Pronunciation:

dex-a-METH-a-sone

Brand Names:

• Dextenza
• Maxidex
• Ocu-Dex

Dosage Forms:

• Suspension
• Insert, Extended Release
• Solution

Classifications:

Therapeutic—

Ophthalmologic Agent

Pharmacologic—

Adrenal Glucocorticoid

Uses of This Medicine:

Dexamethasone eye drops are used to treat inflammation of the eyes caused by allergies and certain conditions, including damage caused by chemical and thermal burns.

Dexamethasone eye insert is used to treat eye pain and swelling after eye surgery. It is also used to treat itching of the eye caused by a condition known as allergic conjunctivitis.

Dexamethasone belongs to the group of medicines known as corticosteroids (steroids or cortisone-like medicines) that is used to relieve the redness, itching, and swelling caused by eye infections and other conditions or procedures (eg, eye surgery).

Dextenza® is to be given only by your doctor. Maxidex® is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of dexamethasone eye insert in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of dexamethasone eye drops in children. Safety and efficacy have been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dexamethasone eye drops or eye insert in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Artemether
• Desmopressin
• Praziquantel
• Rilpivirine
• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Aceclofenac
• Acemetacin
• Aldesleukin
• Alfentanil
• Amiodarone
• Amtolmetin Guacil
• Apalutamide
• Aspirin
• Atogepant
• Balofloxacin
• Bemiparin
• Benzhydrocodone
• Besifloxacin
• Boceprevir
• Bromfenac
• Bufexamac
• Buprenorphine
• Bupropion
• Carbamazepine
• Celecoxib
• Ceritinib
• Cholestyramine
• Choline Salicylate
• Ciprofloxacin
• Clarithromycin
• Clonixin
• Cobicistat
• Codeine
• Conivaptan
• Dabrafenib
• Daclatasvir
• Darunavir
• Desogestrel
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Dienogest
• Diflunisal
• Dihydrocodeine
• Dipyrone
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Dronedarone
• Drospirenone
• Droxicam
• Efavirenz
• Elvitegravir
• Enoxacin
• Enzalutamide
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etodolac
• Etofenamate
• Etonogestrel
• Etoricoxib
• Etravirine
• Fedratinib
• Felbinac
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Fexinidazole
• Fleroxacin
• Floctafenine
• Flufenamic Acid
• Flumequine
• Flurbiprofen
• Fosamprenavir
• Fosphenytoin
• Gatifloxacin
• Gemifloxacin
• Gestodene
• Hemin
• Hydrocodone
• Ibuprofen
• Idelalisib
• Indinavir
• Indomethacin
• Itraconazole
• Ketoconazole
• Ketoprofen
• Ketorolac
• Lapatinib
• Lenacapavir
• Levofloxacin
• Levonorgestrel
• Lomefloxacin
• Lopinavir
• Lornoxicam
• Loxoprofen
• Lumacaftor
• Lumateperone
• Lumiracoxib
• Lurasidone
• Lutetium Lu 177 Dotatate
• Macimorelin
• Meclofenamate
• Medroxyprogesterone
• Mefenamic Acid
• Meloxicam
• Meperidine
• Mestranol
• Methadone
• Mitotane
• Morniflumate
• Moxifloxacin
• Nabumetone
• Nadifloxacin
• Nadroparin
• Naproxen
• Nefazodone
• Nelfinavir
• Nepafenac
• Nevirapine
• Nifedipine
• Niflumic Acid
• Nilotinib
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nimodipine
• Nirmatrelvir
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norfloxacin
• Norgestimate
• Norgestrel
• Ofloxacin
• Omaveloxolone
• Oxaprozin
• Oxycodone
• Oxyphenbutazone
• Parecoxib
• Pazufloxacin
• Pefloxacin
• Pentazocine
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Piketoprofen
• Piperaquine
• Piroxicam
• Posaconazole
• Pranoprofen
• Primidone
• Proglumetacin
• Propyphenazone
• Proquazone
• Prulifloxacin
• Rifampin
• Ritonavir
• Rofecoxib
• Rufloxacin
• Salicylic Acid
• Salsalate
• Saquinavir
• Sargramostim
• Segesterone
• Sodium Salicylate
• Somatrogon-ghla
• Sparfloxacin
• St John's Wort
• Sufentanil
• Sulindac
• Sunitinib
• Tacrolimus
• Telaprevir
• Telithromycin
• Tenoxicam
• Thalidomide
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Tosufloxacin
• Tramadol
• Ubrogepant
• Ulipristal
• Valdecoxib
• Velpatasvir
• Vincristine Sulfate Liposome
• Voriconazole
• Voxilaprevir
• Zolpidem
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alcuronium
• Aminoglutethimide
• Aprepitant
• Atracurium
• Auranofin
• Caspofungin
• Fluindione
• Fosaprepitant
• Fosnetupitant
• Gallamine
• Hexafluorenium
• Licorice
• Metocurine
• Netupitant
• Ospemifene
• Pancuronium
• Rifapentine
• Saiboku-To
• Vecuronium
• Warfarin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cataract or
• Cornea (part of the eye) problems, history of or
• Glaucoma or
• Sclera (part of the eye) problems, history of—Use with caution. May make these conditions worse.

