Generic Medicine Info
Indications and Dosage
Allergic conjunctivitis
Adult: As 0.025% soln: Instill 1 drop in the conjunctival sac of the affected eye(s) bid.
Child: ≥3 yr Same as adult dose.

Allergic rhinitis
Adult: 1 mg bid, increased up to 2 mg bid if needed. Alternatively, 0.5-1 mg at night for the 1st few days of treatment to minimise drowsiness.
Child: ≥3 yr Same as adult dose.
Should be taken with food.
Concomitant use w/ antidiabetic agents.
Special Precautions
Patient w/ history of epilepsy. Childn. Pregnancy and lactation.
Adverse Reactions
Nervous: Drowsiness, dizziness, sedation, somnolence CNS stimulation (e.g. excitation, irritability, insomnia, nervousness), headache, flu-like symptoms.
GI: Dry mouth.
Resp: Pharyngitis, rhinitis.
Genitourinary: Cystitis.
Endocrine: Wt gain.
Ophthalmologic: Transient stinging, eye irritation, punctuate keratitis, corneal erosion, blurred vision, dry eye, burning sensation, conjunctivitis, circumocular rash, eye pain, mydriasis, photophobia, eye discharge, eyelid disease, eye pruritus, xerophthalmia, disease of lacrimal apparatus, conjunctival inj.
Dermatologic: Rash, eczema, urticaria.
Patient Counseling Information
This drug may cause drowsiness, somnolence and blurred vision, if affected, do not drive or operate machinery. Remove contact lenses prior to ophth admin and reinsert after 10-15 min.
Symptoms: Drowsiness, confusion, nystagmus, dyspnoea, bradycardia or tachycardia, disorientation, headache, hypotension, reversible coma; hyperexcitability or convulsions (childn). Management: Symptomatic and supportive treatment. Perform gastric lavage immediately following ingestion. Admin of activated charcoal w/in approx 1 hr following ingestion. Monitor CV function. May give short acting barbiturates or benzodiazepines in case of excitation.
Drug Interactions
May potentiate effects of sedatives, hypnotics and antihistamines.
Potentially Fatal: Reduced platelet count with oral antidiabetics.
Food Interaction
May potentiate effects of alcohol.
Mechanism of Action: Ketotifen is a histamine H1-receptor antagonist and a mast cell stabilizer. It is used in allergic conjunctivitis by interfering w/ chemokine-induced migration of eosinophils into inflamed conjunctiva.
Onset: W/in min (ophth).
Absorption: Completely absorbed from the GI tract (oral). Minimally absorbed (ophth). Bioavailablity: Approx 50%. Time to peak plasma concentration: 2-4 hr.
Distribution: Plasma protein binding: 75%. Enters breast milk.
Metabolism: Undergoes hepatic first-pass metabolism; converted to inactive ketotifen-N-glucuronide metabolite.
Excretion: Mainly via urine (60-70% as metabolites, 1% as unchanged drug). Elimination half-life: Biphasic: 3-5 hr (initial); approx 21 hr (terminal).
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Database. Ketotifen, CID=3827, (accessed on Jan. 21, 2020)

Store below 25°C.
MIMS Class
Antihistamines & Antiallergics / Ophthalmic Decongestants, Anesthetics, Anti-Inflammatories
ATC Classification
R06AX17 - ketotifen ; Belongs to the class of other antihistamines for systemic use.
S01GX08 - ketotifen ; Belongs to the class of other ophthalmologic antiallergics.
Alaway Soln/Drops (Bausch & Lomb Incorporated). DailyMed. Source: U.S. National Library of Medicine. Accessed 04/07/2017.

Alcon Laboratories Australia Pty Ltd. Zaditen 0.25 mg/ml Eye Drops Solution data sheet 15 April 2016. Medsafe. Accessed 04/07/2017.

Anon. Ketotifen (Ophthalmic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. Accessed 04/07/2017.

Buckingham R (ed). Ketotifen Fumarate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. Accessed 04/07/2017.

Joint Formulary Committee. Ketotifen. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. Accessed 04/07/2017.

McEvoy GK, Snow EK, Miller J et al (eds). Ketotifen Fumarate (EENT). AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). Accessed 04/07/2017.

Zaditen 0.25 mg/ml Eye Drops Solution (Laboratories Thea). MHRA. Accessed 04/07/2017.

Zaditen Elixir 1 mg/5mL (Alphasigma SpA). MHRA. Accessed 04/07/2017.

Zaditen Tablets 1 mg (Alphasigma SpA). MHRA. Accessed 04/07/2017.

Disclaimer: This information is independently developed by MIMS based on Ketotifen from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by
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