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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Fluocinolone Acetonide Topical Solution Usp, 0.01%
Brand Name
Fluocinolone Acetonide Topical Solution Usp, 0.01%
Generic Name
Fluocinolone Acetonide Topical Solution Usp, 0.01%
Active Ingredient
Fluocinolone AcetonideCategory
Corticosteroid [EPC]
Variants
3
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| .1 mg/mL | SOLUTION | TOPICAL | 63629-9584 |
| .1 mg/mL | SOLUTION | TOPICAL | 21922-003 |
| .1 mg/mL | SOLUTION | TOPICAL | 72162-1271 |
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Fluocinolone Acetonide Topical Solution Usp, 0.01%, you must consult a qualified healthcare professional.
Detailed information about Fluocinolone Acetonide Topical Solution Usp, 0.01%
Fluocinolone Acetonide is a high-potency synthetic corticosteroid used to treat inflammatory skin conditions and chronic ocular diseases. It functions as a glucocorticoid receptor agonist to reduce swelling, itching, and redness.
For most dermatological conditions, such as atopic dermatitis or psoriasis, the standard adult dosage for Fluocinolone Acetonide 0.025% cream or ointment is application to the affected area 2 to 4 times daily. Healthcare providers typically recommend using the smallest amount necessary to cover the affected area. For scalp-related seborrheic dermatitis, the 0.01% shampoo is usually applied to a wet scalp, worked into a lather, and left for approximately 5 minutes before rinsing; this is typically done once daily until symptoms subside. In the case of chronic uveitis or diabetic macular edema, a single intravitreal implant (0.19 mg or 0.59 mg) is surgically placed or injected by an ophthalmologist, providing therapeutic effects for up to 36 months.
Fluocinolone Acetonide must be used with extreme caution in pediatric patients. For children aged 2 years and older, the 0.01% topical oil (Derma-Smoothe/FS) is often used for atopic dermatitis, typically applied twice daily for no more than 4 weeks. The use of higher concentrations (0.025%) or application to large surface areas is generally avoided in infants and very young children due to the higher risk of systemic absorption and HPA (Hypothalamic-Pituitary-Adrenal) axis suppression. Safety and efficacy in pediatric patients under 2 years of age have not been established for most formulations.
Because Fluocinolone Acetonide is primarily applied topically or locally (in the eye) and systemic absorption is generally low, dosage adjustments for renal (kidney) impairment are typically not required. However, if used over very large surface areas for extended periods, patients with severe renal failure should be monitored for potential systemic steroid accumulation.
In patients with significant hepatic (liver) impairment, the metabolism of systemically absorbed Fluocinolone Acetonide may be delayed. While topical adjustments are rarely necessary, healthcare providers may exercise caution when treating extensive skin areas to prevent systemic corticosteroid toxicity.
Elderly patients often have thinner skin (atrophy), which increases the risk of systemic absorption and local side effects like bruising (purpura). Clinicians often prescribe the lowest effective potency and recommend shorter treatment durations for geriatric populations.
Proper application technique is vital for the safety and efficacy of Fluocinolone Acetonide:
If you miss a dose of topical Fluocinolone Acetonide, apply it as soon as you remember. However, if it is almost time for your next scheduled application, skip the missed dose and return to your regular dosing schedule. Do not apply double amounts to 'make up' for a missed dose, as this increases the risk of local skin thinning.
Acute overdosage via topical application is unlikely to be life-threatening. However, chronic over-application or ingestion can lead to systemic corticosteroid effects. Signs of chronic 'overdose' (systemic absorption) include moon face (rounding of the face), buffalo hump (fat deposit between shoulders), extreme fatigue, and high blood sugar. In case of accidental ingestion, contact a poison control center or seek emergency medical care immediately.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop treatment abruptly without medical guidance, as some conditions may 'rebound' or worsen if the steroid is stopped too quickly.
