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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Fml Forte
Generic Name
Fluorometholone
Active Ingredient
FluorometholoneCategory
Corticosteroid [EPC]
Variants
1
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 2.5 mg/mL | SUSPENSION/ DROPS | OPHTHALMIC | 11980-228 |
Detailed information about Fml Forte
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Fml Forte, you must consult a qualified healthcare professional.
Fluorometholone is a potent ophthalmic corticosteroid used to treat inflammatory conditions of the eye. It belongs to the glucocorticoid class and works by suppressing the immune response to reduce swelling and irritation.
For the treatment of ocular inflammation, the standard adult dosage of Fluorometholone ophthalmic suspension (0.1%) is typically one to two drops instilled into the conjunctival sac (the pocket between the eye and the lower eyelid) two to four times daily. During the initial 24 to 48 hours of treatment, a healthcare provider may safely increase the frequency to two drops every hour if the inflammation is severe.
If using the ophthalmic ointment, a small ribbon (approximately 1/2 inch) is usually applied into the conjunctival sac up to three times daily. As the clinical condition improves, the frequency of application should be gradually tapered rather than discontinued abruptly to prevent a rebound of inflammatory symptoms.
Fluorometholone is generally considered safe for use in children aged 2 years and older. The dosage for pediatric patients is typically the same as the adult dosage (1-2 drops, 2-4 times daily), though healthcare providers will exercise extreme caution. The safety and effectiveness of Fluorometholone in infants and children under the age of 2 have not been established. Pediatric patients are more susceptible to systemic absorption and the subsequent suppression of the adrenal glands; therefore, the shortest duration of treatment possible is recommended.
Because Fluorometholone is administered topically and systemic absorption is minimal, no specific dosage adjustments are typically required for patients with renal impairment. However, clinicians should monitor for any signs of systemic corticosteroid effects in patients with end-stage renal disease.
Similar to renal impairment, the low systemic bioavailability of topical Fluorometholone means that dose adjustments for liver disease are generally unnecessary. However, the liver is the primary site of metabolism for any absorbed drug, so caution is advised in patients with severe hepatic failure.
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may be more prone to developing cataracts or increased intraocular pressure (glaucoma) and should be monitored closely by an ophthalmologist.
Proper administration is critical for the efficacy and safety of Fluorometholone. Follow these steps:
Storage: Store the medication at room temperature (15°C to 30°C or 59°F to 86°F). Protect it from freezing and excessive heat. Keep the bottle tightly closed when not in use.
If you miss a dose of Fluorometholone, apply it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and return to your regular dosing schedule. Do not apply a double dose to make up for a missed one.
An overdose of Fluorometholone ophthalmic solution is unlikely to cause life-threatening symptoms. If the medication is accidentally swallowed, contact a poison control center or seek emergency medical attention. Symptoms of systemic corticosteroid overdose (though rare from eye drops) could include thinning skin, easy bruising, changes in body fat distribution, and increased facial hair.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop the medication without medical guidance, as this can lead to a recurrence of inflammation.
While Fluorometholone is generally well-tolerated, some patients may experience immediate, localized side effects. The most common include:
> Warning: Stop using Fluorometholone and call your doctor immediately if you experience any of the following serious symptoms:
The chronic use of Fluorometholone (typically defined as use exceeding 10 to 14 days) significantly increases the risk of serious complications. The most concerning long-term effect is the development of steroid-induced glaucoma. According to clinical data, approximately 5-15% of the population are 'high steroid responders' who will experience a significant rise in IOP within weeks of starting therapy. Additionally, prolonged use can lead to the thinning of the corneal tissue, making the eye more susceptible to injury and infection. Fungal infections of the cornea are particularly prone to developing coincidentally with long-term local steroid application.
No FDA black box warnings currently exist for Fluorometholone ophthalmic products. However, the lack of a black box warning does not imply the drug is without risk. The standard warnings regarding intraocular pressure and secondary infections are considered 'major precautions' by regulatory bodies.
Report any unusual symptoms or changes in vision to your healthcare provider immediately. Regular eye exams, including pressure checks, are mandatory for anyone using this medication for more than 10 days.
