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Neomycin and Polymyxin B Sulfates and Dexamethasone (Neomycin Sulfate / Polymyxin B Sulfate / Dexamethasone Ophthalmic) - Warnings and Precautions

 
 



WARNINGS:

NOT FOR INJECTION.  Do not touch tube tip to any surface, as this may contaminate the contents.  Prolonged use may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation.  Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections.  In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids.  In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection.  If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients.

Products containing neomycin sulfate may cause cutaneous sensitization.  Employment of steroid medication in the treatment of herpes simplex requires great caution.

PRECAUTIONS:

The initial prescription and renewal of the medication order beyond 8 g 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, flourescein staining.  The possibility of persistent fungal infections of the cornea should be considered after prolonged steroid dosing.  Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial ocular infection.

PREGNANCY:

Pregnancy Category C:  Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose.

In the mouse, corticosteroids produce fetal resorptions and a specific abnormality, cleft palate.  In the rabbit, corticosteroids have produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, palate, etc.

There are no adequate or well-controlled studies in pregnant women.  Neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus.  Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.

NURSING MOTHERS:

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.  It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.  Because many drugs are excreted in human milk, caution should be exercised when neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment is administered to a nursing woman.

PEDIATRIC USE:

Safety and effectiveness in pediatric patients have not been established.

GERIATRIC USE:

No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.

Page last updated: 2011-07-21

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