unoprostone ophthalmic (Rx)

Brand and Other Names:Rescula

Dosing & Uses

AdultPediatric

Dosage Forms & 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

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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Interactions

Interaction Checker

and unoprostone ophthalmic

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (0)

                  Minor (0)

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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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                    Administration

                    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

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                    Images

                    No images available for this drug.
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                    Patient Handout

                    A Patient Handout is not currently available for this monograph.
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                    Formulary

                    FormularyPatient Discounts

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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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                    Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.