Fluorometholone is a potent medication that must be used only under the strict supervision of an eye care professional. It is not for use in treating common 'red eye' unless a specific diagnosis of steroid-responsive inflammation has been made. Using this medication for the wrong condition, such as a viral or fungal infection, can lead to permanent vision loss. Patients must be aware that the symptoms of an eye infection can be masked by the anti-inflammatory effects of the steroid.
There are no FDA black box warnings for Fluorometholone. It is categorized as a safe and effective medication when used according to professional guidelines and with appropriate monitoring.
Patients prescribed Fluorometholone require specific clinical monitoring to ensure safety:
Fluorometholone may cause temporary blurring of vision immediately after application. Do not drive, use machinery, or perform any activity that requires clear vision until you are certain your vision has returned to normal. This is particularly important when using the ointment formulation.
There are no known direct interactions between alcohol and topical Fluorometholone. However, excessive alcohol consumption can impair your ability to administer the medication correctly and may interfere with the body's overall immune response. Discuss your alcohol intake with your doctor if you have concerns.
Do not stop using Fluorometholone suddenly if you have been using it for more than a week. Abrupt discontinuation can lead to a 'rebound' effect, where the original inflammation returns, sometimes more severely than before. Your healthcare provider will provide a tapering schedule, gradually reducing the frequency of drops over several days or weeks.
> Important: Discuss all your medical conditions, especially a history of glaucoma or herpes simplex, with your healthcare provider before starting Fluorometholone.
There are no absolute systemic drug-drug contraindications for topical Fluorometholone because systemic absorption is so low. However, it is contraindicated to use Fluorometholone in the presence of most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, as well as in mycobacterial infection of the eye and fungal diseases of ocular structures.
There are no documented interactions between Fluorometholone and specific foods. Unlike oral steroids, topical Fluorometholone is not affected by the consumption of grapefruit juice or dairy products. Maintaining a healthy, balanced diet supports the body's natural healing processes during treatment for ocular inflammation.
No significant interactions between topical Fluorometholone and herbal supplements have been clinically established. However, patients taking high doses of supplements with anti-inflammatory properties (such as high-dose Omega-3 fatty acids or Turmeric) should inform their doctor, as these may have a theoretical additive effect on the inflammatory response, though this is rarely clinically significant for the eye.
Fluorometholone is not known to interfere with standard blood or urine laboratory tests. However, it may affect the results of certain specialized ophthalmic tests:
For each major interaction, the mechanism usually involves either a pharmacodynamic clash (where two drugs have opposing or additive effects on eye pressure) or a physical interference (where one drop washes out another). Management typically involves spacing out medications or increasing the frequency of clinical monitoring.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including those you only use occasionally.
Fluorometholone must NEVER be used in the following circumstances:
Conditions requiring a careful risk-benefit analysis by a healthcare provider include:
Patients who have had an allergic reaction to other corticosteroids (such as Prednisolone, Dexamethasone, or Hydrocortisone) may also be sensitive to Fluorometholone. While the chemical structures differ slightly, the potential for cross-reactivity exists. Always inform your ophthalmologist if you have ever had an adverse reaction to any 'steroid' medication, whether it was a pill, cream, or eye drop.
> Important: Your healthcare provider will evaluate your complete medical history, including any history of 'cold sores' (herpes simplex) near the eye, before prescribing Fluorometholone.
Fluorometholone is classified under FDA Pregnancy Category C. Animal reproduction studies have shown that corticosteroids are teratogenic (can cause birth defects) when administered systemically at low doses. Specifically, cleft palate and other fetal abnormalities have been observed. There are no adequate and well-controlled studies in pregnant women. Fluorometholone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. If used, healthcare providers recommend using the lowest dose for the shortest duration and performing punctal occlusion (pressing the corner of the eye) to minimize systemic absorption.
It is not known whether topical ophthalmic administration of Fluorometholone results in sufficient systemic absorption to produce detectable quantities in human breast milk. Systemically administered corticosteroids do appear in human milk and could suppress growth or interfere with endogenous corticosteroid production in the nursing infant. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in children below the age of 2 years have not been established. In children 2 years and older, the drug should be used with caution and only for short durations. Children are more susceptible to the systemic effects of topical steroids, including Cushing's syndrome and adrenal suppression, due to their higher surface-area-to-mass ratio. Additionally, the risk of steroid-induced intraocular pressure elevation is present in children, requiring regular monitoring by a pediatric ophthalmologist.
