Neomycin And Polymyxin B Sulfates

Add Info

Neomycin And Polymyxin B Sulfates Recall

Get an alert when a recall is issued.

Ask a Question

Questions & Answers

Add Info

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).

Add Info

Legal Issues

There is currently no legal information available for this drug.

Add Info

FDA Safety Alerts

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

Add Info

Manufacturer Warnings

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

Add Info

FDA Labeling Changes

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

Add Info

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.

Add Info

History

There is currently no drug history available for this drug.

Add Info

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:

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:

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:

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

Sources

Neomycin And Polymyxin B Sulfates Manufacturers

Henry Schein Inc.

Neomycin And Polymyxin B Sulfates | Henry Schein Inc.

Apply the ointment in the affected eye every 3 or 4 hours, depending on the severity of the condition.

Not more than 8 grams should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

No Recall
Henry Schein Inc.

Neomycin And Polymyxin B Sulfates | Henry Schein Inc.

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

No Recall
Mwi

Neomycin And Polymyxin B Sulfates | Mwi

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

No Recall
Mwi

Neomycin And Polymyxin B Sulfates | Virbac Ah Inc

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Rxv

Neomycin And Polymyxin B Sulfates | Rxv

Apply the ointment in the affected eye every 3 or 4 hours, depending on the severity of the condition.

Not more than 8 grams should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS: above.

No Recall
Mwi/vetone

Neomycin And Polymyxin B Sulfates | Mwi/vetone

Apply the ointment in the affected eye every 3 or 4 hours, depending on the severity of the condition.

Not more than 8 grams should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS: above.

No Recall
Akorn, Inc.

Neomycin And Polymyxin B Sulfates | Akorn, Inc.

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

No Recall
Akorn, Inc.

Neomycin And Polymyxin B Sulfates | Akorn, Inc.

Apply the ointment in the affected eye every 3 or 4 hours, depending on the severity of the condition.

Not more than 8 grams should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

No Recall
Bausch & Lomb Incorporated

Neomycin And Polymyxin B Sulfates | Iluminage Beauty, Inc.

apply liberally 15 minutes before sun exposure reapply at least every two hours use a water resistant sunscreen if swimming or sweating
children under 6 months of age: ask a doctor
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m.–2 p.m.

- wear long-sleeved shirts, pants, hats and sunglasses

No Recall
Akorn Animal Health, Inc.

Neomycin And Polymyxin B Sulfates | Akorn Animal Health, Inc.

Properly cleanse area to be treated. Foreign bodies, crusted exudates and debris should be carefully removed. Express a small quantity of ointment into the conjunctival sac beneath the lower eyelid three or four times daily. After application hold the eyelids shut for a short time so that a thin film of ointment covers the cornea.

No Recall