Fluocinonide 0.05% Oint 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
Pregnancy Category
Category C
FDA Approved
Jun 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluocinonide 0.05% ointment is a strong medicine (a corticosteroid) that you put on your skin. It helps reduce redness, swelling, and itching caused by skin conditions like eczema or psoriasis. It works by calming down your 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 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 your 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. Then, apply a thin layer of the medication to the affected skin and gently rub it in. Unless your doctor instructs you to do so, do not cover the treated area with bandages or dressings.
Storing and Disposing of Your Medication
To maintain the medication's effectiveness, 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 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 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 your 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. Then, apply a thin layer of the medication to the affected skin and gently rub it in. Unless your doctor instructs you to do so, do not cover the treated area with bandages or dressings.
Storing and Disposing of Your Medication
To maintain the medication's effectiveness, 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 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 your hands before and after applying the ointment.
- Apply a very thin layer of ointment to the affected skin area. Do not use more than directed.
- Rub it in gently until it disappears.
- Do not cover the treated area with bandages or tight dressings unless your doctor tells you to, as this can increase absorption and side effects.
- Avoid applying to the face, groin, or armpits unless specifically instructed by your doctor, as these areas are more sensitive to side effects.
- Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
- Do not use for longer than prescribed, especially on children, as prolonged use can lead to serious side effects.
- 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 two to four times daily, depending on the severity of the condition.
Dose Range:
2 - 4 mg
Condition-Specific Dosing:
eczema:
Apply a thin film to the affected area 2-4 times daily.
psoriasis:
Apply a thin film to the affected area 2-4 times daily.
Pediatric Dosing
Neonatal:
Not established. Use with extreme caution due to increased risk of systemic absorption and HPA axis suppression.
Infant:
Not established. Use with extreme caution due to increased risk of systemic absorption and HPA axis suppression. Limit duration and area of application.
Child:
Apply a thin film to the affected area sparingly, once or twice daily, for the shortest duration possible. Monitor closely for systemic effects.
Adolescent:
Apply a thin film to the affected area two to four times daily, similar to adults, but monitor for systemic effects if used extensively or for prolonged periods.
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, as systemic absorption is minimal.
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 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. Thus, fluocinonide exerts anti-inflammatory, antipruritic, and vasoconstrictive actions.
Pharmacokinetics
Absorption:
Bioavailability:
Variable; systemic absorption is generally low but can increase significantly with prolonged use, application to large surface areas, occlusive dressings, inflamed or damaged skin, and in pediatric patients. Bioavailability is not precisely quantified for topical application.
Tmax:
Not precisely quantified for topical application; local effects are seen rapidly.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not precisely quantified for topical application; systemically absorbed corticosteroids are bound to plasma proteins to varying degrees.
ProteinBinding:
Not precisely quantified for topical application; systemically absorbed corticosteroids are bound to plasma proteins.
CnssPenetration:
Limited systemic absorption, therefore CNS penetration is minimal under normal topical use.
Elimination:
HalfLife:
Not precisely quantified for topical application; systemically absorbed corticosteroids are excreted renally.
Clearance:
Not precisely quantified for topical application.
ExcretionRoute:
Renal excretion of metabolites.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Within hours for symptomatic relief (e.g., reduction in itching, redness).
PeakEffect:
Within days of consistent application.
DurationOfAction:
Effects persist as long as the drug is applied; local effects can last for several hours after application.
Safety & Warnings
Side Effects
Urgent 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: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, feeling sleepy, 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 unusual symptoms that bother you or do not go away, contact your doctor:
Burning or stinging sensation
Dry skin
Itching
This is not an exhaustive list of 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, 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: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, feeling sleepy, 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 unusual symptoms that bother you or do not go away, contact your doctor:
Burning or stinging sensation
Dry skin
Itching
This is not an exhaustive list of 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 where the ointment is applied (may indicate allergic reaction or worsening condition).
- Thinning of the skin, easy bruising, or stretch marks (striae) in the treated area.
- Acne-like breakouts or increased hair growth in the treated area.
- Signs of skin infection (pus, fever, spreading redness).
- Unusual weight gain, swelling in the face or ankles, increased thirst or urination (signs of systemic absorption and potential hormonal imbalance).
- Blurred vision or other eye problems (if applied near eyes).
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 allergic reaction you experienced, including any symptoms that occurred.
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 this medication can be taken with all your other medications and health conditions. Never start, stop, or change the dose 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 allergic reaction you experienced, including any symptoms that occurred.
