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Drug overview for KETOTIFEN FUMARATE (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
KETOTIFEN FUM 0.035% EYE DROPS
The following indications for KETOTIFEN FUMARATE (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 KETOTIFEN FUMARATE (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 |
|---|---|---|
| KETOTIFEN FUM 0.035% 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 KETOTIFEN FUMARATE (ketotifen fumarate):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for KETOTIFEN FUMARATE (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 KETOTIFEN FUMARATE (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 KETOTIFEN FUMARATE (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
| None |
Category C. (See Users Guide.)
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.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for KETOTIFEN FUMARATE (ketotifen fumarate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for KETOTIFEN FUMARATE (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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