dexamethasone intraocular (Rx)

Brand and Other Names:Dexycu
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intraocular suspension

  • 9% (103.4mg/mL)

Ophthalmic Postoperative Inflammation

Indicated for intraocular administration to treat postoperative inflammation

0.005 mL of 9% suspension (517 mcg) as a single dose administered intraocularly in the posterior chamber at the end of surgery

Safety and efficacy not established

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Adverse Effects

>10%

Increased intraocular pressure (5-15%)

Corneal edema (5-15%)

Iritis (5-15%)

1-10%

Corneal endothelial cell loss (1-5%)

Blepharitis (1-5%)

Eye pain (1-5%)

Cystoid macular edema (1-5%)

Dry eye (1-5%)

Ocular inflammation (1-5%)

Posterior capsule opacification (1-5%)

Blurred vision (1-5%)

Reduced visual acuity (1-5%)

Vitreous floaters (1-5%)

Foreign body sensation (1-5%)

Photophobia (1-5%)

Vitreous detachment (1-5%)

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Warnings

Contraindications

None

Cautions

Prolonged use of corticosteroids may result in glaucoma, with damage to the optic nerve and defects in visual acuity and visual fields; use with caution if glaucoma present

Corticosteroids may delay healing after cataract surgery and increase incidence of bleb formation; perforations reported with use of corticosteroids in diseases causing corneal or scleral thinning

May exacerbate infection; not recommended if active viral diseases of the cornea and conjunctiva present (eg, epithelial herpes simplex keratitis, vaccinia, varicella), mycobacterial eye infection, or ocular fungal disease; caution with history of herpes simplex; prolonged use may suppress host response to infection and increases risk of secondary ocular infections

Use in phakic individuals may promote the development of posterior subcapsular cataracts

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Pregnancy & Lactation

Pregnancy

There are no available data regarding use in pregnant women

Topical ocular administration of dexamethasone in mice and rabbits during the period of organogenesis produced cleft palate and embryofetal death in mice and malformations of abdominal wall/intestines and kidneys in rabbits at doses 7 and 5 times higher than the injected recommended human ophthalmic dose, respectively

Lactation

Systemically administered corticosteroids are present in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other unwanted effects

There is no information regarding the presence of intraocular dexamethasone in human milk, the effects on breastfed infants, or the effects on milk production to inform about risk to an infant during lactation

The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed child or from the underlying maternal condition

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

Corticosteroids have been shown to suppress inflammation by inhibiting multiple inflammatory cytokines, resulting in decreased edema, fibrin deposition, capillary leakage, and migration of inflammatory cells

Absorption

Plasma concentrations

  • Study 1, postsurgery Day 1: 0.09-0.86 ng/mL (342-mg dose); 0.07-1.16 ng/mL (517-mcg dose)
  • Study 2, postsurgery Day 1: 0.349-2.79 ng/mL (517-mcg dose)
  • Few patients had quantifiable plasma concentrations at the final time point of sampling (Day 15 or Day 30)
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Administration

Intraocular Preparation

Each kit is for a single administration and contains drugs (0.5-mL vial), 1-mL syringe, sterile syringe guide, sterile syringe ring, sterile 18-ga needle (1.5-in), and sterile 25-ga bent cannula (8-mm)

See full prescribing information for complete, detailed instructions with diagrams for sterile field preparation

Dexamethasone vial must be vigorously shaken in sideways motion for a minimum of 30 seconds

The suspended drug material must be used immediately after shaking

Intraocular Administration

Administer single dose intraocularly in posterior chamber of the eye at the end of surgery

If the sphere of administered drug after intraocular injection appears to be >2 mm in diameter, remove excess drug material by irrigation and aspiration in the sterile surgical setting

Storage

Store at 20-25°C (68-77°F)

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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.
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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.