Open-angle glaucoma or ocular hypertension: Ophthalmic: Instill 1 drop into affected eye(s) twice daily
There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.
Refer to adult dosing.
May be product dependent
May be used with other eye drops to lower intraocular pressure; if using more than one product, wait at least 5 minutes between application of each medication. Remove contact lenses prior to administration and wait 15 minutes before reinserting. Minimize contamination by not touching the eyelids or surrounding areas with the dropper tip; keep bottle tightly closed when not in use.
Open-angle glaucoma or ocular hypertension: To lower intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Ophthalmic: Burning sensation of eyes (≤25%), stinging of eyes (≤25%), eye pruritus (10% to 25%), eye redness (10% to 25%), xerophthalmia (10% to 25%), increased eyelash length (10% to 14%; ≥1 mm at 12 months)
1% to 10%:
Cardiovascular: Hypertension
Central nervous system: Foreign body sensation of eye (5% to 10%), dizziness, headache, insomnia, pain
Endocrine & metabolic: Diabetes mellitus
Hypersensitivity: Hypersensitivity reaction
Neuromuscular & skeletal: Back pain
Ophthalmic: Abnormal lacrimation (5% to 10%), eyelid disease (5% to 10%), visual disturbance (5% to 10%), decreased eyelash length (7%), blepharitis, cataract, conjunctivitis, corneal lesion, eye discharge, eye irritation, eye pain, hemophthalmos, keratitis, photophobia, vitreous disorder
Respiratory: Flu-like symptoms (6%), bronchitis, cough, pharyngitis, rhinitis, sinusitis
Miscellaneous: Accidental injury
<1%, postmarketing, and/or case reports: Blepharoptosis, color blindness, corneal deposits, corneal edema, corneal opacity, diplopia, hyperpigmentation of eyelids, increased growth in number of eyelashes, increased intraocular pressure (acute), iris hyperpigmentation, iritis, optic atrophy, retinal hemorrhage, visual field defect
Hypersensitivity to unoprostone or any component of the formulation
Concerns related to adverse effects:
• Ocular pigmentation: May cause permanent change in eye color (increases the amount of brown pigment in the iris, may not be noticeable for months to years); long-term consequences and potential injury to eye are not known. May also cause pigment changes to periorbital tissues and eyelashes during use; reversible upon discontinuation in most patients.
• Infection: Bacterial keratitis, caused by inadvertent contamination of multiple-dose ophthalmic solutions, has been reported. Minimize contamination by not touching the eyelids or surrounding areas with the dropper tip; keep bottle tightly closed when not in use.
Disease-related concerns:
• Ocular disease: Use with caution in patients with intraocular inflammation (eg, uveitis); may exacerbate intraocular inflammatory conditions. May cause macular edema, including cystoid macular edema; use cautiously in aphakic patients, pseudophakic patients with torn posterior lens capsules, or in patients at risk for macular edema.
Special populations:
• Contact lens wearers: Contains benzalkonium chloride which may be adsorbed by contact lenses; remove contacts prior to administration and wait 15 minutes before reinserting.
Dosage form specific issues:
• Contains benzalkonium chloride 0.015% as a preservative.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Nonsteroidal Anti-Inflammatory Agents: May diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents may also enhance the therapeutic effects of Prostaglandins (Ophthalmic). Risk C: Monitor therapy
Nonsteroidal Anti-Inflammatory Agents (Ophthalmic): May diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the therapeutic effect of Prostaglandins (Ophthalmic). Risk C: Monitor therapy
In animal reproduction studies, adverse events were observed when administered subcutaneously at doses greater than the recommended human dose. Following ophthalmic administration, systemic absorption is minimal; systemic absorption would be required in order for unoprostone to cross the placenta and reach the fetus. If ophthalmic agents are needed during pregnancy, the minimum effective dose should be used in combination with punctal occlusion to decrease potential exposure to the fetus (Samples, 1988).
It is not known if unoprostone is excreted in breast milk; however, systemic absorption is minimal following ophthalmic administration. The manufacturer recommends that caution be exercised when administering unoprostone to nursing women.
The exact mechanism of action is unknown; however, unoprostone likely decreases IOP by increasing the outflow of aqueous humor. Cardiovascular and pulmonary function were not affected in clinical studies. IOP was decreased by 3-4 mm Hg in patients with a mean baseline IOP of 23 mm Hg. IOP may also be lowered by increased trabecular meshwork outflow via stimulation of calcium-activated BK and CIC-2 type channels (Fung, 2014).
Absorption: Through cornea and conjunctival epithelium (minimal systemic exposure)
Metabolism: Hydrolyzed by esterases unoprostone-free acid
Half-life elimination: 14 minutes
Excretion: Urine (as metabolites)
Solution (Rescula Ophthalmic)
0.15% (per mL): $30.77
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