Fluocinonide 0.05% Gel 15gm
It is used to treat skin rashes and other skin irritation.It is used to treat psoriasis.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
Category C
FDA Approved
Jun 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluocinonide gel is a strong medicine applied to the skin to reduce redness, itching, and swelling caused by certain skin conditions like eczema or psoriasis. It belongs to a group of medicines called corticosteroids.
How to Use This Medicine
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Continue using the medication as directed, even if your symptoms improve.
Applying the Medication
This medication is for topical use only, meaning it should be applied directly to the affected area of skin. Do not take it by mouth. Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application. Clean the affected area before applying the medication and make sure it is completely dry. Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless directed by your doctor, do not cover the treated area with bandages or dressings.
Storing and Disposing of Your Medication
Store the medication at room temperature, keeping the lid tightly closed. Protect it from heat sources. Keep all medications in a safe and secure location, out of the reach of children and pets.
Missing a Dose
If you miss a dose, apply 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 application schedule. Do not apply two doses at the same time or use extra doses to make up for a missed one.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Continue using the medication as directed, even if your symptoms improve.
Applying the Medication
This medication is for topical use only, meaning it should be applied directly to the affected area of skin. Do not take it by mouth. Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application. Clean the affected area before applying the medication and make sure it is completely dry. Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless directed by your doctor, do not cover the treated area with bandages or dressings.
Storing and Disposing of Your Medication
Store the medication at room temperature, keeping the lid tightly closed. Protect it from heat sources. Keep all medications in a safe and secure location, out of the reach of children and pets.
Missing a Dose
If you miss a dose, apply 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 application schedule. Do not apply two doses at the same time or use extra doses to make up for a missed one.
Lifestyle & Tips
- Apply a thin layer of gel to the affected skin area as directed by your doctor, usually 2 to 4 times a day.
- Gently rub it in completely.
- Wash your hands before and after applying the gel, unless your hands are the treated area.
- Do not cover the treated area with bandages or other dressings unless specifically told to do so by your doctor, as this can increase absorption and side effects.
- Avoid applying the gel to your face, groin, or armpits unless directed by your doctor.
- Do not use this medicine for longer than prescribed, as prolonged use can lead to skin thinning or other side effects.
- Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
- Do not use on open wounds or broken skin.
Available Forms & Alternatives
Available Strengths:
- Fluocinonide -E 0.05% Cream 15gm
- Fluocinonide -E 0.05% Cream 60gm
- Fluocinonide -E 0.05% Cream 30gm
- Fluocinonide 0.05% Gel 15gm
- Fluocinonide 0.05% Soln 20ml
- Fluocinonide 0.05% Ointment 30gm
- Fluocinonide 0.05% Oint 60gm
- Fluocinonide 0.05% Gel 60gm
- Fluocinonide 0.05% Oint 15gm
- Fluocinonide 0.05% Gel 30gm
- Fluocinonide 0.1% Cream 120gm
- Fluocinonide 0.1% Cream 30gm
- Fluocinonide 0.1% Cream 60gm
- Fluocinonide 0.05% Cream 60gm
- Fluocinonide 0.05% Cream 30gm
- Fluocinonide 0.05% Cream 120gm
- Fluocinonide 0.05% Cream 15gm
- Fluocinonide 0.05% Soln 60ml
- Fluocinonide 0.05% Soln 60ml
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film to the affected area 2 to 4 times daily.
Dose Range:
2 - 4 mg
Condition-Specific Dosing:
psoriasis:
Apply 2-4 times daily, may use occlusive dressing for severe cases under medical supervision.
eczema:
Apply 2-4 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing not established; use with extreme caution due to increased systemic absorption risk. Avoid prolonged use or large surface areas.
Child:
Apply a thin film to the affected area 2 to 4 times daily. Use lowest effective dose for shortest duration. Avoid occlusive dressings. Increased risk of systemic effects (e.g., HPA axis suppression).
Adolescent:
Apply a thin film to the affected area 2 to 4 times daily. Use lowest effective dose for shortest duration.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for topical use.
Moderate:
No adjustment needed for topical use.
Severe:
No adjustment needed for topical use.
Dialysis:
No specific considerations for topical use due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed for topical use.
Moderate:
No adjustment needed for topical use.
Severe:
No adjustment needed for topical use.
Pharmacology
Mechanism of Action
Fluocinonide is a high-potency topical corticosteroid. It exerts its anti-inflammatory, antipruritic, and vasoconstrictive actions by inducing phospholipase A2 inhibitory proteins, 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. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (depends on skin integrity, vehicle, site, occlusion)
Tmax:
Not precisely quantified for topical application; systemic absorption is minimal and variable.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not precisely quantified for topical application; primarily local distribution.
ProteinBinding:
Not precisely quantified for topical application; if absorbed systemically, binds to plasma proteins.
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not precisely quantified for topical application; systemic half-life is variable.
Clearance:
Not precisely quantified for topical application.
ExcretionRoute:
Renal (if absorbed systemically)
Unchanged:
Not precisely quantified for topical application.
Pharmacodynamics
OnsetOfAction:
Hours to days (for symptomatic relief)
PeakEffect:
Days to weeks (for maximal therapeutic effect)
DurationOfAction:
Varies with application frequency and condition.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing
Skin changes: acne, stretch marks, slow healing, or excessive hair growth
Skin irritation
Thinning of the skin
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 persist, contact your doctor:
Burning or stinging sensations
Dry skin
Itching
This is not an exhaustive list of possible 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, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing
Skin changes: acne, stretch marks, slow healing, or excessive hair growth
Skin irritation
Thinning of the skin
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 persist, contact your doctor:
Burning or stinging sensations
Dry skin
Itching
This is not an exhaustive list of possible 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 of your skin condition or no improvement after 2 weeks.
