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  • CLASSES

    Ophthalmological Corticosteroids

    DEA CLASS

    Rx

    DESCRIPTION

    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.

    COMMON BRAND NAMES

    Flarex, Fluor-Op, FML, FML Forte, FML Forte S.O.P.

    HOW SUPPLIED

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

    DOSAGE & INDICATIONS

    For the treatment of corticosteroid-responsive ophthalmic disorders including allergic conjunctivitis, ocular burns or trauma due to corneal injury resulting from chemical, thermal or penetration trauma, giant papillary conjunctivitis (GPC), keratitis, postoperative ocular inflammation, vernal keratoconjunctivitis, and chronic anterior uveitis.
    NOTE: The benefit of diminution of edema and inflammation from the use of ocular corticosteroids and the inherent risk of infection in certain conditions must be considered. Duration of treatment may vary with type of lesion and therapeutic response. Renewal of prescriptions beyond 20 mL of suspension or 8 grams of ointment should be made by a physician after re-examination with the aid of magnification. Care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of therapy should be carried out by gradually decreasing the frequency of applications.
    Ophthalmic dosage (0.1% or 0.25% ophthalmic suspension)
    Adults, Adolescents and Children >= 2 years

    1 drop into the conjunctival sac 2—4 times per day. During the initial 24—48 hours, may apply 1 drop every 4 hours. If no improvement after 2 days, re-evaluate.

    Ophthalmic ointment dosage
    Adults, Adolescents and Children >= 2 years

    Approximately ½ of an inch applied to the conjunctival sac 1—3 times per day. During the initial 24—48 hours, may apply every 4 hours. If no improvement after 2 days, re-evaluate.

    MAXIMUM DOSAGE

    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.

    DOSING CONSIDERATIONS

    Hepatic Impairment

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

    Renal Impairment

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

    ADMINISTRATION

    Ophthalmic Administration

    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.

    STORAGE

    Flarex:
    - Store below 86 degrees F
    Fluor-Op:
    - Protect from freezing
    - Store between 36 to 77 degrees F
    - Store upright
    FML:
    - Protect from freezing
    - Store between 36 to 77 degrees F
    - Store upright
    FML Forte:
    - Protect from freezing
    - Store at or below 77 degrees F
    FML Forte S.O.P.:
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    In some instances, given appropriate anti-infective treatment concurrently, ocular corticosteroids can be used to limit serious ocular damage.

    Herpes infection, herpes simplex keratitis (dendritic keratitis), varicella, viral infection

    Fluorometholone is contraindicated in most viral diseases of the cornea and conjunctiva, including acute superficial herpes simplex keratitis (dendritic keratitis), varicella, and viral infection. Patients with other active herpes infection of the eye (stromal keratitis or uveitis) should not receive fluorometholone unless in conjunction with antiviral therapy. Persons with a history of herpes infections should be prescribed ocular corticosteroids with caution. In addition, the use of ocular corticosteroids may exacerbate the severity of many viral infections of the eye.

    Fungal infection, mycobacterial infection

    Fluorometholone is contraindicated in mycobacterial infection and fungal infection of the eye or ocular structures. Depending on the severity and the use of concurrent anti-infective agents, bacterial infections of the eye may also preclude use of fluorometholone. The use of the ointment may be more prone to retard corneal healing.

    Contact lenses

    Fluorometholone preparations are contraindicated in anyone with known hypersensitivity to the drug or components of the individual preparations. Patients who wear contact lenses should be aware that benzalkonium chloride, a preservative in many of the fluorometholone products, can be absorbed by soft contact lenses. Patients wearing soft contact lenses should wait >= 15 minutes before inserting their lenses.

    Glaucoma

    Because fluorometholone has resulted in increased intraocular pressures in some individuals, this drug should be used cautiously in patients with glaucoma. If any patient receives this drug beyond 10 days, intraocular pressure should be monitored.

    Pregnancy

    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.

    Breast-feeding

    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.

    Children, infants, neonates

    The safety and efficacy of fluorometholone preparations in neonates, infants and children < 2 years have not been established.

    ADVERSE REACTIONS

    Severe

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

    Moderate

    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

    Mild

    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

    DRUG INTERACTIONS

    There are no drug interactions associated with Fluorometholone products.

    PREGNANCY AND LACTATION

    Pregnancy

    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.

    MECHANISM OF ACTION

    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.

    PHARMACOKINETICS

    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.