FLULON Fluorometholone 0.1% Ophthalmic Suspension 5mL
RXDRUG-DR-XY25291
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Features
Brand
Flulon
Full Details
Dosage Strength
0.1% w/v
Drug Ingredients
- Fluorometholone
Drug Packaging
Ophthalmic Suspension 5ml
Generic Name
Fluorometholone
Dosage Form
Ophthalmic Suspension
Registration Number
DR-XY25291
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
External or anterior ocular inflammatory diseases: Blepharitis, conjunctivitis, keratitis, scleritis, episcleritis, iritis, iridocyclitis, uveitis, postoperative inflammation, etc.
Dosage/Direction for Use
Shake well before use and usually instill 1 or 2 drops a time, 2 to 4 times daily.
The dosage may be adjusted depending on the age of patients and severity of symptoms or as prescribed by the physician.
The dosage may be adjusted depending on the age of patients and severity of symptoms or as prescribed by the physician.
Contraindications
This product is contraindicated in the patients with a history of hypersensitivity to any ingredients of this product.
This product is contraindicated in the following patients, as a general rule. If essential, however, it can be administered with caution.
Patients with corneal erosion ulcer: This product may aggravate these disease or cause corneal perforation.
Patients with viral keratoconjunctivitis, tuberculous eye disease, fungal or purulent eye disease: This product may aggravate the diseases or cause corneal perforation.
This product is contraindicated in the following patients, as a general rule. If essential, however, it can be administered with caution.
Patients with corneal erosion ulcer: This product may aggravate these disease or cause corneal perforation.
Patients with viral keratoconjunctivitis, tuberculous eye disease, fungal or purulent eye disease: This product may aggravate the diseases or cause corneal perforation.
Special Precautions
Precautions concerning Use: Route of administration: Ophthalmic use only; At the time of administration: Instruct the patient to be careful not to touch the tip of the bottle to the eye directly in order to avoid the contamination of the drug; Since particles in the suspension may not disperse depending on storage conditions even after well shaking, store the product in an upright position.
Instruct the patient to consult with a doctor or pharmacist, if the patient accidentally apply more than prescribed dose.
If any other ophthalmic solution is used, wait at least 5 minutes between applying this product and any other ophthalmic solution.
Use in Children: Pediatric Use This product should be used with caution, especially in infants under 2 years of age. The safety of this product in infants and children has not been established.
Instruct the patient to consult with a doctor or pharmacist, if the patient accidentally apply more than prescribed dose.
If any other ophthalmic solution is used, wait at least 5 minutes between applying this product and any other ophthalmic solution.
Use in Children: Pediatric Use This product should be used with caution, especially in infants under 2 years of age. The safety of this product in infants and children has not been established.
Use In Pregnancy & Lactation
Use during Pregnancy, Delivery or Lactation Long-term or frequent use of this product should be avoided in pregnant women or women who may possibly be pregnant. The safety of this product during pregnancy has not been established.
Adverse Reactions
Rarely: <0.1%, occasionally: 0.1%-<5%, no specific designation: ≥5% or incidence unknown) Clinically significant adverse reactions: Ocular hypertension or glaucoma may occur occasionally after several weeks of repeated treatment with this product. The intraocular pressure should be monitored periodically during treatment.
This product may induce corneal herpes, keratomycosis, Pseudomonas aeruginosa infection, etc. Corneal perforation may occur when this product is given to patients with corneal herpes, corneal ulcer or trauma, etc.
Long-term use of this product may cause posterior subcapsular cataract.
Others If the following adverse reactions are observed, appropriate measures such as discontinuing administration should be taken. (See table).
This product may induce corneal herpes, keratomycosis, Pseudomonas aeruginosa infection, etc. Corneal perforation may occur when this product is given to patients with corneal herpes, corneal ulcer or trauma, etc.
Long-term use of this product may cause posterior subcapsular cataract.
Others If the following adverse reactions are observed, appropriate measures such as discontinuing administration should be taken. (See table).
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Pharmacokinetics: Ocular distribution in rabbit: After topical application of 25 μL of 0.1% radiolabeled fluorometholone ophthalmic suspension to the eyes of rabbits, the radioactivity levels reached a peak of 1.99 μg/g at 5 minutes in the cornea and 0.16 μg/g at 45 minutes in the aqueous humor, respectively. The radioactivity levels at 30 minutes after administration were 1.544 μg/g in the cornea, 0.738 μg/g in the bulbar conjunctiva, 0.320 μg/g in the iris, 0.178 μg/g in the sclera, and 0.154 μg/g in the aqueous humor. Fluorometholone was eliminated more rapidly from the ocular tissues than dexamethasone and prednisolone acetate.
MedsGo Class
Eye Corticosteroids
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