FML 0.1% Ophth Suspension 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
Jun 1967
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluorometholone ophthalmic suspension is an eye drop that contains a type of steroid. It is used to treat swelling, redness, and irritation in the eye caused by certain eye conditions or injuries. It works by reducing inflammation.
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 your hands thoroughly before administering eye drops.
- Do not touch the dropper tip to your eye or any other surface to prevent contamination.
- Tilt your head back, pull down your lower eyelid to form a pocket, 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.
- Do not wear contact lenses during treatment unless advised by your doctor. If you must wear them, remove them before applying the drops and wait at least 15 minutes before reinserting.
- Do not stop using this medication suddenly without consulting your doctor, especially if used for a prolonged period.
- Store at room temperature, away from light and moisture. Do not freeze.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
1 drop into the conjunctival sac 2 to 4 times daily.
Dose Range:
2 - 4 mg
Condition-Specific Dosing:
initial_severe_inflammation:
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 efficacy not fully established in children under 2 years of age)
Child:
Generally, similar to adult dosing, but use with caution and monitor IOP closely, especially with prolonged use.
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 the edema, fibrin deposition, capillary dilation, leukocyte migration, collagen deposition, and scar formation associated with inflammation. They act 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.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption after topical ocular administration.
Tmax:
Not clinically relevant for ophthalmic use due to local action.
FoodEffect:
Not applicable for ophthalmic use.
Distribution:
Vd:
Not clinically relevant for ophthalmic use.
ProteinBinding:
High (if systemically absorbed, similar to other corticosteroids)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not clinically relevant for ophthalmic use.
Clearance:
Not clinically relevant for ophthalmic use.
ExcretionRoute:
Renal (if systemically absorbed)
Unchanged:
Not clinically relevant for ophthalmic use.
Pharmacodynamics
OnsetOfAction:
Within hours (anti-inflammatory effect)
PeakEffect:
Within days of regular use
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. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
+ 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. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for guidance:
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 not mentioned here. 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. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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
+ 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. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for guidance:
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 not mentioned here. 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:
- Worsening eye pain, redness, or swelling
- New or worsening blurred vision
- Sensitivity to light
- Discharge from the eye
- Signs of a new eye infection (e.g., pus, severe redness)
- Any new or unusual eye symptoms
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 currently have a bacterial eye infection.
If you have any of the following eye conditions: fungal infection, tuberculosis (TB), or viral infection.
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 previous or 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 symptoms you experienced.
If you currently have a bacterial eye infection.
If you have any of the following eye conditions: fungal infection, tuberculosis (TB), or viral infection.
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 previous or 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 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 both 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 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 both 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 water. If eye irritation occurs, rinse eye with water. For any concerns, call Poison Control at 1-800-222-1222 or seek medical attention.
Drug Interactions
Moderate Interactions
- Other topical ophthalmic corticosteroids (additive effects, increased risk of adverse events)
- Drugs that increase intraocular pressure (e.g., anticholinergics, tricyclic antidepressants) - potential for additive IOP increase.
Confidence Interactions
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: To establish baseline and identify pre-existing glaucoma or ocular hypertension, as corticosteroids can increase IOP.
Timing: Before initiating therapy, especially if therapy is expected to exceed 10 days.
Ophthalmic examination (slit lamp, fundoscopy)
Rationale: To assess baseline ocular health and identify pre-existing conditions that may be exacerbated by corticosteroids (e.g., corneal defects, infections).
Timing: Before initiating therapy.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, especially if treatment duration exceeds 10 days. Frequency depends on patient risk factors and clinical judgment (e.g., weekly to monthly).
Target: Normal range (typically 10-21 mmHg)
Action Threshold: Significant increase from baseline or above normal range; consider dose reduction, discontinuation, or glaucoma management.
Signs of secondary ocular infection (bacterial, fungal, viral)
Frequency: At each follow-up visit and as clinically indicated.
Target: Absence of new or worsening infection.
Action Threshold: Presence of new or worsening infection; consider appropriate antimicrobial therapy and/or discontinuation of corticosteroid.
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.
Corneal integrity (e.g., thinning, perforation)
Frequency: Periodically, especially in patients with pre-existing corneal conditions.
Target: Stable corneal integrity.
Action Threshold: Signs of corneal thinning or perforation; discontinue use immediately.
Symptom Monitoring
- Blurred vision
- Eye pain or discomfort
- Redness or irritation of the eye
- Sensitivity to light (photophobia)
- Discharge from the eye
- Any new or worsening visual disturbances
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 is minimal, but caution is advised.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity observed in animal studies with systemic corticosteroids; however, systemic absorption from ophthalmic use is minimal.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
L3 (Moderately Safe). It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Caution should be exercised when fluorometholone ophthalmic suspension is administered to a nursing mother. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.
Infant Risk:
Low risk due to minimal systemic absorption by the mother.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 2 years have not been established. Prolonged use of corticosteroids in pediatric patients may increase the risk of elevated intraocular pressure and cataract formation. IOP should be monitored closely in pediatric patients receiving prolonged therapy.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No specific dose adjustments are typically required.
Clinical Information
Clinical Pearls
- Always shake the suspension well before use to ensure uniform distribution of the active ingredient.
- Prolonged use (typically >10 days) of ophthalmic corticosteroids significantly increases the risk of elevated intraocular pressure (IOP) and posterior subcapsular cataracts. Regular IOP monitoring is crucial.
- Corticosteroids can mask or exacerbate existing ocular infections (bacterial, viral, fungal). Do not use in untreated acute purulent ocular infections.
- Use with caution in patients with diseases causing thinning of the cornea or sclera, as perforation may occur.
- Patients should be advised not to wear contact lenses during treatment for ocular inflammation or infection, or while using this product.
Alternative Therapies
- Other ophthalmic corticosteroids (e.g., Prednisolone acetate, Dexamethasone sodium phosphate)
- Topical ophthalmic NSAIDs (e.g., Ketorolac, Bromfenac) for inflammation without infection risk or when steroid-induced IOP elevation is a concern.
- Immunomodulators (e.g., Cyclosporine ophthalmic) for chronic inflammatory conditions.
Cost & Coverage
Average Cost:
Varies, typically $20-$60 per 10ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.