"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 "...
DOSAGE AND ADMINISTRATION
Shake well before using. Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased to one application every four hours. 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 FML® 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.
FML® (fluorometholone ophthalmic suspension, USP) 0.1% is supplied sterile in opaque white LDPE plastic bottles with white high impact polystyrene (HIPS) caps as follows:
5 mL in 10 mL bottle - NDC 11980-211-05
10 mL in 15 mL bottle - NDC 11980-211-10
15 mL in 15 mL bottle - NDC 11980-211-15
Store at 2° - 25°C (36°-77°F); protect from freezing. Store in an upright position.
Irvine, CA 92612, U.S.A. ® marks owned by Allergan, Inc. Made in the U.S.A. Revised: 02/2013
Last reviewed on RxList: 3/12/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional FML 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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