NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC

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Overview

What is NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC?

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP is a sterile antimicrobial ointment for ophthalmic use.

Each Gram Contains:

ACTIVES: 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; INACTIVES: White Petrolatum, Mineral Oil.

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 milligram, 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 milligram, 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 milligram.

The structural formula for bacitracin A is:

What does NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC look like?

What are the available doses of NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC?

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What should I talk to my health care provider before I take NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC?

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How should I use NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND 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 SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC?

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What are the warnings of NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC?

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What are the precautions of NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC?

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What are the side effects of NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND 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 (see ). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.

Local irritation on instillation has also been reported.

What should I look out for while using NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC?

Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is contraindicated in those 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 (see ).

What might happen if I take too much NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC?

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How should I store and handle NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC?

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP is supplied in a 3.5 g tube with an ophthalmic tip.Prod. No. 03534DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.FOR OPHTHALMIC USE ONLYNeomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP is supplied in a 3.5 g tube with an ophthalmic tip.Prod. No. 03534DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.FOR OPHTHALMIC USE ONLYNeomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP is supplied in a 3.5 g tube with an ophthalmic tip.Prod. No. 03534DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.FOR OPHTHALMIC USE ONLYNeomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP is supplied in a 3.5 g tube with an ophthalmic tip.Prod. No. 03534DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.FOR OPHTHALMIC USE ONLY

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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:

Staphylococcus aureus

Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter

Neisseria

Pseudomonas aeruginosa

Serratia marcescens

Non-Clinical Toxicology

Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is contraindicated in those 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 (see ).

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 (see ).

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 (see ). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely.

Local irritation on instillation has also been reported.

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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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Review

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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