Fluocinolone Acet 0.025% 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
Jun 1961
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluocinolone acetonide is a type of medicine called a corticosteroid. It's used on the skin to reduce redness, swelling, and itching caused by skin conditions like eczema or psoriasis. It works by calming down the body's inflammatory 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, 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 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.
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. 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 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 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.
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. 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 extra doses.
Lifestyle & Tips
- Wash your hands before and after applying the cream.
- Apply a thin layer of cream only to the affected skin area, as directed by your doctor.
- Rub it in gently until it disappears.
- Do not use more cream than prescribed or apply it more often than directed.
- Avoid getting the cream in your eyes, mouth, or nose. If it gets into these areas, rinse thoroughly with water.
- Do not cover the treated area with bandages, plastic wrap, or other occlusive dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Do not use this cream for longer than prescribed, especially on the face, groin, or armpits, or on children.
- 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 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. May use occlusive dressing for severe cases under medical supervision.
eczema:
Apply a thin film to the affected area 2 to 4 times daily.
Pediatric Dosing
Neonatal:
Not established. Use with extreme caution due to increased risk of systemic absorption and adrenal suppression.
Infant:
Not established. Use with extreme caution due to increased risk of systemic absorption and adrenal suppression.
Child:
Apply a thin film to the affected area 2 to 4 times daily. Use the lowest effective dose for the shortest duration possible. Monitor closely for signs of systemic toxicity (e.g., growth retardation, adrenal suppression).
Adolescent:
Apply a thin film to the affected area 2 to 4 times daily. Use the lowest effective dose for the shortest duration possible.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Dialysis:
No specific adjustment needed due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Fluocinolone acetonide is a synthetic corticosteroid that possesses anti-inflammatory, antipruritic, and vasoconstrictive properties. It is thought to act 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.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (depends on vehicle, skin integrity, site of application, and use of occlusive dressings); generally minimal systemic absorption.
Tmax:
Not applicable for topical application; systemic absorption is slow and variable.
FoodEffect:
Not applicable for topical application.
Distribution:
Vd:
Not precisely quantified for topical application; if absorbed systemically, distributed throughout the body.
ProteinBinding:
Not precisely quantified for topical application; if absorbed systemically, binds to plasma proteins.
CnssPenetration:
Limited/Not applicable for topical application; minimal systemic absorption.
Elimination:
HalfLife:
Not precisely quantified for topical application; if absorbed systemically, half-life is variable.
Clearance:
Not precisely quantified for topical application; if absorbed systemically, cleared primarily by the liver.
ExcretionRoute:
Primarily renal, if absorbed systemically.
Unchanged:
Not precisely quantified for topical application.
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief.
PeakEffect:
Variable, typically within days to weeks of consistent application.
DurationOfAction:
Variable, depends on the severity of the condition and frequency of 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 immediately or seek emergency 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, 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 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 that bother you or persist, contact your doctor for advice:
Burning or stinging sensations
Dry skin
This is not an exhaustive list of potential 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 immediately or seek emergency 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, 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 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 that bother you or persist, contact your doctor for advice:
Burning or stinging sensations
Dry skin
This is not an exhaustive list of potential 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:
- Worsening of your skin condition or no improvement after a few days/weeks of use.
- Severe burning, itching, or irritation at the application site.
- Signs of a new skin infection (e.g., pus, fever, spreading redness).
- Skin thinning, easy bruising, or stretch marks developing.
- Unusual weight gain, swelling in your face or body, or increased thirst/urination (these could be signs of too much steroid being absorbed into your body, especially with long-term or extensive 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 is crucial to avoid 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 vital to verify that it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any 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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid 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 vital to verify that it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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 possible outcome for 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 possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Acute overdose with topical application is unlikely due to minimal systemic absorption.
- Chronic overuse or use on large surface areas, broken skin, or under occlusion can lead to systemic effects such as adrenal suppression (fatigue, weakness, nausea, vomiting, low blood pressure), Cushing's syndrome (moon face, buffalo hump, central obesity, skin thinning, easy bruising, high blood sugar), and growth retardation in children.
