Maxitrol

DRUG DESCRIPTION

MAXITROL (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) is a multiple dose anti-infective steroid combination in sterile suspension form for topical application. The chemical structure for the active ingredient, dexamethasone, is:

Dexamethasone structural formula illustration

Established name: dexamethasone

Chemical name: pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 17, 21-trihydroxy-16-methyl-, (11?, 16?)-. MW = 392.45

The other active ingredients are neomycin sulfate and polymyxin B sulfate. The structural formula for neomycin sulfate is:

Neomycin sulfate structural formula illustration

The structural formula for polymyxin B sulfate is:

[structure]

Each mL contains: Actives: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1 %. Inactives: hypromellose 2910 0.5%, sodium chloride, polysorbate 20, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water, benzalkonium chloride 0.004% (preservative).

What are the possible side effects of neomycin, polymyxin B and dexamethasone ophthalmic (Maxitrol, Ocu-Trol, Poly-Dex)?

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 Maxitrol

What are the precautions when taking neomycin, polymyxin b and dexamethasone ophthalmic (Maxitrol)?

Before using this medication, tell your doctor or pharmacist if you are allergic to neomycin, polymyxin, or dexamethasone; 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 benzalkonium chloride), 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...

Read All Potential Precautions of Maxitrol


Maxitrol 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, 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 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 dexamethasone; 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 benzalkonium chloride), 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.

It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.


Maxitrol Patient Information Including Side Effects

Brand Names: Maxitrol, Ocu-Trol, Poly-Dex

Generic Name: neomycin, polymyxin B, and dexamethasone ophthalmic (Pronunciation: NEE oh MYE sin, POL ee MIX in DEX a METH a sone off THAL mik)

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

What is neomycin, polymyxin B and dexamethasone ophthalmic (Maxitrol)?

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

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

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

Neomycin, polymyxin B and dexamethasone 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 dexamethasone ophthalmic (Maxitrol)?

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 dexamethasone ophthalmic (Maxitrol)?

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 or tube opening to any surface, including your eyes or hands. The dropper or tube opening 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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