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Basic Drug Info
Drug Name:FML FORTE
Manufacturer:Allergan, Inc.
Other Info:sterile



Clinical Trials:


Indications and Usage
FML FORTE® suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.
Inflammation -- A pathological process characterized by injury or destruction of tissues caused by a variety of cytologic and chemical reactions. It is usually manifested by typical signs of pain, heat, redness, swelling, and loss of function.

Corneal Diseases -- Diseases of the cornea.

Contraindications

FML FORTE® 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.

FML FORTE® suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
Virus Diseases -- A general term for diseases produced by viruses.

Corneal Diseases -- Diseases of the cornea.

Dendritic keratitis -- A form of herpetic keratitis characterized by the formation of small vesicles which break down and coalesce to form recurring dendritic ulcers, characteristically irregular, linear, branching, and ending in knoblike extremities. (Dictionary of Visual Science, 3d ed)

Vaccinia -- The cutaneous and occasional systemic reactions associated with vaccination using smallpox (variola) vaccine.

Chickenpox -- A highly contagious infectious disease caused by the varicella-zoster virus (HERPESVIRUS 3, HUMAN). It usually affects children, is spread by direct contact or respiratory route via droplet nuclei, and is characterized by the appearance on the skin and mucous membranes of successive crops of typical pruritic vesicular lesions that are easily broken and become scabbed. Chickenpox is relatively benign in children, but may be complicated by pneumonia and encephalitis in adults. (From Dorland, 27th ed)

Mycobacterium Infections -- Infections with bacteria of the genus MYCOBACTERIUM.

Mycoses -- disease caused by a fungus.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

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 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 viral infections of the eye (including herpes simplex).

Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.

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