Econopred Plus (Ophthalmic)

Prednisolone eye drops are used to treat mild to moderate non-infectious eye allergies and inflammation, including damage from chemical and thermal burns.

Prednisolone eye drops are also used to treat eye inflammation caused by certain conditions.

Prednisolone is a steroid medicine that helps reduce redness, itching, and swelling caused by eye infections and other conditions.

This medicine is available only with your doctor's prescription.

Your eye doctor will want to check your eyes regularly to ensure this medicine is working well and to look for any side effects, especially if you will be using this medicine for 10 days or more.

This medicine is not for long-term use. Steroid eye drops can lead to glaucoma (higher pressure in the eye) or posterior subcapsular cataracts (a rare kind of cataract) if used for too long. You might also experience slow or delayed healing while using this medicine after cataract surgery. Regular eye exams with your doctor are necessary to monitor for these issues.

This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and needs immediate medical help. Contact your doctor right away if you experience a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

Do not stop using Omnipred® eye drops suddenly. Your doctor will need to gradually reduce your dose before you stop it altogether.

If your symptoms do not get better after 2 days or if they worsen, contact your eye doctor (ophthalmologist) immediately.

In deciding to use a medicine, you and your doctor must consider the risks and benefits of the medicine. For this medicine, here are important points to think about:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been enough studies to determine how age affects the use of Omnipred® eye drops in children. Safety and effectiveness have not been established.

There are no pediatric-specific problems with Pred Forte® and Pred Mild® eye drops that would limit their use in children. Safety and effectiveness have been established.

Geriatric

There have not been enough studies to show any problems specific to the elderly that would limit the use of prednisolone eye drops.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine while breastfeeding. Consider the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if there is a risk of interaction. In these cases, your doctor may adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and may not include all possible interactions.

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

• Desmopressin
• Rotavirus Vaccine, Live

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

• Aceclofenac
• Acemetacin
• Aldesleukin
• Amtolmetin Guacil
• Asparaginase
• Aspirin
• Balofloxacin
• Bemiparin
• Besifloxacin
• Bromfenac
• Bufexamac
• Bupropion
• Celecoxib
• Ceritinib
• Choline Salicylate
• Ciprofloxacin
• Clonixin
• Desogestrel
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Dienogest
• Diflunisal
• Dipyrone
• Drospirenone
• Droxicam
• Enoxacin
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Fleroxacin
• Floctafenine
• Flufenamic Acid
• Flumequine
• Flurbiprofen
• Gatifloxacin
• Gemifloxacin
• Gestodene
• Ibuprofen
• Indomethacin
• Ketoprofen
• Ketorolac
• Levofloxacin
• Levonorgestrel
• Lomefloxacin
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Lutetium Lu 177 Dotatate
• Macimorelin
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Mestranol
• Morniflumate
• Moxifloxacin
• Nabumetone
• Nadifloxacin
• Nadroparin
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nomegestrol
• Norethindrone
• Norfloxacin
• Norgestimate
• Norgestrel
• Ofloxacin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Pazufloxacin
• Pefloxacin
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Prulifloxacin
• Rofecoxib
• Rufloxacin
• Salicylic Acid
• Salsalate
• Sargramostim
• Sodium Salicylate
• Somatrogon-ghla
• Sorafenib
• Sparfloxacin
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Tosufloxacin
• Valdecoxib

Using this medicine with any of the following medicines may increase the risk of certain side effects, but taking both medicines may be the best option for you. If both are prescribed together, your doctor may adjust the dose or how often you use one or both.

• Alcuronium
• Amobarbital
• Atracurium
• Auranofin
• Fosphenytoin
• Gallamine
• Hexafluorenium
• Licorice
• Metocurine
• Phenytoin
• Primidone
• Rifampin
• Saiboku-To
• Vecuronium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at the same time as food or specific types of food due to potential interactions. Drinking alcohol or using tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine works. Be sure to inform your doctor if you have any other medical problems, especially:

• Asthma—Prednisolone eye drops contain a sulfite that can trigger asthma attacks in affected patients.

• Cataract or
• Issues with the cornea (part of the eye), history of or
• Glaucoma or
• History of herpes simplex infection or
• Issues with the sclera (part of the eye), history of—Use with caution. May worsen these conditions.

• Recent cataract surgery—Use with caution. May delay healing and increase the risk of side effects.

• Untreated eye infection with pus or
• Fungal eye infection or
• Herpes simplex eye infection or
• Mycobacterial (tuberculosis) eye infection or
• Vaccinia (smallpox) eye infection or
• Varicella (chickenpox) eye infection—Should not be used in patients with these conditions.

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:

Incidence not known

• Backache
• blindness
• blurred vision
• burning, dry, itching eyes
• change in vision
• darkening of the skin
• decreased vision
• diarrhea
• difficulty in focusing
• dizziness
• drooping of the upper eyelids
• eye discharge, excessive tearing
• facial hair growth in females
• fainting
• feeling of having something in the eye
• fractures
• full or round face, neck, or trunk
• increased thirst or urination
• irritability
• loss of appetite
• loss of sexual desire or ability
• menstrual irregularities
• mental depression
• muscle wasting
• nausea
• redness, irritation, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• sensitivity of the eye to light
• skin rash
• slow wound healing
• unusual tiredness or weakness
• vomiting

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:

Incidence not known

• Change in taste
• headache
• loss of taste

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.

In the U.S.

• AK-Pred
• Econopred Plus
• Inflamase
• Ocu-Pred
• Ocu-Pred-A
• Omnipred
• Pred Forte
• Pred Mild
• Prednisol

In Canada

• Minims prednisoLONE 0.5%

Available Dosage Forms:

• Suspension
• Solution

Therapeutic Class: Ophthalmologic Agent

Pharmacologic Class: Adrenal Glucocorticoid

Use this medicine 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.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way. Ask your doctor or pharmacist if you have any questions.

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. Wait at least 15 minutes after using this medicine before putting your contact lenses back in.

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 inflammation of the eye: For ophthalmic dosage form (Omnipred® eye drops): Adults—Instill two drops in the affected eye 4 times a day. Your doctor may adjust your dose as needed. Children—Use and dose must be determined by your doctor. For ophthalmic dosage form (Pred Forte® and Pred Mild® eye drops): Adults—Instill one or two drops in the affected eye 2 to 4 times a day. Your doctor may tell you to use the drops more often during the first 2 days. 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

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.

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

Pred Mild® eye drops may be stored in a cool, dry place.