"The US Food and Drug Administration (FDA) has approved Akorn Inc's phenylephrine hydrochloride ophthalmic solution (2.5% and 10%), the company has announced.
The alpha-1 adrenergic receptor agonist is commonly used by optometrists, ophtha"...
A steroid/anti-infective combination is indicated 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 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.
The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens: Staphylococcus aureus; Escherichia coli; Hemophilus influenzae; Klebsiella/ Enterobacter species; Neisseria species; and Pseudomonas aeruginosa.
The product does not provide adequate coverage against: Serratia marcescens; Streptococci, including Streptococcus pneumoniae.
DOSAGE AND ADMINISTRATION
TO TREAT THE EYE: Instill 1 or 2 drops every 3 or 4 hours, or more frequently as required. Acute infections may require administration every 30 minutes, with frequency of administration reduced as the infection is brought under control. TO TREAT THE LIDS: Instill 1 or 2 drops in the eye every 3 to 4 hours, close the eye and rub the excess on the lids and lid margins.
POLY-PRED® (prednisolone,neomycin and polymyxin b) (prednisolone acetate, neomycin sulfate, polymyxin B sulfate ophthalmic suspension, USP) is supplied sterile in opaque white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows:
5 mL in 10 mL bottle – NDC 0023-0028-05
Note: Store at 15 - 25°C (59 - 77°F). Protect from freezing. Shake well before using. Store in an upright position.
Revised: 05/2006. Allergan, Inc. Irvine, CA 92612, U.S.A.
Last reviewed on RxList: 2/19/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Poly-Pred Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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