Bacitracin Zinc and Polymyxin B Sulfate

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Overview

What is Bacitracin Zinc and Polymyxin B Sulfate?

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP, is a sterile antimicrobial ointment for ophthalmic use. Each gram contains: bacitracin zinc equivalent to 500 bacitracin units, polymyxin B sulfate equivalent to 10,000 polymyxin B units, mineral oil, and white petrolatum.

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 for bacitracin A is:

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:

What does Bacitracin Zinc and Polymyxin B Sulfate look like?

What are the available doses of Bacitracin Zinc and Polymyxin B Sulfate?

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What should I talk to my health care provider before I take Bacitracin Zinc and Polymyxin B Sulfate?

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How should I use Bacitracin Zinc and Polymyxin B Sulfate?

Bacitracin Zinc and Polymyxin B Sulfate 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 Bacitracin Zinc and Polymyxin B Sulfate?

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment is contraindicated in individuals who have shown hypersensitivity to any of its components.

What are the warnings of Bacitracin Zinc and Polymyxin B Sulfate?

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

Topical antibiotics 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 are the precautions of Bacitracin Zinc and Polymyxin B Sulfate?

General:

Bacterial resistance to Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment may also develop. If purulent discharge, inflammation, or pain become 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 has 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.

Information for Patients:

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 (see ).

If the condition persists or gets worse, or if a rash or other 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:

Pregnancy:

Teratogenic effects

Pregnancy Category C

Nursing Mothers:

Pediatric Use:

What are the side effects of Bacitracin Zinc and Polymyxin B Sulfate?

Adverse reactions have occurred with the anti-infective components of Bacitracin Zinc and Polymyxin B Sulfate 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 Bacitracin Zinc and Polymyxin B Sulfate?

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment is contraindicated in individuals who have shown hypersensitivity to any of its components.

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

Topical antibiotics 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 ).

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What might happen if I take too much Bacitracin Zinc and Polymyxin B Sulfate?

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How should I store and handle Bacitracin Zinc and Polymyxin B Sulfate?

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP, is supplied as follows: NDC 0168-0273-38 3.5 gram tubesStore between 15° and 25°C (59° and 77°F).E. FOUGERA & CO.A division of Nycomed US Inc.MELVILLE, NEW YORK 11747I273AR10/07Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP, is supplied as follows: NDC 0168-0273-38 3.5 gram tubesStore between 15° and 25°C (59° and 77°F).E. FOUGERA & CO.A division of Nycomed US Inc.MELVILLE, NEW YORK 11747I273AR10/07Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP, is supplied as follows: NDC 0168-0273-38 3.5 gram tubesStore between 15° and 25°C (59° and 77°F).E. FOUGERA & CO.A division of Nycomed US Inc.MELVILLE, NEW YORK 11747I273AR10/07Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP, is supplied as follows: NDC 0168-0273-38 3.5 gram tubesStore between 15° and 25°C (59° and 77°F).E. FOUGERA & CO.A division of Nycomed US Inc.MELVILLE, NEW YORK 11747I273AR10/07Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP, is supplied as follows: NDC 0168-0273-38 3.5 gram tubesStore between 15° and 25°C (59° and 77°F).E. FOUGERA & CO.A division of Nycomed US Inc.MELVILLE, NEW YORK 11747I273AR10/07Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP, is supplied as follows: NDC 0168-0273-38 3.5 gram tubesStore between 15° and 25°C (59° and 77°F).E. FOUGERA & CO.A division of Nycomed US Inc.MELVILLE, NEW YORK 11747I273AR10/07

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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 bacitracin and polymyxin B sulfate.

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.

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.

Non-Clinical Toxicology

Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment is contraindicated in individuals who have shown hypersensitivity to any of its components.

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

Topical antibiotics 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 ).

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General:

Bacterial resistance to Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment may also develop. If purulent discharge, inflammation, or pain become 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 has 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 Bacitracin Zinc and Polymyxin B Sulfate 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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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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