Derma-Smoothe/ Fs (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 Receptor Agonist; Anti-inflammatory Agent
Pregnancy Category
Category C
FDA Approved
Sep 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Derma-Smoothe/FS is a medicated oil that contains a corticosteroid called fluocinolone. It is used on the scalp to reduce inflammation, itching, and redness caused by conditions like scalp psoriasis. It works by calming down the immune response 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.
Keep the medication away from 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.
Using the Medication on Your Scalp
1. Wash your hands before and after applying the medication.
2. Wet your hair and scalp.
3. Apply a thin layer of the medication to the affected area of your scalp and gently rub it in.
4. Cover your scalp with the provided shower cap.
5. Leave the medication on for at least 4 hours or overnight before washing it off.
6. Wash and rinse your hair with shampoo.
Important Usage Notes
Do not use bandages or dressings unless instructed to do so by your doctor.
Avoid applying extra doses or using two doses at the same time.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures.
Protect the medication from heat sources.
Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If the missed dose is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
* Do not apply extra doses or double 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.
Keep the medication away from 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.
Using the Medication on Your Scalp
1. Wash your hands before and after applying the medication.
2. Wet your hair and scalp.
3. Apply a thin layer of the medication to the affected area of your scalp and gently rub it in.
4. Cover your scalp with the provided shower cap.
5. Leave the medication on for at least 4 hours or overnight before washing it off.
6. Wash and rinse your hair with shampoo.
Important Usage Notes
Do not use bandages or dressings unless instructed to do so by your doctor.
Avoid applying extra doses or using two doses at the same time.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures.
Protect the medication from heat sources.
Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If the missed dose is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
* Do not apply extra doses or double doses to make up for a missed dose.
Lifestyle & Tips
- Apply to dry scalp at bedtime. Part hair to apply directly to affected areas.
- Gently massage into the scalp.
- Leave on overnight (about 8 hours).
- Rinse off thoroughly in the morning with shampoo.
- Do not use more than the prescribed amount or for longer than 4 weeks unless directed by your doctor.
- Avoid contact with eyes. 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 tight caps unless instructed by your doctor, as this can increase absorption and side effects.
- Wash hands thoroughly after application.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to the affected area of the scalp once daily, at bedtime. Leave on overnight (for approximately 8 hours) and then rinse off in the morning.
Condition-Specific Dosing:
scalp_psoriasis:
Apply to the affected area of the scalp once daily, at bedtime. Leave on overnight (for approximately 8 hours) and then rinse off in the morning. Treatment should be limited to 4 weeks. Total dosage should not exceed 60 mL per week.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and effectiveness in pediatric patients under 18 years of age have not been established. Use with caution due to increased risk of systemic absorption and HPA axis suppression.
Adolescent:
Safety and effectiveness in pediatric patients under 18 years of age have not been established. Use with caution due to increased risk of systemic absorption and HPA axis suppression.
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 corticosteroid that possesses anti-inflammatory, antipruritic, and vasoconstrictive properties. Its primary mechanism of action involves binding to cytoplasmic glucocorticoid receptors, which then translocate to the nucleus and modulate gene expression. This leads to the inhibition of prostaglandin and leukotriene synthesis by inducing phospholipase A2 inhibitory proteins (lipocortins), thereby reducing the release of arachidonic acid from cell membrane phospholipids. It also suppresses the migration of neutrophils and macrophages, reverses capillary permeability, and inhibits the release of vasoactive kinins.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption; varies with skin integrity, vehicle, and duration of exposure. Increased absorption with inflamed or damaged skin, and with occlusive dressings.
Tmax:
Not well-defined for topical application; systemic absorption is generally low.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not precisely quantified for topical use; minimal systemic distribution if absorbed.
ProteinBinding:
Variable, but generally high for corticosteroids if systemically absorbed.
CnssPenetration:
Limited
Elimination:
HalfLife:
Not precisely quantified for topical use; systemic half-life of absorbed drug is variable.
Clearance:
Not precisely quantified for topical use.
ExcretionRoute:
Renal excretion of metabolites, if systemically absorbed.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within hours to days for anti-inflammatory effects.
PeakEffect:
Within days to weeks of consistent application.
