Fluocinonide 0.05% Gel 30gm
It is used to treat skin rashes and other skin irritation.It is used to treat psoriasis.
Drug Class
Corticosteroid, Topical
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
Category C
FDA Approved
Aug 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluocinonide gel is a strong medicine applied to the skin to reduce redness, swelling, and itching caused by certain skin conditions like eczema or psoriasis. It belongs to a class of drugs 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 your skin. Do not take it by mouth. Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash your hand after applying the medication. 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 to do so by your doctor, do not cover the treated area with bandages or dressings.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature with 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 dosing schedule. Do not apply two doses at the same time or use extra doses to make up for a missed dose.
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 your skin. Do not take it by mouth. Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash your hand after applying the medication. 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 to do so by your doctor, do not cover the treated area with bandages or dressings.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature with 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 dosing schedule. Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Wash hands before and after applying the gel.
- Apply a thin layer only to the affected skin areas as directed by your doctor.
- Do not use more than prescribed or for longer than recommended.
- Avoid applying to the face, groin, or armpits unless specifically instructed by your doctor.
- Do not cover the treated area with bandages or tight dressings unless directed by your doctor, as this can increase absorption and side effects.
- Avoid contact with eyes, mouth, and other mucous membranes.
- Keep out of reach of children.
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 skin areas two to four times daily, depending on severity.
Dose Range:
2 - 4 mg
Condition-Specific Dosing:
psoriasis:
Apply a thin film to the affected skin areas two to four times daily.
eczema:
Apply a thin film to the affected skin areas two to four times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (use with extreme caution, increased risk of systemic effects)
Child:
Apply a thin film to the affected skin areas two to four times daily. Use with caution, limit duration of therapy and amount applied due to higher risk of systemic absorption and HPA axis suppression.
Adolescent:
Apply a thin film to the affected skin areas two to four times daily.
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 adjustment needed for topical use.
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 corticosteroid. It exerts its anti-inflammatory, antipruritic, and vasoconstrictive actions 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. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (variable, depends on skin integrity, vehicle, duration, and area of application)
Tmax:
Not applicable for topical systemic effects; local effect is rapid.
FoodEffect:
Not applicable
Distribution:
Vd:
Not available (minimal systemic distribution)
ProteinBinding:
Not available (minimal systemic distribution)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not precisely determined for topical use; systemic half-life of corticosteroids varies.
Clearance:
Not precisely determined for topical use.
ExcretionRoute:
Primarily renal excretion if systemically absorbed.
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within hours to days for anti-inflammatory and antipruritic effects.
PeakEffect:
Within days to weeks of consistent application.
DurationOfAction:
Varies with application frequency and individual response.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 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
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ 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 symptoms that bother you or do not go away, contact your doctor or seek medical help:
Burning or stinging
Dry skin
Itching
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 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
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ 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 symptoms that bother you or do not go away, contact your doctor or seek medical help:
Burning or stinging
Dry skin
Itching
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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
- Severe burning, itching, or irritation where the gel is applied
- New skin infections (e.g., pus, spreading redness)
- Thinning of the skin, easy bruising, or stretch marks in the treated area
- Unusual hair growth
- Acne-like breakouts
- Any signs of systemic effects like unusual weight gain, swelling in ankles/feet, increased thirst/urination, or changes in mood (rare, but report immediately)
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.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken safely with all your other 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.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken safely with all your other 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 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 may increase the amount of medication absorbed into the body.
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to discuss this potential risk.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to weigh the benefits and risks of this medication to both you and your baby.
To ensure safe use, avoid applying this medication to cuts, scrapes, or damaged skin. When applying 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 may increase the amount of medication absorbed into the body.
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to discuss this potential risk.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic corticosteroid effects such as Cushing's syndrome (e.g., moon face, central obesity, striae), hyperglycemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
What to Do:
Discontinue use gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control) for advice.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify areas for application.
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin condition (e.g., redness, swelling, itching, lesions)
Frequency: Regularly during treatment, at follow-up visits.
Target: Improvement in symptoms and appearance of dermatosis.
Action Threshold: Lack of improvement, worsening of condition, or development of local adverse effects (e.g., atrophy, striae, infection).
Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, HPA axis suppression)
Frequency: Periodically, especially with prolonged use, large surface area application, or in pediatric patients.
Target: Absence of systemic effects.
Action Threshold: Any signs or symptoms suggestive of systemic corticosteroid effects; consider HPA axis testing (e.g., ACTH stimulation test) if suspected.
Symptom Monitoring
- Worsening of skin condition
- New skin irritation, burning, itching, dryness
- Folliculitis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Secondary infection
- Skin atrophy, striae, telangiectasias (with prolonged use)
- Signs of systemic absorption: weight gain, moon face, central obesity, fatigue, muscle weakness, increased thirst/urination (rare)
Special Patient Groups
Pregnancy
Category C. Use 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 systemic corticosteroids; topical absorption is minimal but caution advised.
Second Trimester:
Minimal systemic absorption, but use with caution.
Third Trimester:
Minimal systemic absorption, but use with caution. Risk of HPA axis suppression in the neonate with extensive maternal use.
Lactation
L3 (Moderate risk). It is not known whether topical corticosteroids are excreted in human milk. Systemic absorption is minimal. Use with caution. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with proper use, but monitor for potential effects if significant maternal absorption occurs.
Pediatric Use
Children are more susceptible to systemic adverse effects (HPA axis suppression, Cushing's syndrome, growth retardation) due to a larger skin surface area to body weight ratio. Use the least potent effective corticosteroid for the shortest duration possible. Avoid occlusive dressings.
Geriatric Use
No specific dosage adjustments are required. Elderly patients may have thinner skin, which could increase the risk of local adverse effects like skin atrophy. Use with caution.
Clinical Information
Clinical Pearls
- Fluocinonide 0.05% gel is a high-potency topical corticosteroid; use it judiciously and for short durations to minimize local and systemic side effects.
- The gel formulation is often preferred for hairy areas or weeping lesions due to its drying effect.
- Educate patients on the 'thin film' application technique and the importance of not exceeding the prescribed frequency or duration.
- Warn patients about potential skin thinning, stretch marks, and easy bruising with prolonged use, especially on sensitive areas like the face or skin folds.
- Consider step-down therapy to a lower potency corticosteroid or intermittent use once the acute flare is controlled to prevent rebound flares and minimize side effects.
Alternative Therapies
- Clobetasol propionate (higher potency topical corticosteroid)
- Betamethasone dipropionate (high potency topical corticosteroid)
- Triamcinolone acetonide (medium potency topical corticosteroid)
- Mometasone furoate (medium potency topical corticosteroid)
- Non-steroidal topical agents (e.g., calcineurin inhibitors like tacrolimus or pimecrolimus for eczema, vitamin D analogs for psoriasis)
Cost & Coverage
Average Cost:
$20 - $100 per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic)
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your 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 is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance and support. 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 detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred.