FML (Fluorometholone Ophthalmic Suspension)
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FML (Fluorometholone Ophthalmic Suspension)

FML®
(fluorometholone) Ophthalmic Suspension, USP 0.1% Sterile

DRUG DESCRIPTION

FML® (fluorometholone ophthalmic suspension, USP) 0.1% is a sterile, topical anti-inflammatory agent for ophthalmic use.

Chemical Name:
Fluorometholone: 9-Fluoro-11β,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione. Structural Formula:

FML® (fluorometholone) structural formula illustration

Contains: Active: fluorometholone 0.1%. Preservative: benzalkonium chloride 0.004%.

Inactives: edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; sodium phosphate, monobasic; and sodium hydroxide to adjust the pH. FML® (fluorometholone ophthalmic suspension) suspension is formulated with a pH from 6.2 to 7.5. It has an osmolality range of 290-350 mOsm/kg.

What are the possible side effects of fluorometholone ophthalmic (Flarex, FML Forte Liquifilm, FML Liquifilm, FML S.O.P.)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • pain behind your eyes, sudden vision changes, severe headache;
  • sudden eye irritation;
  • blurred vision, tunnel vision, eye pain, or seeing halos around lights; or
  • signs of new eye infection, such as swelling, draining, or...

Read All Potential Side Effects and See Pictures of FML »

Last reviewed on RxList: 10/15/2007
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

FML® (fluorometholone ophthalmic suspension) suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

DOSAGE AND ADMINISTRATION

Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosage 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 FML® (fluorometholone ophthalmic suspension) 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.

HOW SUPPLIED

FML® (fluorometholone ophthalmic suspension, USP) 0.1% is supplied sterile in opaque white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows:

5 mL in 10 mL bottle NDC 11980-211-05

10 mL in 15 mL bottle NDC 11980-211-10

15 mL in 15 mL bottle NDC 11980-211-15

Note: Store between 2° and 25°C (36° - 77°F); protect from freezing. Shake well before using.

©2003 Allergan, Inc. Irvine, CA 92612, U.S.A. Revised June 2003. FDA rev date: 9/12/2007

Last reviewed on RxList: 10/15/2007
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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 steroids.

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 irritation have been reported with the use of FML® (fluorometholone ophthalmic suspension) suspension. Other adverse events reported with the use of FML® (fluorometholone ophthalmic suspension) suspension include: allergic reactions, visual disturbance (blurry vision), and taste perversion.

Read the FML (fluorometholone ophthalmic suspension) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 10/15/2007
This monograph has been modified to include the generic and brand name in many instances.

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.

Corticosteroids are not effective in mustard gas keratitis and Sjogren's keratoconjunctivitis.

PRECAUTIONS

General:

The initial prescription and renewal of the medication order beyond 20 milliliters of FML® (fluorometholone ophthalmic suspension) suspension should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be re-evaluated.

As fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate.

If this product is used for 10 days or longer, intraocular pressure should be monitored (see WARNINGS).

Carcinogenesis, mutagenesis, impairment of fertility:

No studies have been conducted in animals or in humans to evaluate the possibility of these effects with fluorometholone.

Pregnancy:

Teratogenic effects. Pregnancy Category C: Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose. Fluorometholone was applied ocularly to rabbits daily on days 6-18 of gestation, and dose-related fetal loss and fetal abnormalities including cleft palate, deformed rib cage, anomalous limbs and neural abnormalities such as encephalocele, craniorachischisis, and spina bifida were observed. There are no adequate and well-controlled studies of fluorometholone in pregnant women, and it is not known whether fluorometholone can cause fetal harm when administered to a pregnant woman. Fluorometholone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from fluorometholone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:

Safety and effectiveness in infants below the age of 2 years have not been established.

Geriatric Use:

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Last reviewed on RxList: 10/15/2007
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

FML® (fluorometholone ophthalmic suspension) 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® (fluorometholone ophthalmic suspension) suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Last reviewed on RxList: 10/15/2007
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.

