FML 0.1% Ophth Suspension 5ml
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
Sep 1967
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluorometholone is an eye drop that contains a corticosteroid, which is a type of anti-inflammatory medicine. It's used to treat swelling, redness, and irritation in the eye caused by certain conditions or injuries.
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.
Preparation and Administration
1. Wash your hands before and after handling the medication.
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 gentle pressure to the inner 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
If you miss a dose, use it as soon as you remember. However, if it's 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.
Preparation and Administration
1. Wash your hands before and after handling the medication.
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 gentle pressure to the inner 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
If you miss a dose, use it as soon as you remember. However, if it's 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.
- Do not touch the dropper tip to your eye or any other surface to prevent contamination.
- Remove contact lenses before applying the drops and wait at least 15 minutes before reinserting them.
- If using other eye drops, wait at least 5-10 minutes between applications.
- Do not stop using the medication suddenly, especially if used for a prolonged period, unless directed by your doctor.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
1 drop into the conjunctival sac 2 to 4 times daily. For severe cases, 1 drop every 4 hours for the first few days, then taper.
Dose Range:
2 - 4 mg
Condition-Specific Dosing:
severe inflammation:
1 drop every 4 hours for the first few days, then taper as inflammation subsides.
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing not fully established; use with caution and monitor IOP.
Child:
Dosing not fully established; use with caution and monitor IOP. Generally, similar to adult dosing but individualized.
Adolescent:
Similar to adult dosing, monitor IOP.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Fluorometholone is a synthetic glucocorticoid 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 inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, collagen deposition, and scar formation associated with inflammation.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 1%) following topical ophthalmic administration.
Tmax:
Not precisely quantified for ophthalmic use due to minimal systemic absorption.
FoodEffect:
Not applicable for ophthalmic administration.
Distribution:
Vd:
Not precisely quantified for ophthalmic use due to minimal systemic absorption; primarily local distribution within ocular tissues.
ProteinBinding:
Not precisely quantified for ophthalmic use; systemic corticosteroids are highly protein bound.
CnssPenetration:
Limited to none due to minimal systemic absorption.
Elimination:
HalfLife:
Not precisely quantified for ophthalmic use; systemic corticosteroids have variable half-lives.
Clearance:
Not precisely quantified for ophthalmic use.
ExcretionRoute:
If systemically absorbed, primarily renal excretion.
Unchanged:
Not precisely quantified for ophthalmic use.
Pharmacodynamics
OnsetOfAction:
Within hours for anti-inflammatory effect.
PeakEffect:
Within days of consistent use.
DurationOfAction:
Several hours per dose.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- 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. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
- 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, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- 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. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
- 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, contact your doctor for medical advice. 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:
- Worsening eye pain or discomfort
- Significant decrease in vision
- New or worsening eye discharge
- Increased redness or swelling of the eye
- Sensitivity to light
- Any signs of a new eye infection (e.g., pus, severe 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 as a result of the allergy.
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 medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health conditions.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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 as a result of the allergy.
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 medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health conditions.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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 use this medication for an extended period beyond what your doctor has prescribed. In pediatric patients, this medication should be used with caution, as children may be at a higher risk of experiencing certain side effects.
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 medication for 10 days or longer, have your eye pressure checked. If you have any questions or concerns, consult with your doctor.
Do not use this medication for an extended period beyond what your doctor has prescribed. In pediatric patients, this medication should be used with caution, as children may be at a higher risk of experiencing certain side effects.
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 to occur with topical ophthalmic use due to minimal systemic absorption. Local irritation may occur with excessive use.
What to Do:
If excessive drops are instilled, flush the eye with lukewarm water. If accidental ingestion occurs, contact a poison control center (1-800-222-1222) or seek medical attention, though systemic toxicity is unlikely due to low concentration and minimal absorption.
Drug Interactions
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: To establish baseline and identify patients at risk for steroid-induced glaucoma, especially with prolonged use (more than 10 days).
Timing: Before initiating therapy, especially if prolonged use is anticipated.
Ophthalmic examination (slit lamp)
Rationale: To assess baseline ocular condition and rule out pre-existing infections or corneal defects.
Timing: Before initiating therapy.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, especially with prolonged use (e.g., weekly for the first few weeks, then monthly).
Target: Normal range (typically 10-21 mmHg), or within patient's baseline.
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.
Action Threshold: Presence of new or worsening infection; discontinue steroid and initiate appropriate antimicrobial therapy.
Corneal integrity (e.g., epithelial defects)
Frequency: Periodically, especially in patients with pre-existing corneal conditions.
Target: Intact corneal epithelium.
Action Threshold: Development or worsening of corneal defects; discontinue steroid.
Symptom Monitoring
- Worsening eye pain
- Decreased vision
- Persistent redness or irritation
- Discharge from the eye
- Sensitivity to light (photophobia)
- New floaters or flashes of light
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity observed in animal studies with systemic corticosteroids; risk with ophthalmic use is low due to minimal systemic absorption.
Second Trimester:
Risk considered low due to minimal systemic absorption.
Third Trimester:
Risk considered low due to minimal systemic absorption.
Lactation
L3 (Moderately Safe). It is not known whether topical ophthalmic fluorometholone is excreted in human milk. Systemic corticosteroids are excreted in human milk and could potentially cause adverse effects in the infant. However, due to minimal systemic absorption, the risk to the nursing infant is considered low. Use with caution.
Infant Risk:
Low risk due to minimal systemic absorption by the mother.
Pediatric Use
Safety and efficacy in pediatric patients have not been fully established. Prolonged corticosteroid use in pediatric patients may cause elevated intraocular pressure and glaucoma, and posterior subcapsular cataract formation. IOP should be monitored closely in children receiving prolonged therapy.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No specific dosage adjustments are required.
Clinical Information
Clinical Pearls
- Shake the bottle well before each use to ensure the suspension is evenly mixed.
- Instruct patients on proper instillation technique to avoid contamination and maximize drug delivery.
- Advise patients not to wear contact lenses during treatment, or to remove them before instillation and wait 15 minutes before reinserting.
- Monitor intraocular pressure (IOP) regularly, especially with prolonged use (more than 10 days), due to the risk of steroid-induced glaucoma.
- Be aware of the potential for secondary ocular infections (bacterial, fungal, viral) as corticosteroids can mask signs of infection or exacerbate existing ones.
- Fluorometholone has a lower propensity to raise IOP compared to other potent corticosteroids like dexamethasone or prednisolone, making it a preferred choice for patients prone to steroid-induced IOP elevation.
Alternative Therapies
- Prednisolone acetate ophthalmic suspension
- Dexamethasone ophthalmic suspension/solution
- Loteprednol etabonate ophthalmic suspension
- Difluprednate ophthalmic emulsion
Cost & Coverage
Average Cost:
$20 - $60 per 5ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred generic)
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 information. If you have any questions or concerns about your 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.