Ketotifen
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
Clinical data | |
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Trade names | Zaditor[1] |
AHFS/Drugs.com | Micromedex Detailed Consumer Information |
MedlinePlus | a604033 |
Pregnancy category |
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Routes of administration | Oral, Eye Drops |
ATC code | |
Legal status | |
Legal status |
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Pharmacokinetic data | |
Bioavailability | 60% |
Protein binding | 75% |
Metabolism | Hepatic |
Elimination half-life | 12 Hours |
Identifiers | |
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CAS Number | |
PubChem CID | |
DrugBank | |
ChemSpider | |
UNII | |
KEGG | |
ChEMBL | |
E number | {{#property:P628}} |
ECHA InfoCard | {{#property:P2566}}Lua error in Module:EditAtWikidata at line 36: attempt to index field 'wikibase' (a nil value). |
Chemical and physical data | |
Formula | C19H19NOS |
Molar mass | 309.426 g/mol |
3D model (JSmol) | |
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(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[2]
- 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 Page=Ketotifen |Label Name=Ketotifen fumarate package (2).png
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|Label Page=Ketotifen |Label Name=Ketotifen fumarate package 2.png
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File:Ketotifen structure.svg | |
Clinical data | |
---|---|
Routes of administration | Oral, Eye Drops |
ATC code | |
Pharmacokinetic data | |
Bioavailability | 60% |
Protein binding | 75% |
Metabolism | Hepatic |
Elimination half-life | 21 Hours |
Identifiers | |
| |
CAS Number | |
PubChem CID | |
DrugBank | |
E number | {{#property:P628}} |
ECHA InfoCard | {{#property:P2566}}Lua error in Module:EditAtWikidata at line 36: attempt to index field 'wikibase' (a nil value). |
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]
bg:Кетотифен it:Ketotifene th:คีโตติเฟน Template:WikiDoc Sources
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