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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 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 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 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.
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.
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.
| 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 0.025% (0.035%) DROP | 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.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
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 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.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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 Lactation information available for this drug.
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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