Neomycin and Polymyxin B sulfates, Bacitracin zinc

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Overview

What is Neomycin and Polymyxin B sulfates, Bacitracin zinc?

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP is a sterile antimicrobial ointment for ophthalmic use. Each gram contains:neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B sulfate equivalent to 10,000 polymyxin B units, and bacitracin zinc equivalent to 400 bacitracin units and petrolatum q.s.

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

Polymyxin B sulfate is the sulfate salt of polymyxin B and B which are produced by the growth of (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 group of var Tracy. It has a potency of not less than 40 bacitracin units per mg. The structural formula is:

What does Neomycin and Polymyxin B sulfates, Bacitracin zinc look like?

What are the available doses of Neomycin and Polymyxin B sulfates, Bacitracin zinc?

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What should I talk to my health care provider before I take Neomycin and Polymyxin B sulfates, Bacitracin zinc?

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How should I use Neomycin and Polymyxin B sulfates, Bacitracin zinc?

Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.

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

What interacts with Neomycin and Polymyxin B sulfates, Bacitracin zinc?

Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is contraindicated in individuals who have shown hypersensitivity to any of its components.

What are the warnings of Neomycin and Polymyxin B sulfates, Bacitracin zinc?

In a few patients on bromocriptine, particularly on long-term and high-dose treatment, retroperitoneal fibrosis has been reported. To ensure recognition of retroperitoneal fibrosis at an early reversible stage it is recommended that its manifestations (e.g., back pain, edema of the lower limbs, impaired kidney function) should be watched in this category of patients. Bromocriptine medication should be withdrawn if fibrotic changes in the retroperitoneum are diagnosed or suspected.

What are the precautions of Neomycin and Polymyxin B sulfates, Bacitracin zinc?

GENERAL

As with other antibiotic preparations, prolonged use of neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs, appropriate measures should be initiated.

Bacterial resistance to neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment may also develop. If purulent discharge, inflammation, or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.

There have been reports of bacterial keratitis associated with the use of topical ophthalmic products in multiple-dose containers which have been inadvertently contaminated by patients, most of whom had a concurrent corneal disease or a disruption of the ocular epithelial surface ().

Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.

INFORMATION FOR PATIENTS

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, eyelid, fingers, or any other surface. The use of this product by more than one person may spread infection.

Patients should also be instructed that ocular products, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated products ().

If the condition persists or gets worse, or if a rash or allergic reaction develops, the patient should be advised to stop use and consult a physician. Do not use this product if you are allergic to any of the listed ingredients.

Keep tightly closed when not in use. Keep out of reach of children.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate or bacitracin. Treatment of cultured human lymphocytes with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 µg/mL) tested; however, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.

Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown. No adverse effects on male or female fertility, litter size or survival were observed in rabbits given bacitracin zinc 100 gm/ton of diet.

PREGNANCY

Teratogenic Effects

NURSING MOTHERS

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is administered to a nursing woman.

PEDIATRIC USE

Safety and effectiveness in children have not been established.

What are the side effects of Neomycin and Polymyxin B sulfates, Bacitracin zinc?

Adverse reactions have occurred with the anti-infective components of neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment. The exact incidence is not known. Reactions occurring most often are allergic sensitization reactions including itching, swelling, and conjunctival erythema (). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.

Local irritation on instillation has also been reported.

To report SUSPECTED ADVERSE REACTIONS, contact Citron Pharma LLC. at 1-855-5-CITRON (1-855-524-8766) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What should I look out for while using Neomycin and Polymyxin B sulfates, Bacitracin zinc?

Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is contraindicated in individuals who have shown hypersensitivity to any of its components.

NOT FOR INJECTION INTO THE EYE. Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment should never be directly introduced into the anterior chamber of the eye. Ophthalmic ointments may retard corneal wound healing. 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. Application of products containing these ingredients should be avoided for the patient thereafter ().

What might happen if I take too much Neomycin and Polymyxin B sulfates, Bacitracin zinc?

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How should I store and handle Neomycin and Polymyxin B sulfates, Bacitracin zinc?

Store REXULTI tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP is supplied in a tube of 1/8 oz (3.5 g) with an ophthalmic tip (NDC 57237-129-53). Store at 15° - 25°C (59°- 77°F). Manufactured for: East Brunswick, NJ 08816 Issued: 04/2016 PIC12953-00Made in CanadaNeomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP is supplied in a tube of 1/8 oz (3.5 g) with an ophthalmic tip (NDC 57237-129-53). Store at 15° - 25°C (59°- 77°F). Manufactured for: East Brunswick, NJ 08816 Issued: 04/2016 PIC12953-00Made in Canada

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Clinical Information

Chemical Structure

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Clinical Pharmacology

A wide range of antibacterial action is provided by the overlapping spectra of neomycin, polymyxin B sulfate, and bacitracin.

Neomycin is bactericidal for many gram-positive and gram-negative organisms. It is an aminoglycoside antibiotic which inhibits protein synthesis by binding with ribosomal RNA and causing misreading of the bacterial genetic code.

Polymyxin B is bactericidal for a variety of gram-negative organisms. It increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane.

Bacitracin is bactericidal for a variety of gram-positive and gram-negative organisms. It interferes with bacterial cell wall synthesis by inhibition of the regeneration of phospholipid receptors involved in peptidoglycan synthesis.

Microbiology

Neomycin sulfate, polymyxin B sulfate and bacitracin zinc together are considered active against the following microorganisms: , streptococci including species, species, and . The product does not provide adequate coverage against .

Non-Clinical Toxicology

Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is contraindicated in individuals who have shown hypersensitivity to any of its components.

NOT FOR INJECTION INTO THE EYE. Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment should never be directly introduced into the anterior chamber of the eye. Ophthalmic ointments may retard corneal wound healing. 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. Application of products containing these ingredients should be avoided for the patient thereafter ().

The risk of using bromocriptine in combination with other drugs has not been systematically evaluated, but alcohol may potentiate the side effects of bromocriptine. Bromocriptine may interact with dopamine antagonists, butyrophenones, and certain other agents. Compounds in these categories result in a decreased efficacy of bromocriptine: phenothiazines, haloperidol, metoclopramide, pimozide. Bromocriptine is a substrate of CYP3A4. Caution should therefore be used when co-administering drugs which are strong inhibitors of this enzyme (such as azole antimycotics, HIV protease inhibitors). The concomitant use of macrolide antibiotics such as erythromycin was shown to increase the plasma levels of bromocriptine (mean AUC and C values increased 3.7-fold and 4.6-fold, respectively). The concomitant treatment of acromegalic patients with bromocriptine and octreotide led to increased plasma levels of bromocriptine (bromocriptine AUC increased about 38%). Concomitant use of bromocriptine with other ergot alkaloids is not recommended. Dose adjustment may be necessary in those cases where high doses of bromocriptine are being used (such as Parkinson’s disease indication).

As with other antibiotic preparations, prolonged use of neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs, appropriate measures should be initiated.

Bacterial resistance to neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment may also develop. If purulent discharge, inflammation, or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.

There have been reports of bacterial keratitis associated with the use of topical ophthalmic products in multiple-dose containers which have been inadvertently contaminated by patients, most of whom had a concurrent corneal disease or a disruption of the ocular epithelial surface ().

Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.

Adverse reactions have occurred with the anti-infective components of neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment. The exact incidence is not known. Reactions occurring most often are allergic sensitization reactions including itching, swelling, and conjunctival erythema (). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.

Local irritation on instillation has also been reported.

To report SUSPECTED ADVERSE REACTIONS, contact Citron Pharma LLC. at 1-855-5-CITRON (1-855-524-8766) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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