unoprostone ophthalmic (Rx)

Brand and Other Names:Rescula
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

ophthalmic solution

  • 15%
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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

<18 years: Safety and efficacy not established

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Adverse 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

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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

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Pregnancy & 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.

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Pharmacology

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)

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Images

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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  • Compare formulary status to other drugs in the same class.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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