Dosing and uses of Rescula (unoprostone ophthalmic)
Adult dosage forms and strengths
ophthalmic solution
- 15%
Open-Angle Glaucoma
Indicated to lower IOP with open-angle glaucoma
1 gtt in affected eye(s) BId
Ocular Hypertension
Indicated to lower IOP with ocular hypertension
1 gtt in affected eye(s) BId
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
Retinitis Pigmentosa (Orphan)
Orphan designation for treatment of retinitis pigmentosa
Orphan sponsor
- Sucampo Pharma Americas, Inc. 4520 East-West Highway Bethesda, MD 20814
Pediatric dosage forms and strengths
<18 years: Safety and efficacy not established
Rescula (unoprostone ophthalmic) adverse (side) effects
>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
Warnings
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 and lactation
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.
Pharmacology of Rescula (unoprostone ophthalmic)
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)