• Cataract surgery—Use with caution. The eye insert may cause delayed healing and increase the risk of unwanted effects.

• Bacterial eye infection, acute, untreated or
• Fungal eye infection or
• Herpes simplex eye infection or
• Mycobacterial eye infection or
• Vaccinia (smallpox) eye infection or
• Varicella (chickenpox) eye infection—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Your eye doctor (ophthalmologist) will give you Dextenza® eye insert in a medical facility. It is inserted inside the lower part of your eye. Dextenza® eye insert will release the medicine for up to 30 days. The insert will be absorbed by the eye and does not require removal.

Use Maxidex® only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects.

To use the eye drops:

• Wash your hands first with soap and water.
• Shake the bottle well before each use.
• Tilt your head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space.
• Let go of the eyelid and gently close your eye. Do not blink. Keep the eye closed and apply pressure to the inner corner of your eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
• If you think you did not get the drop of medicine into your eye properly, use another drop.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Keep the bottle tightly closed and upright when you are not using it.

If you are wearing contact lenses, remove them before putting the drops in your eyes.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic dosage form (eye drops):
  • For inflammation of the eye:
    • Adults—Instill one or two drops in the affected eye 4 to 6 times a day. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your eye doctor (ophthalmologist) check your or your child's progress at regular visits to make sure the medicine is working properly and to check for unwanted effects, especially if you will be using Maxidex® for 10 days or longer.

Steroid eye drops may cause glaucoma (increased pressure inside the eye) or posterior subcapsular cataracts (a rare type of cataract) if used too long. Slow or delayed healing may also occur while you are using this medicine after cataract surgery. You will need to have regular eye exams with your doctor to check for these problems.

If you wear contact lenses, remove them before you put the drops into your eyes. Wait at least 15 minutes after using Maxidex® eye drops before you put your contact lenses back in.

If your symptoms do not improve or if they become worse, check with your eye doctor (ophthalmologist) right away.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blurred vision

decreased vision or other changes in vision

eye pain or redness

sensitivity of the eye to light

throbbing pain of the eye

Less common

Loss of vision

redness of the white part of the eyes or inside of the eyelids

swelling of the eye

Rare

Burning, dry, or itching eyes

delayed eye wound healing

difficulty seeing at night

discharge, excessive tearing

eye irritation

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

Incidence not known

Difficulty in breathing or swallowing

drooping of the upper eyelids

fast heartbeat

skin itching, rash, or redness

swelling of the face, throat, or tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Headache

Rare

Crusting in the corner of the eye

feeling of having something in the eye

Incidence not known

Bigger, dilated, or enlarged pupils

dizziness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.