Fluocinolone Acet 0.01% Scalp Oil
It is used to treat scalp psoriasis.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
Sep 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluocinolone Acetonide 0.01% Scalp Oil is a medicine that contains a type of steroid. It is used on the scalp to help reduce redness, itching, and flaking caused by skin conditions like psoriasis or eczema. It works by calming down the inflammation in the skin.
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, avoiding ingestion or contact with your mouth, nose, and eyes, as it may cause burning.
If you accidentally get the medication in your eyes, rinse immediately with water. If eye irritation persists or you experience changes in vision, contact your doctor.
Unless advised by your doctor, do not cover the treated area with bandages or dressings.
Wash your hands before and after applying the medication.
To apply:
1. Wet your hair and scalp.
2. Gently rub a thin layer of the medication onto the affected area of your scalp.
3. Cover your scalp with the provided shower cap.
4. Leave the medication on for at least 4 hours or overnight before washing it off.
5. Wash and rinse your hair with shampoo.
Storage and Disposal
Store this medication at room temperature, avoiding freezing temperatures and protecting it from heat.
Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If the missed dose is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at once or use extra doses to make up for a missed dose.
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, avoiding ingestion or contact with your mouth, nose, and eyes, as it may cause burning.
If you accidentally get the medication in your eyes, rinse immediately with water. If eye irritation persists or you experience changes in vision, contact your doctor.
Unless advised by your doctor, do not cover the treated area with bandages or dressings.
Wash your hands before and after applying the medication.
To apply:
1. Wet your hair and scalp.
2. Gently rub a thin layer of the medication onto the affected area of your scalp.
3. Cover your scalp with the provided shower cap.
4. Leave the medication on for at least 4 hours or overnight before washing it off.
5. Wash and rinse your hair with shampoo.
Storage and Disposal
Store this medication at room temperature, avoiding freezing temperatures and protecting it from heat.
Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If the missed dose is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at once or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply only to the scalp as directed by your doctor. Do not use on other parts of the body unless specifically instructed.
- Shake the bottle well before each use.
- Part your hair and apply a thin film of the oil to the affected areas of the scalp. Gently rub it in.
- Do not cover the treated area with bandages, caps, or other occlusive dressings unless specifically told to by your doctor, as this can increase absorption and side effects.
- Wash your hands thoroughly after applying the medication.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use for longer than prescribed, especially in children, to avoid potential side effects.
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 the affected areas of the scalp once or twice daily. For scalp psoriasis, often applied at bedtime and left on for 8-12 hours before washing off.
Condition-Specific Dosing:
scalpPsoriasis:
Apply a thin film to the affected areas of the scalp once daily at bedtime. Leave on for 8-12 hours, then wash off. Treatment duration typically up to 4 weeks.
atopicDermatitisOfScalp:
Apply a thin film to the affected areas of the scalp twice daily. Treatment duration typically up to 4 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for infants under 2 years of age.
Child:
For children 2 years and older: Apply a thin film to the affected areas of the scalp once or twice daily. Use with caution due to increased risk of systemic absorption and HPA axis suppression. Limit treatment to the least amount necessary for therapeutic effect.
Adolescent:
Apply a thin film to the affected areas of the scalp once or twice daily.
Dose Adjustments
Renal Impairment:
Mild:
Not typically required for topical use.
Moderate:
Not typically required for topical use.
Severe:
Not typically required for topical use.
Dialysis:
Not typically required for topical use; systemic absorption is generally minimal.
Hepatic Impairment:
Mild:
Not typically required for topical use.
Moderate:
Not typically required for topical use.
Severe:
Not typically required for topical use.
Pharmacology
Mechanism of Action
Fluocinolone acetonide is a corticosteroid that 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. Corticosteroids also possess anti-inflammatory, antipruritic, and vasoconstrictive properties.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (depends on skin integrity, vehicle, duration, and area of application; increased by occlusion or inflamed skin)
Tmax:
Not well-defined for topical application; systemic absorption is generally low but can occur.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not well-quantified for topical use; systemically absorbed corticosteroids are bound to plasma proteins to varying degrees.
ProteinBinding:
Variable (systemically absorbed corticosteroids are bound to plasma proteins)
CnssPenetration:
Limited (systemic absorption is generally low)
Elimination:
HalfLife:
Not well-defined for topical use; systemically absorbed corticosteroids are primarily excreted renally.
Clearance:
Not well-quantified for topical use.
ExcretionRoute:
Renal (primarily as inactive metabolites)
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within days for symptomatic relief.
PeakEffect:
Variable, depends on severity of condition and individual response.
DurationOfAction:
Variable, generally requires daily application.
Confidence:
Medium
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 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, 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
Irritation at the site of application
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 sensations
Dry skin
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. For medical advice about side effects, contact 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 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, 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
Irritation at the site of application
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 sensations
Dry skin
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. For medical advice about side effects, contact 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:
- Worsening of your skin condition or no improvement after the prescribed treatment period.
- Signs of a skin infection (e.g., increased redness, swelling, pus, fever).
