Fluocinonide 0.1% Cream 60gm

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 receptor agonist
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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 topical steroid medication used to reduce inflammation, itching, and redness caused by various skin conditions like eczema, psoriasis, and allergic reactions. It works by calming down the immune 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.
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 skin area exactly 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 for longer than prescribed, as this can increase side effects.
  • Avoid applying the cream to your face, groin, or armpits unless specifically instructed by your doctor, as these areas are more sensitive to side effects.
  • Do not cover the treated area with bandages, plastic wrap, or tight dressings unless your doctor tells you to, as this can increase absorption and side effects.
  • Keep the cream away from your eyes, nose, and mouth. If it gets into your eyes, rinse thoroughly with water.
  • Do not use this cream for diaper rash in infants.
  • Store at room temperature, away from moisture and heat, and out of reach of children.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to the affected area two to four times daily.

Condition-Specific Dosing:

generalUse: Apply sparingly to affected areas. Discontinue when control is achieved.
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Pediatric Dosing

Neonatal: Not established (generally not recommended due to increased systemic absorption risk)
Infant: Not established (generally not recommended due to increased systemic absorption risk)
Child: Use with caution, apply the least amount for the shortest duration possible. Avoid use on face, groin, or axillae. Increased risk of systemic effects (HPA axis suppression, Cushing's syndrome, intracranial hypertension).
Adolescent: Similar to adult dosing, but with caution regarding prolonged use or large surface areas.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)
Dialysis: No specific considerations (minimal systemic absorption)

Hepatic Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)

Pharmacology

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Mechanism of Action

Fluocinonide, a high-potency topical corticosteroid, exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. It induces 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.
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Pharmacokinetics

Absorption:

Bioavailability: Variable, generally low systemic (depends on vehicle, skin integrity, site, and occlusive dressings)
Tmax: Not applicable for systemic effect (topical application)
FoodEffect: Not applicable

Distribution:

Vd: Not applicable for systemic distribution from topical use
ProteinBinding: High (systemically absorbed portion binds to plasma proteins like transcortin and albumin)
CnssPenetration: Limited

Elimination:

HalfLife: Not precisely defined for topical use
Clearance: Not precisely defined for topical use
ExcretionRoute: Primarily renal (for systemically absorbed portion)
Unchanged: Minimal (for systemically absorbed portion)
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Pharmacodynamics

OnsetOfAction: Within hours to days for anti-inflammatory effect
PeakEffect: Days to weeks for full therapeutic effect
DurationOfAction: Varies with frequency of application and severity of condition

Safety & Warnings

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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 immediate medical attention:

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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of high blood sugar: confusion, drowsiness, 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 sensations.
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:

  • Worsening of your skin condition or no improvement after a few days/weeks of use.
  • Signs of skin infection (e.g., increased redness, swelling, pain, pus, fever).
  • Severe burning, itching, irritation, or dryness of the treated skin.
  • Signs of skin thinning, stretch marks, easy bruising, or changes in skin color.
  • Acne-like rash or increased hair growth in the treated area.
  • Rarely, signs of systemic absorption with prolonged or excessive use: unusual weight gain, 'moon face', fatigue, muscle weakness, increased thirst or urination (signs of high blood sugar).
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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 current medications and health conditions. Never start, stop, or adjust the dosage 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, such as 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. Additionally, 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 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, as they will need to weigh the benefits and risks of using this medication to ensure the best outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use, especially over large areas, under occlusion, or in children, can lead to systemic absorption and symptoms of hypercorticism (e.g., Cushing's syndrome, hyperglycemia, glucosuria).
  • Local symptoms include severe skin atrophy, striae, telangiectasias, and secondary infections.

What to Do:

If you suspect an overdose or significant systemic absorption, contact your doctor or Poison Control Center immediately (call 1-800-222-1222). Discontinue use gradually under medical supervision if systemic effects occur.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment (e.g., erythema, scaling, pruritus, lesion type)

Rationale: To establish baseline severity and type of dermatosis for treatment efficacy evaluation.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy of treatment (reduction in symptoms and signs of dermatosis)

Frequency: Regularly during follow-up visits (e.g., weekly to monthly depending on condition and duration of use)

Target: Resolution or significant improvement of dermatosis with minimal residual symptoms.

