Inflamase (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 from 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 side effects, especially if you will be using this medicine for 10 days or longer.

This medicine is not meant for long-term use. Steroid eye drops can cause glaucoma (increased pressure inside the eye) or posterior subcapsular cataracts (a rare type of cataract) if used for too long. Slow or delayed healing may also happen while you are 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 requires 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 lower your dose before you stop it completely.

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 need to consider the risks and benefits. Here are important things to think about for this medicine:

Allergies

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

Pediatric

There have not been appropriate studies on how Omnipred® eye drops affect children. Safety and effectiveness have not been established.

There have been studies on Pred Forte® and Pred Mild® eye drops in children, and no specific problems have been found that would limit their use in pediatric patients. Safety and efficacy have been established.

Geriatric

There have not been appropriate studies on prednisolone eye drops in elderly patients, and no specific problems have been found that would limit their use in this age group.

Breast Feeding

There are no adequate studies to determine the risk to infants when this medication is used during breastfeeding. Weigh the possible benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together, but your doctor might need to adjust the dose or take other precautions. When taking this medicine, it is 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 are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to prescribe this medication or change your other medicines.

• Desmopressin
• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some situations. If both are prescribed, your doctor may change the dose or frequency of use for one or both medicines.

• 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 using both may be necessary for your treatment. If both are prescribed, your doctor may change the dose or how often you use one or both medicines.

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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken with food or certain types of food due to possible interactions. Using alcohol or 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 you can use this medicine. Make sure to inform your doctor if you have any other medical problems, especially:

• Asthma—Prednisolone eye drops contain a sulfite that can trigger attacks in people with this condition.

• Cataract or
• Cornea (part of the eye) problems, history of or
• Glaucoma or
• Herpes simplex infection, history of or
• Sclera (part of the eye) problems, 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.