Fluorometholone 0.1% Opth Susp 5ml
It is used to treat eye swelling.It is used to treat eye irritation.
Drug Class
Ophthalmic anti-inflammatory
Pharmacologic Class
Corticosteroid
Pregnancy Category
Category C
FDA Approved
Jan 1970
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 itching in your eyes caused by certain eye conditions, like 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.
Preparation and Administration
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
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 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
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 your hands thoroughly before administering the 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 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.
- Do not wear contact lenses during treatment unless advised by your doctor.
- Store at room temperature, away from light and moisture.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1 drop in the affected eye(s) 2 to 4 times daily. For severe inflammation, 1 drop every 4 hours for the first 24 to 48 hours, then decrease frequency as inflammation subsides.
Dose Range:
2 - 4 mg
Condition-Specific Dosing:
ocular_inflammation:
1 drop 2-4 times daily; for severe cases, 1 drop every 4 hours for 24-48 hours, then taper.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (safety and efficacy not established in children under 2 years of age)
Child:
Dosing similar to adults, but use with caution and only if clearly needed. Safety and efficacy not established in children under 2 years of age.
Adolescent:
Dosing similar to adults.
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, collectively called lipocortins. These proteins 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 the migration of polymorphonuclear leukocytes and reverse increased capillary permeability.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption after topical ophthalmic administration.
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (primarily local action)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Renal (for systemically absorbed drug), but negligible systemic excretion.
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Within hours (for anti-inflammatory effect)
PeakEffect:
Days (for full anti-inflammatory effect)
DurationOfAction:
Depends on severity of inflammation and dosing frequency (typically 6-8 hours per dose)
Confidence:
Medium
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 do not go away, contact your doctor:
Eye irritation
Burning or stinging sensations
Blurred eyesight
Feeling that something is 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. 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 do not go away, contact your doctor:
Eye irritation
Burning or stinging sensations
Blurred eyesight
Feeling that something is 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:
- Worsening eye pain or discomfort
- Increased redness or swelling of the eye
- Pus or discharge from the eye
- Significant decrease in vision
- New or worsening 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 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 medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change 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 medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change 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 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 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 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 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 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. For any concerns, contact a poison control center (Call 1-800-222-1222) or seek medical attention.
Drug Interactions
Moderate Interactions
- Other ophthalmic medications that may increase intraocular pressure (additive effect)
Confidence Interactions
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: To establish baseline and monitor for steroid-induced glaucoma, especially with prolonged use (>10 days).
Timing: Before initiating treatment, especially if prolonged use is anticipated.
Slit lamp examination
Rationale: To assess baseline ocular inflammation and corneal integrity.
Timing: Before initiating treatment.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, especially if treatment exceeds 10 days or in patients predisposed to elevated IOP (e.g., glaucoma patients).
Target: Normal range (typically 10-21 mmHg)
Action Threshold: Significant increase from baseline or above normal range; consider discontinuing or reducing dose, or adding IOP-lowering medication.
Visual Acuity
Frequency: Periodically
Target: Stable or improving
Action Threshold: Decreased vision; investigate for complications like cataract or infection.
Signs of secondary ocular infection (bacterial, fungal, viral)
Frequency: Regularly during treatment
Target: Absence of new or worsening infection
Action Threshold: Presence of new or worsening infection; discontinue steroid and initiate appropriate anti-infective therapy.
Symptom Monitoring
- Blurred vision
- Eye pain
- Redness or irritation that worsens or does not improve
- Discharge from the eye
- Sensitivity to light
- Signs of new infection (e.g., pus, increased redness, swelling)
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, but systemic absorption from ophthalmic use is minimal.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though risk is low due to minimal systemic absorption.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
Considered compatible with breastfeeding. Systemic absorption is minimal, making infant exposure unlikely to be significant.
Infant Risk:
Low risk (L3 - moderately safe) due to minimal systemic absorption into breast milk.
Pediatric Use
Safety and efficacy have not been established in children under 2 years of age. Use with caution in older children, and monitor for increased intraocular pressure.
Geriatric Use
No specific dosage adjustments are required. Elderly patients may be more susceptible to steroid-induced increases in intraocular pressure.
Clinical Information
Clinical Pearls
- Always shake the suspension well before each use to ensure uniform distribution of the active ingredient.
- Prolonged use (typically >10 days) of ophthalmic corticosteroids can lead to increased intraocular pressure (IOP) and potentially glaucoma, as well as posterior subcapsular cataracts. Regular IOP monitoring is crucial.
- Corticosteroids can mask or exacerbate existing ocular infections (bacterial, fungal, viral, especially herpes simplex). Do not use in active herpes simplex keratitis.
- Thinning of the cornea or sclera can occur with prolonged use, leading to perforation.
- Fluorometholone is considered a 'soft' steroid, meaning it has a lower propensity to raise IOP compared to other corticosteroids like prednisolone acetate, making it a preferred choice for patients at higher risk of steroid-induced glaucoma.
- Patients should be advised not to wear contact lenses during treatment for ocular inflammation.
Alternative Therapies
- Other ophthalmic corticosteroids (e.g., Prednisolone acetate, Dexamethasone, Loteprednol etabonate, Difluprednate)
- Topical ophthalmic NSAIDs (e.g., Ketorolac, Bromfenac, Nepafenac) for non-infectious inflammation, especially post-operative.
- Immunomodulators (e.g., Cyclosporine ophthalmic emulsion) for chronic inflammatory conditions.
Cost & Coverage
Average Cost:
Typically $20-$60 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 is 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 it's a good idea to check with your pharmacist. 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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.