- Severe burning, itching, or irritation at the application site.
- Signs of skin infection (e.g., pus, increased redness, warmth, fever).
- Development of new skin problems like thinning skin, stretch marks, or acne-like breakouts.
- Unusual fatigue, weakness, or swelling (rare, but could indicate systemic absorption).
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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dose 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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dose 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. Before using any other medications or products on your skin, including soaps, consult with your doctor.
To ensure safe use, avoid applying this medication to cuts, scrapes, or damaged skin. When applying it to a large area of skin or near open wounds, exercise caution and discuss with your doctor.
Adhere to your doctor's instructions regarding the duration of treatment, and do not use this medication for longer than prescribed. If the treated area is in the diaper region, avoid using tight-fitting diapers or plastic pants, as this can increase the amount of medication absorbed into the body.
When using this medication in children, exercise caution, as they may be at a higher risk of experiencing certain side effects. In some cases, this medication can affect growth in children and teenagers, making regular growth checks necessary. Consult with your doctor to discuss this potential risk.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the benefits and risks of using this medication during these situations to ensure the best possible outcome for both you and your baby.
To ensure safe use, avoid applying this medication to cuts, scrapes, or damaged skin. When applying it to a large area of skin or near open wounds, exercise caution and discuss with your doctor.
Adhere to your doctor's instructions regarding the duration of treatment, and do not use this medication for longer than prescribed. If the treated area is in the diaper region, avoid using tight-fitting diapers or plastic pants, as this can increase the amount of medication absorbed into the body.
When using this medication in children, exercise caution, as they may be at a higher risk of experiencing certain side effects. In some cases, this medication can affect growth in children and teenagers, making regular growth checks necessary. Consult with your doctor to discuss this potential risk.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the benefits and risks of using this medication during these situations to ensure the best possible outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use of topical corticosteroids can lead to systemic effects due to absorption, including suppression of the hypothalamic-pituitary-adrenal (HPA) axis, Cushing's syndrome, hyperglycemia, and glucosuria. Symptoms may include weight gain, moon face, muscle weakness, and high blood sugar.
What to Do:
If systemic effects are suspected, contact your doctor immediately. Management involves gradual withdrawal of the drug under medical supervision. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition (e.g., erythema, scaling, pruritus, lesions)
Rationale: To assess the severity of the dermatosis and establish a baseline for treatment efficacy.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy of treatment (reduction in symptoms/lesions)
Frequency: Weekly to bi-weekly, then as needed.
Target: Improvement in dermatological condition.
Action Threshold: Lack of improvement or worsening of condition after 2-4 weeks may require re-evaluation of diagnosis or treatment.
Local adverse reactions (e.g., atrophy, striae, telangiectasias, burning, itching, irritation, folliculitis, acneiform eruptions, hypopigmentation)
Frequency: At each follow-up visit.
Target: Absence or minimal adverse effects.
Action Threshold: Presence of significant or worsening adverse effects may require discontinuation or change in therapy.
Signs of skin infection (e.g., pus, increased redness, warmth)
Frequency: At each follow-up visit.
Target: Absence of infection.
Action Threshold: Presence of infection requires appropriate antimicrobial therapy; consider discontinuing fluocinonide until infection is controlled.
Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, glucosuria, HPA axis suppression)
Frequency: Periodically, especially with prolonged use, large surface areas, or occlusive dressings.
Target: Absence of systemic effects.
Action Threshold: If suspected, perform appropriate tests (e.g., ACTH stimulation test, plasma cortisol levels); discontinue or gradually withdraw the drug.
Symptom Monitoring
- Worsening of skin condition
- Increased redness or irritation at application site
- Development of new skin lesions (e.g., pimples, thinning skin)
- Signs of infection (e.g., pus, fever)
- Unusual fatigue or weakness (rare, indicative of systemic absorption)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid large areas, prolonged use, or occlusive dressings.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity with high doses of corticosteroids in animal studies; human data are limited but generally reassuring for topical use.
Second Trimester:
Risk of HPA axis suppression in the fetus with prolonged or high-dose use.
Third Trimester:
Risk of HPA axis suppression in the fetus with prolonged or high-dose use; potential for low birth weight.
Lactation
L3 (Moderately Safe). It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Use with caution. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with appropriate use. Monitor infant for signs of systemic corticosteroid effects (e.g., growth suppression) if mother uses large amounts or for prolonged periods.
Pediatric Use
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Avoid prolonged use, large surface areas, and occlusive dressings. Use the lowest effective dose for the shortest duration possible.
Geriatric Use
No specific dosage adjustments are required. However, elderly patients may have thinner skin, which could potentially increase systemic absorption. Use with caution and monitor for adverse effects.
Clinical Information
Clinical Pearls
- Fluocinonide 0.05% gel is a high-potency topical corticosteroid; use it sparingly and for short durations to minimize side effects.
- Inform patients that the gel formulation may be preferred for hairy areas or weeping lesions due to its drying effect.
- Emphasize the importance of not using occlusive dressings unless specifically instructed by a physician, especially in children, due to increased systemic absorption.
- Advise patients to avoid applying the gel to the face, groin, or axillae unless explicitly directed by a healthcare provider, as these areas are more prone to corticosteroid-induced side effects (e.g., atrophy, telangiectasias).
- Educate patients on signs of local adverse effects (skin thinning, stretch marks, increased hair growth) and systemic effects (rare, but possible with extensive use).
Alternative Therapies
- Other topical corticosteroids (e.g., clobetasol, betamethasone, triamcinolone, hydrocortisone) of varying potencies.
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema.
- Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole) for eczema.
- Systemic therapies (e.g., biologics, oral immunosuppressants) for severe dermatoses.
Cost & Coverage
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 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 this 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 taken, the amount, and the time it happened.