Econopred Plus

You should not use this medication if you are allergic to prednisolone or other steroids, or if you have certain types of infection (viral, fungal, or bacterial) that can affect your eyes.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use prednisolone ophthalmic:

• glaucoma;

• recent cataract surgery; or

• herpes simplex.

FDA pregnancy category C. It is not known whether prednisolone ophthalmic is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether prednisolone ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of prednisolone ophthalmic is not expected to produce life-threatening symptoms.

Do not wear any contact lens that has not been approved by your doctor.

Do not use prednisolone ophthalmic while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using prednisolone ophthalmic before putting your contact lenses in.

Do not use any other eye medications unless your doctor has prescribed them.

Prednisolone ophthalmic can cause side effects that may impair your vision. Be careful if you drive or do anything that requires you to see clearly.

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.

Check with your doctor right away if you have an eye injury, eye infection, or plan to have eye surgery.

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.

If your symptoms do not improve after 2 days or if they become worse, check with your eye doctor (ophthalmologist) right away.

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:

• Blindness
• blurred vision
• burning, dry, itching eyes
• change in vision
• decreased vision
• difficulty in focusing
• drooping of the upper eyelids
• eye discharge, excessive tearing
• feeling of having something in the eye
• redness, irritation, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• sensitivity of the eye to light
• slow wound healing

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:

• 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.

Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.

There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Corticosteroids are capable of producing a rise in intraocular pressure.

Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.

Applies to prednisolone ophthalmic: ophthalmic ointment, ophthalmic solution, ophthalmic suspension

Side effects include:

Elevated IOP, transient stinging or burning, blurred vision, ocular irritation, foreign body sensation.

Applies to prednisolone ophthalmic: ophthalmic solution, ophthalmic suspension

General

While the exact frequency of the reported side effects is unknown, the manufacturer reports the following in decreasing order of frequency: elevation of intraocular pressure with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing.[Ref]

Ocular

Rare (less than 0.1%): Filtering bleb
Frequency not reported: Intraocular pressure increased, glaucoma, optic nerve damage, posterior subcapsular cataract formation, acute anterior uveitis, perforation of globe, keratitis, conjunctivitis, corneal ulcer, mydriasis, conjunctival hyperemia, ptosis, loss of accommodation, secondary ocular infection developed, visual acuity defect, field defect, transient ocular discomfort, ocular hypertension, scleral/corneal perforation, foreign body sensation, burning, stinging, irritation, vision blurred/impaired, corneal calcification[Ref]

Dermatologic

Frequency not reported: Urticaria, pruritus, rash[Ref]

Immunologic

Frequency not reported: Allergic reaction, anaphylaxis[Ref]

Other

Frequency not reported: Wound healing delayed[Ref]

Nervous system

Frequency not reported: Headache[Ref]

Endocrine

Frequency not reported: Systemic hypercorticoidism[Ref]

Gastrointestinal

Frequency not reported: Dysgeusia[Ref]

Some side effects of Econopred Plus may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.