FML Forte (0.25%) Ophth Susp 10ml
It is used to treat eye swelling.It is used to treat eye irritation.
Drug Class
Ophthalmic Corticosteroid
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Mar 1972
DEA Schedule
Not Controlled
Overview
What is this medicine?
FML Forte is an eye drop that contains a corticosteroid medicine called fluorometholone. It is used to reduce swelling, redness, and irritation in the eye caused by certain eye conditions, such as 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 on, and store it 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 on, and store it 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 the eye or any other surface to avoid contamination.
- Tilt your head back, pull down your lower eyelid to form a pouch, and instill the prescribed number of drops.
- Close your eye gently for 1-2 minutes after instilling drops to allow the medication to be absorbed.
- If using other eye drops, wait at least 5-10 minutes between medications.
- Remove contact lenses before using this medication and wait at least 15 minutes before reinserting them.
- Do not stop using the medication suddenly unless advised by your doctor, as this can worsen your condition.
- Store at room temperature, away from light and moisture. Do not freeze.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
1 drop in the conjunctival sac of the affected eye(s) 2 to 4 times daily.
Dose Range:
2 - 4 mg
Condition-Specific Dosing:
severeInflammation:
During the initial 24 to 48 hours, the frequency may be increased to 1 drop every 4 hours.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (safety and effectiveness in children under 2 years of age have not been established)
Child:
Generally similar to adult dosing for children >2 years, but close monitoring for IOP elevation is crucial.
Adolescent:
Similar to adult dosing.
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 glucocorticoid. Corticosteroids inhibit the inflammatory response to a variety of inciting agents and may delay or slow healing. They inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, collagen deposition, fibroblast proliferation, and scar formation associated with inflammation. The exact mechanism of action for ophthalmic corticosteroids is not fully understood but is believed to involve the induction of 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.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption
Tmax:
Not clinically relevant for ophthalmic use due to minimal systemic absorption
FoodEffect:
Not applicable for ophthalmic use
Distribution:
Vd:
Not clinically relevant for ophthalmic use
ProteinBinding:
High (for systemically absorbed corticosteroids, but minimal systemic absorption with ophthalmic use)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not clinically relevant for ophthalmic use
Clearance:
Not clinically relevant for ophthalmic use
ExcretionRoute:
Renal (for systemically absorbed corticosteroids, but minimal systemic absorption with ophthalmic use)
Unchanged:
Not clinically relevant for ophthalmic use
Pharmacodynamics
OnsetOfAction:
Within hours (for anti-inflammatory effect)
PeakEffect:
Variable, depends on severity of inflammation
DurationOfAction:
Several hours per dose
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious allergic reaction:
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
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. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
Eye irritation
Burning or stinging sensations
Blurred eyesight
Feeling of something being in the eye
* Changes in taste
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious allergic reaction:
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
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. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
Eye irritation
Burning or stinging sensations
Blurred eyesight
Feeling of something being in the eye
* Changes in taste
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also 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 vision changes (e.g., blurred vision, halos around lights)
- Signs of a new eye infection (e.g., increased redness, pus, discharge)
- Severe eye irritation or allergic reaction (e.g., swelling of eyelids, rash)
- Headache with eye pain
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 symptoms you experienced.
If you 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, tell your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking.
Any natural products or vitamins you are using.
All your health problems.
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 symptoms you experienced.
If you 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, tell your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking.
Any natural products or vitamins you are using.
All your health problems.
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 drug 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 use for 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 the risk of certain side effects may be higher in pediatric patients.
If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication to ensure the best outcome for you and your baby.
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 drug 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 use for 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 the risk of certain side effects may be higher in pediatric patients.
If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication to ensure the best outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic use due to minimal systemic absorption. Local irritation may occur with excessive use.
What to Do:
If swallowed, drink fluids. If eye irritation occurs, rinse eye with water. In case of accidental ingestion or severe reaction, contact a poison control center or seek medical attention. Call 1-800-222-1222 for Poison Control.
Drug Interactions
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: To establish baseline and monitor for steroid-induced glaucoma, especially in patients predisposed to elevated IOP.
Timing: Before initiating therapy, especially if prolonged use is anticipated.
Ophthalmic examination (slit lamp)
Rationale: To assess the initial inflammatory condition and rule out corneal defects or infections.
Timing: Before initiating therapy.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, especially with prolonged use (e.g., >10 days) or in patients with glaucoma.
Target: Individualized, typically <21 mmHg or within patient's normal range.
Action Threshold: Significant increase from baseline or above normal range; consider discontinuing or reducing dose, or adding IOP-lowering medication.
Signs of secondary infection (bacterial, fungal, viral)
Frequency: At each follow-up visit and if symptoms worsen.
Target: Absence of new or worsening infection signs.
Action Threshold: Presence of new or worsening infection; discontinue steroid and initiate appropriate antimicrobial therapy.
Posterior subcapsular cataract formation
Frequency: Periodically with prolonged use (months to years).
Target: Absence of new or worsening cataracts.
Action Threshold: Development or progression of cataracts; consider alternative therapy or surgical intervention.
Symptom Monitoring
- Blurred vision
- Eye pain
- Redness or irritation of the eye
- Discharge from the eye
- Sensitivity to light
- Any new or worsening eye symptoms
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women. Systemic absorption from ophthalmic use is minimal.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity observed in animal studies with systemic corticosteroids; however, minimal systemic absorption from ophthalmic use reduces this risk.
Second Trimester:
Minimal risk due to minimal systemic absorption.
Third Trimester:
Minimal risk due to minimal systemic absorption.
Lactation
L3 (Moderately safe). It is not known whether ophthalmic fluorometholone is excreted in human milk. However, systemic absorption is minimal, so the risk to the nursing infant is considered low. Use with caution.
Infant Risk:
Low risk due to minimal systemic absorption. Monitor infant for any unusual signs or symptoms.
Pediatric Use
Safety and effectiveness in children under 2 years of age have not been established. Prolonged use of ophthalmic corticosteroids in pediatric patients may increase the risk of elevated intraocular pressure and cataract formation. Close monitoring of IOP is essential if used in children.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may be more susceptible to the typical adverse effects of corticosteroids, such as elevated IOP, especially with prolonged use.
Clinical Information
Clinical Pearls
- Always shake the bottle well before each use to ensure uniform suspension.
- Prolonged use (typically >10 days) requires regular monitoring of intraocular pressure (IOP) due to the risk of steroid-induced glaucoma.
- Corticosteroids can mask or exacerbate existing ocular infections (bacterial, viral, fungal). Do not use in undiagnosed red eye.
- Patients should be advised not to wear contact lenses during treatment for ocular inflammation or if signs of infection are present. If contact lenses must be worn, remove them before instilling drops and wait 15 minutes before reinserting.
- Discontinuation should be gradual if used for prolonged periods to prevent rebound inflammation.
Alternative Therapies
- Prednisolone acetate ophthalmic suspension
- Dexamethasone ophthalmic solution/suspension
- Loteprednol etabonate ophthalmic suspension
- Difluprednate ophthalmic emulsion
Cost & Coverage
Average Cost:
Varies widely by pharmacy and insurance plan per 10ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (for generic), Tier 2 or 3 (for brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.