Fluocinonide 0.05% Cream 30gm
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 (a corticosteroid) that you put on your skin to reduce redness, swelling, itching, and discomfort caused by various skin conditions like eczema or psoriasis. It works by calming down the body's inflammatory response in the skin.
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 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 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
- Wash your hands before and after applying the cream.
- Apply a thin layer to the affected skin area as directed by your doctor.
- Do not cover the treated area with bandages or plastic wrap unless specifically told to by your doctor, as this can increase absorption and side effects.
- Avoid applying the cream to your face, groin, or armpits unless your doctor specifically instructs you to, as these areas are more sensitive to side effects.
- Do not use this medicine for longer than prescribed, especially on children, as it can lead to serious side effects.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use on broken or infected skin without consulting your doctor.
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, depending on the severity of the condition.
Dose Range:
2 - 4 mg
Condition-Specific Dosing:
psoriasis:
Apply 2-4 times daily
eczema:
Apply 2-4 times daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established; use with extreme caution due to increased systemic absorption risk. Avoid prolonged use.
Child:
Not established; use with extreme caution due to increased systemic absorption risk. Avoid prolonged use and occlusive dressings. Limit treatment to the least amount compatible with an effective therapeutic regimen.
Adolescent:
Similar to adult dosing, but monitor closely for systemic effects, especially with extensive use or occlusion.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical use.
Moderate:
No specific adjustment needed for topical use.
Severe:
No specific adjustment needed for topical use.
Dialysis:
No specific considerations for topical use, as systemic absorption is minimal.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical use.
Moderate:
No specific adjustment needed for topical use.
Severe:
No specific adjustment needed for topical use.
Pharmacology
Mechanism of Action
Fluocinonide is a high-potency topical corticosteroid. It induces 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. Thus, fluocinonide exerts anti-inflammatory, antipruritic, and vasoconstrictive actions.
Pharmacokinetics
Absorption:
Bioavailability:
Varies; systemic absorption depends on vehicle, integrity of epidermal barrier, duration of exposure, and use of occlusive dressings. Can be significant with large surface areas or damaged skin.
Tmax:
Not typically defined for topical application; systemic effects can occur over days to weeks with prolonged use.
FoodEffect:
Not applicable
Distribution:
Vd:
Not typically defined for topical application.
ProteinBinding:
Variable, binds to plasma proteins if systemically absorbed.
CnssPenetration:
Limited, but can occur with significant systemic absorption.
Elimination:
HalfLife:
Not typically defined for topical application; systemic half-life of corticosteroids varies.
Clearance:
Not typically defined for topical application.
ExcretionRoute:
Primarily renal, with some biliary excretion, if systemically absorbed.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief.
PeakEffect:
Days to weeks of consistent application.
DurationOfAction:
Varies with application frequency and individual response; effects persist for hours after application.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when 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, 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
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Burning or stinging
Dry skin
Itching
This is not an exhaustive list of possible side effects. If you have 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.
While rare, some people may experience severe and potentially life-threatening side effects when 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, 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
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Burning or stinging
Dry skin
Itching
This is not an exhaustive list of possible side effects. If you have 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:
- Increased redness, itching, burning, or irritation at the application site
- Signs of skin infection (pus, spreading redness, fever)
- Skin thinning, easy bruising, stretch marks (striae)
- Acne-like breakouts or unusual hair growth
- Changes in skin color
- Signs of systemic absorption (rare but serious): unexplained weight gain, swelling in the face (moon face), fatigue, muscle weakness, high blood sugar (increased thirst, urination)
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 identify 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 change 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 identify 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 change 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 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 area of skin or near open wounds, exercise caution and discuss any concerns 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 may 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 any concerns.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to weigh the benefits and risks of using this medication to ensure the best possible outcome for you and your baby.
To minimize potential risks, 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 any concerns 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 may 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 any concerns.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to weigh the benefits and risks of using this medication to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic absorption, potentially causing Cushing's syndrome (characterized by weight gain, moon face, buffalo hump, high blood pressure, muscle weakness) and adrenal insufficiency (fatigue, weakness, nausea, vomiting, low blood pressure) upon withdrawal.
- Local skin atrophy, striae, telangiectasias.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition (type, severity, location of dermatosis)
Rationale: To assess initial state and guide treatment.
Timing: Prior to initiation of therapy
Area of body surface affected
Rationale: To estimate potential for systemic absorption and guide dosing.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical response (reduction in inflammation, pruritus)
Frequency: Regularly, at follow-up visits (e.g., weekly to bi-weekly initially)
Target: Significant improvement in symptoms
Action Threshold: Lack of improvement or worsening of condition after 2 weeks may indicate need for re-evaluation or alternative therapy.
Local adverse effects (skin atrophy, striae, telangiectasias, burning, itching, irritation, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, miliaria)
Frequency: At each follow-up visit
Target: Absence of these effects
Action Threshold: Presence of these effects requires dose reduction, discontinuation, or change in therapy.
Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, glycosuria, adrenal suppression)
Frequency: Periodically, especially with prolonged use, large surface areas, or occlusive dressings. Consider morning cortisol levels if adrenal suppression is suspected.
Target: Normal physiological parameters
Action Threshold: Abnormal findings require immediate medical attention and gradual withdrawal of the corticosteroid.
Symptom Monitoring
- Worsening of skin condition
- Increased redness, swelling, or pus (signs of infection)
- Severe burning, itching, or stinging at application site
- Skin thinning, easy bruising, or stretch marks (striae)
- Unusual hair growth
- Acne-like eruptions
- Weight gain, moon face, fatigue, muscle weakness (signs of systemic absorption)
Special Patient Groups
Pregnancy
Category C. Should be used 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 fetal harm not definitively established, but systemic absorption should be minimized.
Second Trimester:
Risk of systemic absorption and potential fetal effects (e.g., growth retardation) if used extensively.
Third Trimester:
Risk of systemic absorption and potential fetal effects (e.g., growth retardation) if used extensively.
Lactation
Caution is advised. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with limited, short-term use on small areas. Higher risk with extensive use, prolonged use, or application to areas where infant could ingest.
Pediatric Use
Children are more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, intracranial hypertension) due to a larger skin surface area to body weight ratio. Use the lowest effective dose for the shortest duration possible. Not recommended for prolonged use or on large body areas.
Geriatric Use
No specific dosage adjustments are necessary. However, elderly patients may have thinner, more fragile skin, increasing the risk of local adverse effects like skin atrophy and purpura. Monitor closely.
Clinical Information
Clinical Pearls
- Fluocinonide 0.05% is a high-potency topical corticosteroid; use it judiciously and for short durations to minimize local and systemic side effects.
- Educate patients on proper application technique: thin film, rub in gently, wash hands, and avoid occlusive dressings unless specifically instructed.
- Warn patients about potential for skin atrophy, striae, and telangiectasias, especially with prolonged use on sensitive areas (face, intertriginous areas).
- Be aware of the risk of rebound flares or worsening of the condition if the medication is stopped abruptly after prolonged use.
- Consider stepping down to a lower potency corticosteroid or alternative therapy once the acute inflammation is controlled.
Alternative Therapies
- Other topical corticosteroids (e.g., clobetasol propionate for higher potency, triamcinolone acetonide for medium potency, hydrocortisone for low potency)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing therapy, especially on the face or intertriginous areas.
- Emollients and moisturizers for barrier repair and symptom relief.
- Systemic therapies (e.g., oral corticosteroids, immunosuppressants, biologics) for severe, widespread, or refractory dermatoses.
Cost & Coverage
Average Cost:
Varies widely, typically $20-$100+ per 30gm 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 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 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.