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 this medication can be taken with all your other medications and health conditions. Never start, stop, or change the dose 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, planning 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 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, planning 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, especially over large areas or under occlusion, can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including:
- Weight gain (especially in the face and trunk)
- Moon face
- Buffalo hump
- Thinning skin, easy bruising
- Muscle weakness
- Fatigue
- High blood sugar (hyperglycemia)
- High blood pressure
- Adrenal suppression (HPA axis suppression)
What to Do:
If you suspect an overdose or systemic side effects, stop using the medication and contact your doctor or poison control center immediately. For severe symptoms, seek emergency medical attention. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis, identify areas of inflammation, infection, or atrophy.
Timing: Prior to initiation of therapy.
Extent of affected body surface area (BSA)
Rationale: To guide appropriate amount of medication and assess risk of systemic absorption.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (reduction in inflammation, pruritus, erythema)
Frequency: Weekly or bi-weekly during initial treatment, then as clinically indicated.
Target: Significant improvement in symptoms and skin appearance.
Action Threshold: Lack of improvement or worsening symptoms may indicate need for re-evaluation, alternative therapy, or presence of infection.
Local adverse effects (skin atrophy, striae, telangiectasias, folliculitis, signs of infection)
Frequency: At each follow-up visit, especially with prolonged use.
Target: Absence of new or worsening local adverse effects.
Action Threshold: Development of significant local adverse effects warrants reduction in frequency, change to lower potency steroid, or discontinuation.
Signs of systemic absorption (e.g., HPA axis suppression, Cushing's syndrome symptoms)
Frequency: Periodically, especially in pediatric patients, with extensive use, or under occlusion.
Target: Absence of systemic symptoms.
Action Threshold: Presence of symptoms (e.g., weight gain, moon face, fatigue, hyperglycemia) requires immediate evaluation and potential discontinuation.
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
- Fatigue
- Muscle weakness
- Increased thirst/urination (signs of hyperglycemia)
Special Patient Groups
Pregnancy
Fluocinonide is classified as Pregnancy Category C. It should be used 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 low with topical use, but the potential for fetal harm cannot be completely ruled out.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though systemic absorption is low. Use only if clearly needed.
Second Trimester:
Risk generally considered lower than first trimester, but still use with caution and only if benefits outweigh risks.
Third Trimester:
Risk of HPA axis suppression in the neonate with prolonged or extensive maternal use near term. Use with caution.
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 of adverse effects to the infant due to minimal systemic absorption, but monitor for any unusual symptoms. 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 due to a larger skin surface area to body weight ratio. Use the smallest amount for the shortest duration possible. Avoid occlusive dressings. Monitor for growth retardation, delayed weight gain, and other signs of systemic toxicity.
Geriatric Use
No specific dose adjustments are recommended for geriatric patients. However, elderly patients may have thinner skin, which could potentially increase systemic absorption. Monitor for adverse effects, particularly skin atrophy.
Clinical Information
Clinical Pearls
- Fluocinonide 0.05% ointment is a high-potency topical corticosteroid; it should be used judiciously and typically for short-term treatment of severe dermatoses.
- Avoid prolonged continuous use (e.g., more than 2-4 weeks) to minimize the risk of local side effects (skin atrophy, striae) and systemic absorption.
- Not recommended for use on the face, groin, or axillae due to increased risk of skin thinning and other adverse effects in these sensitive areas, unless specifically directed by a dermatologist.
- If long-term therapy is required, consider intermittent dosing (e.g., 2-3 days on, 4-5 days off) or switching to a lower-potency corticosteroid.
- Patients should be educated on proper application technique (thin film, gentle rubbing) and the importance of not exceeding prescribed amounts or duration.
- Tapering the frequency of application may be necessary after prolonged use to prevent rebound flares of the skin condition.
Alternative Therapies
- Other topical corticosteroids of varying potencies (e.g., clobetasol propionate, betamethasone dipropionate, triamcinolone acetonide, hydrocortisone).
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for conditions like eczema, especially on sensitive areas.
- Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole) for mild to moderate atopic dermatitis.
- Topical retinoids (e.g., tazarotene) for psoriasis.
- Vitamin D analogs (e.g., calcipotriene) for psoriasis.
- Emollients and moisturizers for barrier repair and symptom relief.
- Systemic therapies (e.g., biologics, oral immunosuppressants) for severe, widespread, or refractory dermatoses.
Cost & Coverage
Average Cost:
$15 - $50 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 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 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 overdose, including the medication taken, the amount, and the time it occurred.