unoprostone ophthalmic (Rx)

>10%

Burning/stinging (10-25%)

Dry eyes (10-25%)

Itching (10-25%)

Increased length of eyelashes (10-25%)

Conjunctival injection (10-25%)

1-10%

Abnormal vision (5-10%)

Eyelid disorder (5-10%)

Foreign body sensation (5-10%)

Lacrimation disorder(5-10%)

Decreased length of eyelashes (5-10%)

Blepharitis (1-5%)

Cataract (1-5%)

Conjunctivitis (1-5%)

Corneal lesion/erosion (1-5%)

Ocular discharge/hemorrhage/pain (1-5%)

Keratitis (1-5%)

Irritation (1-5%)

Photophobia (1-5%)

Vitreous disorder (1-5%)

Blurred vision (1-5%)

Conjunctival hyperemia (1-5%)

<1%

Hyperpigmentation of the eyelid or iris and increased number of eyelashes

Acute elevated IOP

Color blindness

Corneal deposits

Corneal edema

Corneal opacity

Diplopia

Optic atrophy

Ptosis

Retinal hemorrhage

Visual field defect

Postmarketing Reports

Chemosis

Dry mouth

Nausea

Vomiting

Palpitations

Contraindications

Hypersensitivity

Cautions

Increased pigmentation may occur due to increased melanin content in iris, eyelid periorbital tissues, and eyelashes

May exacerbated active intraocular inflammation (eg, uveitis)

Macular edema, including cystoid macular edema reported; caution in aphakic patients or pseudophakic patients with torn posterior lens capsule

Pregnancy Category: C

Lactation: Unknown if distributed into human milk; use caution

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.

Mechanism of Action

Decreases intraocular pressure by increasing outflow of aqueous humor through the trabecular meshwork

Pharmacokinetics

Absorbed: through cornea and conjunctival epithelium; minimal systemic absorption

Half-Life: 14 min

Peak Plasma: <1.5 ng/mL

Metabolism: hydrolyzed by esterases to unoprostone free acid

Excretion: urinary (as metabolites)

Ophthalmic Administration

May use with other topical ophthalmic drugs to lower IOP; if 2 drugs are used, separate administration by at least 5 minutes

Contains benzalkonium chloride, which may be absorbed by soft contact lenses; remove contact lenses before administration and wait at least 15 minutes after administration before reinserting contact lenses

Avoid touching eyelids or surrounding areas with dropper bottle tip to minimize contaminating dropper tip and solution