FML Forte (0.25%) Ophth Susp 5ml
It is used to treat eye swelling.It is used to treat eye irritation.
Drug Class
Ophthalmic Anti-inflammatory
Pharmacologic Class
Corticosteroid, Ophthalmic
Pregnancy Category
Category C
FDA Approved
Aug 1967
DEA Schedule
Not Controlled
Overview
What is this medicine?
FML Forte is an eye drop that contains a type of medicine called a corticosteroid. It's used to reduce swelling, redness, and irritation in the eye caused by certain eye conditions, like allergies or injuries. It works by calming down the body's immune response in the eye.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve. This medication is for eye use only.
Administration Instructions
1. Wash your hands before and after using the medication to prevent contamination.
2. Avoid touching the container tip to your eye, lid, or surrounding skin, as this can introduce bacteria and lead to severe eye problems or vision loss.
3. Remove contact lenses before using the medication. You can reinsert your lenses 15 minutes after administration, unless your eyes are irritated or infected.
4. Shake the container well before use.
5. Tilt your head back and gently drop the medication into your eye.
6. After administration, keep your eyes closed and apply pressure to the inside corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures. Keep the container upright with the cap tightly closed. Store all medications in a safe location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve. This medication is for eye use only.
Administration Instructions
1. Wash your hands before and after using the medication to prevent contamination.
2. Avoid touching the container tip to your eye, lid, or surrounding skin, as this can introduce bacteria and lead to severe eye problems or vision loss.
3. Remove contact lenses before using the medication. You can reinsert your lenses 15 minutes after administration, unless your eyes are irritated or infected.
4. Shake the container well before use.
5. Tilt your head back and gently drop the medication into your eye.
6. After administration, keep your eyes closed and apply pressure to the inside corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
Storage and Disposal
Store the medication at room temperature, away from freezing temperatures. Keep the container upright with the cap tightly closed. Store all medications in a safe location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Shake the bottle well before each use.
- Wash hands thoroughly before administering eye drops.
- Do not touch the dropper tip to any surface (including the eye) to prevent contamination.
- Tilt head back, pull down lower eyelid, and look up. Instill the prescribed number of drops into the conjunctival sac.
- Close eye gently for 1-2 minutes after instillation to allow absorption and minimize systemic absorption.
- If using other eye drops, wait at least 5-10 minutes between applications.
- Remove contact lenses before use and wait at least 15 minutes before reinserting them.
- Do not stop using the drops suddenly, especially after prolonged use, without consulting your doctor, as inflammation may return.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
1 drop into the conjunctival sac 2 to 4 times daily. During the initial 24 to 48 hours, the dosing frequency may be increased to 1 drop every 4 hours.
Condition-Specific Dosing:
severeInflammation:
1 drop every 4 hours for the first 24-48 hours, then reduce frequency as inflammation subsides.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not fully established; use with caution and monitor IOP. Dosing typically similar to adults, 1 drop 2-4 times daily.
Adolescent:
Dosing typically similar to adults, 1 drop 2-4 times daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (minimal systemic absorption).
Dialysis:
No specific considerations (minimal systemic absorption).
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (minimal systemic absorption).
Pharmacology
Mechanism of Action
Fluorometholone is a synthetic corticosteroid that inhibits the inflammatory response to a variety of agents. It acts by inducing phospholipase A2 inhibitory proteins (lipocortins), which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Corticosteroids also suppress migration of polymorphonuclear leukocytes and reverse increased capillary permeability.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible systemic absorption after ophthalmic administration.
Tmax:
Not applicable (minimal systemic absorption).
FoodEffect:
Not applicable.
Distribution:
Vd:
Not applicable (minimal systemic absorption).
ProteinBinding:
Not applicable (minimal systemic absorption).
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimal systemic absorption).
Clearance:
Not applicable (minimal systemic absorption).
ExcretionRoute:
Not applicable (minimal systemic absorption).
Unchanged:
Not applicable (minimal systemic absorption).
Pharmacodynamics
OnsetOfAction:
Within hours (anti-inflammatory effect).
PeakEffect:
Within days of consistent use.
DurationOfAction:
Varies, requires frequent dosing.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening side effect:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
- Changes in eyesight, eye pain, or severe eye irritation.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or if they bother you or do not go away, contact your doctor:
- Eye irritation
- Burning or stinging sensations
- Blurred eyesight
- Feeling that something is in the eye
- Change in taste
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening side effect:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
- Changes in eyesight, eye pain, or severe eye irritation.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or if they bother you or do not go away, contact your doctor:
- Eye irritation
- Burning or stinging sensations
- Blurred eyesight
- Feeling that something is in the eye
- Change in taste
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- New or worsening eye pain
- Significant increase in eye redness or irritation
- Blurred vision that does not improve
- Pus or discharge from the eye
- Sensitivity to light
- Any signs of a new eye infection
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you currently have a bacterial eye infection.
