Neomycin And Polymyxin B Sulfates

Neomycin And Polymyxin B Sulfates

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Questions & Answers

Side Effects & Adverse Reactions

NOT FOR INJECTION INTO THE EYE. Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment should never be directly introduced into the anterior chamber of the eye. Ophthalmic ointments may retard corneal wound healing.

Prolonged use of corticosteroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation.

Prolonged use may suppress the host immune response and thus increase the hazard of secondary ocular infections. Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation.

Acute purulent infections of the eye may be masked or enhanced by the presence of corticosteroid medication.

If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in uncooperative patients. Corticosteroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.

The use of corticosteroids after cataract surgery may delay healing and increase the incidence of filtering blebs.

Use of the ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of corticosteroid medication in the treatment of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.

Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known. The manifestations of sensitization to topical antibiotics are usually itching, reddening, and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication. Applications of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS: General).

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists.

Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of corticosteroid use in certain 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 (see CLINICAL PHARMACOLOGY: Microbiology).

The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens: Staphylococcus aureus, streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa.

The product does not provide adequate coverage against Serratia marcescens.

History

There is currently no drug history available for this drug.

Other Information

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment, USP is a sterile antimicrobial and anti-inflammatory ointment for ophthalmic use. The color of the product is colorless to light yellowish.

Each Gram Contains:

ACTIVES: Neomycin Sulfate equivalent to 3.5 mg neomycin base, Polymyxin B Sulfate equal to 10,000 polymyxin B units, Bacitracin Zinc equivalent to 400 bacitracin units, and Hydrocortisone 10 mg (1%);

INACTIVE: White Petrolatum q.s.

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 mcg of neomycin standard per mg, calculated on an anhydrous basis.

The structural formulae are:

Neomycin Sulfate Structural Formula

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:

Polymyxin B Sulfate Structural Formula

Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis var Tracy. It has a potency of not less then 40 bacitracin units per mg. The structural formula is:

Bacitracin Zinc Structural Formula

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

Hydrocortisone Structural Formula

Neomycin And Polymyxin B Sulfates Manufacturers


  • Henry Schein Inc.
    Neomycin And Polymyxin B Sulfates, Bacitracin Zinc, And Hydrocortisone (Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc And Hydrocortisone) Ointment [Henry Schein Inc.]
  • Henry Schein Inc.
    Neomycin And Polymyxin B Sulfates, And Bacitracin Zinc (Neomycin Sulfate, Polymyxin B Sulfate And Bacitracin Zinc) Ointment [Henry Schein Inc.]
  • Mwi
    Neomycin And Polymyxin B Sulfates, And Bacitracin Zinc (Neomycin Sulfate, Polymyxin B Sulfate And Bacitracin Zinc) Ointment [Mwi]
  • Mwi
    Neomycin And Polymyxin B Sulfates, Bacitracin Zinc, And Hydrocortisone (Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc And Hydrocortisone) Ointment [Mwi]
  • Rxv
    Neomycin And Polymyxin B Sulfates, Bacitracin Zinc And Hydrocortisone (Neomycin Sulfate And Polymyxin B Sulfate, Bacitracin Zinc And Hydrocortisone) Ointment [Rxv]
  • Mwi/vetone
    Neomycin And Polymyxin B Sulfates, Bacitracin Zinc And Hydrocortisone (Neomycin Sulfate And Polymyxin B Sulfate, Bacitracin Zinc And Hydrocortisone) Ointment [Mwi/vetone]
  • Akorn, Inc.
    Neomycin And Polymyxin B Sulfates, And Bacitracin Zinc (Neomycin Sulfate, Polymyxin B Sulfate And Bacitracin Zinc) Ointment [Akorn, Inc.]
  • Akorn, Inc.
    Neomycin And Polymyxin B Sulfates, Bacitracin Zinc, And Hydrocortisone (Neomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc, Hydrocortisone) Ointment [Akorn, Inc.]
  • Bausch & Lomb Incorporated
    Neomycin And Polymyxin B Sulfates, Bacitracin Zinc And Hydrocortisone (Neomycin Sulfate And Polymyxin B Sulfate, Bacitracin Zinc And Hydrocortisone) Ointment [Bausch & Lomb Incorporated]
  • Akorn Animal Health, Inc.
    Neomycin And Polymyxin B Sulfates, And Bacitracin Zinc (Neomycin Sulfate, Polymyxin B Sulfate And Bacitracin Zinc) Ointment [Akorn Animal Health, Inc.]

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