dexamethasone intravitreal implant (Rx)

Brand and Other Names:Ozurdex
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intravitreal implant

  • 0.7mg

Macular Edema

Treatment of macular edema following branch retinal vein occlusion or central retinal vein occlusion

1 implant (0.7 mg) inserted into affected eye by intravitreal injection

Diabetic Macular Edema

1 implant (0.7 mg) inserted into affected eye by intravitreal injection

Noninfectious Uveitis

Indicated for noninfectious uveitis affecting the posterior segment of the eye

Insert 1 intravitreal implant (0.7 mg) inserted into affected eye

Administration

For ophthalmic intravitreal injection only

Preservative free pouch with a single-use applicator

Procedure should be carried out under controlled aseptic conditions

Following the intravitreal injection, monitor patients for signs and symptoms of endophthalmitis, eye inflammation, increased IOP, and retinal detachments

Refer to manufacturer package instructions for proper administration

Safety and efficacy not established in pediatrics

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Adverse Effects

>10%

Increased IOP (25%)

Conjunctival hemorrhage (20%)

1-10%

Headache (3%)

Conjunctival hyperemia (7%)

Eye pain (7%)

Cataract (4%)

Ocular hypertension (4%)

Vitreous detachment (3%)

Postmarking Reports

Complication of device insertion resulting in ocular tissue injury including sclera, subconjunctiva, lens and retina (implant misplacement)

Device dislocation with or without corneal edema

Endophthalmitis

Hypotony of the eye (associated with vitreous leakage due to injection)

Retinal detachment

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Warnings

Contraindications

Hypersensitivity to any components of the product

Ocular or periocular infection

Patients with glaucoma, who have cup to disc ratios of greater than 0.8

Aphakic eyes with rupture of the posterior lens capsule

Eyes with ACIOL (Anterior Chamber Intraocular Lens) and torn and rupture posterior lens capsule

Cautions

Intravitreal injections have been associated with endophthalmitis, eye inflammation, increased IOP, and retinal detachments; monitor patients following the injection

Use of corticosteroids may produce posterior subcapsular cataracts, increased IOP, and glaucoma, and may enhance the establishment of secondary ocular infections caused by bacteria, fungi, or viruses

Use cautiously in patients with a history of ocular herpes simplex; reactivation of viral infection possible; Not for use in presence of active ocular herpes simplex

May mask infections or enhance existing infections

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Pregnancy & Lactation

Pregnancy Category: C

Pregnancy

There are no adequate and well-controlled studies in pregnant women; topical ocular administration of dexamethasone in mice and rabbits during period of organogenesis produced cleft palate and embryofetal death in mice, and malformations of abdominal wall/intestines and kidneys in rabbits at doses 5 and 4 times higher than recommended human ophthalmic dose (RHOD) (0.7 milligrams dexamethasone), respectively

Lactation

Systemically administered corticosteroids are present in human milk and can suppress growth and interfere with endogenous corticosteroid production or cause other unwanted effects; there is no information regarding presence of dexamethasone in human milk, effects on breastfed infants, or on milk production to inform risk of therapy to an infant during lactation; the developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for therapy and potential adverse effects on breastfed child

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

Dexamethasone, a potent corticosteroid, suppresses inflammation by inhibiting multiple inflammatory cytokines, resulting in decreased edema, fibrin deposition, capillary leakage, and migration of inflammatory cells

Absorption

Negligible systemic absorption

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Decadron oral
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0.5 mg tablet
Decadron oral
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4 mg tablet
Decadron oral
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0.75 mg tablet
Dexamethasone Intensol oral
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1 mg/mL drops
Maxidex ophthalmic (eye)
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0.1 % drops
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0.5 mg/5 mL solution
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0.5 mg/5 mL solution
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0.5 mg/5 mL elixir
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6 mg tablet
dexamethasone oral
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0.5 mg tablet
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4 mg tablet
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4 mg tablet
HiDex oral
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1.5 mg (21 tabs) tablet
Dxevo oral
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1.5 mg (39 tabs) tablet
Dexabliss oral
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1.5 mg (39 tabs) tablet
TaperDex oral
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1.5 mg (49 tabs) tablet
TaperDex oral
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1.5 mg (21 tabs) tablet
TaperDex oral
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1.5 mg (27 tabs) tablet

Copyright © 2010 First DataBank, Inc.

