Fluocinolone Acet 0.025% Crm 60gm
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 Anti-inflammatory Agent, Antipruritic
Pharmacologic Class
Topical Corticosteroid, Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluocinolone Acetonide cream is a topical steroid medication used to reduce redness, itching, and swelling caused by various skin conditions like eczema, dermatitis, and 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, 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. 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 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 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. 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 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 to the affected skin area as directed by your doctor, usually 2 to 4 times a day.
- Gently rub the cream into the skin until it disappears.
- Do not cover the treated area with bandages or other dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
- 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, as these areas are more susceptible to side effects.
- Do not use for longer than prescribed, especially on children, as prolonged use can lead to skin thinning or other side effects.
- Inform your doctor if your condition does not improve or worsens after a few days or weeks of treatment.
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:
generalDermatoses:
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 systemic absorption risk)
Infant:
Apply a thin film to the affected area 2 to 4 times daily. Use with caution; avoid prolonged use or large areas.
Child:
Apply a thin film to the affected area 2 to 4 times daily. Use with caution; avoid prolonged use or large areas.
Adolescent:
Apply a thin film to the affected area 2 to 4 times daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
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, 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:
Varies (dependent on vehicle, skin integrity, occlusion)
Tmax:
Not applicable (topical)
FoodEffect:
Not applicable (topical)
Distribution:
Vd:
Not available (systemic distribution if absorbed)
ProteinBinding:
Varies (systemic corticosteroids are bound to plasma proteins)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not available (systemic half-life if absorbed)
Clearance:
Not available
ExcretionRoute:
Renal (if systemically absorbed)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Rapid (symptomatic relief within hours to days)
PeakEffect:
Days to weeks for full therapeutic effect
DurationOfAction:
Maintained with regular 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, 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 unusual symptoms that bother you or persist, contact your doctor for guidance:
Burning or stinging sensations
Dry skin
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can 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, 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 unusual symptoms that bother you or persist, contact your doctor for guidance:
Burning or stinging sensations
Dry skin
This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can 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 the skin condition or development of new symptoms.
- Signs of a skin infection (e.g., pus, increased redness, warmth, fever).
- Severe burning, stinging, itching, or irritation at the application site.
- Signs of skin thinning, easy bruising, stretch marks, or changes in skin color.
- Unusual hair growth on the treated area.
- Signs of systemic absorption (rare but serious): unexplained weight gain, swelling in ankles/feet, increased thirst or urination, fatigue, muscle weakness, vision problems (report immediately).
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
Natural products, such as herbal supplements
Vitamins
Any existing health problems
Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication in conjunction with your other treatments. Do not initiate, discontinue, or modify 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.
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
Natural products, such as herbal supplements
Vitamins
Any existing health problems
Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication in conjunction with your other treatments. Do not initiate, discontinue, or modify 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:
- Unlikely with acute topical overdose.
- Chronic overuse or application to large surface areas, especially under occlusion, can lead to systemic effects such as Cushing's syndrome (e.g., moon face, central obesity, striae), hyperglycemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
What to Do:
Discontinue use gradually under medical supervision. Symptomatic and supportive treatment. For severe systemic effects, call 911 or a poison control center (1-800-222-1222).
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify any contraindications or pre-existing skin issues.
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy (reduction in inflammation, pruritus)
Frequency: Regularly during treatment
Target: Improvement in symptoms
Action Threshold: Lack of improvement or worsening symptoms may require re-evaluation of diagnosis or treatment.
Local adverse effects (e.g., skin atrophy, striae, telangiectasias, folliculitis, perioral dermatitis)
Frequency: Regularly during treatment, especially with prolonged use or sensitive areas
Target: Absence of new or worsening local adverse effects
Action Threshold: Development of significant local adverse effects may require discontinuation or change in therapy.
Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, HPA axis suppression)
Frequency: Periodically, especially with prolonged use, large surface areas, or occlusive dressings
Target: Normal physiological parameters
Action Threshold: Symptoms or signs of systemic absorption (e.g., unexplained weight gain, fatigue, increased thirst/urination) warrant immediate medical evaluation and potential discontinuation.
Symptom Monitoring
- Worsening skin condition
- Signs of skin infection (pus, fever, increased pain)
- Severe burning, stinging, or irritation at application site
- Skin thinning, easy bruising, stretch marks (striae)
- Changes in skin color (hypopigmentation)
- Unusual hair growth (hypertrichosis)
- Systemic effects (rare): unexplained weight gain, swelling in ankles/feet, increased thirst/urination, fatigue, muscle weakness, vision problems
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 risk, but data are limited. Avoid if possible.
Second Trimester:
Use with caution; minimal systemic absorption expected.
Third Trimester:
Use with caution; minimal systemic absorption expected.
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 to infant due to minimal systemic absorption, but limited data. Monitor infant for adverse effects.
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 steroid for the shortest duration possible. Avoid occlusive dressings.
Geriatric Use
Generally safe. No specific dose adjustments are typically needed. However, geriatric patients may have thinner, more fragile skin, increasing the risk of local adverse effects like skin atrophy and purpura. Monitor closely.
Clinical Information
Clinical Pearls
- Fluocinolone acetonide 0.025% cream is considered a medium-potency topical corticosteroid.
- The potency of topical corticosteroids can be increased by using occlusive dressings, but this also significantly increases the risk of systemic absorption and local side effects.
- This medication is not indicated for the treatment of rosacea or perioral dermatitis, as it can worsen these conditions.
- Avoid prolonged use on sensitive areas such as the face, groin, and axillae due to the increased risk of skin atrophy, telangiectasias, and other local side effects.
- Patients should be instructed to apply the smallest amount necessary to cover the affected area to minimize potential side effects.
- Discontinuation of prolonged therapy, especially with high-potency steroids or extensive use, should be gradual to prevent rebound flares.
Alternative Therapies
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing therapy
- Emollients and moisturizers for barrier repair
- Antihistamines for pruritus relief
- Phototherapy (UVB, PUVA) for chronic conditions like psoriasis
- Systemic immunosuppressants (e.g., methotrexate, cyclosporine) for severe, refractory dermatoses
Cost & Coverage
Average Cost:
Varies widely (e.g., $20 - $100+) per 60gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic formulations)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. 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.