DurationOfAction:
Effects persist as long as applied; local effects may last for hours after application.
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 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 adrenal gland problems: severe nausea or vomiting, extreme dizziness or fainting, muscle weakness, 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 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.
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 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 adrenal gland problems: severe nausea or vomiting, extreme dizziness or fainting, muscle weakness, 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 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
- Thinning of the skin or stretch marks (striae)
- Acne-like breakouts or hair bumps (folliculitis)
- Changes in skin color (lightening)
- Signs of infection (pus, fever, worsening pain)
- Unusual fatigue, weakness, nausea, or dizziness (signs of systemic absorption/HPA axis suppression)
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.
If you have a peanut allergy, be aware that some brands of this medication contain peanut oil. Before using, consult with 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 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 with your doctor.
Do not exceed the prescribed duration of use, as directed by your doctor.
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. 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 this medication to 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 with 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 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 with your doctor.
Do not exceed the prescribed duration of use, as directed by your doctor.
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. 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 this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic effects due to absorption, including Cushing's syndrome, hyperglycemia, and HPA axis suppression.
- Symptoms of HPA axis suppression may include fatigue, weakness, nausea, vomiting, dizziness, and low blood pressure.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Monitoring
Baseline Monitoring
Assessment of scalp condition (e.g., erythema, scaling, pruritus)
Rationale: To establish baseline severity and guide treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response (reduction in symptoms)
Frequency: Weekly or as clinically indicated during treatment period.
Target: Improvement in scalp lesions and symptoms.
Action Threshold: Lack of improvement or worsening symptoms may indicate need for re-evaluation or alternative therapy.
Signs of local adverse reactions (e.g., atrophy, striae, folliculitis, irritation)
Frequency: At each follow-up visit.
Target: Absence of significant adverse reactions.
Action Threshold: Presence of significant adverse reactions may require discontinuation or adjustment of therapy.
Signs of HPA axis suppression (e.g., fatigue, weight loss, dizziness)
Frequency: Periodically, especially with prolonged use, extensive application, or in pediatric patients.
Target: Normal HPA axis function.
Action Threshold: Suspicion of HPA axis suppression warrants further evaluation (e.g., ACTH stimulation test) 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
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in animals.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though systemic absorption from topical use is generally low.
Second Trimester:
Risk generally considered lower than first trimester, but still use with caution.
Third Trimester:
Risk generally considered lower than first trimester, but still use with caution. Avoid large areas or prolonged use.
Lactation
Caution should be exercised when Derma-Smoothe/FS 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.
Infant Risk:
Low risk with limited, short-term use on small areas. Avoid applying to areas that may come into direct contact with the infant's skin or mouth.
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 with caution and for the shortest duration possible. Not recommended for children under 18 years of age.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may have thinner skin, which could potentially increase systemic absorption, though this is generally not a major concern with appropriate use.
Clinical Information
Clinical Pearls
- Derma-Smoothe/FS is specifically formulated for the scalp and should not be used on other body areas unless directed by a physician.
- The oil formulation helps to hydrate the scalp and penetrate scales, making it effective for conditions like scalp psoriasis.
- Patients should be instructed on the correct application technique, including leaving the oil on overnight and rinsing thoroughly in the morning.
- Limit treatment duration to 4 weeks to minimize the risk of local and systemic side effects.
- Monitor for signs of skin atrophy, striae, or HPA axis suppression, especially with prolonged use or in susceptible individuals.
- This product is flammable; patients should avoid fire, flame, and smoking during and immediately after application.
Alternative Therapies
- Other topical corticosteroids (e.g., clobetasol, betamethasone, triamcinolone)
- Calcipotriene (topical vitamin D analog)
- Tazarotene (topical retinoid)
- Coal tar shampoos/solutions
- Salicylic acid preparations
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for off-label use in seborrheic dermatitis
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe cases of scalp psoriasis
Cost & Coverage
Average Cost:
Varies, typically $100-$500+ per 60 mL bottle
Generic Available:
Yes
Insurance Coverage:
Varies by plan, often Tier 2 or 3 for brand, Tier 1 for 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 your 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 taken, the amount, and the time it happened.