Dosing & Uses
Dosage Forms & Strengths
drug-eluting contact lens
- 19mcg/lens
Allergic Conjunctivitis
Daily disposable etafilcon A drug-eluting contact lens packaged with an H1 histamine receptor antagonist, indicated for prevention of ocular itch owing to allergic conjunctivitis and correction of refractive ametropia (myopia and hyperopia) in aphakic and/or phakic patients who do not have red eye(s), are suitable for contact lens wear, and do not have more than 1 D of astigmatism
Insert 1 lens per eye qDay; discard lens after single day’s use
See fitting instruction guide for professional fitting instructions and information
Dosage Forms & Strengths
drug-eluting contact lens
- 19mcg/lens
Allergic Conjunctivitis
Daily disposable etafilcon A drug-eluting contact lens packaged with an H1 histamine receptor antagonist, indicated for prevention of ocular itch owing to allergic conjunctivitis and correction of refractive ametropia (myopia and hyperopia) in aphakic and/or phakic patients who do not have red eye(s), are suitable for contact lens wear, and do not have more than 1 D of astigmatism
<11 years: Safety and efficacy not established
≥11 years: Insert 1 lens per eye qDay; discard lens after single day’s use
See fitting instruction guide for professional fitting instructions and information
Adverse Effects
1-10%
Eye irritation (≥1%)
Eye pain (≥1%)
Instillation site irritation (≥1%)
Frequency Not Defined
Corneal ulceration
Corneal infections
Warnings
Contraindications
Ocular hyperemia
Corneal hypoesthesia
Corneal infection
Cautions
Corneal ulcers: Do not insert lenses with corneal epithelial breakdown, corneal ulceration, dry eye disease, or with injury or abnormality that affects the eyelids or anterior segment of the eye; wearing lenses overnight or smoking increases risk of corneal ulceration
Contact lens-related complications: Do not use to treat or prevent lens-related symptoms including irritation, discomfort, or redness; if patient experiences symptoms of contact lens intolerance or keratitis, remove lens(es) immediately; instruct patients experiencing excessive tearing, vision changes, or redness of the eye to contact eye care professional immediately
Chemical exposures: If chemicals of any kind are splashed into eyes, flush eyes immediately with water and contact eye care professional immediately or visit hospital emergency room without delay
Acanthamoeba keratitis: Do not wear while swimming or in hot tubs; do not rinse lenses with tap water owing to impurities that may contaminate or damage lenses and lead to eye infection or injury
Backup eyeglasses: All contact lens wearers require a functional pair of eyeglasses when unable to wear contact lenses
Eye protection: Determine need for eye protective equipment for job/tasks
Concomitant use of eye drops: Do not use eye drops or eye medications containing benzalkonium chloride simultaneously; wait at least 10 minutes after eye drop application before inserting/reinserting lenses
Pregnancy & Lactation
Pregnancy
There are no human data that establish the presence or absence of drug-associated risk in pregnant females
Animal data
- Oral administration of 45 mg/kg/day ketotifen to pregnant rabbits resulted in increased incidence of retarded ossification of the sternebrae; this dose (normalized to body surface area) was ~23,000 times higher than the daily maximum recommended human ophthalmic dose (MRHOD) of 0.038 mg
- An oral dose of 50 mg/kg/day ketotifen (~13,000 times higher than MRHOD) administered to rats from Day 15 of pregnancy until Day 21 postpartum produced maternal toxicity, a slight increase in postnatal mortality and a slight decrease in body weight gain in offspring during the first 4 days post-partum
Lactation
No information regarding presence or absence of ketotifen fumarate or its metabolites in human milk, or on breastfed infants and milk production
Ketotifen fumarate identified in breast milk in rats following oral administration; unknown whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in breast milk
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Histamine-1 (H1) receptor antagonist; stabilizes mast cells and prevents eosinophil accumulation; this action prevents onset of ocular allergic itch allowing for continued lens wear during episodes of allergen exposure
Ketotifen duration of action demonstrated through 12 hr
The device component acts as a refracting medium to focus light rays on retina to correct refractive ametropia for as long as the lens is worn (up to 24 hr while awake)
Administration
Ophthalmic Administration
Prevention of itch demonstrated to last through 12 hr; however, may be worn beyond 12 hr for vision correction
Maximum daily wearing time determined by eye care professional based on patient’s individual response to contact lenses
Remove lenses prior to sleep
Do not use eye drops containing benzalkonium chloride simultaneously with this product; wait 10 minutes after applying eye drop with benzalkonium chloride before inserting or reinserting lenses
If the lens sticks (stops moving), instruct patient to remove lens; may apply a few drops of non-preserved sterile saline solution directly to eye to assist with removal
Consult eye care professional if non-movement of lens continues after a few minutes
Do not use contact lens cleaning and disinfectant solutions with lens
DO not use if sterile blister package is opened or damaged
Storage
Store at 15-25ºC (59-77ºF)
Protect from light
Store lenses in carton until use
Images
Formulary
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