DrugindexOnline^{2nd edition}

Pronouncation: (flure-oh-METH-oh-LONE/sull-fah-SEE-tah-mide)
Class: Corticosteroid, Anti-inflammatory, Anti-infective

Trade Names:
FML-S
- Ophthalmic Suspension 0.1% fluorometholone and 10% sodium sulfacetamide

Mechanism of Action

Pharmacology

Fluorometholone

Depresses formation, release, and activity of endogenous mediators of inflammation as well as modifying body's immune response.

Sulfacetamide

Competitively antagonizes PABA, an essential component of folic acid synthesis.

Indications and Usage

Treatment of steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns or penetration of foreign bodies. Use of corticosteroids in combination with an anti-infective agent is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present.

Contraindications

Epithelial herpes simplex keratitis (dendritic keratitis) and vaccinia; varicella, mycobacterial infection, and fungal diseases of the ocular structure; hypersensitivity to any component of this product.

Dosage and Administration

Adults

Topical Instill 1 gtt into the conjunctival sac 4 times daily, taking care not to discontinue therapy prematurely.

Drug Interactions

None well documented.

Incompatibility

Silver preparations.

Laboratory Test Interactions

None well documented.

Adverse Reactions

EENT

Local irritation; elevation in IOP with possible development of glaucoma; optic nerve damage; posterior subscapular cataract formation; delayed wound healing.

Hematologic

Agranulocytosis; aplastic anemia and other blood dyscrasias.

Hepatic

Fulminant hepatic necrosis.

Miscellaneous

Allergic sensitization; Stevens-Johnson syndrome; toxic epidermal necrolysis; secondary infections (including fungal).

Precautions

Pregnancy

Category C .

Lactation

Undetermined; however, systemic hydrocortisone is excreted in breast milk.

Children

Safety and efficacy not established.

Hypersensitivity

Deaths associated with sulfonamide administration have been reported rarely from hypersensitivity reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, agranulocytosis, aplastic anemia, and other blood dyscrasias. Early indications of serious blood disorders include sore throat, fever, pallor, purpura, or jaundice.

Herpes simplex

Use corticosteroid with caution in patients with a history of herpes simplex.

Long-term use

Long-term use of topical corticosteroids may cause corneal and scleral thinning, possibly leading to perforation.

Ocular damage

Prolonged use may result in glaucoma with damage to the optic nerve, defects in visual acuity, fields of vision, and in posterior subcapsular cataract formation.

Secondary infection

Prolonged use may result in bacterial or fungal overgrowth of nonsusceptible microorganisms.

Sensitivity

May occur irrespective of the route of administration.

Patient Information

• Review prescribed dosing schedule with patient, family, or caregiver.
• Remind patient, family, or caregiver that suspension is for use in the eye only.
• Teach patient, family, or caregiver proper technique for instilling suspension: wash hands; do not allow tip of dropper bottle to touch eye, eyelid, fingers, or any other surface. Tilt head back, look up; pull lower eyelid down to form pocket; place prescribed number of gtt in the pocket. Look downward before closing eye. Do not rub eye.
• Advise patient, family, or caregiver that if more than 1 topical ophthalmic drug is being used, instill eye gtt first, wait at least 5 min, and then instill ointment last.
• Inform patient that temporary blurred vision and stinging of the eye are the most common adverse reactions and to contact health care provider if they occur and are bothersome.
• Advise patient to contact eye doctor if eye or eyelid inflammation is noted or if eye symptoms do not improve or worsen.
• Advise patient that the entire course of therapy must be completed to ensure maximal benefit and to complete full course of therapy even if symptoms have resolved.
• Instruct patient not to wear contact lenses during treatment.