FML Forte

DRUG DESCRIPTION

FML FORTE® (fluorometholone ophthalmic suspension 0.25%) sterile ophthalmic suspension is a topical anti-inflammatory product for ophthalmic use.

Chemical Name:

Fluorometholone: 9-Fluoro-11?, 17-dihydroxy-6?-methylpregna-1,4-diene-3,20-dione.

Structural Formula:

FML FORTE® (fluorometholone ophthalmic suspension, USP) Structural Formula Illustration

Contains:

Active: fluorometholone 0.25%. Preservative: benzalkonium chloride 0.005%. 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 Forte® (fluorometholone ophthalmic suspension 0.25%) suspension is formulated with a pH from 6.2 to 7.5.

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...

Read All Potential Side Effects and See Pictures of FML Forte »

What are the precautions when taking fluorometholone ophthalmic suspension 0.25% (FML Forte)?

Before using fluorometholone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye infections, recent eye surgery, cataracts, glaucoma (open-angle type), severe nearsightedness (myopia), diabetes.

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use...

Read All Potential Precautions of FML Forte »


FML Forte Consumer (continued)

SIDE EFFECTS: Stinging/burning of the eyes for 1 to 2 minutes and temporary blurred vision may occur when you apply this medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Use of this medication for prolonged periods or in high doses may cause serious eye problems (such as high pressure inside the eyes and cataracts). Tell your doctor immediately if any of these unlikely but serious side effects occur: vision problems, eye pain.

This medication may mask the signs of an eye infection. It may also put you at greater risk of developing an eye infection, especially with prolonged use. Report any new or worsening symptoms such as eye discharge/swelling/redness, vision problems, or no improvement of your current eye condition. Your doctor will need to adjust your treatment.

Tell your doctor immediately if any of these unlikely but serious side effects occur: headache, dizziness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using fluorometholone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye infections, recent eye surgery, cataracts, glaucoma (open-angle type), severe nearsightedness (myopia), diabetes.

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If you develop a new eye infection or injury, or require eye surgery, ask your doctor if you should continue to use your current bottle of fluorometholone eye drops or start a new bottle.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if the medication in this product passes into breast milk. Consult your doctor before breast-feeding.


FML Forte 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 Forte)?
  • What are the possible side effects of fluorometholone ophthalmic (FML Forte)?
  • What is the most important information I should know about fluorometholone ophthalmic (FML Forte)?
  • What should I tell my healthcare provider before using fluorometholone ophthalmic (FML Forte)?
  • How should I use fluorometholone ophthalmic (FML Forte)?
  • What happens if I miss a dose (FML Forte)?
  • What happens if I overdose (FML Forte)?
  • What should I avoid while using fluorometholone ophthalmic (FML Forte)?
  • What other drugs will affect fluorometholone ophthalmic (FML Forte)?
  • Where can I get more information?

What is fluorometholone ophthalmic (FML Forte)?

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 Forte)?

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.

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

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.

Related Drug Centers
  • Fluorometholone
  • Fluorometholone Forte


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