Fluocinolone Acetonide Body Oil
It is used to treat eczema.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Topical corticosteroid
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Mar 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluocinolone Acetonide Body Oil is a medicine applied to the skin to reduce redness, itching, and swelling caused by skin conditions like atopic dermatitis (eczema). 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. If you accidentally get the medication in your eyes, rinse them immediately with water. If you experience persistent eye irritation or changes in vision, contact your doctor.
Unless instructed to do so by your doctor, do not cover the treated area with bandages or dressings.
Wash your hands before and after applying the medication. However, if the treated area is on your hand, do not wash your hand after application.
Clean and dry the affected area before applying the medication.
Apply a thin layer of the medication to the affected skin and gently rub it in.
When applying the medication to a hairy area, part the hair to ensure the medication reaches the affected skin.
Special Precautions
Avoid using tight-fitting diapers or plastic pants if the treated area is in the diaper region, as this may increase the amount of medication absorbed into the body.
Do not apply the medication to the face, groin, armpits, or other skin folds unless instructed to do so by your doctor.
Storage and Disposal
Store the medication at room temperature, away from heat sources. Do not freeze.
Keep the medication 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 application 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. If you accidentally get the medication in your eyes, rinse them immediately with water. If you experience persistent eye irritation or changes in vision, contact your doctor.
Unless instructed to do so by your doctor, do not cover the treated area with bandages or dressings.
Wash your hands before and after applying the medication. However, if the treated area is on your hand, do not wash your hand after application.
Clean and dry the affected area before applying the medication.
Apply a thin layer of the medication to the affected skin and gently rub it in.
When applying the medication to a hairy area, part the hair to ensure the medication reaches the affected skin.
Special Precautions
Avoid using tight-fitting diapers or plastic pants if the treated area is in the diaper region, as this may increase the amount of medication absorbed into the body.
Do not apply the medication to the face, groin, armpits, or other skin folds unless instructed to do so by your doctor.
Storage and Disposal
Store the medication at room temperature, away from heat sources. Do not freeze.
Keep the medication 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 application schedule.
Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Apply a thin film to the affected skin areas once daily, as directed by your doctor.
- Gently rub the oil into the skin until it is absorbed.
- Do not use more than the prescribed amount or for longer than 4 weeks unless specifically instructed by your doctor.
- Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not use on the face, groin, or armpits unless specifically directed by your doctor.
- Do not cover the treated area with bandages or other occlusive dressings unless instructed by your doctor, as this can increase absorption and side effects.
- Wash hands thoroughly after applying the medication, unless your hands are the treated area.
- Keep out of reach of children.
Available Forms & Alternatives
Available Strengths:
- Fluocinolone 0.01% Cream 60gm
- Fluocinolone Acet 0.025% Oint 60gm
- Fluocinolone Acet 0.025% Oint 15gm
- Fluocinolone Acet 0.01% Crm 15gm
- Fluocinolone Acet 0.01% Crm 60gm
- Fluocinolone Acet 0.01% Soln 60ml
- Fluocinolone Acetonide Body Oil
- Fluocinolone Acet 0.01% Scalp Oil
- Fluocinolone 0.01% Oil Drops (ear)
- Fluocinolone Acet 0.025% Crm 15gm
- Fluocinolone Acet 0.025% Crm 60gm
- Fluocinolone Acet 0.025% Oint 15gm
- Fluocinolone Acet 0.025% Oint 60gm
- Fluocinolone Acet 0.01% Scalp Oil
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film to affected areas of the body once daily.
Condition-Specific Dosing:
atopicDermatitis:
Apply a thin film to affected areas of the body once daily. Gently rub in. Discontinue use when control is achieved. Use for no more than 4 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for infants under 2 years of age.
Child:
For atopic dermatitis in patients 2 years of age and older: Apply a thin film to affected areas of the body once daily. Gently rub in. Discontinue use when control is achieved. Use for no more than 4 weeks. Pediatric patients may be more susceptible to systemic toxicity.
Adolescent:
Apply a thin film to affected areas of the body once daily. Gently rub in. Discontinue use when control is achieved. Use for no more than 4 weeks.
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.
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
Fluocinolone acetonide is a synthetic fluorinated 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 can occur, especially with prolonged use, large surface areas, occlusive dressings, or compromised skin barrier. Generally low.
Tmax:
Not well-defined for topical application; peak systemic levels are generally very low.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not well-defined for topical application; if absorbed systemically, distributes widely.
ProteinBinding:
Variable; if absorbed systemically, binds to plasma proteins.
CnssPenetration:
Limited, unless significant systemic absorption occurs.
Elimination:
HalfLife:
Not well-defined for topical application; systemic half-life of absorbed drug is variable.
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Renal excretion of metabolites.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Within hours for symptomatic relief (e.g., reduced itching, redness); full therapeutic effect may take several days.
PeakEffect:
Days to weeks of consistent application.
DurationOfAction:
Effects persist as long as treatment continues; varies based on individual response and severity of condition.
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: 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, excessive 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
Irritation at the site of application
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people experience no side effects or only mild 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 sensations
Dry skin
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: 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, excessive 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
Irritation at the site of application
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people experience no side effects or only mild 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 sensations
Dry skin
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, itching, or irritation at the application site
- Signs of skin infection (e.g., pus, worsening pain, fever)
- Skin thinning, easy bruising, or stretch marks (striae)
- Acne-like breakouts or increased hair growth in treated areas
- Unusual fatigue, weight gain, or swelling (signs of systemic absorption, especially in children)
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 affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe use, tell your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
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 affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe use, tell your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems
Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
If you have a peanut allergy, be aware that some brands of this medication contain peanut oil. Before using, consult your pharmacist to determine if your specific brand contains peanut oil.
