"The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements "...
Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
DOSAGE AND ADMINISTRATION
Shake Well Before Using
Two drops topically in the eye(s) four times daily. In cases of bacterial infections, concomitant use of anti-infective agents is mandatory. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated (SEE PRECAUTIONS).
The dosing of Omnipred (prednisolone acetate) suspension may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.
Omnipred (prednisolone acetate) (prednisolone acetate ophthalmic suspension) is supplied in a white, round low density polyethylene DROP-TAINER® dispenser with a natural low density polyethylene dispensing plug and pink polypropylene cap. Tamper evidence is provided with a shrink band around the closure and neck area of the package.
Omnipred (prednisolone acetate) suspension:
5 mL NDC 0065-06378-27
10 mL NDC 0065-06378-25
STORE at 8° - 24°C (46° - 75°F) in an UPRIGHT position.
ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA. Revised: June 2006. FDA Rev date: 10/11/2007
Last reviewed on RxList: 10/31/2007
This monograph has been modified to include the generic and brand name in many instances.
Additional Omnipred Information
Report Problems to the Food and Drug Administration
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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