There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Corticosteroids are capable of producing a rise in intraocular pressure. In clinical studies of documented steroid-responders, fluorometholone demonstrated a significantly longer average time to produce a rise in intraocular pressure than dexamethasone phosphate; however, in a small percentage of individuals, a significant rise in intraocular pressure occurred within one week. The ultimate magnitude of the rise was equivalent for both drugs.

Last reviewed on RxList: 10/15/2007
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician.

This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Keep out of the reach of children.

The preservative in FML® (fluorometholone ophthalmic suspension) suspension, benzalkonium chloride, may be absorbed by soft contact lenses. Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling FML® (fluorometholone ophthalmic suspension) suspension to insert soft contact lenses.

Last reviewed on RxList: 10/15/2007
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician.

This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Keep out of the reach of children.

The preservative in FML® (fluorometholone ophthalmic suspension) suspension, benzalkonium chloride, may be absorbed by soft contact lenses. Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling FML® (fluorometholone ophthalmic suspension) suspension to insert soft contact lenses.

Last reviewed on RxList: 10/15/2007
This monograph has been modified to include the generic and brand name in many instances.

FML®
(fluorometholone) Ophthalmic Suspension, USP 0.1% Sterile

DRUG DESCRIPTION

FML® (fluorometholone ophthalmic suspension, USP) 0.1% is a sterile, topical anti-inflammatory agent for ophthalmic use.

Chemical Name:
Fluorometholone: 9-Fluoro-11β,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione. Structural Formula:

FML® (fluorometholone) structural formula illustration

Contains: Active: fluorometholone 0.1%. Preservative: benzalkonium chloride 0.004%.

Inactives: edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; sodium phosphate, monobasic; and sodium hydroxide to adjust the pH. FML® (fluorometholone ophthalmic suspension) suspension is formulated with a pH from 6.2 to 7.5. It has an osmolality range of 290-350 mOsm/kg.

Last reviewed on RxList: 10/15/2007
This monograph has been modified to include the generic and brand name in many instances.

FML®
(fluorometholone) Ophthalmic Suspension, USP 0.1% Sterile

DRUG DESCRIPTION

FML® (fluorometholone ophthalmic suspension, USP) 0.1% is a sterile, topical anti-inflammatory agent for ophthalmic use.

Chemical Name:
Fluorometholone: 9-Fluoro-11β,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione. Structural Formula:

FML® (fluorometholone) structural formula illustration

Contains: Active: fluorometholone 0.1%. Preservative: benzalkonium chloride 0.004%.

Inactives: edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; sodium phosphate, monobasic; and sodium hydroxide to adjust the pH. FML® (fluorometholone ophthalmic suspension) suspension is formulated with a pH from 6.2 to 7.5. It has an osmolality range of 290-350 mOsm/kg.

Last reviewed on RxList: 10/15/2007
This monograph has been modified to include the generic and brand name in many instances.

FML®
(fluorometholone) Ophthalmic Suspension, USP 0.1% Sterile

DRUG DESCRIPTION

FML® (fluorometholone ophthalmic suspension, USP) 0.1% is a sterile, topical anti-inflammatory agent for ophthalmic use.

Chemical Name:
Fluorometholone: 9-Fluoro-11β,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione. Structural Formula:

FML® (fluorometholone) structural formula illustration

Contains: Active: fluorometholone 0.1%. Preservative: benzalkonium chloride 0.004%.

Inactives: edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; sodium phosphate, monobasic; and sodium hydroxide to adjust the pH. FML® (fluorometholone ophthalmic suspension) suspension is formulated with a pH from 6.2 to 7.5. It has an osmolality range of 290-350 mOsm/kg.

Last reviewed on RxList: 10/15/2007
This monograph has been modified to include the generic and brand name in many instances.

FML Patient Information Including Side Effects

Brand Names: Flarex, FML Forte Liquifilm, FML Liquifilm, FML S.O.P.

Generic Name: fluorometholone ophthalmic (Pronunciation: FLURE oh METH oh lone)

What is fluorometholone ophthalmic (FML)?

Fluorometholone is a steroid medicine. It prevents the release of substances in the body that cause inflammation.

Fluorometholone ophthalmic (for the eyes) is used to treat eye swelling caused by infections, injury, surgery, or other conditions.

