Fluocinonide 0.1% Cream 30gm

Manufacturer TARO Active Ingredient Fluocinonide 0.1% Cream(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 0.1% Cream is a strong corticosteroid medicine applied to the skin to reduce redness, swelling, and itching caused by various skin conditions like eczema or psoriasis. It works by calming down the body's inflammatory response in the skin.
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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.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
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 dry it thoroughly.
Unless instructed by your doctor, do not apply the medication to your face, underarms, or groin area.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Do not cover the treated area with bandages or dressings unless your doctor advises you to do so.

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

  • Apply a thin layer of cream to the affected area as directed by your doctor, usually two to four times a day.
  • Wash your hands before and after applying the cream.
  • Do not use more cream than prescribed or apply it more often than directed.
  • Do not use this cream on your face, groin, or underarms unless specifically told to by your doctor, as these areas are more sensitive to side effects.
  • Do not cover the treated area with bandages or other dressings unless your doctor tells you to, as this can increase absorption and side effects.
  • Avoid getting the cream in your eyes, nose, or mouth. If it gets into your eyes, rinse thoroughly with water.
  • Do not use this cream for longer than prescribed, especially in children, as prolonged use can lead to thinning of the skin or other serious side effects.
  • Inform your doctor if your condition does not improve or worsens after a few days or weeks of treatment.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to the affected skin areas two to four times daily, depending on severity.
Dose Range: 2 - 4 mg

Condition-Specific Dosing:

psoriasis: Apply a thin film to the affected skin areas two to four times daily.
eczema: Apply a thin film to the affected skin areas two to four times daily.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, if at all, due to increased systemic absorption risk)
Infant: Not established (use with extreme caution, if at all, due to increased systemic absorption risk)
Child: Apply a thin film to the affected skin areas two to four times daily. Limit treatment to the least amount necessary for therapeutic effect. Avoid use on face, groin, or axillae. Avoid occlusive dressings. Monitor for HPA axis suppression.
Adolescent: Apply a thin film to the affected skin areas two to four times daily. Limit treatment to the least amount necessary for therapeutic effect. Avoid use on face, groin, or axillae. Avoid occlusive dressings.
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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 adjustment needed 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

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Mechanism of Action

Fluocinonide is a high-potency 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 (depends on skin integrity, vehicle, duration of exposure, and use of occlusive dressings; systemic absorption can occur, especially with prolonged use, large surface areas, or damaged skin)
Tmax: Not well-defined for topical application (systemic absorption is generally minimal)
FoodEffect: Not applicable for topical administration

Distribution:

Vd: Not well-defined for topical application (if absorbed systemically, distributes throughout the body)
ProteinBinding: High (if absorbed systemically, binds to plasma proteins)
CnssPenetration: Limited (if absorbed systemically)

Elimination:

HalfLife: Not well-defined for topical application (systemic half-life of corticosteroids varies)
Clearance: Not well-defined for topical application
ExcretionRoute: Renal (primarily via the kidneys, if absorbed systemically)
Unchanged: Not available
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Pharmacodynamics

OnsetOfAction: Within hours to days (local anti-inflammatory effect)
PeakEffect: Within days to weeks (maximal therapeutic effect)
DurationOfAction: Varies with application frequency and condition

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 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 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 have mild 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
Itching

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.
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Seek Immediate Medical Attention If You Experience:

  • Increased redness, itching, or irritation at the application site
  • Burning or stinging sensation
  • Thinning of the skin (atrophy)
  • Stretch marks (striae)
  • Spider veins (telangiectasias)
  • Acne-like breakouts
  • Hair growth in the treated area
  • Changes in skin color
  • Signs of skin infection (e.g., pus, fever, spreading redness)
  • Unusual tiredness or weakness
  • Weight gain, especially in the face or trunk (signs of Cushing's syndrome, rare with topical use)
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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, 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 existing health problems, 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. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
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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 skin products, including soaps, consult with your doctor to ensure safe use.

