Fluocinonide 0.05% Cream 120gm
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 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 medicines called corticosteroids.
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.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the area being treated.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless instructed to do so by your doctor, do not cover the treated area with bandages or dressings.
Storage and Disposal
Store the medication at room temperature with the lid tightly closed.
Protect the medication from heat.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or use 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.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the area being treated.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless instructed to do so by your doctor, do not cover the treated area with bandages or dressings.
Storage and Disposal
Store the medication at room temperature with the lid tightly closed.
Protect the medication from heat.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Apply a thin layer only to the affected skin area as directed by your doctor.
- Do not use on the face, groin, or armpits unless specifically instructed by a doctor, as these areas are more susceptible to side effects.
- Do not cover the treated area with bandages, plastic wrap, or tight dressings unless instructed by your doctor, as this can increase the amount of medicine absorbed into your body.
- Wash your hands thoroughly before and after applying the cream.
- Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
- Do not use for longer than prescribed, especially in children, to minimize the risk of side effects.
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 two to four times daily.
Condition-Specific Dosing:
Psoriasis/Eczema:
Apply a thin film to the affected area two to four times daily. Once control is achieved, reduce frequency or switch to a less potent steroid.
Pediatric Dosing
Neonatal:
Not established. Not recommended for prolonged use due to systemic absorption risk.
Infant:
Not established. Not recommended for prolonged use due to systemic absorption risk.
Child:
Use with caution, generally once daily for short periods, due to higher risk of systemic absorption and HPA axis suppression. Not for prolonged use or large surface areas.
Adolescent:
Similar to adult, but caution with large areas/prolonged use due to potential for systemic absorption.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical application.
Moderate:
No specific adjustment needed for topical application.
Severe:
No specific adjustment needed for topical application.
Dialysis:
No specific considerations for topical application.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical application.
Moderate:
No specific adjustment needed for topical application.
Severe:
No specific adjustment needed for topical application.
Pharmacology
Mechanism of Action
Fluocinonide, a high-potency topical corticosteroid, exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. These effects are thought to be mediated by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. Lipocortins 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:
Highly variable; depends on vehicle, skin integrity, site of application, and occlusion. Systemic absorption can occur.
Tmax:
Not precisely quantified for topical systemic effects.
FoodEffect:
Not applicable
Distribution:
Vd:
Not precisely quantified for topical.
ProteinBinding:
High (>90%) once absorbed systemically.
CnssPenetration:
Limited, but can occur with significant systemic absorption.
Elimination:
HalfLife:
Not well-defined for topical systemic effects.
Clearance:
Not precisely quantified for topical.
ExcretionRoute:
Primarily renal excretion of metabolites.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief.
PeakEffect:
Days to weeks for full therapeutic effect.
DurationOfAction:
Varies, generally 12-24 hours per application.
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 immediately or seek emergency 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, extreme dizziness or fainting, muscle weakness, 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 for guidance:
Burning or stinging sensations
Dry skin
Itching
This is not an exhaustive list of potential 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 immediately or seek emergency 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, extreme dizziness or fainting, muscle weakness, 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 for guidance:
Burning or stinging sensations
Dry skin
Itching
This is not an exhaustive list of potential 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 the skin condition or no improvement after the prescribed treatment period.
- Signs of skin infection (e.g., pus, increased redness, warmth, fever).
- Severe burning, stinging, or irritation at the application site.
- New skin thinning, stretch marks (striae), or changes in skin color in the treated area.
- Signs of systemic absorption, such as unusual weight gain, swelling in ankles/feet, increased thirst or urination, or vision problems (rare with proper topical use).
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, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or health problems, so it is crucial to discuss your complete medical history with your doctor.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any pre-existing conditions
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent any potential interactions or complications.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or health problems, so it is crucial to discuss your complete medical history with your doctor.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your health problems, including any pre-existing conditions
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent any potential interactions or complications.
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 skin products, such as soaps, consult with your doctor to ensure safe use.
To minimize potential risks, avoid applying this medication to cuts, scrapes, or damaged skin. When applying it to a large skin area or near open wounds, exercise caution and discuss with your doctor.
Adhere to your doctor's prescribed treatment duration and do not use this medication for an extended period. 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 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 to weigh the benefits and risks of using this medication for both you and your baby.
