Fluocinonide 0.05% Cream 15gm

Manufacturer TARO Active Ingredient Fluocinonide Cream, Gel, Ointment, and Solution(floo oh SIN oh nide) Pronunciation floo oh SIN oh nide
It is used to treat skin rashes and other skin irritation.It is used to treat psoriasis.
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Drug Class
Topical Corticosteroid
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Pharmacologic Class
Glucocorticoid
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Pregnancy Category
Category C
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FDA Approved
Jun 1971
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Fluocinonide is a strong medicine applied to the skin to reduce redness, itching, and swelling caused by skin conditions like eczema or psoriasis. It belongs to a group of medicines called corticosteroids.
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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.
Keep the medication away from your mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the area being treated.
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.
Unless instructed to do so by your doctor, do not cover the treated area with bandages or dressings.

Storage and Disposal

Store the medication at room temperature with the lid tightly closed.
Protect the medication from heat.
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.
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Lifestyle & Tips

  • Wash your hands before and after applying the cream.
  • Apply a thin layer of cream to the affected skin area, gently rubbing it in until it disappears. Do not use more than prescribed.
  • Do not cover the treated area with bandages or other dressings unless directed by your doctor, as this can increase absorption and side effects.
  • Avoid applying the cream to the face, groin, or armpits unless specifically instructed by your doctor, as these areas are more prone to side effects.
  • Do not use this medication for longer than prescribed, especially on children, as it can lead to serious side effects.
  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Do not use for diaper rash unless specifically advised by a doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to the affected area 2 to 4 times daily, depending on the severity of the condition.
Dose Range: 2 - 4 mg

Condition-Specific Dosing:

psoriasis: Apply 2-4 times daily.
eczema: Apply 2-4 times daily.
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Pediatric Dosing

Neonatal: Not established. Use with extreme caution due to increased risk of systemic absorption and HPA axis suppression.
Infant: Not established. Use with extreme caution due to increased risk of systemic absorption and HPA axis suppression.
Child: Apply a thin film to the affected area 2 to 4 times daily. Limit treatment to the smallest amount compatible with an effective therapeutic regimen. Avoid use on large surface areas or under occlusive dressings. Monitor for signs of systemic toxicity (e.g., HPA axis suppression).
Adolescent: Apply a thin film to the affected area 2 to 4 times daily.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed for topical application.
Moderate: No specific adjustment needed for topical application.
Severe: No specific adjustment needed for topical application.
Dialysis: No specific considerations for topical application, as systemic absorption is minimal.

Hepatic Impairment:

Mild: No specific adjustment needed for topical application.
Moderate: No specific adjustment needed for topical application.
Severe: No specific adjustment needed for topical application.

Pharmacology

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Mechanism of Action

Fluocinonide is a high-potency topical 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.
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Pharmacokinetics

Absorption:

Bioavailability: Variable; systemic absorption can occur, especially through inflamed, damaged, or occluded skin. Bioavailability is generally low but increases with larger surface areas, prolonged use, and occlusive dressings.
Tmax: Not typically quantified for topical application due to variable systemic absorption.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not specifically quantified for topical application; if absorbed systemically, it is distributed throughout the body.
ProteinBinding: Not specifically quantified for topical application; systemically absorbed corticosteroids are highly protein-bound.
CnssPenetration: Limited, unless significant systemic absorption occurs.

Elimination:

HalfLife: Not well-defined for topical application due to variable absorption and local action. Systemically absorbed corticosteroids have variable half-lives.
Clearance: Not specifically quantified for topical application.
ExcretionRoute: Renal excretion of metabolites, if absorbed systemically.
Unchanged: Minimal, if absorbed systemically.
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Pharmacodynamics

OnsetOfAction: Within hours to days for symptomatic relief.
PeakEffect: Within days to weeks of consistent application.
DurationOfAction: Varies depending on application frequency and individual response; local effects persist for several hours after application.

Safety & Warnings

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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 medical attention immediately:

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 passing out
+ 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
Skin irritation
Thinning of the skin

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 symptoms that bother you or do not go away, contact your doctor or seek medical help:

Burning or stinging
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.
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Seek Immediate Medical Attention If You Experience:

  • Increased irritation, redness, or burning at the application site
  • Signs of skin infection (pus, spreading redness, fever)
  • Skin thinning, easy bruising, or stretch marks
  • Acne or hair growth in the treated area
  • If used extensively or for prolonged periods, watch for signs of systemic absorption like unusual tiredness, weight gain (especially in the face/trunk), or swelling in the ankles/feet.
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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, any of 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 drug may interact with other prescription or over-the-counter (OTC) medications, natural products, or vitamins, which could affect its safety and efficacy.
A complete list of all your current medications, including prescription and OTC drugs, natural products, and vitamins. This will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as these may impact the safety and effectiveness of this medication.

