Fluorometholone 0.1% Opth 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
Jun 1978
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluorometholone is an eye drop that contains a type of medicine called a corticosteroid. It works by reducing swelling, redness, and irritation in the eye caused by certain eye conditions, such as allergies 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.
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 them 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 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 Instructions
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.
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 them 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 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 Instructions
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.
- 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 the lower eyelid to form a pocket, and instill the prescribed number of drops.
- Close the eye gently for 1-2 minutes after instillation to allow the medication to be absorbed.
- If using other eye drops, wait at least 5 minutes between medications.
- Remove contact lenses before instilling drops and wait at least 15 minutes before reinserting them.
- Do not discontinue use abruptly without consulting your doctor, especially after prolonged use.
Available Forms & Alternatives
Available Strengths:
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:
severeInflammation:
Initially 1 drop every 4 hours for the first 24 to 48 hours, then decrease frequency as inflammation subsides.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established, use with caution and close monitoring if prescribed.
Child:
1 drop into the conjunctival sac 2 to 4 times daily, similar to adult dosing, but use with caution and monitor IOP.
Adolescent:
1 drop into the conjunctival sac 2 to 4 times daily, 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 that inhibits the inflammatory response to a variety of agents and may delay or slow healing. 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. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from ophthalmic administration.
Tmax:
Not applicable for systemic effects; local ocular concentration peaks rapidly.
FoodEffect:
Not applicable (ophthalmic route).
Distribution:
Vd:
Not applicable (minimal systemic absorption); primarily distributed within ocular tissues.
ProteinBinding:
High (for systemically absorbed corticosteroids), but minimal systemic absorption limits relevance.
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Not precisely determined for ophthalmic use due to minimal systemic absorption; systemic corticosteroids have variable half-lives.
Clearance:
Not precisely determined for ophthalmic use.
ExcretionRoute:
Primarily renal (for systemically absorbed corticosteroids), but minimal systemic absorption limits relevance.
Unchanged:
Not significant for ophthalmic use.
Pharmacodynamics
OnsetOfAction:
Within hours for anti-inflammatory effect.
PeakEffect:
Within 1-2 days of regular use.
DurationOfAction:
Effects persist for several hours after each dose.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help 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 attention 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
+ 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 any other unusual symptoms that bother you or do not go away, contact your doctor:
Eye irritation
Burning or stinging sensations
Blurred eyesight
Feeling of something being in the eye
* Change 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.
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 attention 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
+ 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 any other unusual symptoms that bother you or do not go away, contact your doctor:
Eye irritation
Burning or stinging sensations
Blurred eyesight
Feeling of something being in the eye
* Change 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:
- Worsening eye pain or discomfort
- Significant increase in eye redness or swelling
- New or worsening blurred vision
- Pus or discharge from the eye
- Signs of a new eye infection (e.g., fever, severe pain)
- Any new visual disturbances like halos around lights or decreased peripheral vision (could indicate increased eye pressure)
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 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
Carefully review your medications and health conditions with your doctor to confirm it is safe to take this medication. Never start, stop, or adjust the dosage of any medication without first consulting 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 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
Carefully review your medications and health conditions with your doctor to confirm it is safe to take this medication. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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. Adhere to the treatment schedule recommended 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. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby, allowing you to make an informed decision about treatment.
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. Adhere to the treatment schedule recommended 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. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby, allowing you to make an informed decision about treatment.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic use due to minimal systemic absorption. Local irritation may occur with excessive use.
What to Do:
If accidentally ingested or excessive topical application, rinse eye with water. For systemic concerns, contact a poison control center (1-800-222-1222) or seek medical attention.
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 presence of infection.
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: Individualized, typically <21 mmHg or within patient's normal range.
Action Threshold: Significant increase from baseline or above normal range; consider discontinuation or alternative therapy.
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 corticosteroid and treat infection appropriately.
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 risk-benefit.
Corneal integrity (e.g., thinning, perforation)
Frequency: Regularly, especially in patients with pre-existing corneal conditions.
Target: Stable corneal integrity.
Action Threshold: Signs of corneal thinning or perforation; discontinue use.
Symptom Monitoring
- Blurred vision
- Eye pain
- Redness or irritation that worsens
- Discharge from the eye
- Sensitivity to light
- New or worsening visual disturbances
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 systemically administered corticosteroids.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though systemic absorption from ophthalmic use is minimal.
Second Trimester:
Risk considered low due to minimal systemic absorption.
Third Trimester:
Risk considered low due to minimal systemic absorption.
Lactation
Caution should be exercised when fluorometholone is administered to a nursing woman. However, due to minimal systemic absorption, the risk to the infant is considered low.
Infant Risk:
Low (L3 - Moderately safe, but some concern).
Pediatric Use
Safety and effectiveness in pediatric patients under 2 years of age have not been established. Prolonged use in children may increase the risk of IOP elevation and cataract formation. Close monitoring of IOP is recommended.
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 development of cataracts and glaucoma, so regular monitoring of IOP and lens status is important.
Clinical Information
Clinical Pearls
- Fluorometholone is a 'soft' steroid, meaning it has a lower propensity to raise intraocular pressure (IOP) compared to stronger corticosteroids like dexamethasone or prednisolone, making it a preferred choice for longer-term use or in patients prone to steroid-induced glaucoma.
- Always shake the suspension well before use to ensure uniform distribution of the active ingredient.
- Educate patients on the importance of not discontinuing the medication abruptly, especially for chronic inflammatory conditions, as this can lead to a rebound of inflammation.
- Monitor for signs of secondary ocular infections, as corticosteroids can mask or exacerbate them.
- Long-term use (typically >10 days) requires regular monitoring of IOP due to the risk of steroid-induced glaucoma and posterior subcapsular cataracts.
Alternative Therapies
- Prednisolone acetate ophthalmic suspension (stronger corticosteroid)
- Dexamethasone ophthalmic suspension (stronger corticosteroid)
- Loteprednol etabonate ophthalmic suspension (another 'soft' steroid)
- Nonsteroidal anti-inflammatory drugs (NSAIDs) ophthalmic drops (e.g., ketorolac, bromfenac) for non-infectious inflammation.
- Immunomodulators (e.g., cyclosporine ophthalmic emulsion) for chronic inflammatory conditions.
Cost & Coverage
Average Cost:
$50 - $150 per 10ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (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's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't 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 details about the medication taken, the amount, and the time it happened.