Medication info

Fluoto Eye Drops (Fluorometholone)

Prescription medicationApproval withdrawn
Ingredient · strength
Fluorometholone›Strength being verified
Manufacturer / importer
코스맥스파마(주)
Appearance
A white suspension contained in a clear plastic bottle.
Packaging
5mL/bottle × 1, 20
Approval status
Approval withdrawn

MFDS item code 201900302 · Notified 2019.01.22

This product's status changed to Approval withdrawn on 2023.07.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of inflammatory diseases of the external and anterior segments of the eye (such as blepharitis, conjunctivitis, etc.)
Who uses it
Adults
Adult dosage
Instill 1–2 drops at a time, 2–4 times a day. Adjust according to symptoms.

Ingredients

Manufacturer
코스맥스파마(주)

Efficacy & effects

Treatment of inflammatory diseases of the external and anterior segments of the eye (such as blepharitis, conjunctivitis, etc.)

  • Blepharitis
  • conjunctivitis
  • keratitis
  • scleritis
  • episcleritis
  • iritis
  • cyclitis
  • uveitis
  • post-surgery inflammation
View approved original text

This eye drop at 0.1% is used for various inflammatory diseases that occur in the external and anterior segments of the eye. Specifically, it is effective for inflammation such as blepharitis, conjunctivitis, keratitis, scleritis, episcleritis, iritis, cyclitis, and uveitis. Additionally, it is utilized in the treatment of inflammation resulting from surgery, aiding in alleviating inflammation and maintaining eye health. It is used for the treatment of various inflammatory diseases.

Dosage and Administration

Adult dosage

Instill 1–2 drops at a time, 2–4 times a day. Adjust according to symptoms.

Precautions

This medication should not be administered to patients with viral keratoconjunctivitis, fungal eye diseases, mycobacterial infections, or chronic blepharitis. Additionally, patients who have had an allergic reaction to this medication should not use it. It is generally not indicated in cases where the corneal epithelium is ruptured or ulcerated, in patients with tuberculous or purulent eye diseases, glaucoma patients, and infants under 2 years old, unless necessary it should be administered cautiously. Long-term use of this medication may lead to increased intraocular pressure, glaucoma, and damage to the optic nerve, thus regular checks of intraocular pressure are necessary. Caution is needed as the use of this medication in cases of corneal infection, ulceration, or trauma may cause perforation. The risk of posterior subcapsular cataracts or secondary infections may increase with prolonged use. When there is acute purulent ocular infection, this medication may mask symptoms or worsen the condition, so caution is required. The phosphate component contained in this medication may rarely induce corneal calcification in patients with severe corneal damage. It may also delay wound healing after cataract surgery and increase blister formation. Care should be taken as prolonged use may lead to suppression of pituitary and adrenal cortex function. If any allergic symptoms occur during use, administration should be stopped immediately. It can be fatal if infected with chickenpox or measles, so it is essential to check the patient’s history and vaccination status before administering. In cases of infection risk, appropriate medical attention should be sought immediately. Using this medication on reddened eyes without a doctor's diagnosis may lead to blindness; therefore, guidance from a professional is necessary. Patients with a history of herpes simplex require careful monitoring and regular check-ups. Children and patients who cannot cooperate should also regularly check intraocular pressure during long-term administration. This medication is ineffective for certain keratitis, so if symptoms persist or worsen for over 48 hours, use should be discontinued, and a doctor should be consulted. Contact lens wearers should remove their lenses before administration and wait at least 30 minutes before re-inserting. Vision may be temporarily blurred after instillation, so driving or operating hazardous machinery should be avoided. Special attention is needed for children or patients taking CYP3A4 inhibitors as they are at a higher risk of systemic side effects. The risk of systemic side effects may increase when used with CYP3A4 inhibitors, thus it should only be used under a doctor’s judgment. Pregnant women or those who may become pregnant should avoid prolonged or frequent use, and breastfeeding women should preferably not use it; if unavoidable, breastfeeding should be discontinued. The safety for children and infants has not been established, so caution should be exercised. Elderly patients may have decreased physiological functions, thus extra caution is necessary. This medication is for ophthalmic use only, and care should be taken to avoid contact of the bottle tip with the eye. Shake well before use, avoid sharing to prevent contamination, and discard any remaining medication after opening. For single-use products, discard the first 1–2 drops before using. During storage, keep in a tightly sealed container away from air or moisture, and maintain a temperature between 1 and 30 degrees Celsius to preserve the medication’s effectiveness.

Side effects and when to seek care immediately

Mild side effects

Decreased vision, visual field loss, increased intraocular pressure, herpes keratitis, fungal keratitis, Pseudomonas aeruginosa infection, corneal ulcer, posterior subcapsular cataract, secondary ocular infection, acute uveitis, conjunctivitis, mydriasis, conjunctival congestion, accommodation paralysis, ptosis, corneal calcification, delayed wound healing, suppression of pituitary and adrenal gland function, hypersensitivity reactions, temporary blurred vision.

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture, and it is safely stored at room temperature between 1 and 30 degrees Celsius. This way, the efficacy of the medication can be maintained for a longer period.

Appearance and packaging

Appearance

A white suspension contained in a clear plastic bottle.

Package unit

5mL/bottle × 1, 20

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.