Cortisporin Ophthalmic Suspension

DRUG DESCRIPTION

CORTISPORIN Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) is a sterile antimicrobial and anti-inflammatory suspension for ophthalmic use. Each mL contains: neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and hydrocortisone 10 mg (1%). The vehicle contains thimerosal 0.001% (added as a preservative) and the inactive ingredients cetyl alcohol, glyceryl monostearate, mineral oil, polyoxyl 40 stearate, propylene glycol, and Water for Injection. Sulfuric acid may be added to adjust pH.

Neomycin sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 ?g of neomycin standard per mg, calculated on an anhydrous basis. The structural formulae are:

Polymyxin B sulfate is the sulfate salt of polymyxin B1 and 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 mg, calculated on an anhydrous basis. The structural formulae are:

Hydrocortisone, 11?,17,21-trihydroxypregn-4-ene-3,20-dione, is an anti-inflammatory hormone. Its structural formula is:

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

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 Cortisporin Ophthalmic Suspension

What are the precautions when taking neomycin and polymyxin b sulfates and hydrocortisone opthalmic suspension (Cortisporin Ophthalmic Suspension)?

Before using this medication, tell your doctor or pharmacist if you are allergic to neomycin, polymyxin, or hydrocortisone; or to aminoglycoside antibiotics (e.g., gentamicin, tobramycin); or to corticosteroids (e.g., dexamethasone, prednisone); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride, thimerosal), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: other ear problems (e.g., a hole in your eardrum, middle ear infection), an eye/ear infection not caused by bacteria (e.g., viral, fungal,...

Read All Potential Precautions of Cortisporin Ophthalmic Suspension


Cortisporin Ophthalmic Suspension Consumer (continued)

SIDE EFFECTS: This medication may temporarily sting or burn your eye/ear for a minute or two when applied. If this effect persists or worsens, notify 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/ear infection and may increase your risk for other eye/ear problems (e.g., glaucoma, cataracts, hearing loss). 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/ear symptoms (e.g., discharge, swelling, redness), vision/hearing problems, eye pain.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 hydrocortisone; or to aminoglycoside antibiotics (e.g., gentamicin, tobramycin); or to corticosteroids (e.g., dexamethasone, prednisone); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride, thimerosal), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: other ear problems (e.g., a hole in your eardrum, middle ear infection), an eye/ear infection not caused by bacteria (e.g., viral, fungal, mycobacterial).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other eye problems (e.g., glaucoma).

If you are using this medication to treat the eyes, your vision may be temporarily unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Cortisporin Ophthalmic Suspension Patient Information Including Side Effects

Brand Names:

Generic Name: neomycin, polymyxin B, and hydrocortisone ophthalmic (Pronunciation: NEE oh MYE sin, POL ee MIX in, HYE droe KOR ti sone off THAL mik)

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

What is neomycin, polymyxin B and hydrocortisone ophthalmic ?

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

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

Neomycin, polymyxin B and hydrocortisone ophthalmic is used to treat bacterial infections of the eyes.

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

What are the possible side effects of neomycin, polymyxin B and hydrocortisone ophthalmic ?

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 hydrocortisone ophthalmic ?

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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