To minimize potential risks, avoid applying this medication to cuts, scrapes, or damaged skin. When applying it to a large skin area or near open wounds, exercise caution and discuss with your doctor.
Adhere to your doctor's prescribed treatment duration and do not use this medication for an extended period. 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 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 to weigh the benefits and risks of using this medication for both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use, especially over large surface areas or under occlusion, can lead to systemic effects such as Cushing's syndrome (e.g., moon face, central obesity), hyperglycemia (high blood sugar), glucosuria (sugar in urine), and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
- Local effects of overuse include significant skin atrophy, striae, telangiectasias (spider veins), and purpura.
What to Do:
If systemic effects are suspected, discontinue the medication gradually under medical supervision. Symptomatic and supportive care should be provided. For accidental ingestion or significant overdose, contact a poison control center immediately (e.g., 1-800-222-1222 in the US).
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment (type, severity, location of lesion)
Rationale: To establish baseline for treatment efficacy and identify contraindications or areas requiring special caution.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (reduction in inflammation, pruritus)
Frequency: Weekly to monthly, depending on severity and duration of use.
Target: Resolution or significant improvement of dermatological condition.
Action Threshold: Lack of improvement or worsening of condition after appropriate duration of therapy.
Adverse skin reactions (e.g., atrophy, striae, telangiectasias, folliculitis)
Frequency: At each follow-up visit.
Target: Absence of new or worsening adverse reactions.
Action Threshold: Appearance of significant local adverse effects requiring dose reduction or discontinuation.
Signs of systemic absorption (e.g., HPA axis suppression, Cushing's syndrome, hyperglycemia)
Frequency: Periodically, especially with prolonged use, large surface areas, or occlusive dressings.
Target: Normal adrenal function and metabolic parameters.
Action Threshold: Clinical signs or symptoms suggestive of systemic corticosteroid effects; consider laboratory testing (e.g., ACTH stimulation test) if suspected.
Symptom Monitoring
- Skin irritation
- Burning
- Itching
- Dryness
- Folliculitis
- Hypertrichosis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Maceration of the skin
- Secondary infection
- Skin atrophy
- Striae
- Miliaria
- Unusual weight gain (systemic)
- Swelling in ankles/feet (systemic)
- Increased thirst/urination (systemic)
- Vision problems (systemic)
- Fatigue (systemic, HPA axis suppression)
Special Patient Groups
Pregnancy
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Avoid large areas or prolonged use.
Trimester-Specific Risks:
First Trimester:
Limited data, but systemic absorption is low with proper topical use. Risk generally considered low for topical corticosteroids.
Second Trimester:
Risk generally considered low for topical corticosteroids.
Third Trimester:
Risk generally considered low for topical corticosteroids.
Lactation
Use with caution. It is not known whether topical corticosteroids are excreted in human milk. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with proper application technique (avoiding breast area), but potential for systemic absorption and excretion in milk exists.
Pediatric Use
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, intracranial hypertension). Use the least potent effective dose for the shortest duration. Not recommended for infants.
Geriatric Use
No specific dosage adjustments needed. Use with caution in patients with thin or fragile skin, as they may be more prone to local adverse effects like skin atrophy.
Clinical Information
Clinical Pearls
- Fluocinonide 0.05% is a high-potency topical corticosteroid; its potency varies by formulation (ointment > cream > gel > solution).
- Avoid prolonged use, especially on the face, intertriginous areas (skin folds), or in children, due to increased risk of skin atrophy, striae, and systemic absorption.
- Patients should be educated on proper application technique, including applying a thin layer and avoiding excessive amounts.
- Not indicated for use in rosacea or perioral dermatitis, as it can exacerbate these conditions.
- Consider tapering down to a lower potency corticosteroid or reducing frequency once the condition is controlled to minimize side effects.
Alternative Therapies
- Other topical corticosteroids of varying potencies (e.g., clobetasol, betamethasone, triamcinolone, hydrocortisone)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
- Vitamin D analogs (e.g., calcipotriene) for psoriasis
- Topical retinoids (e.g., tazarotene) for psoriasis
- Emollients and moisturizers for barrier repair and symptom relief
Cost & Coverage
Average Cost:
$20 - $100+ per 120gm tube
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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.