Clinical data indicates that there are no significant differences in the safety or efficacy of Fluorometholone between elderly patients (65 and older) and younger adults. However, geriatric patients are statistically more likely to have pre-existing glaucoma or cataracts. Therefore, the monitoring of intraocular pressure and lens clarity is particularly important in this population. No specific dosage adjustments are required based on age alone.
No dosage adjustments are provided in the manufacturer's labeling for patients with renal impairment. Because the drug is applied topically and has very low systemic bioavailability, it is unlikely that kidney function will significantly impact the drug's safety profile. However, in patients on dialysis, clinicians should remain vigilant for any unexpected systemic steroid effects.
Specific dosing guidelines for patients with hepatic impairment are not available. While the liver is responsible for metabolizing any Fluorometholone that enters the bloodstream, the amounts involved in ophthalmic therapy are typically too low to necessitate dose modification. In patients with severe Child-Pugh Class C cirrhosis, healthcare providers may monitor more closely for signs of systemic corticosteroid excess.
> Important: Special populations require individualized medical assessment. Pregnant or nursing women should always consult their obstetrician before using any medicated eye drops.
Fluorometholone is a glucocorticoid receptor agonist. Its primary molecular target is the cytosolic glucocorticoid receptor (GR). Upon binding, the Fluorometholone-GR complex moves into the nucleus and acts as a transcription factor. It inhibits the expression of genes that code for inflammatory proteins (like COX-2 and various cytokines) and promotes the expression of anti-inflammatory proteins like Lipocortin-1. Lipocortin-1 inhibits the enzyme phospholipase A2, which is the 'gatekeeper' of the inflammatory pathway, preventing the release of arachidonic acid and the subsequent production of prostaglandins and leukotrienes. This results in decreased capillary permeability, reduced edema, and suppressed leukocyte infiltration.
The anti-inflammatory effect of Fluorometholone is local and dose-dependent. The 'onset' of action (reduction in redness and swelling) can often be seen within 24 to 48 hours, although the full therapeutic effect may take longer depending on the severity of the condition. Unlike some other steroids, Fluorometholone is often described as having a 'dissociated' profile, meaning it maintains high anti-inflammatory potency while having a lower propensity to increase intraocular pressure in many patients, though this risk is never zero.
| Parameter | Value |
|---|---|
| Bioavailability | High (Local Ocular); Very Low (Systemic) |
| Protein Binding | 70% - 80% (Systemic) |
| Half-life | 2 - 4 hours (Systemic elimination) |
| Tmax | 30 - 60 minutes (Aqueous humor) |
| Metabolism | Hepatic (minor systemic fraction) |
| Excretion | Renal (primarily as metabolites) |
The chemical name for Fluorometholone is 9-fluoro-11β,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione. Its molecular formula is C22H29FO4, and it has a molecular weight of 376.46 g/mol. It is a white to yellowish-white crystalline powder that is practically insoluble in water but soluble in alcohol. The addition of the fluorine atom at the 9-position and the methyl group at the 6-position enhances its anti-inflammatory potency compared to hydrocortisone.
Fluorometholone is classified as a Corticosteroid [EPC] and a Corticosteroid Hormone Receptor Agonist [MoA]. Within the field of ophthalmology, it is categorized as a 'soft' or 'medium-potency' steroid, distinguishing it from 'strong' steroids like prednisolone acetate 1% or dexamethasone 0.1%. This classification guides clinicians in choosing the appropriate strength for the level of inflammation being treated.
Common questions about Fml Forte
Fluorometholone is an ophthalmic corticosteroid used to treat various inflammatory conditions of the eye, such as allergic conjunctivitis, acne rosacea keratitis, and inflammation of the cornea or iris. It works by suppressing the immune system's response to injury or irritation, thereby reducing redness, swelling, and itching. Healthcare providers often prescribe it for conditions where a potent anti-inflammatory effect is needed but where a lower risk of increasing eye pressure is desired. It is available as both an eye drop suspension and an eye ointment. It is not an antibiotic and will not treat infections caused by bacteria, viruses, or fungi.
