Fluocinolone Acet 0.025% Oint 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 Corticosteroid
Pharmacologic Class
Glucocorticoid Receptor Agonist; Anti-inflammatory Agent
Pregnancy Category
Category C
FDA Approved
Sep 1961
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluocinolone acetonide is a topical corticosteroid medicine used to reduce inflammation, redness, and itching caused by various skin conditions like eczema and dermatitis. 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, unless your hand is the treated area. In that case, 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.
Do not apply the medication to the face, groin, armpits, or other skin folds unless instructed to do so by your doctor.
Storage and Disposal
Store the medication at room temperature, away from heat sources. Do not freeze.
Keep the medication 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, unless your hand is the treated area. In that case, 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.
Do not apply the medication to the face, groin, armpits, or other skin folds unless instructed to do so by your doctor.
Storage and Disposal
Store the medication at room temperature, away from heat sources. Do not freeze.
Keep the medication 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 ointment.
- Apply a thin layer of ointment to the affected skin area as directed by your doctor. Do not use more than prescribed.
- Gently rub it in until it disappears. Do not bandage or cover the treated area unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid getting the ointment in your eyes, nose, mouth, or on mucous membranes. If it gets into your eyes, rinse thoroughly with water.
- Do not use this ointment for longer than prescribed, especially on the face, groin, or armpits, or in children, as prolonged use can lead to skin thinning or other side effects.
- Inform your doctor if your condition does not improve after 2 weeks of treatment or if it worsens.
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.
Dose Range:
2 - 4 mg
Condition-Specific Dosing:
dermatoses:
Apply a thin film to the affected area 2 to 4 times daily, or as directed by physician.
Pediatric Dosing
Neonatal:
Not established (use with extreme caution due to increased systemic absorption risk)
Infant:
Not established (use with extreme caution due to increased systemic absorption risk)
Child:
Apply a thin film to the affected area 2 to 4 times daily. Use the least amount for the shortest duration possible. Avoid use on large surface areas or under occlusive dressings.
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 corticosteroid that possesses anti-inflammatory, antipruritic, and vasoconstrictive properties. Its anti-inflammatory effects are thought to involve the induction of phospholipase A2 inhibitory proteins, 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:
Minimal systemic absorption (typically <1-5% in intact skin, higher with damaged skin, inflammation, or occlusive dressings)
Tmax:
Not applicable (topical application)
FoodEffect:
Not applicable (topical application)
Distribution:
Vd:
Not applicable (minimal systemic distribution)
ProteinBinding:
Not available (minimal systemic absorption)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not precisely quantified for topical use (systemic half-life of corticosteroids varies)
Clearance:
Not precisely quantified for topical use
ExcretionRoute:
Primarily renal excretion if absorbed systemically
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within hours to days (local anti-inflammatory effect)
PeakEffect:
Days to weeks (for full therapeutic effect)
DurationOfAction:
Varies with application frequency and condition
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, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Irritation at the site where the medication was applied
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
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 immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Irritation at the site where the medication was applied
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
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
- Burning or stinging sensation that doesn't go away
- Thinning of the skin, easy bruising, or stretch marks (striae)
- Acne-like breakouts or increased hair growth in the treated area
- Signs of infection (pus, fever, spreading redness)
- Any signs of systemic side effects like unusual weight gain, swelling in ankles/feet, increased thirst/urination (rare, but possible with extensive or prolonged 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 you are taking.
* Any health problems you have, 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 other medications and health conditions. Do not initiate, discontinue, or modify the dose 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 health problems you have, 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 other medications and health conditions. Do not initiate, discontinue, or modify the dose 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.
This medication is not intended 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.
Do not use this medication for a longer duration than prescribed by your doctor. If the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in children. 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 these situations to ensure the best outcome for both you and your baby.
This medication is not intended 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.
Do not use this medication for a longer duration than prescribed by your doctor. If the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in children. 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 these situations to ensure the best outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use of topical corticosteroids can lead to systemic effects due to absorption, including adrenal suppression (fatigue, weakness, nausea, vomiting, low blood pressure), Cushing's syndrome (weight gain, moon face, buffalo hump, stretch marks), hyperglycemia (high blood sugar), and growth retardation in children.
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. Treatment is supportive and may involve gradual withdrawal of the medication under medical supervision.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify areas for treatment.
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy (reduction in inflammation, pruritus)
Frequency: Regularly during treatment (e.g., weekly to bi-weekly)
Target: Improvement in symptoms
Action Threshold: Lack of improvement or worsening symptoms may require re-evaluation of diagnosis or treatment.
Local adverse reactions (e.g., atrophy, striae, telangiectasias, burning, itching, irritation)
Frequency: Regularly during treatment
Target: Absence of or minimal adverse effects
Action Threshold: Presence of significant or worsening local adverse effects may require discontinuation or change in therapy.
Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, adrenal suppression)
Frequency: Periodically, especially with prolonged use, large surface areas, or occlusive dressings, particularly in children.
Target: Absence of systemic effects
Action Threshold: Presence of systemic effects requires immediate discontinuation and medical evaluation.
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
- Weight gain (systemic)
- Moon face (systemic)
- Fatigue (systemic)
Special Patient Groups
Pregnancy
Fluocinolone acetonide is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with corticosteroids.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenic effects, though systemic absorption from topical use is minimal.
Second Trimester:
Minimal systemic absorption, but use with caution.
Third Trimester:
Minimal systemic absorption, but use with caution.
Lactation
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when fluocinolone acetonide is administered to a nursing woman. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk, but monitor for potential effects if significant absorption occurs.
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 potent corticosteroid for the shortest duration possible. Avoid occlusive dressings.
Geriatric Use
No specific dosage adjustments are required. However, elderly patients may have thinner skin and be more prone to local adverse effects such as skin atrophy and purpura. Monitor for these effects.
Clinical Information
Clinical Pearls
- Fluocinolone acetonide 0.025% ointment is a medium-potency topical corticosteroid.
- Ointments are generally more potent than creams or lotions of the same concentration and are preferred for dry, scaly lesions.
- Avoid prolonged use on the face, groin, or axillae due to increased risk of skin atrophy, telangiectasias, and striae.
- Do not use on infected skin without concomitant antimicrobial therapy.
- Patients should be advised to use the smallest amount necessary to cover the affected area and to avoid occlusive dressings unless specifically instructed by a physician.
- Adrenal suppression is rare with appropriate topical use but can occur, especially in children or with extensive/prolonged application.
Alternative Therapies
- Other topical corticosteroids (e.g., hydrocortisone, triamcinolone, betamethasone, clobetasol)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing therapy
- Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole)
- Emollients and moisturizers for dry skin conditions
Cost & Coverage
Average Cost:
$20 - $50 per 60gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (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 occurred.