Neomycin polymyxin b sulfates and dexamethasone ophthalmic suspension for ears

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension is a multiple dose anti-infective steroid combination in a sterile suspension for topical application.
Neomycin Sulfate is the sulfate salt of neomycin B and C which are produced by the growth of Streptomyces fradiae Waksman. It has a potency equivalent to not less than 600 micrograms of neomycin base per milligram, calculated on an anhydrous basis.
Polymyxin B Sulfate is the sulfate salt of Polymyxin B1 and B2 which are produced by the growth of Bacillus polymyxa Migula. It has a potency of not less than 6,000 Polymyxin B units per milligram, calculated on an anhydrous basis.

Indications and Usage:
For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain cases of infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical radiation or thermal burns; or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

Dosage:
Apply to 1-2 drops to eye(s) every 4 to 6 hours

Contraindications:
Epithelial herpes simplex keratitis, vaccinia, varicella and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication.

Pregnancy. Pregnancy C:
Dexamethasone has been shown to be Teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose.
In the mouse, corticosteroids produce fetal resorptions and a specific abnormality, cleft palate. In the rabbit, corticosteroids have produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, palate, etc.
There are no adequate or well-controlled studies in pregnant in women. Neomycin, Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.

Adverse Reactions:
Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available.
Reactions occurring most often from the presence of the anti-infective ingredients are allergic sensitizations. The reactions due to the steroid component are; elevation of intraocular pressure with possible development of glaucoma, and infrequent optic nerve damage; posterior sub capsular cataract formation; and delayed wound healing.

Secondary Infection:
The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used.
Secondary bacterial ocular infection following suppression of host responses also occurs.

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Maxitrol Side Effects Center

What Is Maxitrol?

Maxitrol (neomycin and polymyxin B sulfates and dexamethasone) Ophthalmic Suspension Sterile is a combination of two antibiotics and a steroid used to treat bacterial infections of the eyes. Maxitrol is available in generic form.

What Are Side Effects of Maxitrol?

Common side effects of Maxitrol include:

  • stinging/burning of the eyes for 1 to 2 minutes when Maxitrol is applied,
  • irritation,
  • itching,
  • redness,
  • blurred vision,
  • eyelid itching,
  • eyelid swelling, or
  • sensitivity to light.

Serious side effects are generally not expected with Maxitrol. Use of Maxitrol for prolonged or 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 Maxitrol for longer than prescribed. Tell your doctor if you experience unlikely but serious side effects of Maxitrol including new or worsening eye symptoms (e.g., discharge, swelling, redness), vision problems, or eye pain.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Maxitrol

Dosing of Maxitrol: One to two drops in the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily.

What Drugs, Substances, or Supplements Interact with Maxitrol?

Avoid other eye medications unless approved by your doctor. Before using Maxitrol, tell your doctor if you are taking an oral steroid medication such as prednisone (Deltasone, Orasone, others). Other drugs may also interact with Maxitrol.

Maxitrol During Pregnancy or Breastfeeding

Talk to your doctor before taking any prescription or over-the-counter medicines. During pregnancy, Maxitrol should be used only when prescribed. It is not known if this drug passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Maxitrol (neomycin and polymyxin B sulfates and dexamethasone) Ophthalmic Suspension Sterile Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

Neomycin polymyxin b sulfates and dexamethasone ophthalmic suspension for ears

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Maxitrol Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • blurred vision, tunnel vision, eye pain, or seeing halos around lights;
  • swelling, redness, severe discomfort, crusting or drainage (may be signs of infection);
  • pain behind your eyes, sudden vision changes; or
  • a wound that will not heal.

Common side effects may include:

  • blurred vision; or
  • mild eye irritation.

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.

Read the entire detailed patient monograph for Maxitrol (Neomycin, Polymyxin B and Dexamethasone Ophthalmic)

Neomycin polymyxin b sulfates and dexamethasone ophthalmic suspension for ears

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Maxitrol Professional Information

SIDE EFFECTS

Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available.

Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. The reactions due to the corticosteroid component are: elevation of IOP with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. Corticosteroid-containing preparations have also been reported to cause perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, and conjunctival hyperemia have occasionally been reported following use of steroids.

Additional adverse reactions identified from post marketing use include ulcerative keratitis, headache, and Stevens-Johnson syndrome.

The following additional adverse reactions have been reported with dexamethasone use: Cushing's syndrome and adrenal suppression may occur after use of dexamethasone in excess of the listed dosing instructions in predisposed patients, including children and patients treated with CYP3A4 inhibitors.

DRUG INTERACTIONS

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Read the entire FDA prescribing information for Maxitrol (Neomycin, Polymyxin B and Dexamethasone Ophthalmic)

© Maxitrol Patient Information is supplied by Cerner Multum, Inc. and Maxitrol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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Can neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension be used in ears?

Neomycin, polymyxin B, and hydrocortisone combination ear drops is used to treat infections of the ear canal and to help provide relief from redness, irritation, and discomfort of certain ear problems. It is also used to treat ear infections as a complication after ear surgery (eg, mastoidectomy, fenestration).

How long does it take for neomycin polymyxin ear drops to work?

Hydrocortisone - neomycin - polymyxin B ear drops are used to treat certain bacterial infections of the outer ear canal. This medication should start to work within 48 hours.

How long do you leave neomycin in your ear?

Drop the prescribed number of drops into the ear canal. Keep the ear facing up for about 5 minutes to allow the medicine to coat the ear canal. (For young children and other patients who cannot stay still for 5 minutes, try to keep the ear facing up for at least 1 or 2 minutes.)

Can you use dexamethasone eye drops in the ear?

Dexamethasone eye drops may be used to reduce redness, burning, and swelling or inflammation in the ear. Talk to your doctor about the possible risks of using this drug for your condition. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.