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Patient Handout

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Patient Education
dexamethasone ophthalmic (eye)

DEXAMETHASONE SOLUTION/SUSPENSION - OPHTHALMIC/OTIC

(dex-a-METH-a-sone)

COMMON BRAND NAME(S): Maxidex

USES: This medication is used to treat certain eye conditions due to inflammation or injury. Dexamethasone works by relieving symptoms such as swelling, redness, and itching. It belongs to a class of drugs known as corticosteroids.This medication may also be used to treat swelling, redness, and itching of the outer ear due to inflammatory conditions.

HOW TO USE: EYE: Unless otherwise directed by your doctor, do not wear contact lenses while you are using this medicine. Sterilize contact lenses according to the manufacturer's directions, and check with your doctor before you begin using them again.If your doctor does approve the wearing of contact lenses during treatment with this medication, remove the lenses before using the eye drops. The preservative in this product may be absorbed by contact lenses. Wait at least 15 minutes after each dose of the eye drop before wearing the lenses again.To apply eye drops, wash your hands first. If you are using a suspension form of this medication, shake the bottle well before using. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place 1 drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed and if your dose is for more than 1 drop.Apply as often as directed by your doctor. Do not rinse the dropper. Replace the dropper cap after each use.If you are using another kind of eye medication (for example, other drops or ointments), wait at least 5 to 10 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye.EAR: Clean and dry the ear canal before using this medication. To make sure the right amount of medication is given, and to avoid touching the ear with the dropper, have another person insert the drops if possible. To lower the risk of dizziness, hold the container in your hand for a few minutes in order to warm it.To apply ear drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your ear or any other surface. If you are using a suspension form of this medication, shake the bottle well before using. Lie on your side or tilt the affected ear upward. Hold the dropper directly over the ear and place the prescribed number of drops into the ear canal. To help the drops roll into the ear of an adult, hold the earlobe up and back. For children, hold the earlobe down and back. Keep the head tilted for 5 minutes, or insert a soft cotton plug if so directed. Alternatively, your doctor may instruct you to place a cotton/gauze plug in the ear canal, moisten it with the medication, and leave it in the ear for 12 to 24 hours or as directed. The plug should be replaced at least once a day.Repeat these steps for the other ear if so directed. Apply as often as directed by your doctor. Do not rinse the dropper. Replace the dropper cap after each use.Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day.The dosage and length of treatment are based on your medical condition and response to treatment. Do not use this medication more often or for longer than prescribed because doing so may increase your risk of side effects.Continue to use this medication for the full time prescribed. Do not stop using this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.Do not use this product if it becomes contaminated (for example, drops turn a dark color). Use of contaminated eye medication can cause infection, serious damage to the eye, and loss of vision. Use of contaminated ear medication can cause infection, serious damage to the ear, and hearing loss. Contact your doctor or pharmacist for more information.Tell your doctor if your condition does not improve in a few days or if it worsens.

SIDE EFFECTS: Rarely, stinging/burning of the eyes for 1 to 2 minutes may occur when you apply this medication. If used in the ear, stinging/burning may also rarely occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Use of this medication for prolonged periods or in high doses may cause serious eye problems (such as high pressure inside the eyes and cataracts). Tell your doctor right away if any of these unlikely but serious side effects occur: vision problems, eye pain.This medication may mask the signs of an eye/ear infection. It may also put you at greater risk of developing an eye/ear infection, especially with prolonged use. Report any new or worsening symptoms such as eye/ear discharge/swelling/redness, vision/hearing problems, or no improvement of your current eye/ear condition. Your doctor will need to adjust your treatment.Tell your doctor right away if any of these unlikely but serious side effects occur: headache, dizziness.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using dexamethasone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as sulfites found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye infections, recent eye surgery, cataracts, glaucoma (open-angle type), severe nearsightedness (myopia), diabetes, other ear problems (such as a hole in your eardrum, ear infections).After you apply this drug in the eyes, your vision may become temporarily unstable. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).If you develop a new eye infection or injury, or require eye surgery, ask your doctor if you should continue to use your current bottle of dexamethasone eye drops or start a new bottle.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known if the medication in this product passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.Laboratory and/or medical tests (such as eye exams, measurement of the pressure inside the eyes, ear exams) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep the bottle upright and tightly closed when not in use. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

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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.