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Neomycin and Polymyxin B Sulfates and Dexamethasone (Neomycin Sulfate / Polymyxin B Sulfate / Dexamethasone Ophthalmic) - Indications and Dosage

 
 



INDICATIONS AND USAGE:

For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or 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 conjunctivitises 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 conbination 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 drugs in this product is active against the following common bacterial eye pathogens:  Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Niesseria species, and Pseudomonas aeruginosa.

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

DOSAGE AND ADMINISTRATION:

Apply a small amount into the conjunctival sac(s) up to three or four times daily.

How to Apply neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment:

  1. Tilt your head back.
  2. Place a finger on your cheek just under your eye and gently pull down until a "V" pocket is formed between your eyeball and your lower lid.
  3. Place a small amount (about 1/2 inch) of neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment in the "V" pocket.  Do not let the tip of the tube touch your eye.
  4. Look downward before closing your eye.
Not more than 8 g should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

HOW SUPPLIED:

Neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment USP is supplied in 3.5 g (1/8 oz) sterile tamper evident tubes with ophthalmic tip.

NDC 48102-003-35

Store at 20o-25oC (68o-77oF) [See USP Controlled room temperature].

FERA

Mfd. for:

Fera Pharmaceuticals, LLC

Locust Valley, NY  11560


PF00335A
R0311

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