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FLAREXTMFluorometholone Acetate Ophthalmic Suspension 0.1%

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SYMPTOMS & TREATMENT OF OVERDOSAGE

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Overdosage in the use of topical ophthalmic corticosteroids is a remote possibility. Discontinue medication when heavy or protracted use is suspected.

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DOSAGE & ADMINISTRATION

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One to two drops instilled into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosage may be safely increased to two drops every two hours. Care should be taken not to discontinue therapy prematurely.
Special Instructions
Patients should be advised to shake well before using and to avoid contamination of the dropper tip.

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AVAILABILITY OF DOSAGE FORMS

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FLAREXTM is available as a sterile ophthalmic suspension of fluorometholone acetate 0.1% in Drop-Tainer® Dispensers containing 5mL. The suspension is preserved with benzalkonium chloride 0.01%.
Fluorometholone acetate is a Schedule F (prescription) drug.

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PHARMACEUTICAL INFORMATION

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| Proper Name:
| Fluorometholone acetate
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| Chemical Name:
| 9-fluoro-118,-17-dihydroxy-6alpha-methylpregna-1,4-diene-3,20-dione, 17-acetate
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| Empirical Formula:
| C24H31FO5
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| Physical Form:
| White to creamy-white powder
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| Solubility:
| Freely soluble in chloroform and acetone, soluble in ethanol, very slightly soluble in water.
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| Melting Point:
| Approximately 230°C
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| Specific Rotation:
| +28° in chloroform
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COMPOSITION

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FLAREX is a sterile suspension of fluorometholone acetate 0.1% with benzalkonium chloride 0.01% (as preservative), sodium chloride, monobasic sodium phosphate, edetate disodium, hydroxyethyl cellulose, tyloxapol, hydrochloric acid and/or sodium hydroxide (to adjust pH), and purified water.

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