Fluocinonide -E 0.05% Cream 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
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 various 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 with your medication 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 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
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 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 with your medication 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 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
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 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 very thin layer to the affected area(s) as directed by your doctor. Do not use more than prescribed.
- Wash your hands before and after applying the cream.
- Do not cover the treated area with bandages or other dressings unless specifically told to by your doctor, as this can increase absorption and side effects.
- Avoid using on the face, groin, or armpits unless specifically instructed by your doctor, as these areas are more susceptible to side effects.
- Do not use for longer than prescribed, typically no more than 2 weeks for most conditions.
- Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
- Do not use on children without consulting a doctor, as they are more sensitive to its 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 skin areas two to four times daily, depending on the severity of the condition.
Dose Range:
2 - 4 mg
Condition-Specific Dosing:
generalApplication:
Apply a thin film to the affected skin areas. Rub in gently and completely. Do not use occlusive dressings unless directed by a physician. Limit treatment to 2 weeks for most conditions. Do not exceed 60 grams per week.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Use with caution; not recommended for prolonged use or on large body surface areas due to increased risk of systemic absorption and adrenal suppression. Consult a physician.
Adolescent:
Similar to adult dosing, but with increased caution regarding systemic absorption, especially with prolonged use or on large body surface areas.
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 is a high-potency topical 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; however, the extent of percutaneous absorption is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Absorption is increased on denuded skin, with inflammation, and in areas with thin stratum corneum (e.g., face, scrotum).
Tmax:
Not precisely quantified for topical application due to minimal systemic absorption.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not precisely quantified for topical application.
ProteinBinding:
If absorbed systemically, corticosteroids are bound to plasma proteins to varying degrees.
CnssPenetration:
Limited, unless significant systemic absorption occurs.
Elimination:
HalfLife:
Not precisely quantified for topical application.
Clearance:
Not precisely quantified for topical application.
ExcretionRoute:
Metabolites are primarily excreted by the kidneys, with some excretion in the bile.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Rapid, symptomatic relief often within hours to days.
PeakEffect:
Within several days of consistent application.
DurationOfAction:
Depends on frequency of application and individual response; effects persist as long as treatment continues.
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 symptoms that bother you or persist, contact your doctor for advice:
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 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 symptoms that bother you or persist, contact your doctor for advice:
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 the skin condition or no improvement after a few days.
- Severe burning, itching, or irritation at the application site.
- Signs of skin infection (e.g., pus, spreading redness, fever).
- Development of new skin problems like thinning skin, stretch marks, or changes in skin color.
- Unusual weight gain, swelling in the face, or increased hair growth (signs of 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.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate existing health problems.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Existing health problems or conditions
Before making any changes to your medication regimen, consult with your doctor to confirm that it is safe to take this medication in conjunction with your other drugs and health conditions. Do not start, stop, or adjust the dosage 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.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate existing health problems.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Existing health problems or conditions
Before making any changes to your medication regimen, consult with your doctor to confirm that it is safe to take this medication in conjunction with your other drugs and health conditions. Do not start, stop, or adjust the dosage 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 skin products, such as soaps, consult with your doctor to ensure safe use.
When applying this medication, avoid putting it on cuts, scrapes, or damaged skin. Exercise caution when applying it to a large area of skin or near open wounds, and discuss this with your doctor.
Do not use this medication for a longer period than prescribed by your doctor. If you are treating a skin area that will be covered by a diaper, avoid using tight-fitting diapers or plastic pants, as this can increase the amount of medication absorbed into the body.
If the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in children. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Discuss this with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks to both you and your baby.
When applying this medication, avoid putting it on cuts, scrapes, or damaged skin. Exercise caution when applying it to a large area of skin or near open wounds, and discuss this with your doctor.
Do not use this medication for a longer period than prescribed by your doctor. If you are treating a skin area that will be covered by a diaper, avoid using tight-fitting diapers or plastic pants, as this can increase the amount of medication absorbed into the body.
