Fluocinolone Acet 0.01% Soln 60ml
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 topical corticosteroid medication used to reduce inflammation, itching, and redness caused by various skin conditions like eczema 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. 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 application 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 application schedule.
Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Wash hands before and after applying the medication.
- Apply a thin layer to the affected skin area as directed by your doctor.
- Do not cover the treated area with bandages or tight 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 for longer than prescribed, especially on the face, groin, or armpits, or in children, due to increased risk of side effects.
- Do not use on broken or infected skin unless directed by your doctor.
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, or as directed by a physician.
Condition-Specific Dosing:
psoriasis_seborrheic_dermatitis:
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, or as directed by a physician. Use with caution and for the shortest duration possible due to increased systemic absorption risk.
Child:
Apply a thin film to the affected area 2 to 4 times daily, or as directed by a physician. Use with caution and for the shortest duration possible due to increased systemic absorption risk.
Adolescent:
Apply a thin film to the affected area 2 to 4 times daily, or as directed by a physician.
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 specific considerations 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 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, 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:
Minimal systemic absorption from intact skin; absorption increases with inflammation, skin barrier disruption, prolonged use, and occlusive dressings.
Tmax:
Not applicable for topical local effect; systemic absorption peak is variable if significant absorption occurs.
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable for topical local effect; if absorbed systemically, distributes widely.
ProteinBinding:
Variable, generally high for corticosteroids (e.g., >90% for hydrocortisone).
CnssPenetration:
Limited from topical application; possible with significant systemic absorption.
Elimination:
HalfLife:
Not precisely determined for topical; systemic half-life of corticosteroids varies.
Clearance:
Not precisely determined for topical; systemic clearance is hepatic.
ExcretionRoute:
Primarily renal if absorbed systemically.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief.
PeakEffect:
Days to weeks of consistent application.
DurationOfAction:
Varies with application frequency and severity of 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 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 do not go away, contact your doctor:
Burning or stinging sensation
Dry skin
This is not an exhaustive list of possible side effects. 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, 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 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 do not go away, contact your doctor:
Burning or stinging sensation
Dry skin
This is not an exhaustive list of possible side effects. 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:
- Increased redness, itching, or burning at the application site
- Skin thinning, easy bruising, or stretch marks (striae)
- Acne-like eruptions or folliculitis
- Signs of skin infection (pus, warmth, spreading redness)
- Unusual weight gain, swelling in ankles/feet, increased thirst/urination (signs of systemic absorption, especially in children or with prolonged/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.
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 and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication. 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 and vitamins you are using
* Any health problems you have
Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication. 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 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 pregnancy or breastfeeding to ensure the best 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 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 pregnancy or breastfeeding to ensure the best outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Chronic overuse or misuse can lead to systemic corticosteroid effects such as Cushing's syndrome (moon face, buffalo hump, central obesity), hyperglycemia, glucosuria, and adrenal suppression. Acute overdose is unlikely with topical application.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment for systemic effects. Call 1-800-222-1222 (Poison Control) for advice if significant ingestion or systemic symptoms occur.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify any pre-existing skin thinning, infection, or atrophy.
Timing: Prior to initiation of therapy.
Routine Monitoring
Local skin reactions (e.g., atrophy, striae, telangiectasias, burning, itching, irritation)
Frequency: At each follow-up visit, or as symptoms arise.
Target: Absence of new or worsening reactions.
Action Threshold: If severe or persistent reactions occur, discontinue use and reassess treatment.
Signs of systemic corticosteroid absorption (e.g., Cushing's syndrome, hyperglycemia, adrenal suppression)
Frequency: Periodically, especially with prolonged use, large surface area application, or occlusive dressings.
Target: Normal clinical signs and laboratory values (e.g., blood glucose, cortisol levels if indicated).
Action Threshold: If signs/symptoms develop, consider tapering or discontinuing therapy and consult endocrinology.
Signs of secondary infection
Frequency: At each follow-up visit.
Target: Absence of erythema, pus, warmth, or increased pain.
Action Threshold: If infection suspected, discontinue fluocinolone and initiate appropriate antimicrobial therapy.
Symptom Monitoring
- Worsening of skin irritation (burning, itching, redness)
- Development of new skin changes (thinning, easy bruising, stretch marks, acne-like eruptions)
- Signs of infection (pus, increased pain, fever)
- Unusual fatigue, weight gain, swelling (potential systemic absorption)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Category C. Avoid large areas, prolonged use, or occlusive dressings.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity with high doses of systemic corticosteroids; topical absorption is generally low but caution advised.
Second Trimester:
Risk of fetal growth restriction or adrenal suppression with high doses of systemic corticosteroids; topical absorption is generally low.
Third Trimester:
Risk of fetal growth restriction or adrenal suppression with high doses of systemic corticosteroids; topical absorption is generally low.
Lactation
Use with caution. It is not known whether topical corticosteroids are excreted in human milk. Systemic corticosteroids are excreted in human milk and could cause adverse effects in the infant. Minimize infant exposure by avoiding application to the breast area.
Infant Risk:
Low risk with appropriate use (small areas, short duration), but potential for systemic effects if significant absorption occurs in mother.
Pediatric Use
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, intracranial hypertension, growth retardation) than adult patients. Use the least potent corticosteroid for the shortest duration possible. Avoid occlusive dressings.
Geriatric Use
No specific dosage adjustments are typically required. However, elderly patients may have thinner skin, which could potentially increase systemic absorption. Monitor for skin atrophy and other local side effects.
Clinical Information
Clinical Pearls
- Fluocinolone acetonide 0.01% solution is a medium-potency topical corticosteroid, often used for scalp psoriasis or seborrheic dermatitis due to its liquid formulation.
- Instruct patients to apply sparingly and rub in gently. For scalp conditions, it can be applied directly to the affected areas.
- Warn patients about the potential for skin thinning (atrophy), especially with prolonged use or on sensitive areas like the face, groin, or skin folds.
- If no improvement is seen after 2-4 weeks, re-evaluate the diagnosis and treatment plan.
- Patients should be advised not to use this medication for conditions other than those for which it was prescribed.
Alternative Therapies
- Other topical corticosteroids (e.g., clobetasol, betamethasone, triamcinolone, hydrocortisone) of varying potencies.
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema.
- Vitamin D analogs (e.g., calcipotriene) for psoriasis.
- Topical antifungals for seborrheic dermatitis if fungal component is suspected.
- Emollients and moisturizers for barrier repair.
Cost & Coverage
Average Cost:
$30 - $100 per 60ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.