What to Do:
If you suspect chronic overdose or experience systemic symptoms, contact your doctor immediately. For acute ingestion, call a poison control center (1-800-222-1222) or seek emergency medical attention. Management is supportive and symptomatic.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis (e.g., inflammation, erythema, pruritus, scaling) and identify any signs of infection.
Timing: Prior to initiation of therapy.
Extent of affected body surface area (BSA)
Rationale: To assess potential for systemic absorption, especially in children or with extensive use.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (reduction in symptoms)
Frequency: Regularly, at follow-up visits (e.g., weekly to bi-weekly initially, then as needed).
Target: Significant improvement in inflammation, pruritus, and other dermatological symptoms.
Action Threshold: Lack of improvement or worsening of symptoms may indicate need for re-evaluation of diagnosis or treatment.
Local adverse effects (e.g., skin atrophy, striae, telangiectasias, folliculitis, burning, itching, irritation)
Frequency: At each follow-up visit and patient self-monitoring.
Target: Absence of or minimal local adverse effects.
Action Threshold: Development of significant local adverse effects warrants reduction in frequency, change in potency, or discontinuation.
Signs of systemic absorption (e.g., adrenal suppression, Cushing's syndrome, hyperglycemia, glucosuria)
Frequency: Periodically, especially with prolonged use, large surface areas, or occlusive dressings. Consider plasma cortisol levels or ACTH stimulation test if suspicion is high.
Target: Normal adrenal function.
Action Threshold: Signs of systemic absorption require immediate medical attention and discontinuation or reduction of therapy.
Symptom Monitoring
- Increased redness or irritation at application site
- Burning or stinging sensation
- Itching that worsens
- Skin thinning or easy bruising
- Development of stretch marks (striae)
- Acne-like eruptions
- Increased hair growth at application site
- Signs of skin infection (pus, fever, spreading redness)
- Unusual weight gain or swelling (especially in face, ankles, feet)
- Increased thirst or urination (signs of high blood sugar)
- Fatigue or weakness (signs of adrenal suppression)
Special Patient Groups
Pregnancy
Category C. Use 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 minimal with topical use, but extensive use or use of high potency steroids may lead to detectable systemic levels.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though risk with topical minimal.
Second Trimester:
Generally considered safer than first trimester, but still use with caution.
Third Trimester:
Risk of adrenal suppression in the neonate if used extensively or for prolonged periods near term.
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 direct infant ingestion.
Infant Risk:
Low risk with limited, short-term use. Potential for adverse effects (e.g., growth suppression, adrenal suppression) if significant systemic absorption occurs in the mother and is transferred to the infant via milk, or if applied directly to 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 because of a larger skin surface area to body weight ratio. Use the lowest effective dose for the shortest duration possible. Monitor for signs of systemic toxicity, including growth retardation.
Geriatric Use
No specific dosage adjustments are typically required. However, geriatric patients may have thinner, more fragile skin, which could increase susceptibility to local adverse effects like skin atrophy and purpura. Monitor skin integrity closely.
Clinical Information
Clinical Pearls
- Fluocinolone acetonide 0.025% cream is considered a medium-potency topical corticosteroid.
- The cream formulation is generally less potent than the ointment formulation of the same concentration.
- Avoid prolonged use on the face, groin, or axillae, as these areas are more susceptible to local side effects like skin atrophy, telangiectasias, and striae.
- Patients should be advised to use the smallest amount necessary to cover the affected area and to discontinue use once the condition is controlled.
- If no improvement is seen after 2-4 weeks, the diagnosis and treatment plan should be re-evaluated.
Alternative Therapies
- Other topical corticosteroids (e.g., hydrocortisone, triamcinolone, betamethasone, clobetasol - varying potencies)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for conditions like eczema, especially on sensitive areas.
- Emollients and moisturizers (as adjunctive therapy or for mild conditions).
- Antihistamines (for associated pruritus).
- Phototherapy (for extensive or severe psoriasis/eczema).
- Systemic immunosuppressants (for severe, refractory dermatoses).
Cost & Coverage
Average Cost:
$10 - $50 per 15gm tube (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (preferred generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.