The most common side effects of Fluorometholone include a temporary burning or stinging sensation in the eye immediately after the drops are applied. Some patients may also experience temporary blurred vision, which usually clears within a few minutes. While Fluorometholone is designed to be safer for eye pressure than some other steroids, an increase in intraocular pressure (IOP) is still a common concern and must be monitored by a doctor. Other localized effects can include mild eye irritation, redness, or a feeling that something is in the eye. If these symptoms persist or worsen, you should contact your eye care professional.
There is no known direct interaction between alcohol and Fluorometholone eye drops. Because the medication is applied topically to the eye and very little reaches the bloodstream, moderate alcohol consumption is generally not considered dangerous. However, alcohol can sometimes interfere with the body's ability to heal or may make you more likely to forget a scheduled dose. It is always best to maintain a healthy lifestyle while treating an eye condition to support the recovery process. If you have specific concerns about alcohol and your eye health, discuss them with your healthcare provider.
Fluorometholone is classified as FDA Pregnancy Category C, meaning its safety in human pregnancy has not been established through controlled studies. Animal studies have shown that systemic corticosteroids can cause birth defects, such as cleft palate, even at low doses. Therefore, Fluorometholone should only be used during pregnancy if your doctor determines that the potential benefits to the mother outweigh the risks to the developing fetus. If you are prescribed this medication while pregnant, your doctor may suggest using the 'punctal occlusion' technique (pressing on the corner of the eye) to minimize the amount of drug that enters your bloodstream. Always inform your obstetrician if you are using any medicated eye drops.
Most patients begin to notice an improvement in their symptoms, such as reduced redness and swelling, within 24 to 48 hours of starting Fluorometholone. However, the exact time it takes to work depends on the severity of the inflammation and the specific condition being treated. It is important to continue using the medication exactly as prescribed by your doctor, even if your symptoms seem to improve quickly. Stopping the medication too early can cause the inflammation to return. If you do not see any improvement after several days of treatment, you should contact your eye doctor for a follow-up evaluation.
You should not stop taking Fluorometholone suddenly, especially if you have been using it for more than a week. Abruptly discontinuing a corticosteroid can lead to a 'rebound' effect, where the eye inflammation returns and may even be more severe than it was initially. Your healthcare provider will usually provide a tapering schedule, which involves slowly reducing the number of drops you use each day until the medication is stopped completely. This allows your eye tissues to adjust and prevents the recurrence of symptoms. Always follow the specific tapering instructions provided by your ophthalmologist.
If you miss a dose of Fluorometholone, you should apply it as soon as you remember. However, if it is nearly time for your next scheduled dose, it is better to skip the missed dose and simply continue with your regular schedule. Do not apply extra drops or a 'double dose' to make up for the one you missed, as this could increase the risk of side effects like high eye pressure. Consistency is key to managing ocular inflammation effectively. Setting a daily alarm or using a medication tracking app can help you remember to take your eye drops on time.
Weight gain is a common side effect of oral corticosteroids (pills), but it is extremely rare with ophthalmic (eye drop) versions like Fluorometholone. Because the medication is applied topically, only a very tiny amount ever reaches the rest of your body. Systemic side effects like weight gain, a 'moon face,' or fat redistribution typically only occur if the medication is used at very high doses for a very long period. To further reduce the risk of any systemic absorption, you can press on the tear duct in the inner corner of your eye for one minute after applying the drops. If you notice unusual weight gain, talk to your doctor to rule out other causes.
Fluorometholone can generally be used with other medications, but you must inform your doctor about everything you are using, including other eye drops and oral supplements. If you are using multiple eye drops, you should wait at least 5 to 10 minutes between each one to ensure the first drop isn't washed out by the second. There is a potential interaction with topical NSAID eye drops, which can slow corneal healing. Additionally, because Fluorometholone can raise eye pressure, it may interfere with the effectiveness of glaucoma medications. Your doctor will coordinate your treatment plan to ensure all medications work effectively together.
Yes, Fluorometholone is available as a generic medication in both suspension and ointment forms. The generic versions are bioequivalent to brand-name products like FML or Flarex, meaning they contain the same active ingredient and work the same way in the body. Generic medications are typically more cost-effective than brand-name versions. When your doctor writes a prescription for Fluorometholone, the pharmacist will often dispense the generic version unless your doctor specifically requests the brand name. Both generic and brand-name versions require a prescription from a licensed healthcare provider and should be used with the same level of caution.
Other drugs with the same active ingredient (Fluorometholone)