Fluocinonide 0.05% Ointment 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
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
This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. 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 that hand after application. Clean the affected area before applying the medication and make sure it is completely dry. Then, 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.
Storage and Disposal
To maintain the medication's effectiveness, store it at room temperature with the lid tightly closed. Protect the medication from heat sources. Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose
If you forget to apply a dose, put it on 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 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 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
This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. 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 that hand after application. Clean the affected area before applying the medication and make sure it is completely dry. Then, 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.
Storage and Disposal
To maintain the medication's effectiveness, store it at room temperature with the lid tightly closed. Protect the medication from heat sources. Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose
If you forget to apply a dose, put it on 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 application schedule. Do not apply two doses at the same time or use extra doses to make up for a missed one.
Lifestyle & Tips
- Wash hands before and after applying the ointment.
- Apply a thin layer of ointment only to the affected skin areas as directed by your doctor.
- Do not use more than the prescribed amount 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 prone 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.
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
Infant:
Not established, use with extreme caution due to higher surface area to body weight ratio and potential for systemic absorption.
Child:
Apply a thin film to the affected skin areas two to four times daily. Use with caution, for shortest duration possible, and smallest amount necessary. Avoid use on face, groin, or axillae, or under occlusive dressings.
Adolescent:
Apply a thin film to the affected skin areas two to four times daily. Use with caution, for shortest duration possible, and smallest amount necessary. Avoid use on face, groin, or axillae, or under occlusive dressings.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for topical use.
Moderate:
No adjustment needed for topical use.
Severe:
No adjustment needed for topical use.
Dialysis:
No specific considerations for topical use, systemic absorption is minimal.
Hepatic Impairment:
Mild:
No adjustment needed for topical use.
Moderate:
No adjustment needed for topical use.
Severe:
No adjustment needed for topical use.
Pharmacology
Mechanism of Action
Fluocinonide is a high-potency corticosteroid. It exerts its anti-inflammatory, antipruritic, and vasoconstrictive actions by inducing phospholipase A2 inhibitory proteins, 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 is generally low but can increase significantly with prolonged use, extensive body surface area application, occlusive dressings, or compromised skin barrier. Percutaneous absorption ranges from less than 1% to 5%.
Tmax:
Not well-defined for topical application; systemic effects, if any, would be delayed.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not well-defined for topical administration; if absorbed systemically, distributes throughout the body.
ProteinBinding:
If absorbed systemically, corticosteroids are bound to plasma proteins to varying degrees, primarily to globulin and albumin.
CnssPenetration:
Limited, unless significant systemic absorption occurs.
Elimination:
HalfLife:
Not well-defined for topical administration; systemic half-life of corticosteroids varies.
Clearance:
Not well-defined for topical administration.
ExcretionRoute:
Primarily renal, if absorbed systemically.
Unchanged:
Minimal, if absorbed systemically.
Pharmacodynamics
OnsetOfAction:
Within hours to days for anti-inflammatory and antipruritic effects.
PeakEffect:
Days to weeks of consistent application.
DurationOfAction:
Varies with frequency of application and individual response; effects persist as long as applied.
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 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 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 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 questions or concerns, don't hesitate to reach out to 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 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 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 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 questions or concerns, don't hesitate to reach out to 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, swelling, or irritation at the application site.
- Thinning of the skin (atrophy), easy bruising, or stretch marks (striae).
- Acne-like breakouts or increased hair growth in the treated area.
- Signs of infection (pus, fever, worsening pain).
- Unusual weight gain, swelling in the face, or fatigue (signs of systemic absorption, rare but serious).
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 assess 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 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 assess 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 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 minimize potential risks, avoid applying this medication to cuts, scrapes, or damaged skin. When applying it to a large skin area or near open wounds, exercise caution and discuss the application 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 can 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, making regular growth checks necessary. Consult with your doctor to discuss the potential risks and benefits.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to weigh the benefits and risks of using this medication for both you and your baby.
To minimize potential risks, avoid applying this medication to cuts, scrapes, or damaged skin. When applying it to a large skin area or near open wounds, exercise caution and discuss the application 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 can 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, making regular growth checks necessary. Consult with your doctor to discuss the potential risks and benefits.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to weigh the benefits and risks of using this medication for both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including: moon face, central obesity, striae, muscle weakness, hypertension, hyperglycemia, and adrenal suppression.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call a poison control center immediately (1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition and extent of dermatosis
Rationale: To establish a baseline for evaluating treatment efficacy and adverse effects.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (reduction in inflammation, pruritus, erythema)
Frequency: Regularly, at follow-up visits (e.g., weekly to bi-weekly initially, then as needed).
Target: Improvement in symptoms and appearance of affected skin.
Action Threshold: Lack of improvement or worsening of symptoms may indicate need for re-evaluation of diagnosis or treatment.
Local skin adverse reactions (e.g., atrophy, striae, telangiectasias, folliculitis, burning, itching, irritation)
Frequency: At each follow-up visit and patient self-monitoring.
Target: Absence or minimal signs of adverse reactions.
Action Threshold: Presence of significant or worsening local adverse reactions warrants discontinuation or change in therapy.
Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, HPA axis suppression)
Frequency: Periodically, especially with extensive or prolonged use, or in pediatric patients. Consider morning cortisol levels if HPA axis suppression is suspected.
Target: Normal adrenal function.
Action Threshold: Signs of systemic absorption require immediate discontinuation and medical evaluation.
Symptom Monitoring
- Burning
- Itching
- Irritation
- Dryness
- Folliculitis
- Hypertrichosis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Skin maceration
- Secondary infection
- Skin atrophy
- Striae
- Miliaria
- Weight gain (rare, systemic)
- Moon face (rare, systemic)
- Fatigue (rare, systemic)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with corticosteroids. Systemic absorption is possible with topical use.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenic effects, though risk from topical use is low.
Second Trimester:
Risk generally considered low with appropriate topical use.
Third Trimester:
Risk generally considered low with appropriate topical use; however, high doses or prolonged use near term could theoretically affect fetal adrenal function.
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. If used, avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with appropriate use, but monitor infant for any unusual effects.
Pediatric Use
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients due to a larger skin surface area to body weight ratio. Use the least potent corticosteroid for the shortest duration possible. Avoid occlusive dressings. Not recommended for infants.
Geriatric Use
No specific dosage adjustments are typically needed. However, elderly patients may have thinner skin, which could increase susceptibility to local adverse effects like skin atrophy and purpura. Monitor closely for skin integrity.
Clinical Information
Clinical Pearls
- Fluocinonide 0.05% ointment is a high-potency topical corticosteroid. It should be used for short durations (typically no more than 2-4 weeks) to avoid skin atrophy and other local side effects.
- The ointment formulation is generally more potent and occlusive than creams or gels, making it suitable for dry, scaly lesions.
- Avoid using on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more susceptible to side effects like skin thinning and striae.
- Patients should be instructed on the 'fingertip unit' method for appropriate dosing to avoid overuse.
- Tapering off high-potency corticosteroids after prolonged use may be necessary to prevent rebound flares of the skin condition.
Alternative Therapies
- Other topical corticosteroids (e.g., clobetasol propionate, betamethasone dipropionate, triamcinolone acetonide, hydrocortisone)
- Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for sensitive areas or long-term use
- Vitamin D analogs (e.g., calcipotriene) for psoriasis
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread conditions
- Emollients and moisturizers for barrier repair
Cost & Coverage
Average Cost:
$20 - $100 per 30gm 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 ensure you receive the best possible care.