Fluocinonide 0.1% 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
Pregnancy Category
Category C
FDA Approved
Jun 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluocinonide 0.1% Cream 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
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.
Unless instructed by your doctor, do not apply the medication to your face, underarms, or groin area.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Do not cover the treated area with bandages or dressings unless your doctor advises you to do so.
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.
Unless instructed by your doctor, do not apply the medication to your face, underarms, or groin area.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Do not cover the treated area with bandages or dressings unless your doctor advises you to do so.
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 of cream to the affected skin area, gently rubbing it in until it disappears.
- Do not use more cream than prescribed or apply it more often than directed.
- Do not cover the treated area with bandages or other dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid applying the cream to your face, groin, or armpits unless directed by your doctor.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use this cream for longer than prescribed, especially on children, as it can lead to serious 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 skin areas two to four times daily, depending on the severity of the condition.
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
Infant:
Apply a thin film to the affected skin areas two to four times daily. Use with caution, especially on large surface areas or under occlusion, due to increased risk of systemic absorption.
Child:
Apply a thin film to the affected skin areas two to four times daily. Use with caution, especially on large surface areas or under occlusion, due to increased risk of systemic absorption.
Adolescent:
Apply a thin film to the affected skin areas two to four times daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for topical application.
Moderate:
No adjustment needed for topical application.
Severe:
No adjustment needed for topical application.
Dialysis:
No specific considerations for topical application.
Hepatic Impairment:
Mild:
No adjustment needed for topical application.
Moderate:
No adjustment needed for topical application.
Severe:
No adjustment needed for topical application.
Pharmacology
Mechanism of Action
Fluocinonide is a high-potency corticosteroid. It exerts its therapeutic effects primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions. Corticosteroids are thought to act 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:
Variable (systemic absorption can occur, especially with prolonged use, large surface areas, inflamed skin, or occlusive dressings)
Tmax:
Not applicable for topical application (systemic absorption is generally minimal)
FoodEffect:
Not applicable
Distribution:
Vd:
Not precisely quantified for topical application
ProteinBinding:
Variable (systemically absorbed corticosteroids are bound to plasma proteins, primarily transcortin and albumin)
CnssPenetration:
Limited (systemic absorption is generally minimal)
Elimination:
HalfLife:
Not precisely quantified for topical application (systemically absorbed corticosteroids have variable half-lives)
Clearance:
Not precisely quantified for topical application
ExcretionRoute:
Renal (systemically absorbed metabolites)
Unchanged:
Not precisely quantified
Pharmacodynamics
OnsetOfAction:
Hours to days (for symptomatic relief)
PeakEffect:
Days to weeks (for maximal therapeutic effect)
DurationOfAction:
Varies with frequency of application and severity of condition
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: 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, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme 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:
Burning or stinging sensation
Dry skin
Itching
This is not an exhaustive list of potential side effects. If you have questions or concerns, 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 or seek immediate 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, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme 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:
Burning or stinging sensation
Dry skin
Itching
This is not an exhaustive list of potential side effects. If you have questions or concerns, 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 irritation, burning, or itching at the application site.
- Signs of skin infection (e.g., pus, spreading redness, fever).
- Thinning of the skin, easy bruising, or stretch marks (striae) where the cream is applied.
- Acne-like breakouts or increased hair growth in the treated area.
- Any signs of systemic side effects, especially in children, such as unusual weight gain, rounding of the face (moon face), delayed growth, or fatigue (signs of Cushing's syndrome or adrenal suppression).
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 affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
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
Natural products, such as herbal supplements
Vitamins
Any existing health problems
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. 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.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
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
Natural products, such as herbal supplements
Vitamins
Any existing health problems
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. 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.
To apply this medication correctly, avoid putting it on cuts, scrapes, or damaged skin. When applying it to a large area of skin or near open wounds, exercise caution and discuss with your doctor.
Use this medication only for the duration prescribed by your doctor. Do not exceed the recommended treatment period.
