Fluocinonide 0.05% Soln 20ml
It is used to treat skin rashes and other skin irritation.It is used to treat psoriasis.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Jun 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluocinonide 0.05% solution is a strong medicine applied to the skin to help reduce redness, swelling, and itching caused by certain skin conditions like eczema or psoriasis. It works by calming down the skin's immune response.
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
This medication is for topical use only, meaning it should be applied directly to the skin. Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation.
Before applying the medication, wash your hands thoroughly. If the area being treated is on your hand, you do not need to wash that hand after application. Clean the affected area before applying the medication and make sure it is completely dry. Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless instructed by your doctor to do so, do not cover the treated area with bandages or dressings.
Storage and Disposal
To maintain the medication's effectiveness, store it at room temperature with the lid tightly closed. Protect the medication from heat sources. Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next scheduled 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 make up for a missed dose.
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
This medication is for topical use only, meaning it should be applied directly to the skin. Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation.
Before applying the medication, wash your hands thoroughly. If the area being treated is on your hand, you do not need to wash that hand after application. Clean the affected area before applying the medication and make sure it is completely dry. Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless instructed by your doctor to do so, do not cover the treated area with bandages or dressings.
Storage and Disposal
To maintain the medication's effectiveness, store it at room temperature with the lid tightly closed. Protect the medication from heat sources. Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next scheduled 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 make up for a missed dose.
Lifestyle & Tips
- Apply a thin layer of the solution to the affected skin area as directed by your doctor, usually 2 to 3 times a day.
- Gently rub it in until it disappears.
- Wash your hands before and after applying the medicine.
- Do not use more medicine than prescribed or apply it more often than directed.
- Do not use this medicine on your face, groin, or underarms unless specifically told to by your doctor, as these areas are more sensitive to side effects.
- Avoid getting the solution in your eyes, nose, or mouth. If it gets into your eyes, rinse thoroughly with water.
- Do not cover the treated area with bandages, plastic wrap, or other occlusive dressings unless your doctor tells you to, as this can increase absorption and side effects.
- Do not use this medicine for longer than prescribed, typically no more than 2 weeks for acute flares, to minimize the risk of side effects.
- Inform your doctor if your condition does not improve or worsens after a few days of treatment.
Available Forms & Alternatives
Available Strengths:
- Fluocinonide -E 0.05% Cream 15gm
- Fluocinonide -E 0.05% Cream 60gm
- Fluocinonide -E 0.05% Cream 30gm
- Fluocinonide 0.05% Gel 15gm
- Fluocinonide 0.05% Soln 20ml
- Fluocinonide 0.05% Ointment 30gm
- Fluocinonide 0.05% Oint 60gm
- Fluocinonide 0.05% Gel 60gm
- Fluocinonide 0.05% Oint 15gm
- Fluocinonide 0.05% Gel 30gm
- Fluocinonide 0.1% Cream 120gm
- Fluocinonide 0.1% Cream 30gm
- Fluocinonide 0.1% Cream 60gm
- Fluocinonide 0.05% Cream 60gm
- Fluocinonide 0.05% Cream 30gm
- Fluocinonide 0.05% Cream 120gm
- Fluocinonide 0.05% Cream 15gm
- Fluocinonide 0.05% Soln 60ml
- Fluocinonide 0.05% Soln 60ml
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film of solution to the affected area 2 to 3 times daily.
Condition-Specific Dosing:
psoriasis:
Apply 2-3 times daily, may use occlusive dressing for severe cases under medical supervision.
eczema:
Apply 2-3 times daily.
Pediatric Dosing
Neonatal:
Not established (increased risk of systemic absorption and adverse effects).
Infant:
Not established (increased risk of systemic absorption and adverse effects).
Child:
Use with caution, generally not recommended for prolonged use or on large surface areas due to increased risk of systemic toxicity (e.g., HPA axis suppression, Cushing's syndrome). Limit treatment to the least amount compatible with an effective therapeutic regimen. Apply once daily for short durations if necessary.
Adolescent:
Similar to adult dosing, but monitor closely for systemic effects if used extensively or for prolonged periods.
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, as systemic absorption is minimal under normal conditions.
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
Fluocinonide is a high-potency corticosteroid. It acts 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. Thus, fluocinonide exerts anti-inflammatory, antipruritic, and vasoconstrictive actions.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (depends on skin integrity, vehicle, presence of occlusive dressings, and surface area applied). Systemic absorption can occur, especially through inflamed, damaged, or occluded skin.
Tmax:
Not precisely defined for topical application due to variable absorption.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not precisely defined for topical administration; systemically absorbed corticosteroids are bound to plasma proteins to varying degrees.
ProteinBinding:
High (for systemically absorbed corticosteroids).
CnssPenetration:
Limited (systemic absorption is generally low).
Elimination:
HalfLife:
Not precisely defined for topical administration; systemically absorbed corticosteroids are excreted primarily by the kidneys.
Clearance:
Not precisely defined for topical administration.
ExcretionRoute:
Renal (primarily as inactive metabolites).
Unchanged:
Minimal (for systemically absorbed drug).
Pharmacodynamics
OnsetOfAction:
Within hours to days for anti-inflammatory and antipruritic effects.
PeakEffect:
Within days of consistent application.