When applying this medication, avoid putting it on cuts, scrapes, or damaged skin. Exercise caution when applying it to a large area of skin or near open wounds, and discuss this with your doctor.

Do not use this medication for a longer period than prescribed by your doctor. In addition, if you are treating an area that will be covered by a diaper, avoid using tight-fitting diapers or plastic pants, as this can increase the amount of medication absorbed into the body.

This medication is not intended to treat acne, rosacea, or rashes around the mouth. If you are a parent or caregiver of a child using this medication, use it with caution, as children may be at a higher risk for 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, as they will need to weigh the benefits and risks of this medication for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including: moon face, central obesity, thinning skin, easy bruising, muscle weakness, hyperglycemia, glucosuria, and growth retardation in children.

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify any pre-existing skin infections or atrophy.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus)

Frequency: Regularly, at follow-up visits (e.g., weekly to bi-weekly initially, then as needed)

Target: Improvement in symptoms and appearance of affected skin.

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

Local adverse reactions (e.g., skin atrophy, striae, telangiectasias, folliculitis, burning, itching, irritation)

Frequency: At each follow-up visit and patient self-monitoring.

Target: Absence of significant adverse reactions.

Action Threshold: Presence of significant or persistent adverse reactions may require dose reduction, discontinuation, or change in therapy.

Signs of HPA axis suppression (especially with prolonged use, large surface areas, or occlusive dressings)

Frequency: Periodically, especially in pediatric patients or those at high risk (e.g., ACTH stimulation test, plasma cortisol levels).

Target: Normal HPA axis function.

Action Threshold: Evidence of HPA axis suppression requires gradual withdrawal of the drug, temporary discontinuation, or substitution with a less potent corticosteroid.

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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
  • Signs of systemic absorption (e.g., Cushing's syndrome symptoms, hyperglycemia, glucosuria, growth retardation in children)

Special Patient Groups

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Pregnancy

Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in animal studies when administered systemically at relatively low doses. The potential for systemic absorption of topical corticosteroids should be considered.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though systemic absorption from topical use is generally low.
Second Trimester: Risk generally considered low with limited topical use.
Third Trimester: Risk generally considered low with limited topical use, but potential for HPA axis suppression in the neonate if significant systemic absorption occurs.
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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 fluocinonide cream is administered to a nursing woman. If used, avoid application to the breast area to prevent direct infant exposure.

Infant Risk: Low risk with limited topical use, but monitor infant for potential adverse effects if significant maternal systemic absorption occurs.
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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 for the shortest duration possible. Avoid occlusive dressings. Monitor for growth retardation and HPA axis suppression.

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Geriatric Use

No specific dosage adjustments are required. However, elderly patients may have thinner, more fragile skin, which could increase the risk of local adverse effects like atrophy or bruising. Use with caution and monitor skin integrity.

Clinical Information

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Clinical Pearls

  • Fluocinonide 0.1% cream is a high-potency topical corticosteroid; it should be used for short durations (typically 2-4 weeks) to avoid local and systemic side effects.
  • Avoid using on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more prone to atrophy, telangiectasias, and other side effects.
  • Occlusive dressings significantly increase systemic absorption and local side effects; use only if specifically instructed by a physician.
  • Patients should be educated on the proper application technique (thin film, gentle rubbing) and the importance of not exceeding the prescribed duration or frequency.
  • In pediatric patients, the risk of HPA axis suppression is higher; careful monitoring and limiting the duration of therapy are crucial.
  • If no improvement is seen after 2 weeks, re-evaluate the diagnosis and treatment plan.
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Alternative Therapies

  • Other topical corticosteroids (e.g., clobetasol propionate for higher potency, triamcinolone acetonide for medium potency, hydrocortisone for low potency)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
  • Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole) for eczema
  • Vitamin D analogs (e.g., calcipotriene) for psoriasis
  • Topical retinoids for psoriasis
  • Emollients and moisturizers for dry skin conditions
  • Systemic therapies (e.g., biologics, oral immunosuppressants) for severe dermatoses
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Cost & Coverage

Average Cost: $20 - $100 per 30gm 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 seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.