This medication is not intended for treating diaper rash. Before using any other medications or products on your skin, including soaps, discuss with your doctor to ensure safe use.
Avoid applying this medication to cuts, scrapes, or damaged skin. When applying to a large area of skin or near open wounds, exercise caution and consult your doctor.
Do not exceed the prescribed duration of use. Your doctor will advise you on the appropriate treatment period.
When administering this medication to children, use with caution, as the risk of certain side effects may be increased in this population. In some cases, this medication may affect growth in children and teenagers, necessitating regular growth checks. Consult your doctor to discuss this potential risk.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to weigh the benefits and risks of using this medication during these situations to ensure the well-being of both you and your baby.
If you have a peanut allergy, be aware that some brands of this medication contain peanut oil. Before using, consult your pharmacist to determine if your specific brand contains peanut oil.
This medication is not intended for treating diaper rash. Before using any other medications or products on your skin, including soaps, discuss with your doctor to ensure safe use.
Avoid applying this medication to cuts, scrapes, or damaged skin. When applying to a large area of skin or near open wounds, exercise caution and consult your doctor.
Do not exceed the prescribed duration of use. Your doctor will advise you on the appropriate treatment period.
When administering this medication to children, use with caution, as the risk of certain side effects may be increased in this population. In some cases, this medication may affect growth in children and teenagers, necessitating regular growth checks. Consult your doctor to discuss this potential risk.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to weigh the benefits and risks of using this medication during these situations to ensure the well-being of both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic absorption, potentially causing Cushing's syndrome (e.g., moon face, central obesity, thin skin, easy bruising), hyperglycemia (high blood sugar), and glucosuria (sugar in urine).
- In children, chronic overdose can lead to growth retardation and delayed weight gain.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment should be initiated. Call a poison control center immediately (1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of atopic dermatitis (e.g., erythema, induration, lichenification, pruritus) and identify areas for treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response (reduction in symptoms)
Frequency: Regularly during treatment, typically weekly or bi-weekly.
Target: Improvement in skin lesions and reduction in pruritus.
Action Threshold: If no improvement after 4 weeks, reassess diagnosis or treatment plan. If worsening, discontinue and investigate.
Local adverse reactions (e.g., skin atrophy, striae, telangiectasias, folliculitis)
Frequency: At each follow-up visit.
Target: Absence of or minimal local adverse effects.
Action Threshold: If significant local adverse effects develop, reduce frequency, discontinue, or switch to a lower potency corticosteroid.
Signs of HPA axis suppression (especially in children or with extensive/prolonged use)
Frequency: Consider periodic evaluation (e.g., ACTH stimulation test, plasma cortisol) if risk factors are present.
Target: Normal HPA axis function.
Action Threshold: If HPA axis suppression is suspected or confirmed, gradually withdraw the drug, reduce frequency, or substitute with a less potent corticosteroid.
Symptom Monitoring
- Burning
- Itching
- Irritation
- Dryness
- Folliculitis
- Hypertrichosis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Skin maceration
- Secondary infection
- Skin atrophy
- Striae
- Miliaria
- Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, glucosuria, growth retardation in children)
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. High doses or prolonged use may lead to systemic absorption and potential fetal harm.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though data for topical corticosteroids are limited. Avoid extensive use.
Second Trimester:
Risk of systemic absorption and potential fetal effects (e.g., growth restriction, adrenal suppression) increases with extensive or prolonged use.
Third Trimester:
Risk of systemic absorption and potential fetal effects (e.g., growth restriction, adrenal suppression) increases with extensive or prolonged use. Neonatal adrenal insufficiency is a theoretical risk.
Lactation
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Use with caution. 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 significant maternal systemic absorption is suspected.
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 effective dose for the shortest duration possible. Not recommended for children under 2 years of age.
Geriatric Use
No specific dosage adjustments are required. However, geriatric patients may have thinner skin and be more prone to local adverse effects such as skin atrophy and purpura. Monitor closely for skin integrity.
Clinical Information
Clinical Pearls
- Fluocinolone Acetonide Body Oil (Derma-Smoothe/FS) is specifically formulated for atopic dermatitis on the body and scalp psoriasis. Ensure the correct formulation is used for the intended area.
- This oil formulation can be particularly beneficial for dry, scaly skin conditions due to its emollient properties.
- Emphasize the 'thin film' application to patients to minimize systemic absorption and local side effects.
- Educate patients on the signs of skin atrophy (thinning, bruising, stretch marks) and HPA axis suppression, especially with prolonged use or in children.
- For atopic dermatitis, treatment should be discontinued once control is achieved, typically within 4 weeks, to prevent potential side effects.
Alternative Therapies
- Other topical corticosteroids (e.g., triamcinolone, betamethasone, clobetasol, hydrocortisone)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for atopic dermatitis
- Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole) for atopic dermatitis
- Systemic therapies (e.g., oral corticosteroids, immunosuppressants, biologics) for severe cases
- Emollients and moisturizers as adjunctive therapy
Cost & Coverage
Average Cost:
Varies widely, typically $500 - $1500+ per 120 mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Specialty/Non-preferred Brand)
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 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 details about the medication taken, the amount, and the time it happened.