Action Threshold: Lack of improvement, worsening of condition, or development of adverse effects.

Adverse skin reactions (e.g., skin atrophy, striae, telangiectasias, folliculitis, acne, perioral dermatitis, hypopigmentation, secondary infection)

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

Target: Absence of adverse reactions.

Action Threshold: Presence of adverse reactions requiring dose reduction, discontinuation, or alternative therapy.

Signs of systemic absorption (e.g., HPA axis suppression, Cushing's syndrome symptoms, hyperglycemia)

Frequency: Periodically, especially with prolonged use, large surface area application, or occlusive dressings. More critical in pediatric patients.

Target: Normal adrenal function and metabolic parameters.

Action Threshold: Symptoms or lab abnormalities suggestive of systemic corticosteroid effects.

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Symptom Monitoring

  • Improvement in redness, itching, swelling, and lesion appearance.
  • Signs of skin thinning, stretch marks, easy bruising, acne-like rash, changes in skin color.
  • Signs of secondary infection (e.g., increased redness, warmth, pus, fever).
  • Unusual fatigue, weight gain, increased thirst/urination (rare, signs of systemic absorption).

Special Patient Groups

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Pregnancy

Fluocinonide is Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid large areas, prolonged use, or occlusive dressings.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity with high systemic exposure (unlikely with proper topical use).
Second Trimester: Risk of fetal growth restriction or adrenal suppression with high systemic exposure.
Third Trimester: Risk of fetal adrenal suppression with high systemic exposure.
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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 breast area to prevent infant ingestion.

Infant Risk: Low risk with proper use, but monitor infant for adverse effects if used on large areas or for prolonged periods by the mother.
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Pediatric Use

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (e.g., HPA axis suppression, Cushing's syndrome, intracranial hypertension). Use the least potent effective corticosteroid for the shortest duration possible. Avoid use on face, groin, or axillae. Not recommended for infants. Close monitoring for growth retardation and weight gain is advised.

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Geriatric Use

No specific dosage adjustments are generally needed. Use with caution in patients with fragile skin or pre-existing skin atrophy, as they may be more susceptible to local adverse effects.

Clinical Information

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Clinical Pearls

  • Fluocinonide 0.1% Cream is a high-potency topical corticosteroid; use sparingly and for short durations (typically no more than 2-4 weeks) to minimize adverse effects, especially skin atrophy and HPA axis suppression.
  • Educate patients on proper application technique: apply a very thin film, gently rub in, and avoid occlusive dressings unless specifically instructed by a physician.
  • Not for routine use on the face, groin, or axillae due to higher risk of adverse effects (e.g., skin atrophy, telangiectasias, perioral dermatitis) in these sensitive areas.
  • Monitor for signs of local adverse effects (skin atrophy, striae, telangiectasias, folliculitis, secondary infections) and, rarely, systemic absorption (e.g., Cushing's syndrome symptoms), especially with prolonged use, large surface areas, or in pediatric patients.
  • Consider step-down therapy to lower potency corticosteroids or non-steroidal options once acute inflammation is controlled to prevent rebound flares and minimize long-term side effects.
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Alternative Therapies

  • Other topical corticosteroids (e.g., clobetasol propionate, betamethasone dipropionate, triamcinolone acetonide, hydrocortisone)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for sensitive areas or long-term use
  • Topical PDE4 inhibitors (e.g., crisaborole)
  • Topical JAK inhibitors (e.g., ruxolitinib)
  • Emollients and moisturizers for barrier repair
  • Phototherapy (e.g., UVB) for widespread conditions
  • Systemic immunosuppressants (e.g., methotrexate, cyclosporine, biologics) for severe, refractory cases
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Cost & Coverage

Average Cost: Price range varies widely per 60gm 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'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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.