Itch Relief (ketotifen) [prescribing information]. Livonia, MI: Rugby Laboratories; October 2015.
  4. Samples JR, Meyer SM. Use of ophthalmic medications in pregnant and nursing women. Am J Ophthalmol. 1988;106(5):616-623. doi:10.1016/0002-9394(88)90597-1 [PubMed 2903673]
  5. Urtti A, Salminen L. Minimizing systemic absorption of topically administered ophthalmic drugs. Surv Ophthalmol. 1993;37(6):435-456. [PubMed 8100087]
  6. Zaditor (ketotifen) [prescribing information]. Duluth, GA: Novartis Ophthalmics; October 2002.
  7. Zaditor (ketotifen) [prescribing information]. Fort Worth, TX: Alcon Laboratories Inc; October 2020.
  8. Zaditor (ketotifen) [product monograph]. Concord, Ontario, Canada: Aurium Pharma; February 2012.
  9. 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]
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