"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 "...
VASOCIDIN (sulfacetamide and prednisolone) is indicated for corticosteroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain 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 superficial ocular 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 drug in this product is active against the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.
This product does not provide adequate coverage against: Neisseria species, Serratia marcescens.
A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.
DOSAGE AND ADMINISTRATION
Instill two drops of VASOCIDIN (sulfacetamide and prednisolone) Ophthalmic Solution topically in the eye(s) every four hours.
Not more than 20 mL should be prescribed initially. If signs and symptoms fail to improve after two days, patients should be reevaluated (see PRECAUTIONS).
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 application.
VASOCIDIN (sulfacetamide and prednisolone) Ophthalmic Solution: 5 mL NDC 58768-887-05, and 10 mL NDC 58768-887-10 dropper-tip plastic squeeze bottles.
To be dispensed only in original, unopened container. Store at controlled room temperature 15° to 30°C (59° to 86°F). Keep from freezing. PROTECT FROM LIGHT.
Sulfonamide solutions darken on prolonged standing and exposure to heat and light. Do not use if solution has darkened. Yellowing does not affect activity.
KEEP OUT OF REACH OF CHILDREN.
CAUTION: Federal law prohibits dispensing without prescription.
Mfd. by OMJ Pharmaceuticals, Inc., San Germán, P.R., 00683 for: Novartis Ophthalmics, Duluth, GA 30097. Rev February 2001.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/8/2009
Additional Vasocidin Information
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