When using topical Fluocinolone Acetonide, the most frequently reported side effects are localized to the site of application. These include:
For the intravitreal implants, common side effects include increased intraocular pressure (IOP) and the development of cataracts (clouding of the lens), occurring in a significant percentage of patients over time.
Fluocinolone Acetonide is a potent medication that must be used strictly as directed. It is intended for external use only (unless using the specific ocular implant). Avoid contact with the eyes, mouth, and nose. If the medication enters the eyes, rinse thoroughly with cool water. Patients should be aware that corticosteroids can lower the body's ability to fight infections; therefore, any new skin infection should be reported to a physician before continuing use.
No FDA black box warnings for Fluocinolone Acetonide.
While there are no absolute 'never-use' drug-drug contraindications for topical Fluocinolone Acetonide due to its low systemic absorption, it should not be used concurrently with other potent topical corticosteroids on the same skin site. This increases the risk of skin atrophy and HPA axis suppression without providing additional therapeutic benefit.
Fluocinolone Acetonide must NEVER be used in the following circumstances:
Fluocinolone Acetonide is classified as FDA Pregnancy Category C. Studies in laboratory animals have shown that corticosteroids can be teratogenic (cause birth defects) when administered systemically at relatively low dosage levels. There are no adequate and well-controlled studies in pregnant women regarding the topical use of Fluocinolone Acetonide. Therefore, it should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Specifically, it should not be used in large amounts or for long periods in pregnant patients, particularly during the first trimester when organogenesis (organ formation) occurs.
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids do appear in human milk and could suppress growth or cause other untoward effects in the nursing infant. Caution should be exercised when Fluocinolone Acetonide is administered to a nursing woman. If used, it should not be applied to the breasts before nursing to prevent accidental ingestion by the infant.
Pediatric patients are at a significantly higher risk for HPA axis suppression and Cushing's syndrome than adults due to a larger skin surface area to body weight ratio. Growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Use should be limited to the least amount compatible with an effective therapeutic regimen. Specifically, the Derma-Smoothe/FS oil is the only form extensively studied and approved for children as young as 2 years for atopic dermatitis.
Fluocinolone Acetonide is a corticosteroid with primarily glucocorticoid activity. It binds to the glucocorticoid receptor (GR) in the cytoplasm. The activated GR complex then translocates to the nucleus, where it acts as a transcription factor. It upregulates the expression of anti-inflammatory proteins (transactivation) and downregulates the expression of pro-inflammatory proteins (transrepression) by inhibiting the activity of NF-kappaB and AP-1. This results in decreased production of prostaglandins, leukotrienes, and various cytokines, effectively dampening the immune response at the site of application.
The onset of action for topical Fluocinolone Acetonide is usually within 1 to 3 hours for the reduction of itching, though visible reduction in redness and swelling may take 24 to 48 hours. The duration of effect after a single application is typically 6 to 12 hours. Tolerance (tachyphylaxis) can develop with continuous use, where the drug becomes less effective over time; this is why 'pulse therapy' (intervals of use and rest) is often recommended.
| Parameter | Value |
Common questions about Fluocinolone Acetonide Topical Solution Usp, 0.01%
Fluocinolone Acetonide is primarily used to treat various inflammatory skin conditions such as eczema, psoriasis, and seborrheic dermatitis. It works by reducing the swelling, itching, and redness associated with these disorders. In addition to skin care, it is used as an intravitreal implant for chronic eye conditions like diabetic macular edema and uveitis. Some specialized forms are also used to treat inflammatory conditions of the ear canal. Always use the specific formulation prescribed for your condition, as a scalp oil cannot be used in the eyes.
The most common side effects are localized to the area of application and include burning, stinging, itching, and dryness. These symptoms are usually mild and temporary, occurring as the skin adjusts to the medication. If you are using the ocular implant, the most common side effects are increased eye pressure and the development of cataracts. Some patients may also notice small white bumps (folliculitis) or a change in skin color at the application site. If these effects persist or worsen, you should contact your healthcare provider for guidance.