DurationOfAction:
Effects persist as long as applied, with residual effects for a period after discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
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
Skin irritation
Thinning of the skin
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Burning or stinging sensation
Dry skin
Itching
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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
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
Skin irritation
Thinning of the skin
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Burning or stinging sensation
Dry skin
Itching
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:
- Severe burning, itching, or irritation of the treated skin
- Skin thinning, easy bruising, or stretch marks (striae)
- Changes in skin color
- Acne-like rash or increased hair growth at the application site
- Signs of skin infection (e.g., pus, spreading redness, fever)
- Unusual tiredness or weakness
- Weight gain, especially in the face or upper back
- Swelling in the ankles or feet
- Blurred vision or other vision problems (rare, with systemic absorption)
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.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken 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 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.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken 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. Before using any other medications or skin products, such as soaps, consult with your doctor to ensure safe use.
When applying this medication, avoid putting it on cuts, scrapes, or damaged skin. If you need to apply it to a large area of skin or near open wounds, exercise caution and discuss this with your doctor.
Do not use this medication for a longer period than prescribed by your doctor. If the treated area is in the diaper region, avoid using tight-fitting diapers or plastic pants, as this can increase the amount of medication absorbed into the body.
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Discuss this with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as you will need to discuss the benefits and risks of using this medication to both you and your baby.
When applying this medication, avoid putting it on cuts, scrapes, or damaged skin. If you need to apply it to a large area of skin or near open wounds, exercise caution and discuss this with your doctor.
Do not use this medication for a longer period than prescribed by your doctor. If the treated area is in the diaper region, avoid using tight-fitting diapers or plastic pants, as this can increase the amount of medication absorbed into the body.
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Discuss this with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as you will need to discuss the benefits and risks of using this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or extensive use, especially under occlusion or on large surface areas, can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome) or adrenal suppression.
- Symptoms may include: moon face, central obesity, thinning skin, easy bruising, muscle weakness, fatigue, high blood pressure, high blood sugar.
What to Do:
If you suspect an overdose or systemic effects, contact your doctor or a poison control center immediately. In the US, call 1-800-222-1222. Treatment is supportive and may involve gradual withdrawal of the corticosteroid.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify any signs of infection or skin breakdown.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response (reduction in inflammation, pruritus)
Frequency: Regularly, typically at follow-up visits (e.g., weekly to bi-weekly initially).
Target: Improvement in symptoms and appearance of affected skin.
Action Threshold: Lack of improvement or worsening of condition may indicate need for re-evaluation or alternative therapy.
Local adverse effects (e.g., skin atrophy, striae, telangiectasias, folliculitis, secondary infection)
Frequency: At each follow-up visit and with patient self-monitoring.
Target: Absence of new or worsening local adverse effects.
Action Threshold: Presence of significant local adverse effects warrants discontinuation or reduction in potency/frequency.
Signs of systemic absorption (e.g., Cushing's syndrome, HPA axis suppression)
Frequency: Periodically, especially with prolonged use, extensive body surface area application, or in pediatric patients.
Target: Normal adrenal function (e.g., normal cortisol levels if tested).
Action Threshold: Symptoms or lab findings suggestive of systemic absorption require immediate medical evaluation and potential discontinuation.
Symptom Monitoring
- Worsening of skin condition
- Increased redness, swelling, or pain (signs of infection)
- Burning or stinging sensation
- Itching
- Skin thinning or fragility
- Development of stretch marks (striae)
- Acne-like rash
- Excessive hair growth at application site
- Changes in skin color
- Blurred vision or other visual disturbances (rare, with systemic absorption)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid large amounts, prolonged use, or application to large surface areas.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though data for topical corticosteroids are limited and generally reassuring for limited use.
Second Trimester:
Risk of systemic absorption and potential fetal effects (e.g., low birth weight) with extensive or prolonged use.
Third Trimester:
Risk of systemic absorption and potential fetal effects (e.g., low birth weight, adrenal suppression) with extensive or prolonged use.
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 with limited, short-term topical use. Potential for adverse effects if significant systemic absorption occurs in the mother and drug is transferred to milk, or if applied directly to breast and ingested by infant.
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. Prolonged use should be avoided. Not recommended for infants. Monitor for growth retardation, delayed weight gain, and intracranial hypertension.
Geriatric Use
No specific dosage adjustments are necessary. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects such as skin atrophy, purpura, and telangiectasias. Monitor closely for these effects.
Clinical Information
Clinical Pearls
- Fluocinonide 0.05% is a high-potency topical corticosteroid; use it judiciously and for the shortest duration possible to achieve therapeutic effect.
- The solution formulation is particularly useful for hairy areas of the body (e.g., scalp) or weeping lesions.
- Educate patients on proper application technique: thin layer, gentle rubbing, and avoiding occlusive dressings unless specifically instructed by a physician.
- Warn patients about the potential for skin atrophy, striae, and telangiectasias with prolonged use, especially on sensitive areas like the face or intertriginous zones.
- Consider step-down therapy to a lower potency corticosteroid or a steroid-sparing agent once the acute flare is controlled.
Alternative Therapies
- Other high-potency topical corticosteroids (e.g., Clobetasol propionate, Halobetasol propionate)
- Medium-potency topical corticosteroids (e.g., Triamcinolone acetonide, Mometasone furoate)
- Low-potency topical corticosteroids (e.g., Hydrocortisone)
- Topical calcineurin inhibitors (e.g., Tacrolimus, Pimecrolimus) for steroid-sparing therapy
- Emollients and moisturizers for barrier repair
- Systemic therapies for severe dermatoses (e.g., oral corticosteroids, biologics, immunosuppressants)
Cost & Coverage
Average Cost:
$50 - $200 per 20ml solution
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 happened.