Pronunciation:

pred-NIS-oh-lone

Brand Names:

• AK-Pred
• Econopred Plus
• Inflamase
• Ocu-Pred
• Ocu-Pred-A
• Omnipred
• Pred Forte
• Pred Mild
• Prednisol
• Minims prednisoLONE 0.5%

Dosage Forms:

• Suspension
• Solution

Classifications:

Therapeutic—

Ophthalmologic Agent

Pharmacologic—

Adrenal Glucocorticoid

Uses of This Medicine:

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

Prednisolone eye drops is also used to treat inflammation of the eyes caused by certain conditions.

Prednisolone is a steroid medicine that is used to relieve the redness, itching, and swelling caused by eye infections and other conditions.

This medicine 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 Omnipred® eye drops 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 Pred Forte® and Pred Mild® 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 prednisolone eye drops 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.

• Desmopressin
• 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.

• Aldesleukin
• Asparaginase
• Aspirin
• Balofloxacin
• Bemiparin
• Besifloxacin
• Bupropion
• Carbamazepine
• Ceritinib
• Ciprofloxacin
• Cosyntropin
• Desogestrel
• Dienogest
• Drospirenone
• Enoxacin
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Fleroxacin
• Flumequine
• Gatifloxacin
• Gemifloxacin
• Gestodene
• Levofloxacin
• Levonorgestrel
• Lomefloxacin
• Lutetium Lu 177 Dotatate
• Macimorelin
• Mestranol
• Moxifloxacin
• Nadifloxacin
• Nadroparin
• Nomegestrol
• Norethindrone
• Norfloxacin
• Norgestimate
• Norgestrel
• Ofloxacin
• Pazufloxacin
• Pefloxacin
• Prulifloxacin
• Rufloxacin
• Sargramostim
• Somatrogon-ghla
• Sorafenib
• Sparfloxacin
• Tosufloxacin

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

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:

• Asthma—Prednisolone eye drops contain a sulfite which can trigger attacks in patients 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 make these conditions worse.

• Cataract surgery, recent—Use with caution. May cause delayed healing and increase the risk of unwanted effects.

• Eye infection with pus, untreated 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.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

Your eye doctor will want to examine your eyes at regular visits to make sure this medicine is working properly and to check for unwanted effects, especially if you will be using this medicine for 10 days or longer.

This medicine is not for long-term use. 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.

This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have 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 slowly decrease your dose before you stop it completely.

If your symptoms do not improve after 2 days 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:

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.