Fluocinonide 0.05% Soln 60ml

Manufacturer ZYDUS PHARMACEUTICALS (USA) 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
Corticosteroid, Potent
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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 solution is a strong medicine applied to the skin to reduce redness, itching, and swelling caused by certain skin conditions like eczema or psoriasis. It's a type of steroid that works by calming down the skin's immune response.
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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 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.
Do not cover the treated area with bandages or dressings unless your doctor instructs 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

  • Wash hands before and after applying the medication.
  • Apply a thin layer only to the affected skin areas 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 applying to the face, groin, or armpits unless specifically directed by your doctor, as these areas are more susceptible to side effects.
  • Do not use for longer than prescribed, typically no more than 2 weeks continuously for adults, especially on the face or in skin folds.
  • Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
  • Do not use on broken, infected, or irritated skin without consulting your doctor.

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 the severity of the condition.
Dose Range: 2 - 4 mg

Condition-Specific Dosing:

psoriasis: Apply 2-4 times daily. Discontinue when control is achieved. Do not use for more than 2 weeks continuously without re-evaluation.
eczema: Apply 2-4 times daily. Discontinue when control is achieved. Do not use for more than 2 weeks continuously without re-evaluation.
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Pediatric Dosing

Neonatal: Not established. Use generally not recommended due to increased risk of systemic absorption and adrenal suppression.
Infant: Not established. Use generally not recommended due to increased risk of systemic absorption and adrenal suppression.
Child: Use with caution, for shortest duration possible, and smallest amount. Limit to 2 weeks of treatment. Not recommended for children under 12 years without specific medical advice due to increased risk of systemic absorption and adrenal suppression.
Adolescent: Similar to adult dosing, but with caution regarding duration and area of application due to potential for systemic absorption.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

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

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; systemic absorption can occur, especially with prolonged use, large surface areas, occlusive dressings, or compromised skin barrier. Generally low for intact skin.
Tmax: Not precisely quantifiable for topical application due to variable systemic absorption.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not precisely quantifiable for topical application; if absorbed systemically, distributed throughout the body.
ProteinBinding: Not precisely quantifiable for topical application; if absorbed systemically, corticosteroids are bound to plasma proteins to varying degrees.
CnssPenetration: Limited (if any) for topical application.

Elimination:

HalfLife: Not precisely quantifiable for topical application; if absorbed systemically, corticosteroids are excreted renally.
Clearance: Not precisely quantifiable for topical application.
ExcretionRoute: Renal (if absorbed systemically).
Unchanged: Not precisely quantifiable for topical application.
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Pharmacodynamics

OnsetOfAction: Within hours to days for symptomatic relief.
PeakEffect: Within days of consistent application.
DurationOfAction: Varies with application frequency and individual response; effects persist as long as applied.

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 immediately or seek 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, excessive 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. 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 persist, contact your doctor:

Burning or stinging sensations
Dry skin
Itching

This is not an exhaustive list of potential 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 redness, itching, or irritation at the application site
  • Burning or stinging sensation that doesn't go away
  • Skin thinning, easy bruising, or stretch marks (striae)
  • Acne-like breakouts or increased hair growth where applied
  • Signs of skin infection (pus, warmth, spreading redness)
  • Unusual weight gain, swelling in the face or ankles, or muscle weakness (signs of systemic absorption, especially in children or with extensive 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, 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 medications, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and over-the-counter drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.

To ensure your safety, 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 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. If you are treating a skin 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.

When using this medication in children, it is crucial to 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, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of using this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Prolonged use or application over large areas can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including: moon face, buffalo hump, central obesity, thinning skin, easy bruising, muscle weakness, high blood pressure, high blood sugar, and adrenal suppression.
  • In children, signs of systemic toxicity include growth retardation, delayed weight gain, and adrenal suppression.

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call a poison control center immediately (1-800-222-1222 in the US) or seek emergency medical attention.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment (type, severity, location of lesion)

Rationale: To establish baseline for treatment efficacy and identify contraindications.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Local skin reactions (atrophy, striae, telangiectasias, folliculitis, perioral dermatitis)

Frequency: Regularly during treatment, especially with prolonged use or on sensitive areas.

Target: Absence of adverse reactions.

Action Threshold: If present, consider reducing frequency, potency, or discontinuing use.

Signs of systemic absorption (e.g., Cushing's syndrome, adrenal suppression)

Frequency: Periodically, especially in pediatric patients, with extensive use, or under occlusion.

Target: Normal growth, normal hypothalamic-pituitary-adrenal (HPA) axis function.

Action Threshold: If suspected, perform HPA axis suppression tests (e.g., ACTH stimulation test) and discontinue drug gradually.

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Symptom Monitoring

  • Worsening of skin condition
  • Signs of skin infection (redness, pus, warmth, pain)
  • Skin thinning, bruising, or stretch marks
  • Increased hair growth at application site
  • Acne-like eruptions
  • Changes in vision (e.g., cataracts, glaucoma, if absorbed systemically over long periods)
  • Unusual fatigue or weakness (signs of adrenal suppression)

Special Patient Groups

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Pregnancy

Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown corticosteroids to be teratogenic.

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; however, potential for HPA axis suppression in the neonate if used extensively or for prolonged periods near term.
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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 the breast area to prevent infant ingestion.

Infant Risk: Low risk with limited, short-term use. Monitor infant for potential adverse effects if extensive maternal use.
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Pediatric Use

Children are more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio and immature skin barrier. Use the least potent corticosteroid for the shortest duration possible. Adrenal suppression, Cushing's syndrome, and intracranial hypertension have been reported. Monitor growth and development.

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Geriatric Use

No specific dosage adjustments are generally needed. However, elderly patients may have thinner skin, which could increase the risk of local side effects like atrophy or purpura. Use with caution and monitor skin integrity.

Clinical Information

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Clinical Pearls

  • Fluocinonide 0.05% solution is a high-potency topical corticosteroid. It should be used for short-term treatment of severe inflammatory dermatoses.
  • The solution formulation is often preferred for hairy areas or weeping lesions.
  • Avoid prolonged use (typically >2 weeks) to prevent local side effects (skin atrophy, striae, telangiectasias) and systemic absorption.
  • Do not use on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more prone to adverse effects.
  • Occlusive dressings significantly increase systemic absorption and should be avoided unless specifically prescribed and monitored by a physician.
  • Patients should be advised to report any signs of local irritation, infection, or systemic side effects.
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Alternative Therapies

  • Other topical corticosteroids of varying potencies (e.g., clobetasol, betamethasone, triamcinolone, hydrocortisone)
  • Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for sensitive areas or long-term use
  • Emollients and moisturizers for barrier repair
  • Systemic therapies (e.g., methotrexate, biologics) for severe, widespread conditions
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Cost & Coverage

Average Cost: Varies, typically $30-$100+ per 60ml solution
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 or 4 (brand)
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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 this medication, don't 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.