Dosing & Uses
Dosage Forms & Strengths
ophthalmic solution
- 100% (1.338 g/mL; 3mL per 5-mL multidose bottle)
Dry Eye Disease
Indicated for treatment of signs and symptoms of dry eye disease (DED)
Instill 1 drop into affected eye(s) QID
<18 years: Safety and efficacy not established
Adverse Effects
1-10%
Blurred vision and conjunctival redness (1-3%)
Warnings
Contraindications
None
Cautions
Do not administer while wearing contact lenses; advise patients to remove contact lenses before and for at least 30 minutes after administration
Pregnancy & Lactation
Pregnancy
There are no adequate and well-controlled studies of perfluorohexyloctane ophthalmic in pregnant females
Animal studies
- No adverse maternal or developmental effects were observed in rats at doses up to 162 times the recommended human ophthalmic dose (RHOD) with PO administration during organogenesis
- Maternal toxicity, miscarriages, and reduced fetal weights observed in rabbits at all oral doses tested, with the lowest dose at 41 times the RHOD
Lactation
Data are not available on presence of perfluorohexyloctane in human milk, effects on breastfed infants, or effects on milk production
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
Exact mechanism of action in dry eye disease is unknown
Perfluorohexyloctane is a semifluorinated alkane; it forms a monolayer at the tear film air-liquid interface, which can be expected to reduce evaporation
Absorption
Low systemic blood levels observed after topical ocular administration
Metabolism
Not metabolized by human liver microsomes in vitro
Administration
Ophthalmic Administration
For topical ophthalmic use only
Do not touch tip of applicator to microbial contamination
Remove contact lenses before administration, and wait at least 30 minutes after administering drops before reinserting
Storage
Store at 15-25ºC (59-77ºF)
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Formulary
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