To minimize risks and ensure safe use, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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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 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.

Adhere to your doctor's instructions regarding the duration of use; do not use this medication for longer than prescribed. 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, necessitating regular growth checks; consult with your doctor to discuss this potential risk.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to weigh the benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use 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 symptoms may include severe skin atrophy, striae, or telangiectasias.

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify any contraindications (e.g., active infection).

Timing: Prior to initiation of therapy.

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus)

Frequency: Regularly during treatment, typically weekly or bi-weekly initially.

Target: Improvement in symptoms and skin appearance.

Action Threshold: Lack of improvement or worsening symptoms may indicate need for re-evaluation or alternative therapy.

Local adverse effects (e.g., skin atrophy, striae, telangiectasias, folliculitis, perioral dermatitis)

Frequency: At each follow-up visit.

Target: Absence of or minimal adverse effects.

Action Threshold: Presence of significant adverse effects warrants reduction in potency, frequency, or discontinuation.

Signs of HPA axis suppression (e.g., fatigue, weight loss, hypotension, hyperglycemia) - especially with prolonged use, large surface areas, or occlusive dressings

Frequency: Periodically, especially in pediatric patients or those at high risk for systemic absorption.

Target: Normal adrenal function.

Action Threshold: Suspicion of HPA axis suppression may warrant laboratory testing (e.g., ACTH stimulation test, morning cortisol) and gradual withdrawal of therapy.

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Symptom Monitoring

  • Worsening of skin condition
  • Signs of skin infection (redness, pus, warmth, pain)
  • Excessive skin thinning or bruising
  • Development of stretch marks (striae)
  • Increased hair growth at application site
  • Acne-like eruptions
  • Fatigue, weakness, dizziness (signs of systemic absorption/HPA axis suppression)

Special Patient Groups

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Pregnancy

Category C. Use 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 are limited for topical corticosteroids. Avoid if possible.
Second Trimester: Risk of systemic absorption and potential fetal effects (e.g., growth restriction, adrenal suppression) increases with higher potency, larger surface areas, and prolonged use.
Third Trimester: Risk of systemic absorption and potential fetal effects (e.g., growth restriction, adrenal suppression) increases with higher potency, larger surface areas, and prolonged use.
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Lactation

L3 (Moderately Safe). 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. Minimize infant exposure by avoiding application to the breast area and ensuring the infant does not come into direct contact with treated skin.

Infant Risk: Low risk with limited, short-term use. Potential for adverse effects (e.g., growth suppression, HPA axis suppression) if significant systemic absorption occurs in the mother and is transferred to the infant.
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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 that provides effective therapy. Limit treatment to the smallest amount compatible with an effective therapeutic regimen. Avoid occlusive dressings. Monitor for signs of systemic toxicity.

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Geriatric Use

No specific dosage adjustments are typically required. However, geriatric patients may have thinner, more fragile skin, increasing susceptibility to local adverse effects like skin atrophy, purpura, and striae. Monitor closely for skin integrity.

Clinical Information

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Clinical Pearls

  • Fluocinonide 0.05% is a high-potency topical corticosteroid; use it judiciously and for the shortest duration necessary to control symptoms.
  • Avoid prolonged use, especially on the face, intertriginous areas (skin folds), or in children, due to increased risk of local and systemic side effects.
  • Educate patients on proper application technique: a thin film, gently rubbed in, and avoiding occlusive dressings unless specifically instructed.
  • Consider step-down therapy to a lower potency corticosteroid or intermittent use once the acute flare is controlled to minimize side effects.
  • Always rule out fungal or bacterial infections before initiating corticosteroid therapy, as corticosteroids can worsen these conditions.
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Alternative Therapies

  • Clobetasol propionate (very high potency)
  • Betamethasone dipropionate (high potency)
  • Mometasone furoate (medium potency)
  • Triamcinolone acetonide (medium potency)
  • Hydrocortisone (low potency)
  • Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing therapy
  • Emollients and moisturizers for barrier repair
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Cost & Coverage

Average Cost: $15 - $50 per 15gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with 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 reporting the incident, be prepared to provide detailed information about the medication taken, the amount consumed, and the time it occurred.