fluorometholone ophthalmic suspension 1 mg/mL
fluorometholone · SUSPENSION/ DROPS · Amneal Pharmaceuticals NY LLC
Fluorometholone ophthalmic suspension is a corticosteroid eye drop used to treat inflammation and swelling in the eyes caused by conditions such as allergies, infections, or eye surgery. It works by reducing inflammation to relieve discomfort and improve symptoms.
Key Facts
- Brand Name
- fluorometholone ophthalmic suspension
- Generic Name
- fluorometholone
- NDC Code (Product)
60219-1586- Manufacturer
- Amneal Pharmaceuticals NY LLC
- Strength
- 1 mg/mL
- Dosage Form
- SUSPENSION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA216348
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 01/09/2023
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Fluorometholone ophthalmic suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.
Dosage & Administration
DOSAGE AND ADMINISTRATION Shake well before using. Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased to one application every four hours. Care should be taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS ). The dosing of fluorometholone ophthalmic suspension may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.
Warnings
WARNINGS Prolonged use of corticosteroids may increase intraocular pressure in susceptible individuals, resulting 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 also suppress the host immune response and thus increase the hazard of secondary ocular infections. Various ocular diseases and 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 infections of the eye may be masked or activity 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. Intraocular pressure should be checked frequently. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. Use of ocular steroids may prolong the course and may exacerbate the severity of many …
Contraindications
CONTRAINDICATIONS Fluorometholone ophthalmic suspension is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye, and fungal diseases of ocular structures. Fluorometholone ophthalmic suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
Adverse Reactions
ADVERSE REACTIONS Adverse reactions include, in decreasing order of frequency, elevation of intraocular pressure (IOP) with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing. Although systemic effects are extremely uncommon, there have been rare occurrences of systemic hypercorticoidism after use of topical dermatologic steroids applied to the skin. Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis and perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local 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. The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used (see WARNINGS ). Transient burning and stinging upon instillation and other minor symptoms of ocular …
Frequently Asked Questions
What is fluorometholone ophthalmic suspension used for?
Fluorometholone ophthalmic suspension is a corticosteroid eye drop used to treat inflammation and swelling in the eyes caused by conditions such as allergies, infections, or eye surgery. It works by reducing inflammation to relieve discomfort and improve symptoms.
Is fluorometholone ophthalmic suspension a controlled substance?
fluorometholone ophthalmic suspension is not classified as a controlled substance by the DEA.
What is the generic name for fluorometholone ophthalmic suspension?
The generic name for fluorometholone ophthalmic suspension is fluorometholone. There are 6 other brand versions of fluorometholone.
What is the NDC code for fluorometholone ophthalmic suspension 1 mg/mL?
The NDC (National Drug Code) for fluorometholone ophthalmic suspension 1 mg/mL is 60219-1586, listed by Amneal Pharmaceuticals NY LLC.