Fluocinonide -E 0.05% Cream 60gm
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 corticosteroid cream used on the skin to reduce inflammation, itching, and redness caused by various skin conditions like eczema and psoriasis. It works by calming down the body's immune response in the skin.
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 precisely. 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 irritation or 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 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 instructed 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 medication's effectiveness and safety, store it at room temperature with the lid tightly closed. Protect it from heat sources. Keep all medications in a 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 to you and follow the instructions precisely. 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 irritation or 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 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 instructed 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 medication's effectiveness and safety, store it at room temperature with the lid tightly closed. Protect it from heat sources. Keep all medications in a 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 thin layer of cream to the affected skin area as directed by your doctor, usually 2 to 4 times a day.
- Gently rub it in completely.
- Wash your hands before and after applying the cream, unless your hands are the treated area.
- Do not use this medication on your face, groin, or armpits unless specifically instructed by your doctor.
- Do not cover the treated area with bandages, plastic wrap, or other occlusive dressings unless your doctor tells you to, as this can increase absorption and side effects.
- Avoid getting the cream in your eyes, nose, or mouth. If it gets into these areas, rinse thoroughly with water.
- Do not use for longer than prescribed, as prolonged use can lead to skin thinning or other 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 2 to 4 times daily.
Condition-Specific Dosing:
psoriasis:
Apply a thin film to the affected area 2 to 4 times daily.
eczema:
Apply a thin film to the affected area 2 to 4 times daily.
Pediatric Dosing
Neonatal:
Not established. Use generally not recommended due to increased systemic absorption risk.
Infant:
Not established. Use generally not recommended due to increased systemic absorption risk.
Child:
Apply a thin film to the affected area 2 to 4 times daily. Limit treatment to the least amount necessary for therapeutic effect. Avoid prolonged use or use on large body surface areas due to increased risk of systemic absorption and HPA axis suppression.
Adolescent:
Apply a thin film to the affected area 2 to 4 times daily. Limit treatment to the least amount necessary for therapeutic effect.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations needed due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Fluocinonide is a high-potency 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. Corticosteroids also possess vasoconstrictive, antipruritic, and anti-inflammatory properties.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (depends on skin integrity, vehicle, use of occlusive dressings, and duration of treatment)
Tmax:
Not applicable for topical absorption (systemic levels are generally low)
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not available (systemic distribution is minimal)
ProteinBinding:
Not available (systemic protein binding would occur if absorbed)
CnssPenetration:
Limited (systemic absorption is minimal)
Elimination:
HalfLife:
Not available (systemic half-life not clinically relevant for topical use)
Clearance:
Not available
ExcretionRoute:
Renal (metabolites are primarily excreted by the kidneys)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Hours to days (for anti-inflammatory and antipruritic effects)
PeakEffect:
Days to weeks (with consistent application)
DurationOfAction:
Varies with application frequency (typically 12-24 hours per application)
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help 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 have minor ones, it's essential to contact your doctor or seek medical help if you're bothered by any of the following:
Burning or stinging
Dry skin
Itching
This is not an exhaustive list of all 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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help 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 have minor ones, it's essential to contact your doctor or seek medical help if you're bothered by any of the following:
Burning or stinging
Dry skin
Itching
This is not an exhaustive list of all 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 no improvement after a few days/weeks of treatment.
- Signs of skin infection (e.g., pus, spreading redness, fever).
- Severe burning, itching, irritation, or dryness at the application site.
- New skin problems like thinning skin, stretch marks, acne, or changes in skin color.
- Signs of systemic absorption, especially with prolonged or extensive use: unusual weight gain, rounding of the face (moon face), fatigue, muscle weakness, swelling in ankles/feet, or vision problems.
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.
* 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 with all your current medications and health conditions. Never 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.
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.
* 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 with all your current medications and health conditions. Never 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 an 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 an 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:
- Symptoms of Cushing's syndrome (e.g., moon face, central obesity, thinning skin, easy bruising, muscle weakness)
- Hyperglycemia (high blood sugar)
- Glucosuria (sugar in the urine)
- Suppression of the hypothalamic-pituitary-adrenal (HPA) axis (fatigue, weakness, nausea, vomiting, low blood pressure)
What to Do:
If you suspect an overdose or significant systemic absorption, contact your doctor or poison control center immediately. Call 1-800-222-1222. Treatment is symptomatic and supportive. Gradual withdrawal of the corticosteroid may be necessary to prevent adrenal insufficiency.
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
Area of involvement
Rationale: To determine the extent of skin affected and guide appropriate amount of medication.
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy of treatment
Frequency: Weekly or as clinically indicated
Target: Reduction in inflammation, pruritus, and erythema
Action Threshold: Lack of improvement or worsening symptoms may require re-evaluation of diagnosis or treatment plan.
Local adverse effects (e.g., skin atrophy, striae, telangiectasias, folliculitis, acneiform eruptions, hypopigmentation)
Frequency: At each follow-up visit
Target: Absence of or minimal local side effects
Action Threshold: Presence of significant local side effects may require reduction in frequency, change to lower potency steroid, or discontinuation.
Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, glucosuria, HPA axis suppression)
Frequency: Periodically, especially with prolonged use, extensive body surface area application, or occlusive dressings
Target: Normal adrenal function, blood glucose levels
Action Threshold: Symptoms or signs of systemic absorption warrant immediate discontinuation and medical evaluation.
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
- Telangiectasias
- Unusual weight gain
- Moon face
- Fatigue
- Muscle weakness
Special Patient Groups
Pregnancy
Fluocinonide is Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity observed in animal studies with high doses of corticosteroids. Human data are limited.
Second Trimester:
Risk of systemic absorption and potential fetal effects, though generally low with topical use.
Third Trimester:
Risk of systemic absorption and potential fetal effects, though generally low with topical use. Neonates born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
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 direct infant exposure.
Infant Risk:
Low risk with appropriate use, but monitor infant for any unusual effects. Avoid direct contact with infant's skin.
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 topical corticosteroid therapy should be avoided in pediatric patients. Not recommended for infants. Use the least potent effective corticosteroid for the shortest duration possible.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may have thinner skin, which could increase the risk of local side effects like atrophy or purpura. Use with caution and monitor for skin integrity.
Clinical Information
Clinical Pearls
- Fluocinonide is a high-potency (Class II) topical corticosteroid. Use it sparingly and for limited durations to minimize local and systemic side effects.
- Avoid using on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more susceptible to corticosteroid-induced skin atrophy, telangiectasias, and striae.
- Occlusive dressings significantly increase systemic absorption and should only be used if explicitly prescribed by a healthcare professional.
- Not for use in fungal, viral, or bacterial skin infections without concomitant appropriate antimicrobial therapy.
- Patients should be advised to report any signs of local irritation, infection, or systemic side effects promptly.
Alternative Therapies
- Other topical corticosteroids (e.g., Clobetasol, Betamethasone, Triamcinolone, Mometasone)
- Topical calcineurin inhibitors (e.g., Tacrolimus, Pimecrolimus) for conditions like eczema
- Emollients and moisturizers for dry skin conditions
- Systemic therapies (e.g., oral corticosteroids, immunosuppressants) for severe, widespread dermatoses
Cost & Coverage
Average Cost:
$20 - $60 per 60gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 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 emergency 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.