Fluocinonide 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 0.05% Cream is a strong topical steroid medication used to reduce redness, itching, and swelling caused by various skin conditions like eczema and psoriasis. It works by calming down the skin's immune response.
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
- 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 until it disappears.
- Wash your hands before and after applying the cream, unless your hands are the treated area.
- 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, as these areas are more sensitive to side effects.
- Do not use for longer than prescribed, especially on children, as prolonged use can lead to skin thinning or other side effects.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use on open wounds or infected skin without specific medical advice.
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.
Dose Range:
2 - 4 mg
Condition-Specific Dosing:
psoriasis:
Apply 2 to 4 times daily, may use occlusive dressings for severe cases under medical supervision.
eczema:
Apply 2 to 4 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Apply a thin film to the affected area 2 to 4 times daily. Use with caution; increased risk of systemic absorption due to higher surface area to body weight ratio and immature skin barrier. Avoid occlusive dressings.
Child:
Apply a thin film to the affected area 2 to 4 times daily. Use with caution; increased risk of systemic absorption. Avoid occlusive dressings.
Adolescent:
Apply a thin film to the affected area 2 to 4 times daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically needed for topical use.
Moderate:
No adjustment typically needed for topical use.
Severe:
No adjustment typically needed for topical use.
Dialysis:
No specific considerations for topical use, as systemic absorption is minimal.
Hepatic Impairment:
Mild:
No adjustment typically needed for topical use.
Moderate:
No adjustment typically needed for topical use.
Severe:
No adjustment typically needed for topical use.
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:
Varies (generally low, but increased by inflammation, skin barrier defects, occlusion, and application to thin skin areas)
Tmax:
Not well-defined for topical application
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not available (minimal systemic distribution from topical use)
ProteinBinding:
Not available (minimal systemic protein binding from topical use)
CnssPenetration:
Limited
Elimination:
HalfLife:
Not well-defined for topical application
Clearance:
Not available
ExcretionRoute:
Renal (if systemically absorbed)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief
PeakEffect:
Within days of consistent application
DurationOfAction:
Varies, generally requires multiple daily applications
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 medical attention immediately:
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 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 do not go away, contact your doctor or seek medical help:
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, 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 medical attention immediately:
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 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 do not go away, contact your doctor or seek medical help:
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, 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, or irritation at the application site
- Burning or stinging sensation that doesn't go away
- Skin thinning, easy bruising, or stretch marks (striae)
- Changes in skin color (lightening or darkening)
- Development of acne-like bumps or increased hair growth in the treated area
- Signs of a new skin infection (pus, worsening pain, fever)
- Any signs of systemic side effects with prolonged or extensive use, such as unusual weight gain, swelling in the face, or fatigue (rare)
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 drug may interact with other prescription or over-the-counter medications, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as these may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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 drug may interact with other prescription or over-the-counter medications, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as these may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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 an extended period beyond the duration prescribed by your doctor. If the treated area is in the diaper region, 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, 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. Consult with your doctor to discuss this potential risk.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the benefits and risks of using this medication with you, considering both your health and the health of 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 an extended period beyond the duration prescribed by your doctor. If the treated area is in the diaper region, 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, 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. Consult with your doctor to discuss this potential risk.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to discuss the benefits and risks of using this medication with you, considering both your health and the health of your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic absorption and symptoms of hypercorticism (e.g., Cushing's syndrome), including: weight gain, moon face, central obesity, thinning skin, easy bruising, muscle weakness, and hyperglycemia.
- Adrenal suppression (fatigue, weakness, nausea, vomiting, low blood pressure) can occur, especially in children.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition and extent of dermatosis
Rationale: To establish baseline severity and guide treatment.
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy (reduction in inflammation, pruritus)
Frequency: Weekly to bi-weekly during initial treatment, then as needed
Target: Significant improvement in symptoms
Action Threshold: Lack of improvement or worsening symptoms after 1-2 weeks; consider alternative diagnosis or treatment.
Local adverse reactions (e.g., atrophy, striae, telangiectasias, burning, itching, irritation, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection)
Frequency: At each follow-up visit
Target: Absence or minimal reactions
Action Threshold: Presence of significant or worsening local reactions; discontinue use or reduce frequency/potency.
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 systemic effects
Action Threshold: Any signs or symptoms of systemic absorption; discontinue use and evaluate adrenal function.
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
- Weight gain (rare, systemic)
- Moon face (rare, systemic)
- Fatigue (rare, systemic)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown corticosteroids to be teratogenic. Systemic absorption is possible with topical use.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though systemic absorption from topical use is generally low.
Second Trimester:
Risk generally considered low with appropriate topical use.
Third Trimester:
Risk generally considered low with appropriate topical use.
Lactation
Use with caution. 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 infant for potential adverse effects if extensive maternal use.
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 corticosteroid that is effective. Avoid prolonged use and occlusive dressings. Monitor for growth retardation and delayed weight gain.
Geriatric Use
No specific dosage adjustments are required. However, elderly patients may have thinner skin and be more prone to skin atrophy and other local side effects. Monitor for skin integrity and adverse reactions.
Clinical Information
Clinical Pearls
- Fluocinonide 0.05% is a high-potency topical corticosteroid; use it sparingly and for short durations (typically no more than 2-4 weeks) to minimize side effects, especially on sensitive areas.
- Avoid using on the face, groin, or axillae unless specifically directed by a dermatologist, due to increased risk of skin atrophy, telangiectasias, and perioral dermatitis.
- Occlusive dressings significantly increase systemic absorption and local side effects; use only if specifically prescribed by a physician.
- Patients should be advised to report any signs of local irritation, infection, or systemic effects (e.g., unusual weight gain, swelling) to their healthcare provider.
- Tapering off high-potency steroids after prolonged use may be necessary to prevent rebound flares of the dermatosis.
Alternative Therapies
- Clobetasol propionate (very high potency)
- Betamethasone dipropionate (high potency)
- Mometasone furoate (medium potency)
- Triamcinolone acetonide (medium potency)
- Hydrocortisone (low potency)
- Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing therapy
- Crisaborole (Eucrisa) for mild to moderate atopic dermatitis
Cost & Coverage
Average Cost:
$15 - $50 per 60gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.