Refresh (ketotifen fumarate)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Ketotifen fumarate is a selective histamine H1-receptor antagonist and mast-cell stabilizer.
Ketotifen fumarate is a selective histamine H1-receptor antagonist and mast-cell stabilizer. Ketotifen suppresses the release of mediators from cells involved in hypersensitivity reactions and decreases chemotaxis and activation of eosinophils.
Ketotifen 0.025% ophthalmic solution is minimally absorbed following topical application to the eye. The onset of action is within 15 minutes following administration and duration is at least 8 hours.
USES: This medication is used to prevent and treat itching of the eyes caused by allergies (allergic/seasonal conjunctivitis). Ketotifen is an antihistamine for the eye that treats allergic symptoms by blocking a certain natural substance (histamine). It is also a mast cell stabilizer that prevents allergic reactions by reducing the release of natural substances that cause an allergic reaction.
Generic name: ketotifen fumarate
Pronunciation: (KEE-toe-TYE-fen)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
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Indications
The following indications are listed for Refresh:
- Allergic Conjunctivitis
Also known as: Allergy Eye Itch, Atopic Conjunctivitis, Itchy Eyes Due To Allergies, Ocular Itching Due To Allergies.
Dosing
Dosage of ketotifen fumarate is expressed in terms of ketotifen.
The recommended dosage of ketotifen for the temporary relief of ocular itching associated with allergic conjunctivitis in adults and pediatric patients 3 years of age and older is 1 drop of a 0.025% solution in the affected eye(s) twice daily at an interval of 8-12 hours. The drug should not be administered more frequently than twice daily.
Ketotifen fumarate is applied topically to the eye as an ophthalmic solution. Care should be taken to avoid contamination of the solution container.
Ketotifen fumarate ophthalmic solution should not be used for the symptomatic management of contact lens-related irritation. Patients should be advised to remove their contact lenses prior to administration of each dose of ketotifen fumarate ophthalmic solution because the solution contains benzalkonium chloride, which may be absorbed by some soft contact lenses. Patients may reinsert contact lenses 10 minutes following administration of the ophthalmic solution.
Store ketotifen fumarate 0.025% ophthalmic solution between 4-25degreesC.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Known hypersensitivity to ketotifen or any ingredient in the formulation.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
There is no enhanced messaging for this drug.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy have not been established in pediatric patients younger than 3 years of age. Ketotifen fumarate ophthalmic solution should not be used in pediatric patients younger than 3 years of age unless otherwise directed by a clinician.
Animal reproductive studies showed developmental skeletal abnormalities at a dose 30,000 times the maximum recommended human ocular dose. Because the drug is minimally absorbed following topical administration to the eye, it is not likely to have an effect on reproductive safety.
No enhanced messaging available.
No enhanced messaging available.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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