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
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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0.5 mg/5 mL elixir
dexamethasone oral
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dexamethasone oral
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dexamethasone oral
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Maxidex ophthalmic (eye)
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0.1 % drops
Dxevo oral
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1.5 mg (39 tabs) tablet
Dexabliss oral
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1.5 mg (39 tabs) tablet
Dexamethasone Intensol oral
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1 mg/mL drops
ZCort oral
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1.5 mg (25 tabs) tablet
Decadron oral
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0.5 mg tablet
Decadron oral
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0.75 mg tablet
Decadron oral
-
4 mg tablet

Copyright © 2010 First DataBank, Inc.

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Patient Handout

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Patient Education
dexamethasone oral

DEXAMETHASONE - ORAL

(dex-uh-METH-uh-sown)

COMMON BRAND NAME(S): Decadron

USES: Dexamethasone is used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions, skin diseases, eye problems, breathing problems, bowel disorders, cancer, and immune system disorders. It is also used as a test for an adrenal gland disorder (Cushing's syndrome).Dexamethasone belongs to a class of drugs known as corticosteroids. It decreases your immune system's response to various diseases to reduce symptoms such as swelling and allergic-type reactions.

HOW TO USE: Take this medication by mouth as directed by your doctor. Take with food or milk to prevent stomach upset. Take the tablet form of this medication with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.If you take this medication once daily, take it in the morning before 9 AM. If you are taking this medication every other day or on another schedule besides a daily one, it may help to mark your calendar with a reminder.The dosage and length of treatment are based on your medical condition and response to treatment. Take this medication exactly as prescribed. Follow the dosing schedule carefully. Your doctor may attempt to reduce your dose slowly from time to time to minimize side effects.Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience symptoms such as nausea, dizziness, weakness, or muscle/joint pain. To prevent these symptoms while you are stopping treatment with this drug, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details. Report any new or worsening symptoms right away.Tell your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: Stomach upset, heartburn, headache, trouble sleeping, or increased appetite may occur. If any of these effects last or get worse, 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.Tell your doctor right away if you have any serious side effects, including: signs of infection (such as sore throat that doesn't go away, fever), bone/joint pain, fast/slow/irregular heartbeat, eye pain/pressure, vision problems, unusual weight gain, puffy face, swelling of the ankles/feet, symptoms of stomach/intestinal bleeding (such as stomach/abdominal pain, black/tarry stools, vomit that looks like coffee grounds), mental/mood changes (such as depression, mood swings, agitation), menstrual period changes, muscle pain/cramps, weakness, easy bruising/bleeding, slow wound healing, thinning skin, seizures.This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 taking 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, 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: infections (such as tuberculosis, herpes, fungal infections), kidney disease, liver disease, mental/mood disorders (such as psychosis, anxiety, depression), mineral imbalance (such as low level of potassium/calcium in the blood), thyroid disease, stomach/intestinal problems (such as ulcer, ulcerative colitis, diverticulitis, unexplained diarrhea), high blood pressure, heart problems (such as heart failure, recent heart attack), diabetes, eye diseases (such as cataracts, glaucoma), bone loss (osteoporosis), blood clots.Using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. If you will be using this medication for a long time, carry a warning card or medical ID bracelet that identifies your use of this medication.This medication may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.This medicine may cause stomach bleeding. Daily use of alcohol while using this medicine may increase your risk for stomach bleeding. Limit alcoholic beverages. Consult your doctor or pharmacist for more information.Tell your health care professional that you are using dexamethasone before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).The liquid form of this medication may contain sugar and/or alcohol. Caution is advised if you have diabetes, liver disease, or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely.Older adults may be more sensitive to the side effects of this drug, especially bone loss/pain, stomach/intestinal bleeding, and mental/mood changes (such as confusion).This medication may slow down a child's growth if used for a long time. Consult the doctor or pharmacist for more details. See the doctor regularly so your child's height and growth can be checked.During pregnancy, this medication should be used only when clearly needed. It may rarely harm an unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for an extended time may have hormone problems. Tell your doctor right away if you notice symptoms such as nausea/vomiting that doesn't stop, severe diarrhea, or weakness in your newborn.It is unknown if this medication passes into breast milk. Consult your doctor before breast- feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: aldesleukin, drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as dabigatran/warfarin, NSAIDs such as aspirin/celecoxib/ibuprofen), mifepristone.This medication can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include certain cancer drugs (such as dasatinib, lapatinib, sunitinib), praziquantel, rilpivirine, among others.If your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually 81-162 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.This medication may interfere with certain lab tests (including skin tests), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

OVERDOSE: 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.If this medication is used for an extended time, lab and/or medical tests (such as blood mineral levels, blood glucose, complete blood count, bone density tests, blood pressure, eye exams) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.This medication may cause bone problems (osteoporosis) when taken for an extended time. Lifestyle changes that may help reduce the risk of bone problems include doing weight-bearing exercise, getting enough calcium and vitamin D, stopping smoking, and limiting alcohol. Discuss with your doctor lifestyle changes that might benefit you.

MISSED DOSE: If you are taking this medication daily and on a regular schedule, and you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.If you are taking this medication every other day or are slowly reducing your dose, and you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised March 2022. Copyright(c) 2022 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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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.