Fluocinolone Acet 0.025% Oint 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 ointment is a topical medicine used to reduce redness, swelling, and itching caused by various 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 to do so 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 to do so 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 ointment.
- Apply a thin layer of the ointment to the affected skin area as directed by your doctor, usually 2 to 4 times a day.
- Rub it in gently until it disappears.
- Do not use more than the prescribed amount or for longer than directed, as this can increase the risk of side effects.
- 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 getting the ointment in your eyes, nose, or mouth. If it gets into these areas, rinse thoroughly with water.
- Do not use on the face, groin, or armpits unless directed by your doctor.
- 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.
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 systemic absorption)
Infant:
Apply a thin film to the affected area 2 to 4 times daily. Use with caution, especially on large surface areas or under occlusion, due to increased systemic absorption and potential for HPA axis suppression.
Child:
Apply a thin film to the affected area 2 to 4 times daily. Use with caution, especially on large surface areas or under occlusion, due to increased systemic absorption and potential for HPA axis suppression.
Adolescent:
Apply a thin film to the affected area 2 to 4 times daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (topical application, minimal systemic absorption)
Moderate:
No adjustment needed (topical application, minimal systemic absorption)
Severe:
No adjustment needed (topical application, minimal systemic absorption)
Dialysis:
No specific considerations (topical application, minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (topical application, minimal systemic absorption)
Moderate:
No adjustment needed (topical application, minimal systemic absorption)
Severe:
No adjustment needed (topical application, minimal systemic absorption)
Pharmacology
Mechanism of Action
Fluocinolone acetonide is a synthetic fluorinated corticosteroid. It exerts its therapeutic effects primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions. Corticosteroids are thought to act 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:
Variable (depends on skin integrity, vehicle, duration of exposure, and use of occlusive dressings; generally low systemic absorption)
Tmax:
Not well-defined for topical application due to minimal systemic absorption
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not well-defined for topical application due to minimal systemic absorption
ProteinBinding:
Not well-defined for topical application due to minimal systemic absorption (systemically absorbed corticosteroids are extensively protein bound)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not well-defined for topical application due to minimal systemic absorption
Clearance:
Not well-defined for topical application due to minimal systemic absorption
ExcretionRoute:
Renal (for systemically absorbed drug)
Unchanged:
Not well-defined for topical application due to minimal systemic absorption
Pharmacodynamics
OnsetOfAction:
Within hours to days (for symptomatic relief)
PeakEffect:
Within days to weeks (for maximal 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 or seek immediate 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
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Burning or stinging
Dry skin
Not all possible side effects are listed here. If you have questions or concerns about side effects, consult 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, 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
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Burning or stinging
Dry skin
Not all possible side effects are listed here. If you have questions or concerns about side effects, consult 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
- Development of new skin problems like acne, thinning skin, stretch marks, or changes in skin color
- Signs of skin infection (e.g., pus, fever, increased pain)
- Unusual fatigue, weakness, or weight gain (signs of possible systemic absorption, especially with prolonged 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 allergic reaction you experienced, including any symptoms that occurred.
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 or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that this medication can be taken safely 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 allergic reaction you experienced, including any symptoms that occurred.
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 or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that this medication can be taken safely 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.
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 have a higher risk of experiencing 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.
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 have a higher risk of experiencing 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 of topical corticosteroids can lead to systemic effects due to absorption, including Cushing's syndrome (e.g., moon face, buffalo hump, central obesity), hyperglycemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
- Local overdose symptoms include skin thinning, stretch marks, acne, and increased hair growth at the application site.
What to Do:
If systemic symptoms occur, consult a healthcare professional immediately. Gradual withdrawal of the drug may be necessary. For local symptoms, discontinue use and consult a doctor. Call 1-800-222-1222 (Poison Control Center) for advice if accidental ingestion or significant overdose is suspected.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify any signs of infection or contraindications.
Timing: Prior to initiation of therapy
Routine Monitoring
Efficacy (reduction in inflammation, pruritus)
Frequency: Regularly, at follow-up visits
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., atrophy, striae, telangiectasias, folliculitis, perioral dermatitis)
Frequency: Regularly, at follow-up visits
Target: Absence of adverse reactions
Action Threshold: Presence of significant local adverse reactions may require discontinuation or change in therapy.
Signs of infection (e.g., redness, warmth, pus)
Frequency: Regularly, at follow-up visits
Target: Absence of infection
Action Threshold: Presence of infection requires appropriate antimicrobial therapy and potential discontinuation of corticosteroid.
Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, glucosuria, HPA axis suppression)
Frequency: Periodically, especially with prolonged use, large surface area application, or occlusive dressings
Target: Normal HPA axis function (e.g., normal cortisol levels)
Action Threshold: Evidence of systemic absorption or HPA axis suppression requires gradual withdrawal of the drug or reduction in frequency/potency.
Symptom Monitoring
- Worsening of skin condition
- Increased redness or irritation at application site
- Burning or stinging sensation
- Itching that does not improve
- Development of new skin lesions (e.g., pimples, thinning skin, stretch marks)
- Signs of skin infection (e.g., pus, fever)
- Unusual fatigue or weakness (potential sign of systemic absorption)
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 corticosteroids to be teratogenic.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though systemic absorption from topical use is generally low.
Second Trimester:
Use with caution; minimal systemic absorption expected.
Third Trimester:
Use with caution; minimal systemic absorption expected. Avoid large areas or prolonged use.
Lactation
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Use with caution in nursing mothers. If used, avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with proper application (avoiding breast area), but potential for systemic effects in infant 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 adults because of 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 dose adjustments are generally needed. However, elderly patients may have thinner skin, which could potentially increase systemic absorption. Monitor for adverse effects.
Clinical Information
Clinical Pearls
- Topical corticosteroids should be applied sparingly in a thin film to the affected area. Excessive application does not improve efficacy and increases the risk of side effects.
- Avoid prolonged use, especially on the face, groin, or axillae, as these areas are more susceptible to corticosteroid-induced skin atrophy.
- Occlusive dressings significantly increase the absorption of topical corticosteroids and should only be used if specifically directed by a physician.
- If a skin infection is present, it should be treated with appropriate antimicrobial therapy before or concurrently with corticosteroid use.
- Patients should be advised to report any signs of local irritation, infection, or systemic side effects to their healthcare provider.
Alternative Therapies
- Hydrocortisone (lower potency topical corticosteroid)
- Triamcinolone acetonide (medium potency topical corticosteroid)
- Betamethasone valerate (medium potency topical corticosteroid)
- Clobetasol propionate (higher potency topical corticosteroid)
- Non-steroidal topical agents (e.g., calcineurin inhibitors like tacrolimus or pimecrolimus for eczema)
Cost & Coverage
Average Cost:
$15 - $40 per 15gm 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 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 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.