FML Forte S.O.P.

Ophthalmological Corticosteroids

Administer topically to the eye; do not administer by any other route.
Wash hands before and after use.
Tilt patient's head back slightly and pull the lower eyelid down to form a pouch. Try not to touch the tip of the dropper to the eye, fingertips, or any other surface. Squeeze the prescribed number of drops into the pouch. Have patient close the eye gently to spread the drops.
Administer doses at regular intervals.
Administer ophthalmic solutions or suspensions prior to applying eye ointments. Allow 5—10 minutes between different ocular product applications.
To prevent infection of the eyes, do not share any eye products or other personal care items with other patients.

visual impairment / Early / Incidence not known
ocular hypertension / Delayed / Incidence not known
uveitis / Delayed / Incidence not known
keratoconjunctivitis / Early / Incidence not known

Cushing's syndrome / Delayed / 0-1.0
hypothalamic-pituitary-adrenal (HPA) suppression / Delayed / 0-1.0
cataracts / Delayed / Incidence not known
ocular infection / Delayed / Incidence not known
impaired wound healing / Delayed / Incidence not known
hyperemia / Delayed / Incidence not known
ocular inflammation / Early / Incidence not known
blurred vision / Early / Incidence not known
blepharitis / Early / Incidence not known
conjunctival hyperemia / Early / Incidence not known
conjunctivitis / Delayed / Incidence not known

foreign body sensation / Rapid / Incidence not known
lacrimation / Early / Incidence not known
ocular discharge / Delayed / Incidence not known
blepharedema / Early / Incidence not known
ocular pain / Early / Incidence not known
rash / Early / Incidence not known
ocular irritation / Rapid / Incidence not known
ocular pruritus / Rapid / Incidence not known
mydriasis / Early / Incidence not known
ptosis / Delayed / Incidence not known

Flarex, Fluor-Op, FML, FML Forte

Rx

Ophthalmic synthetic fluorinated corticosteroid used for conjunctivitis and other responsive inflammatory eye conditions; preferred for long-term treatment vs other corticosteroids because it is less likely to increase IOP.

1 to 2 drops in the affected eye(s) 4 times daily; may increase dose to 2 drops in the affected eye(s) every 2 hours for the first 24 to 48 hours. Reevaluate if no improvement after 2 weeks.

1 drop in the affected eye(s) 2 to 4 times daily; may increase dose to 1 drop in the affected eyes every 4 hours for the first 24 to 48 hours. Reevaluate if no improvement after 2 days. Withdraw treatment by gradually decreasing dose in chronic conditions.

1 drop in the affected eye(s) 2 to 4 times daily; may increase dose to 1 drop in the affected eyes every 4 hours for the first 24 to 48 hours. Reevaluate if no improvement after 2 days. Withdraw treatment by gradually decreasing dose in chronic conditions.

0.5 inch ribbon in the affected eye(s) 1 to 3 times daily; may increase dose to 0.5 inch ribbon in the affected eye(s) every 4 hours for the first 24 to 48 hours. Reevaluate if no improvement after 2 days. Withdraw treatment by gradually decreasing dose in chronic conditions.

0.5 inch ribbon in the affected eye(s) 1 to 3 times daily; may increase dose to 0.5 inch ribbon in the affected eye(s) every 4 hours for the first 24 to 48 hours. Reevaluate if no improvement after 2 days. Withdraw treatment by gradually decreasing dose in chronic conditions.

1 to 2 drops in each eye 4 times daily, initially. Reduce dose to 1 to 2 drops in each eye twice daily after 1 to 2 weeks if positive response in signs and/or symptoms and start cyclosporine, then taper or discontinue steroid therapy after 2 to 4 weeks. Consider extending duration to 4 weeks if no response at 2 weeks, especially in patients with moderate to severe disease.

†Indicates off-label use

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

There are no drug interactions associated with Fluorometholone products.

Flarex/Fluorometholone/Fluorometholone Acetate/Fluor-Op/FML/FML Forte Ophthalmic Susp: 0.1%, 0.25%
FML Forte S.O.P. Ophthalmic Ointment: 0.1%

Corticosteroid dosage must be individualized and is highly variable depending on the nature and severity of the disease and on patient response. Renewal of fluorometholone prescriptions beyond 20 ml of ophthalmic suspension or 8 grams of ophthalmic ointment should be made by only after re-examination with the aid of magnification.

Ocular topical corticosteroids exert anti-inflammatory activity against inciting agents of mechanical, chemical or immunological nature. The exact mechanism in ocular disease remains to be elucidated. Corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. These lipocortins are postulated to control the biosynthesis of mediators of inflammation, especially prostaglandins and leukotrienes, via inhibiting the release of the precursor molecule arachadonic acid. In ocular medicine, these actions inhibit edema, capillary dilatation, migration of leukocytes, fibrin and collagen deposition, and scar formation associated with inflammation. Ocular application of corticosteroids also results in potentiation of epinephrine vasoconstriction, decreased macrophage movement, and stabilization of lysosomal membranes. Corticosteroids are able to increase intraocular pressures, the degree of which is related to the relative potency of the agent employed, as well as the concentration of the agent and the release from the pharmaceutical vehicle. Decreases in vascularization and scarring make these agents useful in limiting tissue damage in chemical and thermal exposures.

Fluoromethalone is administered via the ophthalmic route. Like most ophthalmic corticosteroids, fluoromethalone is absorbed through the aqueous humor, and distributes into the local tissues. Minimal systemic absorption occurs. Fluorometholone has lower systemic penetration activity than other ocular steroids, such as dexamethasone. The low overall doses used in ophthalmic administration usually circumvent the appearance of clinical evidence of systemic absorption. Metabolism of the ocular corticosteroids occurs locally. Ophthalmic ointments will have a lower metabolic clearance rate than solutions or suspensions due to product formulation and contact times.

Fluorometholone is classified in FDA pregnancy category C. There are no adequate and well-controlled studies in pregnant women. According to the manufacturer, fluorometholone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

It is not known whether ophthalmic administration of fluorometholone results in sufficient systemic absorption to produce detectable quantities in breast milk; but pharmacokinetic studies indicate that systemic absorption after ophthalmic administration of fluorometholone is limited and therefore unlikely that a significant amount of drug would be excreted into breast-milk. The drug is likely compatible with breast-feeding. To further minimize the amount of drug that reaches the systemic circulation and breast milk, apply pressure over the tear duct by the corner of the eye for 1 minute after ophthalmic administration. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.