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.
This medication is not intended to treat acne, rosacea, or rashes around the mouth. If you are a parent or caregiver of a child using this medication, use it with caution, as children may be at a higher risk of experiencing certain side effects.
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so be sure to discuss this with your doctor.
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 outcome for you and your baby.
To apply this medication correctly, avoid putting it on cuts, scrapes, or damaged skin. When applying it to a large area of skin or near open wounds, exercise caution and discuss with your doctor.
Use this medication only for the duration prescribed by your doctor. Do not exceed the recommended treatment period.
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.
This medication is not intended to treat acne, rosacea, or rashes around the mouth. If you are a parent or caregiver of a child using this medication, use it with caution, as children may be at a higher risk of experiencing certain side effects.
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so be sure to discuss this with your doctor.
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 outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic absorption, potentially causing symptoms of hypercorticism (Cushing's syndrome), hyperglycemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 for poison control advice.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify any contraindications (e.g., skin infections).
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response (reduction in inflammation, pruritus)
Frequency: Periodically, as clinically indicated (e.g., weekly to bi-weekly initially, then less frequently)
Target: Improvement in symptoms and appearance of skin lesions.
Action Threshold: Lack of improvement or worsening of symptoms after 2-4 weeks may indicate need for re-evaluation or alternative therapy.
Local adverse effects (e.g., skin atrophy, striae, telangiectasias, folliculitis, perioral dermatitis)
Frequency: At each follow-up visit, especially with prolonged use.
Target: Absence of significant skin changes.
Action Threshold: Presence of significant skin atrophy or other adverse effects warrants reduction in frequency, potency, or discontinuation.
Signs of HPA axis suppression (e.g., fatigue, weakness, weight loss, hypotension) - primarily in pediatric patients or with extensive/occlusive use
Frequency: Consider if large areas are treated, prolonged use, or in pediatric patients.
Target: Normal adrenal function.
Action Threshold: Symptoms suggestive of HPA axis suppression may require laboratory testing (e.g., ACTH stimulation test) and gradual withdrawal of therapy.
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 systemic absorption (e.g., Cushing's syndrome, hyperglycemia, glucosuria, HPA axis suppression)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Category C.
Trimester-Specific Risks:
First Trimester:
Limited data, potential for teratogenicity with high doses of systemic corticosteroids. Topical absorption is generally low.
Second Trimester:
Limited data, potential for teratogenicity with high doses of systemic corticosteroids. Topical absorption is generally low.
Third Trimester:
Limited data, potential for teratogenicity with high doses of systemic corticosteroids. Topical absorption is generally low.
Lactation
Caution should be exercised when fluocinonide is administered to a nursing woman. 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 appropriate use, but monitor for potential systemic effects in infant if significant maternal absorption occurs.
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. Use the least potent effective corticosteroid for the shortest duration possible. Avoid occlusive dressings and prolonged use.
Geriatric Use
No specific dosage adjustments are typically required. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects (e.g., skin atrophy, purpura) and potentially systemic absorption. Monitor for skin integrity and adverse effects.
Clinical Information
Clinical Pearls
- Fluocinonide 0.1% Cream is a high-potency topical corticosteroid; use it sparingly and for the shortest duration necessary to control symptoms.
- Avoid prolonged use, especially on the face, groin, or axillae, due to increased risk of skin atrophy, telangiectasias, and striae.
- Educate patients on proper application technique: a thin film, gently rubbed in, and avoiding occlusive dressings unless specifically instructed.
- Monitor pediatric patients closely for signs of HPA axis suppression, as they are more susceptible.
- If no improvement is seen after 2-4 weeks, re-evaluate the diagnosis and treatment plan.
Alternative Therapies
- Other topical corticosteroids (e.g., clobetasol propionate, betamethasone dipropionate, triamcinolone acetonide, 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
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe cases
Cost & Coverage
Average Cost:
$30 - $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 is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.