Omnipred

DRUG DESCRIPTION

Omnipred (prednisolone acetate ophthalmic suspension) is an adrenocortical steroid product prepared as sterile ophthalmic suspension. The active ingredient is represented by the chemical structure:

Prednisolone Acetate Structural Formula Illustration

Established name: Prednisolone Acetate

Chemical name: Pregna-1,4-diene-3,20-dione,21-(acetyloxy)-11,17-dihydroxy-,(11?)-.

Each mL contains: Active: prednisolone acetate 1.0%. Preservative: benzalkonium chloride 0.01%. Vehicle: hypromellose. Inactives: dibasic sodium phosphate, polysorbate 80, edetate disodium, glycerin, citric acid and/or sodium hydroxide (to adjust pH), purified water.

What are the precautions when taking prednisolone acetate (Omnipred)?

Before using prednisolone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as sulfites found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye infections, recent eye surgery, cataracts, glaucoma (open-angle type), severe nearsightedness (myopia), diabetes.

After you apply this drug, your vision may become temporarily unstable. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist...

Read All Potential Precautions of Omnipred


Omnipred Consumer (continued)

SIDE EFFECTS: Rarely, stinging/burning of the eyes for 1 to 2 minutes may occur when you apply this medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Use of this medication for prolonged periods or in high doses may cause serious eye problems (such as high pressure inside the eyes and cataracts). Tell your doctor immediately if any of these unlikely but serious side effects occur: vision problems, eye pain.

This medication may mask the signs of an eye infection. It may also put you at greater risk of developing an eye infection, especially with prolonged use. Report any new or worsening symptoms such as eye discharge/swelling/redness, vision problems, or no improvement of your current eye condition. Your doctor will need to adjust your treatment.

Tell your doctor immediately if any of these unlikely but serious side effects occur: headache, dizziness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using prednisolone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as sulfites found in some brands), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye infections, recent eye surgery, cataracts, glaucoma (open-angle type), severe nearsightedness (myopia), diabetes.

After you apply this drug, your vision may become temporarily unstable. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If you develop a new eye infection or injury, or require eye surgery, ask your doctor if you should continue to use your current bottle of prednisolone eye drops or start a new bottle.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if the medication in this product passes into breast milk. Consult your doctor before breast-feeding.



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