Neomycin Polymyxin B Sulfates And Dexamethasone

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Neomycin Polymyxin B Sulfates And Dexamethasone Recall

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Side Effects & Adverse Reactions

Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may also 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 activity enhanced by the presence of corticosteroid medication.

If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.

The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.

Neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.

Products containing neomycin sulfate may cause cutaneous sensitization.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

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Manufacturer Warnings

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

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FDA Labeling Changes

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Uses

For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists.

Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitis 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.

The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus,Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, Pseudomonas aeruginosa.

This product does not provide adequate coverage against Serratia marcescens, and Streptococci, including Streptococcus pneumoniae.

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History

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Other Information

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension USP is a multiple dose anti-infective steroid combination in a sterile suspension for topical application. The active ingredient, Dexamethasone, is represented by the following structural formula:

C22H29FO5

Mol. Wt. 392.47

Chemical Name: Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11β,16α)-.

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 to not less than 600 micrograms of neomycin base per milligram, calculated on an anhydrous basis. The structural formula is:

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 milligram, calculated on an anhydrous basis. The structural formula is:

Polymyxin B Sulfate (structural formula)

Each mL Contains: ACTIVES: Neomycin Sulfate (equivalent to 3.5 mg Neomycin), Polymyxin B Sulfate equal to 10,000 polymyxin B units, Dexamethasone 1 mg (0.1%); INACTIVES: Sodium Chloride, Hypromellose, Polysorbate 20, Purified Water. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (3.5 – 6.0).
PRESERVATIVE ADDED: Benzalkonium Chloride 0.004%

Sources

Neomycin Polymyxin B Sulfates And Dexamethasone Manufacturers

Proficient Rx Lp

Neomycin Polymyxin B Sulfates And Dexamethasone | Proficient Rx Lp

One or two drops topically in the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily.

Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

SHAKE WELL BEFORE USING.

No Recall
Phoenix Pharmaceutical, Inc.

Neomycin Polymyxin B Sulfates And Dexamethasone | Phoenix Pharmaceutical, Inc.

One or two drops topically in the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily.

Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

SHAKE WELL BEFORE USING.

No Recall
Mwi/vetone

Neomycin Polymyxin B Sulfates And Dexamethasone | Mwi/vetone

One or two drops topically in the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily.

Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

SHAKE WELL BEFORE USING.

No Recall
Rxv

Neomycin Polymyxin B Sulfates And Dexamethasone | Rxv

One or two drops topically in the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily.

Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

SHAKE WELL BEFORE USING.

No Recall
H.j. Harkins Company, Inc.

Neomycin Polymyxin B Sulfates And Dexamethasone | H.j. Harkins Company, Inc.

One or two drops topically in the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily.

Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

SHAKE WELL BEFORE USING.

No Recall
Preferred Pharmaceuticals, Inc.

Neomycin Polymyxin B Sulfates And Dexamethasone | Preferred Pharmaceuticals, Inc.

One or two drops topically in the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily.

Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

SHAKE WELL BEFORE USING.

No Recall
Unit Dose Services

Neomycin Polymyxin B Sulfates And Dexamethasone | Unit Dose Services

One or two drops topically in the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily.

Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in above. PRECAUTIONS

SHAKE WELL BEFORE USING.

No Recall
Bausch & Lomb Incorporated

Neomycin Polymyxin B Sulfates And Dexamethasone | Bausch & Lomb Incorporated

One or two drops topically in the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily.

Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

SHAKE WELL BEFORE USING.

No Recall