There is no direct chemical interaction between topical Fluocinolone Acetonide and alcohol. However, alcohol consumption can sometimes worsen underlying skin conditions like psoriasis or seborrheic dermatitis by increasing systemic inflammation. Drinking alcohol may also dehydrate the skin, making the dryness associated with steroid use more uncomfortable. For patients using the ocular implant, alcohol does not typically interfere with the medication's function. It is always best to consume alcohol in moderation and discuss your lifestyle habits with your doctor.
Fluocinolone Acetonide is classified as Pregnancy Category C, meaning its safety has not been fully established in human pregnancy. Animal studies have shown that corticosteroids can cause birth defects when absorbed systemically in high doses. While topical absorption is generally low, doctors usually recommend using it only if the benefits clearly outweigh the risks. It should never be used over large areas of the body or for long periods during pregnancy. If you are pregnant or planning to become pregnant, consult your healthcare provider before starting this medication.
Most patients begin to feel relief from itching and irritation within a few hours of the first application. However, visible improvements in skin redness and scaling may take 3 to 7 days of consistent use. For chronic conditions like psoriasis, it may take up to two weeks to see the full therapeutic benefit. If your symptoms do not improve after two weeks of treatment, you should contact your doctor to re-evaluate the diagnosis. For the ocular implant, the reduction in swelling is gradual and may take several weeks to reach peak effect.
Stopping Fluocinolone Acetonide suddenly after long-term use (more than 2 weeks) can cause a 'rebound' effect where your skin condition returns worse than before. This is because the skin becomes accustomed to the steroid's anti-inflammatory signals. To avoid this, healthcare providers usually recommend tapering the dose by applying it less frequently over several days. In some cases, stopping abruptly can also lead to topical steroid withdrawal, characterized by intense redness and burning. Always follow your doctor's specific instructions for ending your treatment cycle.
If you miss a dose of the topical cream, oil, or ointment, apply it as soon as you remember. If it is nearly time for your next scheduled application, skip the missed dose entirely and continue with your regular routine. Do not apply a double layer of the medication to make up for the missed application, as this increases the risk of skin thinning. Consistency is key to managing inflammatory flares, so try to use the medication at the same times each day. If you miss an appointment for an ocular implant injection, contact your ophthalmologist immediately.
When used topically as directed, Fluocinolone Acetonide is very unlikely to cause weight gain because very little of the drug enters the bloodstream. However, if it is used over very large areas of the body, under plastic wraps (occlusion), or for many months, enough may be absorbed to cause systemic side effects like Cushing's syndrome. Cushing's syndrome can lead to weight gain, particularly in the face and trunk. This is extremely rare with standard topical use but is a reason why doctors monitor long-term users closely. If you notice rapid, unexplained weight gain, notify your doctor.
Fluocinolone Acetonide can generally be used alongside most oral medications, but you should be cautious when using other topical products. Applying multiple steroid creams at once can increase the risk of skin damage and systemic absorption. You should also inform your doctor if you are taking oral steroids like prednisone, as the effects can be additive. There are few known interactions with common drugs like ibuprofen or blood pressure medications. Always provide your healthcare provider with a complete list of all prescriptions, over-the-counter drugs, and herbal supplements you use.
Yes, Fluocinolone Acetonide is available in several generic formulations, including creams, ointments, and scalp oils. Generic versions are required by the FDA to have the same active ingredient, strength, and dosage form as the brand-name products (like Synalar or Derma-Smoothe/FS). Using a generic version can significantly reduce the cost of treatment for most patients. However, the inactive ingredients (the 'vehicle') may vary slightly between manufacturers, which can affect how the cream feels on your skin. Consult your pharmacist to ensure you are receiving the correct generic equivalent for your prescription.