If you have any of the following eye infections: fungal, tuberculosis (TB), or viral.
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your health problems, including any pre-existing conditions
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you currently have a bacterial eye infection.
If you have any of the following eye infections: fungal, tuberculosis (TB), or viral.
This list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your health problems, including any pre-existing conditions
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. When taking this drug, exercise caution when driving or performing tasks that require clear vision, as it may affect your eyesight.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma. It is crucial to discuss this potential risk with your doctor. If you use this medication for 10 days or longer, have your eye pressure checked. If you have any questions or concerns, consult with your doctor.
Do not exceed the prescribed duration of treatment with this medication. Only use it for the length of time specified by your doctor. When administering this drug to children, use it with caution, as they may be at a higher risk of experiencing certain side effects.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma. It is crucial to discuss this potential risk with your doctor. If you use this medication for 10 days or longer, have your eye pressure checked. If you have any questions or concerns, consult with your doctor.
Do not exceed the prescribed duration of treatment with this medication. Only use it for the length of time specified by your doctor. When administering this drug to children, use it with caution, as they may be at a higher risk of experiencing certain side effects.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Overdose Information
Overdose Symptoms:
- Unlikely to occur with ophthalmic use due to minimal systemic absorption. Local irritation may occur with excessive use.
What to Do:
If accidentally ingested, drink fluids. If local irritation occurs, rinse eye with water. Call 1-800-222-1222 for poison control if concerned.
Drug Interactions
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: Corticosteroids can cause an increase in IOP, leading to glaucoma.
Timing: Before initiating therapy, especially for prolonged use (more than 10 days).
Ocular examination (slit lamp)
Rationale: To assess baseline inflammation, corneal integrity, and rule out pre-existing infections.
Timing: Before initiating therapy.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, especially with prolonged use (e.g., weekly or bi-weekly for therapy >10 days).
Target: Normal range (typically 10-21 mmHg), or as determined by ophthalmologist.
Action Threshold: Significant increase in IOP; consider discontinuing or switching therapy.
Signs of secondary infection (bacterial, fungal, viral)
Frequency: At each follow-up visit and if symptoms worsen.
Target: Absence of infection.
Action Threshold: Presence of new or worsening infection; discontinue corticosteroid and initiate appropriate anti-infective therapy.
Corneal integrity (e.g., fluorescein staining)
Frequency: Periodically, especially in patients with corneal defects or prolonged use.
Target: Intact corneal epithelium.
Action Threshold: Delayed healing or new corneal defects; discontinue use.
Symptom Monitoring
- Eye pain
- Redness
- Blurred vision
- Discharge
- Sensitivity to light
- Any worsening of original symptoms
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with systemic corticosteroids, but systemic absorption from ophthalmic use is minimal.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though low risk with ophthalmic use.
Second Trimester:
Low risk with ophthalmic use.
Third Trimester:
Low risk with ophthalmic use.
Lactation
It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when administered to a nursing mother.
Infant Risk:
Low risk due to minimal systemic absorption.
Pediatric Use
Safety and effectiveness in pediatric patients have not been fully established. Prolonged use in children may increase the risk of elevated intraocular pressure and growth retardation (though unlikely with ophthalmic use). IOP should be monitored closely.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. Use with caution in patients with pre-existing conditions like glaucoma or cataracts, as these may be exacerbated.
Clinical Information
Clinical Pearls
- Fluorometholone is a 'soft' steroid, meaning it has a lower propensity to raise intraocular pressure compared to other corticosteroids like dexamethasone or prednisolone, making it a preferred choice for long-term use or in patients prone to IOP elevation.
- Always shake the suspension well before each use to ensure uniform distribution of the active ingredient.
- Prolonged use of ophthalmic corticosteroids can lead to secondary ocular infections (fungal, viral, bacterial), glaucoma, and cataract formation. Regular ophthalmologic examinations, including IOP measurement, are crucial.
- Do not use this medication for undiagnosed red eye, as it may mask or worsen serious eye conditions, especially herpes simplex keratitis.
- Patients should be advised not to wear contact lenses during treatment for ocular inflammation or infection.
Alternative Therapies
- Loteprednol etabonate ophthalmic suspension (Lotemax) - another 'soft' steroid with low IOP-raising potential.
- Prednisolone acetate ophthalmic suspension (Pred Forte) - a stronger corticosteroid, higher risk of IOP elevation.
- Dexamethasone ophthalmic solution/suspension - another strong corticosteroid.
- NSAID ophthalmic drops (e.g., ketorolac, bromfenac) - for non-infectious inflammation, especially post-operative, without the risk of IOP elevation or immunosuppression.
Cost & Coverage
Average Cost:
Varies, typically $30-$100+ per 5ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 2 or 3 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more details. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.