Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate

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Overview

What is Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate?

Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone acetate ophthalmic ointment is a sterile antimicrobial and anti-inflammatory 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, bacitracin zinc equivalent to 400 bacitracin units, hydrocortisone acetate 10 mg (1 %), in a white petrolatum and mineral oil base.

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:

Hydrocortisone acetate, Pregn-4-ene-3,20-dione,21-(acetyloxy)-11,17-dihydroxy-,(11β)–, is an anti-inflammatory hormone. Its structural formula is:

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 ug 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:

What does Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate look like?

What are the available doses of Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate?

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What should I talk to my health care provider before I take Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate?

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How should I use Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate?

Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone acetate 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 ). The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens: streptococci, including species, species, and The product does not provide adequate coverage against

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 above.

What interacts with Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate?

Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone acetate ophthalmic ointment is contraindicated in most viral diseases of the cornea and conjunctiva including: epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone acetate ophthalmic ointment is also contraindicated in individuals who have shown hypersensitivity to any of its components. Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.

What are the warnings of Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate?

To provide information regarding the effects of in utero exposure to carbamazepine, physicians are advised to recommend that pregnant patients taking carbamazepine enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

What are the precautions of Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate?

General: The initial prescription and renewal of the medication order beyond 8 grams should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be re-evaluated. As fungal infections of the cornea are particularly prone to develop coincidentally with long-term corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate. If this product is used for 10 days or longer, intraocular pressure should be monitored (see ). 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.

Information for Patients:

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Pregnancy: Teratogenic Effects: Pregnancy Category C.

Nursing Mothers:

Pediatric Use:

Geriatric Use:

What are the side effects of Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate?

Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid component, the anti-infective component, or the combination. The exact incidence is not known. Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitization reactions including itching, swelling, and conjunctival erythema (see ). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely. The reactions due to the corticosteroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Secondary Infection: The development of the secondary ocular infection has occurred after use of combinations containing corticosteroids and antimicrobials. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of a corticosteroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used (see ). Local irritation on installation has been reported. If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see ).

What should I look out for while using Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate?

Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone acetate ophthalmic ointment is contraindicated in most viral diseases of the cornea and conjunctiva including: epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone acetate ophthalmic ointment is also contraindicated in individuals who have shown hypersensitivity to any of its components. Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.

NOT FOR INJECTION INTO THE EYE. Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone acetate 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 ).

What might happen if I take too much Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate?

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How should I store and handle Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate?

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). PROTECT FROM LIGHT. KEEP TIGHTLY CLOSED. Sarafem is a registered trademark of Eli Lilly and Company. Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate Ophthalmic Ointment is supplied in 3.5 g (1/8 Oz) sterile tamper proof tube with ophthalmic tip,NDCStore at 15° to 25°C (59° to 77°F).E. FOUGERA & CO.a division of Altana Inc.I22938ER8/04#174Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate Ophthalmic Ointment is supplied in 3.5 g (1/8 Oz) sterile tamper proof tube with ophthalmic tip,NDCStore at 15° to 25°C (59° to 77°F).E. FOUGERA & CO.a division of Altana Inc.I22938ER8/04#174Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate Ophthalmic Ointment is supplied in 3.5 g (1/8 Oz) sterile tamper proof tube with ophthalmic tip,NDCStore at 15° to 25°C (59° to 77°F).E. FOUGERA & CO.a division of Altana Inc.I22938ER8/04#174Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate Ophthalmic Ointment is supplied in 3.5 g (1/8 Oz) sterile tamper proof tube with ophthalmic tip,NDCStore at 15° to 25°C (59° to 77°F).E. FOUGERA & CO.a division of Altana Inc.I22938ER8/04#174Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate Ophthalmic Ointment is supplied in 3.5 g (1/8 Oz) sterile tamper proof tube with ophthalmic tip,NDCStore at 15° to 25°C (59° to 77°F).E. FOUGERA & CO.a division of Altana Inc.I22938ER8/04#174Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate Ophthalmic Ointment is supplied in 3.5 g (1/8 Oz) sterile tamper proof tube with ophthalmic tip,NDCStore at 15° to 25°C (59° to 77°F).E. FOUGERA & CO.a division of Altana Inc.I22938ER8/04#174Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate Ophthalmic Ointment is supplied in 3.5 g (1/8 Oz) sterile tamper proof tube with ophthalmic tip,NDCStore at 15° to 25°C (59° to 77°F).E. FOUGERA & CO.a division of Altana Inc.I22938ER8/04#174Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body's defense mechanism against infection, concomitant antimicrobial drugs may be used when this inhibition is considered to be clinically significant in a particular case. When a decision to administer both a corticosteroid and antimicrobials is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of all drugs is administered. When each type of drug is in the same formulation, compatibility of ingredients is assured and the correct volume of drug is delivered and retained. The relative potency of corticosteroids depends on the molecular structure, concentration, and release from the vehicle.

The anti-infective components in neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone acetate ophthalmic ointment are included to provide action against specific organisms susceptible to it. Neomycin sulfate and polymyxin B sulfate are active in vitro against susceptible strains of the following microorganisms: , streptococci including species, species, and The product does not provide adequate coverage against (see ).

Non-Clinical Toxicology

Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone acetate ophthalmic ointment is contraindicated in most viral diseases of the cornea and conjunctiva including: epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone acetate ophthalmic ointment is also contraindicated in individuals who have shown hypersensitivity to any of its components. Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.

NOT FOR INJECTION INTO THE EYE. Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone acetate 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 ).

The vasodilating effects of nitroglycerin may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety.

Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary.

General: The initial prescription and renewal of the medication order beyond 8 grams should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be re-evaluated. As fungal infections of the cornea are particularly prone to develop coincidentally with long-term corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate. If this product is used for 10 days or longer, intraocular pressure should be monitored (see ). 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.

Information for Patients:

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Pregnancy: Teratogenic Effects: Pregnancy Category C.

Nursing Mothers:

Pediatric Use:

Geriatric Use:

Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid component, the anti-infective component, or the combination. The exact incidence is not known. Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitization reactions including itching, swelling, and conjunctival erythema (see ). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely. The reactions due to the corticosteroid component in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Secondary Infection: The development of the secondary ocular infection has occurred after use of combinations containing corticosteroids and antimicrobials. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of a corticosteroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used (see ). Local irritation on installation has been reported. If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see ).

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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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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

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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