Other drugs with the same active ingredient (Fluocinolone Acetonide)
> Warning: Stop using Fluocinolone Acetonide and call your doctor immediately if you experience any of these serious reactions:
Prolonged use of Fluocinolone Acetonide (typically beyond 2-4 weeks of continuous use) can lead to permanent skin changes. Skin atrophy is the most significant concern, as thinned skin is more prone to tearing and bruising. There is also the risk of 'topical steroid withdrawal' (TSW), where the skin becomes intensely red, burning, and inflamed upon stopping the medication. In ocular use, long-term effects almost inevitably include the need for cataract surgery or the long-term use of pressure-lowering eye drops.
No FDA black box warnings currently exist for Fluocinolone Acetonide. However, the FDA requires rigorous labeling regarding the risks of HPA axis suppression in pediatric patients and the risk of glaucoma/cataracts for ocular formulations.
Report any unusual symptoms to your healthcare provider. You may also report side effects to the FDA at 1-800-FDA-1088.
For patients using Fluocinolone Acetonide over large surface areas or for long durations, healthcare providers may require the following monitoring:
Topical Fluocinolone Acetonide typically does not affect the ability to drive or operate machinery. However, the intravitreal implants may cause temporary blurred vision immediately following the procedure. Patients should wait until their vision clears before engaging in these activities.
There are no direct contraindications between topical Fluocinolone Acetonide and moderate alcohol consumption. However, alcohol can trigger flares in certain skin conditions like psoriasis and seborrheic dermatitis, potentially reducing the perceived efficacy of the treatment.
Treatment with Fluocinolone Acetonide should be tapered (gradually reduced) rather than stopped abruptly, especially if it has been used for more than two weeks. Sudden discontinuation can lead to a 'rebound' effect, where the original skin condition returns with greater intensity. Your doctor may suggest applying the medication less frequently (e.g., every other day) before stopping completely.
> Important: Discuss all your medical conditions, including any history of skin infections or glaucoma, with your healthcare provider before starting Fluocinolone Acetonide.
Fluocinolone Acetonide may interfere with certain laboratory tests:
For each major interaction, the mechanism typically involves either pharmacodynamic synergy (adding to the effect of other steroids) or pharmacokinetic interference via the CYP450 enzyme system. Management usually involves dose timing adjustments or switching to a lower-potency agent.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including over-the-counter creams and ointments.
Conditions requiring a careful risk-benefit analysis include:
Patients who have had allergic reactions to other corticosteroids (such as Triamcinolone, Desonide, or Hydrocortisone) may exhibit cross-sensitivity to Fluocinolone Acetonide. While not guaranteed, the structural similarities between these molecules increase the risk of a secondary allergic response.
> Important: Your healthcare provider will evaluate your complete medical history, including any history of 'steroid phobia' or previous adverse reactions, before prescribing Fluocinolone Acetonide.
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine if they respond differently from younger subjects. However, because elderly patients are more likely to have thin, fragile skin and compromised hepatic or renal function, the risk of local and systemic side effects is higher. Dose selection should be cautious, often starting at the lower end of the dosing range.
While renal impairment does not significantly affect the initial topical action, the clearance of any systemically absorbed drug may be reduced. No specific dose adjustment is codified, but monitoring for systemic effects is advised in patients with end-stage renal disease (ESRD).
Patients with severe liver disease (Child-Pugh Class C) may have a reduced ability to metabolize absorbed Fluocinolone Acetonide. This increases the risk of systemic steroid toxicity. These patients should be monitored for signs of cortisol excess if treated over large areas.
> Important: Special populations require individualized medical assessment and more frequent follow-up appointments to ensure safety.
| Bioavailability | Low (Topical), 100% (Intravitreal) |
| Protein Binding | ~90% (primarily to albumin) |
| Half-life | 1.5 to 3 hours (Systemic) |
| Tmax | 1-2 hours (Topical absorption) |
| Metabolism | Hepatic (Reduction and Conjugation) |
| Excretion | Renal (primarily as metabolites) |
Fluocinolone Acetonide is classified as a Group IV (Mid-potency) to Group VI (Low-potency) corticosteroid depending on the concentration and vehicle. It is in the same therapeutic class as Triamcinolone Acetonide and Betamethasone.