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Rimexolone

Pronunciation

(ri MEKS oh lone)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

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Suspension, Ophthalmic:

Vexol: 1% (5 mL, 10 mL)

Brand Names: U.S.

  • Vexol

Pharmacologic Category

  • Corticosteroid, Ophthalmic

Pharmacology

Suppresses the inflammatory response by inhibiting edema, capillary dilation, leukocyte migration and scar formation.

Absorption

Through aqueous humor

Metabolism

Hepatic for any amount of drug absorbed

Excretion

Urine and feces (>80%)

Half-Life Elimination

1 to 2 hours

Use: Labeled Indications

Ophthalmic inflammatory conditions: Treatment of postoperative inflammation following ocular surgery; treatment of anterior uveitis

Contraindications

Hypersensitivity to rimexolone or any component of the formulation; acute untreated purulent ocular infections; viral diseases of the cornea and conjunctiva (eg, epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella); mycobacterial or fungal infections of the eye

Documentation of allergenic cross-reactivity for corticosteroids is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosage

Ophthalmic: Adults:

Anterior uveitis: Instill 1 to 2 drops in conjunctival sac of affected eye every hour during waking hours for the first week, then 1 drop every 2 hours during waking hours of the second week, and then taper until uveitis is resolved

Postoperative ocular inflammation: Instill 1 to 2 drops in conjunctival sac of affected eye 4 times daily beginning 24 hours after surgery and continuing through the first 2 weeks of the postoperative period

Dosage adjustment in renal impairment: There are no dosage adjustments provided in the manufacturer’s labeling.

Dosage adjustment in hepatic impairment: There are no dosage adjustments provided in the manufacturer’s labeling.

Administration

For topical ophthalmic use only; to avoid contamination, do not touch dropper tip to eyelids or other surfaces when placing drops in eyes. Shake well before using. The use of the same bottle for both eyes is not recommended in surgical patients.

Storage

Store upright at 2°C to 25°C (36°F to 77°F). Do not freeze.

Drug Interactions

Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin. Avoid combination

Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy

Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Monitor therapy

Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. Specifically, the risk for GI ulceration/irritation or GI bleeding may be increased. Monitor therapy

Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification

NSAID (Ophthalmic): May enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Monitor therapy

Adverse Reactions

1% to 5%: Ocular: Blurred vision, discharge, discomfort, pain, increased intraocular pressure, foreign body sensation, hyperemia, pruritus

<2%:

Cardiovascular: Hypotension

Central nervous system: Headache

Gastrointestinal: Taste perversion

Respiratory: Pharyngitis, rhinitis

<1% (Limited to important or life-threatening): Ocular: Browache, conjunctival edema, corneal edema, corneal erosion, corneal staining, corneal ulcer, dry eye, edema, increased fibrin, infiltrate, irritation, keratitis, lid crusting, photophobia, sticky sensation, tearing

Frequency not defined: Cataracts, damage to the optic nerve, defects in visual activity, perforation of globe, secondary ocular infection

Warnings/Precautions

Concerns related to adverse effects:

• Cataracts: Prolonged use of corticosteroids may result in posterior subcapsular cataract formation. Use following cataract surgery may delay healing or increase the incidence of bleb formation.

• Corneal thinning: Various ophthalmic disorders, as well as prolonged use of corticosteroids, may result in corneal and scleral thinning. Continued use in a patient with thinning may result in perforation.

• Glaucoma: Prolonged use of corticosteroids may result in elevated intraocular pressure (IOP) and/or glaucoma; damage to the optic nerve; and defects in visual acuity and fields of vision. Use with caution in patients with glaucoma; monitor IOP in any patient receiving treatment for ≥10 days.

• Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection (including fungal infections). Acute purulent ocular infections may be masked or exacerbated with use. Fungal infection should be suspected in any patient with persistent corneal ulceration who has received corticosteroids.

Special populations:

• Contact lens wearers: Some preparations contain benzalkonium chloride which may be adsorbed by contact lenses.

Other warnings/precautions:

• Appropriate use: Patients should be re-evaluated if symptoms fail to improve after 2 days. Initial prescription and renewal of medication should be made by healthcare provider only after examination with the aid of magnification such as slit lamp biomicroscopy or fluorescein staining (if appropriate). Corticosteroids should not be used to treat ocular herpes simplex. Use of same bottle in both eyes of postoperative patients is not recommended.

Monitoring Parameters

Intraocular pressure and periodic examination of lens (with prolonged use ≥10 days)

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies following subcutaneous administration. The amount of rimexolone absorbed systemically following ophthalmic administration is low (<80 to 470 pg/mL).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience foreign body sensation of eye. Have patient report immediately to prescriber vision changes, ophthalmalgia, severe eye irritation, or eye discharge (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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