VA Class:OP300

ATC Class:S01CA07

AHFS Class:

• Corticosteroids 52:08.08

Generic Name(s):

• Fluorometholone

• Fluorometholone Acetate

Fluorometholone is a synthetic fluorinated corticosteroid that also is structurally related to progesterone.

Fluorometholone and fluorometholone acetate are applied topically to the eye. Care should be taken to avoid contamination of the tip of the dropper or ointment tube.

One drop of the 0.1% or 0.25% ophthalmic suspension (containing fluorometholone) may be instilled into the conjunctival sac of the affected eye(s) 2-4 times daily or 1.3 cm (½ inch) of the 0.1% ointment may be applied in the conjunctival sac of the affected eye(s) 1-3 times daily. During the initial 24-48 hours of therapy with fluorometholone 0.1% suspension or ointment, dosage may be increased to 1 drop of suspension or 1.3 cm of ointment every 4 hours. If improvement does not occur within several days, the drug should be discontinued and other therapy begun. The duration of treatment depends on the type and severity of the disease and may range from a few days to several weeks; long-term therapy should be avoided. When the drug is discontinued, dosage should be gradually tapered to avoid exacerbation of the disease.

When fluorometholone acetate is used, 1 to 2 drops of the 0.1% ophthalmic suspension may be instilled into the conjunctival sac 4 times daily. During the initial 24-48 hours of therapy, dosage may be increased to 2 drops every 2 hours. If improvement does not occur after 2 weeks, patients should contact a clinician; fluorometholone acetate therapy should not be discontinued prematurely.

One drop of the suspension containing a fixed combination of fluorometholone and sulfacetamide sodium may be instilled into the lower conjunctival sac 4 times daily. When the suspension containing a fixed combination of fluorometholone acetate and tobramycin is used, 1 or 2 drops may be instilled into the conjunctival sac every 4-6 hours; during the initial 24-48 hours of therapy, dosage may be increased to 1 or 2 drops every 2 hours. Therapy should not be discontinued prematurely.

Patients should initially receive a prescription for 20 mL or less of suspension or 8 g or less of ointment and should be reevaluated by their clinician prior to obtaining a refill.

Safety and efficacy of fluorometholone alone or in fixed combination with sulfacetamide sodium or fluorometholone acetate in fixed combination with tobramycin in children younger than 2 years of age have not been established; the manufacturer states that safety and efficacy of fluorometholone acetate alone have not been established in children of any age.

Chemistry and Stability

Chemistry

Fluorometholone is a synthetic fluorinated corticosteroid that also is structurally related to progesterone. Fluorometholone occurs as a white to yellowish-white, odorless, crystalline powder and is practically insoluble in water and slightly soluble in alcohol. The pH of fluorometholone ophthalmic suspension is adjusted to 6-7.5 with sodium hydroxide.

Stability

Fluorometholone ophthalmic suspension should be stored in tight, light-resistant containers at a temperature less than 40°C, preferably between 15-30°C; freezing should be avoided. Fluorometholone acetate ophthalmic suspension should be stored in tight containers at 2-27°C; freezing should be avoided.

Additional Information

For further information on chemistry, pharmacology, pharmacokinetics, uses, cautions, and dosage and administration of fluorometholone, see the EENT Corticosteroids General Statement 52:08.08.