Ketotifen

Ketotifen
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Stefano Giannoni [2]

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Overview

Ketotifen is an Antihistamine that is FDA approved for the prophylaxis of Allergic conjunctivitis. Common adverse reactions include {{{adverseReactions}}}.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Allergic conjuntivitis

• 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ketotifen in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ketotifen in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Allergic conjuntivitis

• Children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours, no more than twice per day.
• Children under 3 years of age: Consult a doctor.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ketotifen in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ketotifen in pediatric patients.

Contraindications

There is limited information regarding Ketotifen Contraindications in the drug label.

Warnings

Do not use

• If you are sensitive to any ingredient in this product
• If solution changes color or becomes cloudy
• To treat contact lens related irritation

When using this product

• Remove contact lenses before use
• Wait at least 10 minutes before re-inserting contact lenses after use
• Do not touch tip of container to any surface to avoid contamination
• Replace cap after each use

Stop use and ask doctor if you experience any of the following:

• Eye pain
• Changes in vision
• Medness of the eyes
• Itching that worsens or lasts more than 72 hours

K*eep out of reach of children.

• If swallowed, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Ketotifen Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Ketotifen Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Ketotifen Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C There is no FDA guidance on usage of Ketotifen in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ketotifen in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Ketotifen during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Ketotifen in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Ketotifen in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Ketotifen in geriatric settings.

Gender

There is no FDA guidance on the use of Ketotifen with respect to specific gender populations.

Race

There is no FDA guidance on the use of Ketotifen with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Ketotifen in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Ketotifen in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Ketotifen in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Ketotifen in patients who are immunocompromised.

Administration and Monitoring

Administration

• Ophthalmic

Monitoring

There is limited information regarding Ketotifen Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Ketotifen and IV administrations.

Overdosage

There is limited information regarding Ketotifen overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Ketotifen

Clinical data
Trade names	Zaditor
AHFS/Drugs.com	Micromedex Detailed Consumer Information
MedlinePlus	a604033
Pregnancy category	US: C (Risk not ruled out)
Routes of administration	Oral, Eye Drops
ATC code	R06AX17 (WHO) S01GX08 (WHO)
Legal status
Legal status	US: Oral - Prescription; Eye Drops - OTC
Pharmacokinetic data
Bioavailability	60%
Protein binding	75%
Metabolism	Hepatic
Elimination half-life	12 Hours
Identifiers
IUPAC name 4-(1-Methylpiperidin-4-ylidene)-4,9-dihydro-10H-benzo[4,5]cyclohepta[1,2-b]thiophen-10-one
CAS Number	34580-14-8 Y
PubChem CID	3827
DrugBank	DB00920 Y
ChemSpider	3695 Y
UNII	HBD503WORO
KEGG	D01332 Y
ChEMBL	ChEMBL534 Y
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C19H19NOS
Molar mass	309.426 g/mol
3D model (JSmol)	Interactive image
SMILES O=C3c1sccc1C(\c2c(cccc2)C3)=C4/CCN(C)CC4
InChI InChI=1S/C19H19NOS/c1-20-9-6-13(7-10-20)18-15-5-3-2-4-14(15)12-17(21)19-16(18)8-11-22-19/h2-5,8,11H,6-7,9-10,12H2,1H3 Y Key:ZCVMWBYGMWKGHF-UHFFFAOYSA-N Y
(verify)

Mechanism of Action

There is limited information regarding Ketotifen Mechanism of Action in the drug label.

Structure

There is limited information regarding Ketotifen Structure in the drug label.

Pharmacodynamics

There is limited information regarding Ketotifen Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Ketotifen Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Ketotifen Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Ketotifen Clinical Studies in the drug label.

How Supplied

There is limited information regarding Ketotifen How Supplied in the drug label.

Storage

• Store at 20° to 25°C (68° to 77°F)

Images

Drug Images

{{#ask: Page Name::Ketotifen |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Ketotifen |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Ketotifen Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Ketotifen interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• Zaditor
• Alaway
• Claritin Eye
• Zyrtec Itchy Eye

Look-Alike Drug Names

There is limited information regarding Ketotifen Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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 |Label Name=Ketotifen fumarate package (2).png

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Ketotifen

File:Ketotifen structure.svg
Clinical data
Routes of administration	Oral, Eye Drops
ATC code	R06AX17 (WHO) S01GX08 (WHO)
Pharmacokinetic data
Bioavailability	60%
Protein binding	75%
Metabolism	Hepatic
Elimination half-life	21 Hours
Identifiers
IUPAC name 4,9-dihydro-4-(1-methyl-4-piperidinylidene)- 10H-benzocyclohepta[1,2-b]thiopen-10-one
CAS Number	34580-14-8
PubChem CID	3827
DrugBank	APRD01061
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C19H19NOS
Molar mass	309.426 g/mol

Ketotifen fumarate (ophthalmic solutions marketed under the brand name Zaditor (Novartis) and Alaway (Bausch and Lomb)) is an H₁-antihistamine/mast cell stabilizer available in two forms. In its ophthalmic form, it is used to treat allergic conjunctivitis, or the itchy red eyes caused by allergies. In its oral form, it is used to prevent asthma attacks. Side effects include drowsiness, weight gain, dry mouth, irritability, and increased nosebleeds.

General Information

Ketotifen relieves and prevents eye itchiness and/or irritation associated with most seasonal allergies. It starts working within minutes after administering the drops. The drug has not been studied in children under 3.

Overdosage

Accidental ingestion of an entire bottle of ketotifen is unlikely to cause side effects since it contains less than 2 mg of medicine.

External links

• Zaditor web site
• {http://www.bausch.com/en_US/consumer/visioncare/product/drops/alaway_con.aspx Alaway web site]