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Drug overview for ALLERGY EYE (KETOTIFEN) (ketotifen fumarate):
Generic name: ketotifen fumarate (KEE-toe-TYE-fen)
Drug class: Ophthalmic Antiallergic Agents
Therapeutic class: Ophthalmic Agents
Ketotifen fumarate is a relatively selective histamine H1-receptor antagonist and mast-cell stabilizer.
No enhanced Uses information available for this drug.
Generic name: ketotifen fumarate (KEE-toe-TYE-fen)
Drug class: Ophthalmic Antiallergic Agents
Therapeutic class: Ophthalmic Agents
Ketotifen fumarate is a relatively selective histamine H1-receptor antagonist and mast-cell stabilizer.
No enhanced Uses information available for this drug.
DRUG IMAGES
- CVS EYE ITCH RELIEF 0.025% DRP
- CVS ALLERGY 0.025% EYE DROPS
The following indications for ALLERGY EYE (KETOTIFEN) (ketotifen fumarate) have been approved by the FDA:
Indications:
Allergic conjunctivitis
Professional Synonyms:
Allergy eye itch
Atopic conjunctivitis
Itchy eyes due to allergies
Ocular itching due to allergies
Indications:
Allergic conjunctivitis
Professional Synonyms:
Allergy eye itch
Atopic conjunctivitis
Itchy eyes due to allergies
Ocular itching due to allergies
The following dosing information is available for ALLERGY EYE (KETOTIFEN) (ketotifen fumarate):
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 children 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.
The recommended dosage of ketotifen for the temporary relief of ocular itching associated with allergic conjunctivitis in adults and children 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.
For topical ophthalmic use only. This preparation should not be used if the solution changes color or becomes cloudy.
DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
---|---|---|
CVS EYE ITCH RELIEF 0.025% DRP | Maintenance | Adults instill 1 drop into affected eye(s) by ophthalmic route 2 times per day |
CVS ALLERGY 0.025% EYE DROPS | Maintenance | Adults instill 1 drop into affected eye(s) by ophthalmic route 2 times per day |
DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
---|---|---|
KETOTIFEN FUM 0.025% EYE DROPS | Maintenance | Adults instill 1 drop into affected eye(s) by ophthalmic route 2 times per day |
KETOTIFEN FUM 0.035% EYE DROPS | Maintenance | Adults instill 1 drop into affected eye(s) by ophthalmic route 2 times per day |
The following drug interaction information is available for ALLERGY EYE (KETOTIFEN) (ketotifen fumarate):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ALLERGY EYE (KETOTIFEN) (ketotifen fumarate):
Drug contraindication overview.
Known hypersensitivity to ketotifen or any ingredient in the formulation.
Known hypersensitivity to ketotifen or any ingredient in the formulation.
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
Moderate List |
---|
No disease contraindications |
The following adverse reaction information is available for ALLERGY EYE (KETOTIFEN) (ketotifen fumarate):
Adverse reaction overview.
Conjunctival injection, headaches, and rhinitis occur in 10-25% of patients. Some events may be related to the underlying ocular disease rather than ketotifen.
Conjunctival injection, headaches, and rhinitis occur in 10-25% of patients. Some events may be related to the underlying ocular disease rather than ketotifen.
There are 10 severe adverse reactions.
More Frequent | Less Frequent |
---|---|
Ocular inflammation Ocular redness |
Conjunctivitis Keratitis Ocular discharge Ocular itching Ocular pain Pruritus of skin Skin rash Urticaria |
Rare/Very Rare |
---|
None. |
There are 8 less severe adverse reactions.
More Frequent | Less Frequent |
---|---|
Headache disorder Rhinitis |
Eye tearing Flu-like symptoms Mydriasis Ocular irritation Pharyngitis Photophobia |
Rare/Very Rare |
---|
None. |
The following precautions are available for ALLERGY EYE (KETOTIFEN) (ketotifen fumarate):
Safety and efficacy not established in children younger than 3 years of age. Ketotifen fumarate ophthalmic solution should not be used in children younger than 3 years of age unless otherwise directed by a clinician.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
None |
Severe Precaution
None |
Management or Monitoring Precaution
Ketotifen (Ophthalmic) | 1 Day – 3 Years | Safety and efficacy not established in pediatrics age < 3 years. |
Category C. (See Users Guide.)
Drug/Drug Class | Severity | Precaution Description | Pregnancy Category Description |
---|---|---|---|
Ketotifen | 2 | Insuff human data avail; consider maternal benefit vs neonatal risk | No fda rating but may have precautions or warnings; may have animal and/or human studies or pre or post marketing information. |
Ketotifen is distributed into milk in rats following oral administration. It is not known if topical ocular administration could result in sufficient systemic absorption to produce detectable distribution in breast milk; therefore, caution should be exercised when ocular ketotifen is administered to a nursing woman.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
Drug Name | Excretion Potential | Effect on Infant | Notes |
---|---|---|---|
Ketotifen | Unknown. It is unknown whether the drug is excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Insufficient human data available |
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for ALLERGY EYE (KETOTIFEN) (ketotifen fumarate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ALLERGY EYE (KETOTIFEN) (ketotifen fumarate)'s list of indications:
Allergic conjunctivitis | |
H10.1 | Acute atopic conjunctivitis |
H10.10 | Acute atopic conjunctivitis, unspecified eye |
H10.11 | Acute atopic conjunctivitis, right eye |
H10.12 | Acute atopic conjunctivitis, left eye |
H10.13 | Acute atopic conjunctivitis, bilateral |
H10.44 | Vernal conjunctivitis |
H10.45 | Other chronic allergic conjunctivitis |
H16.26 | Vernal keratoconjunctivitis, with limbar and corneal involvement |
H16.261 | Vernal keratoconjunctivitis, with limbar and corneal involvement, right eye |
H16.262 | Vernal keratoconjunctivitis, with limbar and corneal involvement, left eye |
H16.263 | Vernal keratoconjunctivitis, with limbar and corneal involvement, bilateral |
H16.269 | Vernal keratoconjunctivitis, with limbar and corneal involvement, unspecified eye |
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