Poly-Pred

DRUG DESCRIPTION

POLY-PRED® (prednisolone acetate, neomycin sulfate, polymyxin B sulfate ophthalmic suspension, USP) is a topical anti-inflammatory/anti-infective combination product for ophthalmic use with a pH of 5.0 - 7.0 and an osmolality of 260-340 mOsm/kg.

Structural Formulas:

POLY-PRED® 
  (prednisolone acetate, neomycin sulfate, polymyxin B sulfate) Structural Formula Illustration

Chemical Name:

Prednisolone acetate: 11?, 17, 21-Trihydroxypregna-1, 4-diene-3, 20-dione 21-acetate.

Neomycin sulfate is the sulfate salt of neomycin B and neomycin C which are produced by the growth of Streptomyces fradiae (Fam. Streptomycetaceae). It has a potency equivalent to not less than 600 micrograms per milligram of neomycin base, calculated on an anhydrous basis.

Polymyxin B sulfate is the sulfate salt of polymyxin B1 and polymyxin B2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per milligram, calculated on an anhydrous basis.

Contains: Actives: prednisolone acetate (microfine suspension) 0.5%, neomycin sulfate equivalent to 0.35% neomycin base, polymyxin B sulfate 10,000 units/mL. Inactives: polysorbate 80; polyvinyl alcohol; propylene glycol; purified water; sodium acetate; and thimerosal 0.001% (preservative). The pH range is 5.0 - 7.0.

What are the possible side effects of neomycin, polymyxin B, and prednisolone ophthalmic (Poly Pred)?

Serious side effects are not expected with this medication.

Some burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at...

Read All Potential Side Effects and See Pictures of Poly-Pred »

What are the precautions when taking prednisolone,neomycin and polymyxin b (Poly-Pred)?

Before using this medication, tell your doctor or pharmacist if you are allergic to neomycin, polymyxin, or prednisolone; or to aminoglycoside antibiotics (e.g., gentamicin, tobramycin); or to corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like thimerosal), 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: other eye problems (e.g., glaucoma).

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...

Read All Potential Precautions of Poly-Pred »


Poly-Pred Consumer (continued)

SIDE EFFECTS: Stinging/burning of the eyes for 1 to 2 minutes may occur when this medication is applied. 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/repeated periods may result in a new fungal eye infection and may increase your risk for other eye problems (e.g., glaucoma, cataracts, delayed wound healing). Do not use this medication for longer than prescribed. Tell your doctor immediately if any of these unlikely but serious side effects occur: new or worsening eye symptoms (e.g., discharge, swelling, redness), vision problems, eye pain.

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 this medication, tell your doctor or pharmacist if you are allergic to neomycin, polymyxin, or prednisolone; or to aminoglycoside antibiotics (e.g., gentamicin, tobramycin); or to corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like thimerosal), 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: other eye problems (e.g., glaucoma).

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.

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

This drug passes into breast milk. Consult your doctor before breast-feeding.


Poly-Pred Patient Information Including Side Effects

Brand Names: Poly Pred

Generic Name: neomycin, polymyxin B, and prednisolone ophthalmic (Pronunciation: NEE oh MYE sin, POL ee MIX in B, and pred NIS oh lone off THAL mik)

  • What is neomycin, polymyxin B, and prednisolone ophthalmic (Poly-Pred)?
  • What are the possible side effects of neomycin, polymyxin B, and prednisolone ophthalmic (Poly-Pred)?
  • What is the most important information I should know about neomycin, polymyxin B, and prednisolone ophthalmic (Poly-Pred)?
  • Who should not use neomycin, polymyxin B, and prednisolone ophthalmic (Poly-Pred)?
  • How should I use neomycin, polymyxin B, and prednisolone ophthalmic (Poly-Pred)?
  • What happens if I miss a dose (Poly-Pred)?
  • What happens if I overdose (Poly-Pred)?
  • What should I avoid while using neomycin, polymyxin B, and prednisolone ophthalmic (Poly-Pred)?
  • What other drugs will affect neomycin, polymyxin B, and prednisolone ophthalmic (Poly-Pred)?
  • Where can I get more information?

What is neomycin, polymyxin B, and prednisolone ophthalmic (Poly-Pred)?

Neomycin and polymyxin B are antibiotics. They are used to treat bacterial infections.

Prednisolone is a steroid. It is used to treat the swelling associated with bacterial infections of the eye.

Neomycin /polymyxin B/prednisolone ophthalmic is used to treat bacterial infections of the eyes.

Neomycin, polymyxin B, and prednisolone ophthalmic may be used for purposes other than those listed in this medication guide.

What are the possible side effects of neomycin, polymyxin B, and prednisolone ophthalmic (Poly-Pred)?

Serious side effects are not expected with this medication.

Some burning, stinging, irritation, itching, redness, blurred vision, eyelid itching, eyelid swelling, or sensitivity to light may occur.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about neomycin, polymyxin B, and prednisolone ophthalmic (Poly-Pred)?

Contact your doctor if your symptoms begin to get worse or if you do not see any improvement in your condition after a few days.

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye.

Apply light pressure to the inside corner of your eye (near your nose) after each drop to prevent the fluid from draining down your tear duct.

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