- Severe burning, itching, or irritation at the application site.
- Unusual hair growth or thinning of the skin where the oil is applied.
- Signs of systemic absorption, especially with prolonged or extensive use (e.g., unusual weight gain, swelling in the face, fatigue, muscle weakness, mood changes).
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
Any natural products or vitamins you are using
* Existing health problems or conditions
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 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
Any natural products or vitamins you are using
* Existing health problems or conditions
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 drug 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, consult with your doctor.
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 with your doctor.
Do not use this medication for a longer duration than prescribed by your doctor.
When administering this drug 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. Discuss this with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of using this medication to both you and your baby.
If you have a peanut allergy, be aware that some brands of this drug 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, consult with your doctor.
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 with your doctor.
Do not use this medication for a longer duration than prescribed by your doctor.
When administering this drug 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. Discuss this with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of using this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or extensive use can lead to systemic effects due to absorption, including:
- Cushing's syndrome (e.g., moon face, central obesity, buffalo hump)
- Hyperglycemia (high blood sugar)
- Glucosuria (sugar in the urine)
- Suppression of the Hypothalamic-Pituitary-Adrenal (HPA) axis (leading to fatigue, weakness, low blood pressure)
What to Do:
If you suspect an overdose or significant systemic absorption, contact your doctor or poison control center immediately. Call 1-800-222-1222. Management is supportive and may involve gradual withdrawal of the medication under medical supervision.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment (e.g., erythema, scaling, pruritus)
Rationale: To establish baseline severity and guide treatment.
Timing: Prior to initiation of therapy.
Extent of affected body surface area
Rationale: To assess potential for systemic absorption and guide dosing.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (reduction in symptoms/lesions)
Frequency: Weekly or as clinically indicated during treatment.
Target: Improvement in skin condition.
Action Threshold: Lack of improvement or worsening symptoms may require re-evaluation of diagnosis or treatment.
Local adverse reactions (e.g., skin atrophy, striae, telangiectasias, folliculitis, irritation)
Frequency: At each follow-up visit.
Target: Absence of significant adverse effects.
Action Threshold: Presence of significant adverse effects may require dose reduction, discontinuation, or alternative therapy.
Signs of secondary infection
Frequency: At each follow-up visit.
Target: Absence of infection.
Action Threshold: Presence of infection requires appropriate antimicrobial treatment; consider discontinuing corticosteroid until infection is controlled.
Hypothalamic-Pituitary-Adrenal (HPA) axis suppression (e.g., plasma cortisol levels, ACTH stimulation test)
Frequency: Consider for prolonged use, extensive body surface area application, or in pediatric patients.
Target: Normal HPA axis function.
Action Threshold: Evidence of suppression requires gradual withdrawal of the drug, reduction in frequency, or substitution with a less potent steroid.
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., weight gain, moon face, fatigue, weakness, mood changes)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid large amounts or prolonged use.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity with high doses of corticosteroids in animal studies; human data are limited.
Second Trimester:
Risk generally considered lower than first trimester, but systemic absorption should be minimized.
Third Trimester:
Risk of HPA axis suppression in the newborn with prolonged or extensive maternal use near term.
Lactation
Caution is advised. 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 limited, short-term use. Monitor infant for potential adverse effects if significant maternal 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 because of a larger skin surface area to body weight ratio. Use the least amount necessary for therapeutic effect and monitor closely for systemic effects.
Geriatric Use
No specific dosage adjustments are typically required. However, geriatric patients may have thinner skin, which could potentially increase systemic absorption or local adverse effects like skin atrophy. Monitor for skin fragility and pre-existing conditions.
Clinical Information
Clinical Pearls
- This formulation is specifically designed for the scalp and is an oil, which can help moisturize and penetrate thick scales often seen in scalp psoriasis.
- Patients should be instructed on proper application technique, including parting hair and applying directly to the scalp, not just the hair.
- Advise patients that the oil can be messy and may stain clothing or bedding if not allowed to absorb or if excess is not removed.
- For scalp psoriasis, it's often applied at night and washed out in the morning, which can improve adherence and efficacy.
- Long-term continuous use, especially on large areas or under occlusion, should be avoided due to the risk of HPA axis suppression and local skin atrophy.
Alternative Therapies
- Other topical corticosteroids (e.g., clobetasol propionate, betamethasone valerate, triamcinolone acetonide in various vehicles like solutions, foams, lotions)
- Vitamin D analogs (e.g., calcipotriene topical solution)
- Calcineurin inhibitors (e.g., tacrolimus ointment, pimecrolimus cream - off-label for scalp)
- Coal tar shampoos/solutions
- Salicylic acid shampoos/solutions
- Systemic therapies (e.g., biologics, oral retinoids, methotrexate) for severe cases not responsive to topical treatment.
Cost & Coverage
Average Cost:
Varies widely (e.g., $50 - $300+) per 60 mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (variable by plan)
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. 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 is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 name of the medication taken, the amount, and the time it occurred.