Tolon

Tolon

fluorometholone

Manufacturer:

Samchundang

Distributor:

AA Medical
Full Prescribing Info
Contents
Fluorometholone.
Description
Each mL contains: Fluorometholone 1 mg.
Excipients/Inactive Ingredients: Edetate disodium, polysorbate 80, sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic anhydrous, benzalkonium chloride, polyvinyl alcohol, hydroxypropylmethylcellulose 2910, hydrochloric acid, sodium hydroxide, sterile purified water.
Indications/Uses
Tolon eye drops is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.
Dosage/Direction for Use
Instill 1-2 drops in the conjunctival sac 2-4 times daily.
Depending on the age and severity of symptoms, the dosage may be adjusted.
Contraindications
Tolon eye drops is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccina, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Tolon eye drops is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
Warnings
Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may suppress the host immune response and thus increase the hazard of secondary ocular infections. Long-term use of topical corticosteroids have been known to cause corneal and scleral thinning. Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. Acute purulent untreated infections of the eye may be masked or actively enhanced by the presence of corticosteroid medication. If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma. The use of steroids alters cataract surgery, may delay healing and increases the incidence of bleb formation.
Special Precautions
The initial prescription and renewal of the medication order beyond 20 milliliters of Tolon eye drops should be made by the physician only after examination of the patients and with the aid of magnification, such as slit lamp biomicroscopy and where appropriate, fluoresce in staining. If signs and symptoms fail to improve after 2 days, the patients should be re-evaluated. As fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate.
Information to the Patients: If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician. This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use.
Pediatric use: Safety and effectiveness in children below the age of two years have not been established.
Use In Pregnancy & Lactation
There are no adequate and well-controlled studies of fluorometholone in pregnant women, and it is not known whether fluorometholone can cause fetal harm when administered to a pregnant women.
Fluorometholone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because of the potential for serious adverse reactions in nursing infants from fluorometholone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Adverse Reactions
Adverse reactions include elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation and delayed wound healing.
Corticosteroid containing preparations have also been reported to cause acute uveitis and perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following use of corticosteroids.
The development of secondary ocular infection (bacterial, fungal and viral) has occurred. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long term applications of steroids. Inform the doctor in case of any adverse reactions related to drug use.
Storage
Store in a tight container at room temperature (1-30°C).
Shelf-Life: 3 years from manufacturing date.
MIMS Class
ATC Classification
S01BA07 - fluorometholone ; Belongs to the class of corticosteroids. Used in the treatment of inflammation of the eye.
Presentation/Packing
Eye drops (white susp) 1 mg/mL x 5 mL x 1's.
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