Fluocinolone Acet 0.01% Crm 15gm
It is used to treat skin rashes and other skin irritation.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 1961
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluocinolone acetonide cream is a medicine applied to the skin to reduce redness, swelling, and itching caused by 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
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 the affected area before applying the medication and make sure it is dry.
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.
Unless directed by your doctor, do not apply the medication to the face, groin, armpits, or other skin folds.
Storage and Disposal
Store the medication at room temperature, away from heat sources, and do not freeze.
Keep all medications 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 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 the affected area before applying the medication and make sure it is dry.
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.
Unless directed by your doctor, do not apply the medication to the face, groin, armpits, or other skin folds.
Storage and Disposal
Store the medication at room temperature, away from heat sources, and do not freeze.
Keep all medications 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 schedule.
Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Wash your hands before and after applying the cream.
- Apply a thin layer of cream to the affected skin area, gently rubbing it in until it disappears.
- Do not cover the treated area with bandages or dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid applying the cream to your eyes, mouth, or inside your nose.
- Do not use this cream for longer than prescribed or on large areas of your body without consulting your doctor.
- Do not use on children's diaper area unless directed by a doctor, as diapers can act as occlusive dressings.
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 area 2 to 4 times daily.
Condition-Specific Dosing:
psoriasis:
Apply a thin film to the affected area 2 to 4 times daily.
eczema:
Apply a thin film to the affected area 2 to 4 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Apply a thin film to the affected area 2 to 4 times daily. Use with caution, especially under occlusion or on large surface areas, due to increased risk of systemic absorption.
Child:
Apply a thin film to the affected area 2 to 4 times daily. Use with caution, especially under occlusion or on large surface areas, due to increased risk of systemic absorption.
Adolescent:
Apply a thin film to the affected area 2 to 4 times daily.
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 adjustment needed 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. It acts by inducing phospholipase A2 inhibitory proteins, lipocortins, which 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:
Not precisely quantified for topical application; systemic absorption varies depending on the vehicle, integrity of the epidermal barrier, and use of occlusive dressings. Absorption is increased on damaged skin, with prolonged use, and on large surface areas.
Tmax:
Not applicable for topical application; systemic absorption is minimal and variable.
FoodEffect:
Not applicable for topical application.
Distribution:
Vd:
Not available for topical application; if absorbed systemically, corticosteroids are bound to plasma proteins, primarily transcortin and albumin.
ProteinBinding:
If absorbed systemically, corticosteroids are bound to plasma proteins (e.g., transcortin, albumin).
CnssPenetration:
Limited for topical application; systemic absorption can lead to CNS effects, but typically not significant with appropriate topical use.
Elimination:
HalfLife:
Not precisely quantified for topical application; if absorbed systemically, corticosteroids are excreted renally.
Clearance:
Not precisely quantified for topical application.
ExcretionRoute:
Renal, if absorbed systemically.
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Hours to days for symptomatic relief.
PeakEffect:
Days to weeks of consistent application.
DurationOfAction:
Varies with application frequency and condition.
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
Irritation at the application site
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, 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
Irritation at the application site
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:
- Skin irritation, burning, itching, or redness that gets worse
- Signs of skin infection (e.g., pus, spreading redness, fever)
- Thinning of the skin, stretch marks, or easy bruising
- Unusual hair growth
- Acne-like rash
- Blurred vision or other eye problems (if applied near eyes)
- Any signs of systemic side effects like swelling in ankles/feet, unusual weight gain, or muscle weakness (rare with proper topical use)
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.
* 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 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.
* 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 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.
Do not use this medication to treat 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 it to a large area of skin or near open wounds, exercise caution and discuss with your doctor.
Use this medication only for the duration prescribed by your doctor. Do not exceed the recommended treatment period.
If the patient is a child, use this medication with caution, as children may be at a higher risk for certain side effects. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to discuss this potential risk.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the benefits and risks of using this medication during pregnancy or breastfeeding to ensure the best outcome for both you and your baby.
Do not use this medication to treat 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 it to a large area of skin or near open wounds, exercise caution and discuss with your doctor.
Use this medication only for the duration prescribed by your doctor. Do not exceed the recommended treatment period.
If the patient is a child, use this medication with caution, as children may be at a higher risk for certain side effects. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to discuss this potential risk.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the benefits and risks of using this medication during pregnancy or breastfeeding to ensure the best outcome for 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, buffalo hump, central obesity, striae, hypertension, hyperglycemia)
- Adrenal suppression (fatigue, weakness, nausea, vomiting, low blood pressure)
- Growth retardation in children
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. In case of acute overdose, call a poison control center immediately (1-800-222-1222 in the US).
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify any signs of infection or skin breakdown.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy of treatment (reduction in inflammation, pruritus)
Frequency: Weekly or as clinically indicated.
Target: Improvement in symptoms.
Action Threshold: Lack of improvement or worsening symptoms may indicate need for re-evaluation or alternative therapy.
Local adverse reactions (e.g., skin atrophy, striae, telangiectasias, folliculitis, burning, itching)
Frequency: At each follow-up visit.
Target: Absence of significant adverse effects.
Action Threshold: Presence of significant or worsening local adverse effects may require dose reduction, discontinuation, or change in therapy.
Signs of HPA axis suppression (especially with prolonged use, large surface areas, or occlusion)
Frequency: Periodically, if risk factors are present (e.g., plasma cortisol levels, ACTH stimulation test).
Target: Normal HPA axis function.
Action Threshold: Evidence of HPA axis suppression requires gradual withdrawal of the drug, or temporary discontinuation, and consideration of systemic corticosteroid replacement.
Symptom Monitoring
- Worsening of skin condition
- Increased redness, swelling, or pain (signs of infection)
- Severe burning, itching, or irritation at application site
- Thinning of skin, easy bruising, or stretch marks
- Unusual hair growth
- Acne-like eruptions
- Changes in vision (if applied near eyes)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid large areas, prolonged use, or occlusive dressings.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though data for topical corticosteroids are limited and generally low risk with appropriate use.
Second Trimester:
Risk of fetal growth restriction or adrenal suppression with high-dose, prolonged, or extensive use.
Third Trimester:
Risk of fetal adrenal suppression with high-dose, prolonged, or extensive use.
Lactation
Use with caution. 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 proper use, but monitor infant for potential adverse effects if significant maternal absorption occurs.
Pediatric Use
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than adult 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 and prolonged use.
Geriatric Use
No specific dosage adjustments are typically needed. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects like skin atrophy or purpura. Monitor for skin integrity.
Clinical Information
Clinical Pearls
- Topical corticosteroids should be applied sparingly as a thin film; a little goes a long way.
- The potency of fluocinolone acetonide 0.01% cream is considered low to medium.
- Avoid using on the face, groin, or axillae unless specifically directed by a physician, as these areas are more prone to atrophy and other side effects.
- Do not use for fungal or bacterial infections without concomitant appropriate antimicrobial therapy, as corticosteroids can mask or worsen infections.
- Patients should be advised to report any signs of local irritation, infection, or lack of improvement to their healthcare provider.
- Long-term use, especially on large surface areas or under occlusion, increases the risk of systemic absorption and HPA axis suppression.
Alternative Therapies
- Other topical corticosteroids (e.g., hydrocortisone, triamcinolone, betamethasone)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
- Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole) for eczema
- Emollients and moisturizers
- Phototherapy
- Systemic immunomodulators (for severe cases)
Cost & Coverage
Average Cost:
$15 - $50 per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2
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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.