Fluorometholone ophthalmic may also be used for other purposes not listed in this medication guide.

What are the possible side effects of fluorometholone ophthalmic (FML)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • pain behind your eyes, sudden vision changes, severe headache;
  • sudden eye irritation;
  • blurred vision, tunnel vision, eye pain, or seeing halos around lights; or
  • signs of new eye infection, such as swelling, draining, or crusting of your eyes.

Less serious side effects may include:

  • increased sensitivity to light; or
  • mild stinging, burning, itching, or irritation in your eyes.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the FML (fluorometholone ophthalmic suspension) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about fluorometholone ophthalmic (FML)?

Do not use this medication if you are allergic to fluorometholone, or if you have any type of viral or fungal eye infection, ocular herpes, tuberculosis, or an untreated infection in your eye or elsewhere, including chickenpox.

Before using fluorometholone ophthalmic, tell your doctor if you are allergic to any drugs, if you have herpes, or if you are also taking an oral steroid medication such as prednisone (Deltasone, Orasone, others), methylprednisolone (Medrol), hydrocortisone (Cortef, Hydrocortone), and others.

Do not use fluorometholone ophthalmic while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using fluorometholone before putting your contact lenses in.

Shake the eye drops gently before each use.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not stop using fluorometholone suddenly without first talking to your doctor. Tell your doctor if your symptoms do not improve after 2 weeks of treatment with fluorometholone ophthalmic.

FML Patient Information including How Should I Take

What should I tell my healthcare provider before using fluorometholone ophthalmic (FML)?

Do not use this medication if you are allergic to fluorometholone, or if you have any type of infection, especially:

  • a fungal eye infection;
  • any type of viral eye infection, such as ocular herpes;
  • tuberculosis; or
  • an untreated infection in your eye or elsewhere, including chickenpox.

Before using fluorometholone ophthalmic, tell your doctor if you are allergic to any drugs, or if you have herpes. You may need a dose adjustment or special tests to safely use fluorometholone.

FDA pregnancy category C. Fluorometholone ophthalmic may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether fluorometholone ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use fluorometholone ophthalmic (FML)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Wash your hands before using your eye drops or ointment.

To apply the eye drops:

  • Shake the bottle gently before each use to be sure the medicine is well mixed.
  • Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.
  • Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.
  • Use only the number of drops your doctor has prescribed.
  • Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

To apply the ointment:

  • You may warm the ointment by holding the medicine tube in your hand for a few minutes before use. Tilt your head back slightly and pull down gently on your lower eyelid. Apply a thin film of the ointment into your lower eyelid. Close your eye and roll your eyeball around for 1 to 2 minutes. If you are applying another eye medication, allow at least 10 minutes before your next application.

Do not stop using fluorometholone suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Tell your doctor if your symptoms do not improve after 2 weeks of treatment with fluorometholone ophthalmic.

To be sure this medication is not causing harmful effects, your eyes will need to be checked on a regular basis. Do not miss any scheduled visits to your doctor.

Store fluorometholone ophthalmic at room temperature away from moisture and heat. Keep the bottle or tube tightly capped. Do not allow this medicine to freeze.

FML Patient Information including If I Miss a Dose

What happens if I miss a dose (FML)?

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose (FML)?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of fluorometholone ophthalmic is not expected to produce life-threatening symptoms.

What should I avoid while using fluorometholone ophthalmic (FML)?

Do not wear any contact lens that has not been approved by your doctor.

Do not use fluorometholone ophthalmic while you are wearing regular contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using fluorometholone before putting your contact lenses in.

Do not use any other eye medications unless your doctor has prescribed them.

Fluorometholone can cause side effects that may impair your vision. Be careful if you drive or do anything that requires you to see clearly.

What other drugs will affect fluorometholone ophthalmic (FML)?

Before using fluorometholone, tell your doctor if you are also taking an oral steroid medication such as prednisone (Deltasone, Orasone, others), methylprednisolone (Medrol), hydrocortisone (Cortef, Hydrocortone), and others.

This list is not complete and there may be other drugs that can interact with fluorometholone ophthalmic. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about fluorometholone ophthalmic.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.10. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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