If the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in children. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Discuss this with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks to both you and your baby.
Overdose Information
Overdose Symptoms:
- Signs of Cushing's syndrome (e.g., moon face, central obesity, striae, hypertension)
- Hyperglycemia (high blood sugar)
- Glucosuria (sugar in urine)
- Adrenal suppression (fatigue, weakness, nausea, vomiting, low blood pressure)
What to Do:
If excessive application or prolonged use leads to systemic effects, consult a healthcare professional immediately. Treatment is symptomatic and supportive. Gradual withdrawal of the corticosteroid may be necessary to prevent adrenal insufficiency. Call a poison control center (1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis, presence of infection, and integrity of skin barrier.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (reduction in inflammation, pruritus)
Frequency: Regularly during treatment (e.g., weekly or bi-weekly)
Target: Resolution or significant improvement of symptoms.
Action Threshold: If no improvement or worsening, re-evaluate diagnosis and treatment plan.
Local adverse reactions (e.g., atrophy, striae, telangiectasias, burning, itching, irritation)
Frequency: Regularly during treatment
Target: Absence or minimal, tolerable reactions.
Action Threshold: If severe or persistent, discontinue use and consult physician.
Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, glucosuria, adrenal suppression)
Frequency: Periodically, especially with prolonged use, large surface area application, or occlusive dressings.
Target: Absence of signs/symptoms.
Action Threshold: If suspected, perform appropriate tests (e.g., plasma cortisol, ACTH stimulation test) and discontinue drug gradually.
Symptom Monitoring
- Burning
- Itching
- Irritation
- Dryness
- Folliculitis
- Hypertrichosis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Maceration of the skin
- Secondary infection
- Skin atrophy
- Striae
- Miliaria
- Signs of Cushing's syndrome (e.g., moon face, central obesity, striae, hypertension)
- Unusual fatigue or weakness (adrenal suppression)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Fluocinonide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic corticosteroids have been shown to be teratogenic in animals.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though systemic absorption from topical use is minimal. Use with caution.
Second Trimester:
Use with caution, only if clearly needed.
Third Trimester:
Use with caution, only if clearly needed. Potential for fetal adrenal suppression with extensive use.
Lactation
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when fluocinonide is administered to a nursing woman. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with proper use due to minimal systemic absorption, but monitor infant for any unusual effects.
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. Prolonged use should be avoided. Not recommended for infants. Use in children should be limited to the least amount compatible with an effective therapeutic regimen.
Geriatric Use
No specific dosage adjustments are recommended. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects like atrophy or purpura. Monitor for skin integrity and adverse reactions.
Clinical Information
Clinical Pearls
- Fluocinonide 0.05% is a high-potency topical corticosteroid. It should be used for short durations (typically 2 weeks) to avoid local and systemic side effects.
- Proper application involves using a very thin film. More is not better and increases the risk of side effects.
- Avoid using on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more prone to atrophy, telangiectasias, and other side effects.
- Occlusive dressings significantly increase systemic absorption and local side effects; use only if explicitly prescribed by a physician.
- Patients should be educated on the signs of skin atrophy (thinning, bruising, shiny appearance) and systemic absorption (e.g., swelling, weight gain, fatigue) and instructed to report them.
- Not for use in rosacea or perioral dermatitis, as it can exacerbate these conditions.
Alternative Therapies
- Other topical corticosteroids of varying potencies (e.g., clobetasol propionate, betamethasone valerate, triamcinolone acetonide, hydrocortisone)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for certain inflammatory skin conditions, especially on sensitive areas.
- Emollients and moisturizers for barrier repair.
- Systemic therapies for severe or widespread dermatoses (e.g., methotrexate, biologics).
Cost & Coverage
Average Cost:
$20 - $80 per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Generally covered by most prescription drug plans (Tier 1 or 2 for 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 your 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, including the amount and time of ingestion.