Fluocinonide -E 0.05% Cream 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
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 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 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. Wash your hands before and after applying the medication, unless your hand is the area being treated, in which case you should not wash your hand after application.
Before applying the medication, clean the affected area and dry it thoroughly. 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 and keep it out of reach of children and pets, along with all other medications.
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 continue with 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 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. Wash your hands before and after applying the medication, unless your hand is the area being treated, in which case you should not wash your hand after application.
Before applying the medication, clean the affected area and dry it thoroughly. 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 and keep it out of reach of children and pets, along with all other medications.
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 continue with 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 cream.
- 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.
- Do not cover the treated area with bandages or tight dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid contact with eyes, mouth, and other mucous membranes.
- Do not use on the face, groin, or underarms unless specifically directed by your doctor, as these areas are more susceptible to side effects.
- 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 the severity of the condition.
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 (use with extreme caution due to increased systemic absorption risk)
Infant:
Not established (use with extreme caution due to increased systemic absorption risk)
Child:
Apply a thin film to the affected skin areas two to four times daily. Use the least amount compatible with an effective therapeutic regimen. Limit treatment to the smallest area and shortest duration possible. Avoid use on face, groin, or axillae.
Adolescent:
Apply a thin film to the affected skin areas two to four times daily.
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.
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 corticosteroid. It acts 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. Corticosteroids also suppress the migration of polymorphonuclear leukocytes and reverse increased capillary permeability.
Pharmacokinetics
Absorption:
Bioavailability:
Variable; depends on vehicle, integrity of epidermal barrier, duration of exposure, and use of occlusive dressings. Systemic absorption can occur.
Tmax:
Not applicable for topical application to achieve systemic peak; local effect is primary.
FoodEffect:
Not applicable for topical application.
Distribution:
Vd:
Not available (primarily local action)
ProteinBinding:
Not available (primarily local action)
CnssPenetration:
Limited (systemic absorption is minimal but can occur)
Elimination:
HalfLife:
Not precisely quantified for topical application due to variable absorption; systemically absorbed corticosteroids are eliminated via renal excretion.
Clearance:
Not precisely quantified for topical application.
ExcretionRoute:
Metabolites are primarily excreted by the kidneys.
Unchanged:
Minimal unchanged drug excreted.
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 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 or seek immediate 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 fainting
+ 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or do not go away:
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 immediate 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 fainting
+ 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or do not go away:
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 or new irritation (burning, itching, redness) at the application site.
- Signs of skin thinning, such as easy bruising, stretch marks, or changes in skin color.
- Acne-like breakouts or increased hair growth where the cream is applied.
- If you experience unusual fatigue, weight gain, swelling in your ankles/feet, or increased thirst/urination, contact your doctor immediately as these could be signs of systemic absorption.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is crucial 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 is essential to avoid potential interactions between this medication and other substances.
* Any existing health problems you have, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor. By sharing this information, you can help your doctor make informed decisions about your treatment and minimize potential risks.
It is crucial 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 is essential to avoid potential interactions between this medication and other substances.
* Any existing health problems you have, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor. By sharing this information, you can help your doctor make informed decisions about your treatment and minimize potential risks.
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.
When using this medication in children, it is crucial to 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. Discuss this with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication 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.
When using this medication in children, it is crucial to 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. Discuss this with your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic effects of corticosteroids, including Cushing's syndrome (moon face, buffalo hump, central obesity, thin skin, easy bruising), hyperglycemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
- Local symptoms may include severe skin atrophy, striae, and 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 assessment
Rationale: To establish baseline severity of dermatosis and identify areas for treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response (reduction in inflammation, pruritus)
Frequency: Regularly during treatment, typically weekly to bi-weekly initially.
Target: Improvement in symptoms and skin appearance.
Action Threshold: Lack of improvement or worsening of condition may indicate need for re-evaluation or alternative therapy.
Signs of local adverse reactions (e.g., skin atrophy, striae, telangiectasias, folliculitis, acneiform eruptions, perioral dermatitis, hypopigmentation)
Frequency: At each follow-up visit.
Target: Absence of or minimal local side effects.
Action Threshold: Presence of significant local adverse effects warrants reduction in potency, frequency, or discontinuation.
Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, HPA axis suppression)
Frequency: Periodically, especially with prolonged use, large surface area application, or occlusive dressings. Consider morning cortisol levels if HPA axis suppression is suspected.
Target: Normal systemic parameters.
Action Threshold: Abnormal findings require immediate medical attention and discontinuation/tapering of therapy.
Symptom Monitoring
- Worsening of skin condition
- New skin irritation, burning, itching, redness
- Thinning of skin, easy bruising
- Appearance of stretch marks (striae)
- Increased hair growth at application site
- Acne-like breakouts
- Changes in skin color (lightening)
- Unusual fatigue, weight gain, swelling (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 teratogenicity with high doses of systemic corticosteroids; topical absorption is generally low but caution advised.
Second Trimester:
Risk generally considered lower than first trimester, but still use with caution.
Third Trimester:
Risk generally considered lower than first trimester, but still use with caution. Potential for HPA axis suppression in the neonate with extensive maternal use near term.
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 of adverse effects in breastfed infants with typical topical use. Monitor for signs of systemic effects in infant if mother uses extensively.
Pediatric Use
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature adults due to a larger skin surface area to body weight ratio. Use the least potent corticosteroid for the shortest duration possible. Avoid use on face, groin, or axillae. Not recommended for infants or neonates.
Geriatric Use
No specific dosage adjustments are typically required. However, elderly patients may have thinner skin, which could potentially increase systemic absorption or local adverse effects. Use with caution and monitor for skin integrity.
Clinical Information
Clinical Pearls
- Fluocinonide 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: apply a thin film, do not use excessive amounts, and avoid occlusive dressings unless specifically instructed.
- Warn patients about potential skin thinning, stretch marks, and discoloration, especially with prolonged use or on sensitive areas.
- Consider step-down therapy to a lower potency corticosteroid or non-steroidal agent once the acute inflammation is controlled.
- Avoid abrupt discontinuation after prolonged use on large areas, as this can lead to rebound flare-ups of the dermatosis.
Alternative Therapies
- Other topical corticosteroids (e.g., clobetasol, betamethasone, triamcinolone, hydrocortisone) of varying potencies.
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema.
- Topical vitamin D analogs (e.g., calcipotriene) for psoriasis.
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread dermatoses.
Cost & Coverage
Average Cost:
Varies widely, typically $30-$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 taken, the amount, and the time it happened.