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Flugestone(Ophthalmic Suspension,Powder Form)

Pharmaceutical Raw Materials Flugestone 17-Acetate Custom Clearance Cronolone 99.9%

Fluorometholone (INN, BAN, JAN) (brand names Efflumidex, Flucon, FML Forte, FML, others)

• Flugestonum (Latin)
• Flugeston (German)
• Flugestone (French)
• Flugestona (Spanish)
• Acetato De Flugestona (Slovenia)
• 9α-Bromo-11-ketoprogesterone
• Fluorometholone
• Medrysone
• Norgestomet

How Supplied the Fluorometholone Ophthalmic Suspension?

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

Storage of FML:

Store at 2° - 25°C (36°-77°F); protect from freezing. Store in an upright position.

Overdose of FML (fluorometholone ophthalmic suspension, USP):

Overdosage by the topical ophthalmic route will not ordinarily cause acute problems.

If accidental overdosage occurs in the eye, the eye should be flushed with water or normal saline. If accidentally ingested, the patient should drink fluids to dilute.

Special warnings and precautions for use FML:

• Eye drops containing corticosteroids should not be used for longer than a week except under an eye specialist's careful surveillance combined with regular measurement of intraocular pressure.

• Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently.
• Acute untreated infection of the eye may be masked or activity enhanced by the presence of steroid medication.

• Use of intraocular steroids may prolong the course and may exacerbate the severity of many viral infections on the eye (including herpes simplex).

• Use of a corticosteroid medication in the treatment of the patients with a history of herpes simplex keratitis requires great caution. Frequent follow-ups including slit lamp microscopy is recommended.

• To prevent eye injury or contamination, care should be taken to avoid touching the applicator tip to the eye or to any other surface. The use of the bottle by more than one person may spread infection.

• FML contains benzalkonium chloride which is irritant to the eye and could cause discoloration of soft contact lenses. Avoid contact with soft contact lenses. Remove contact lenses before FML is used and wait for at least 15 minutes before reinsertion.

• Concomitant ocular medication should be administered 5 minutes prior to the installation of FML.

Side effects of fluorometholone include:

1. Increased pressure in your eye
2. Allergic reactions
3. Feeling like you have something in your eye
4. Burning, stinging, or itchy eyes
5. Redness of your eyelid
6. Eye or eyelid swelling
7. Eye discharge
8. Increased tears
9. Skin rash
10. Changes in how foods taste
11. Eye pain
12. Blurry vision

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