Lidex 0.05% Cream 30gm

Manufacturer MEDICIS 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 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 is a strong medicine applied to the skin to reduce redness, swelling, and itching caused by skin conditions like eczema or psoriasis. It works by calming down the skin's immune response.
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How to Use This Medicine

Using Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. Continue using the medication as directed, even if your symptoms improve.

Applying the Medication

This medication is for topical use only, which means it should be applied directly to the affected area of your skin. Do not take it by mouth. Avoid getting the medication in your mouth, nose, or eyes, as it may cause irritation or burning.

Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash your hand after applying the medication. 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 your doctor instructs you to do so, do not cover the treated area with bandages or dressings.

Storing and Disposing of Your Medication

To keep your medication effective and safe, store it at room temperature with the lid tightly closed. Protect it from heat and keep it out of reach of children and pets. Store all medications in a safe and secure location.

What to Do If You Miss a Dose

If you forget to apply a dose of your medication, 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 continue with your regular schedule. Do not apply two doses at the same time or extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Wash your hands before and after applying the cream.
  • Apply a thin layer to the affected area as directed by your doctor, usually 2 to 4 times a day.
  • Rub it in gently until it disappears.
  • Do not use more than prescribed or for longer than recommended.
  • Avoid applying to the face, groin, or armpits unless specifically instructed by your doctor.
  • Do not cover the treated area with bandages or plastic wrap unless your doctor tells you to, as this can increase absorption and side effects.
  • Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
  • Do not use on open wounds or infected skin without medical advice.
  • Keep out of reach of children.

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.

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
Infant: Apply a thin film to the affected skin areas two to four times daily. Use with caution; increased risk of systemic absorption due to larger skin surface area to body weight ratio.
Child: Apply a thin film to the affected skin areas two to four times daily. Use with caution; increased risk of systemic absorption due to larger skin surface area to body weight ratio.
Adolescent: Apply a thin film to the affected skin areas two to four times daily.
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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 specific considerations for topical use, as systemic absorption is minimal.

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: Minimal systemic absorption; varies with vehicle, skin integrity, and use of occlusive dressings. Can be up to 5-10% with damaged skin or occlusion.
Tmax: Not well-defined for topical application; local effect is rapid.
FoodEffect: Not applicable

Distribution:

Vd: Not applicable for topical use due to minimal systemic absorption.
ProteinBinding: Not applicable for topical use due to minimal systemic absorption.
CnssPenetration: Limited

Elimination:

HalfLife: Not well-defined for topical application; systemic half-life of absorbed drug is typically hours.
Clearance: Not well-defined for topical application.
ExcretionRoute: Primarily renal for systemically absorbed drug; minimal systemic absorption.
Unchanged: Not applicable
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Pharmacodynamics

OnsetOfAction: Within hours for symptomatic relief (e.g., reduction in itching, redness).
PeakEffect: Within days of consistent application.
DurationOfAction: Varies; effects persist as long as applied regularly.

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, 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. Although 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 for advice:

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:

  • Worsening of your skin condition or no improvement after 1-2 weeks.
  • Signs of skin infection (e.g., pus, spreading redness, fever).
  • Severe burning, itching, or irritation at the application site.
  • Skin thinning, easy bruising, stretch marks (striae), or changes in skin color.
  • Any signs of systemic side effects, such as unusual weight gain, swelling in the face, or fatigue (rare, but possible with extensive or prolonged 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 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. 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.

If the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in children. 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, plan to become pregnant, or are 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:

  • Excessive or prolonged use can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including: weight gain, moon face, central obesity, thinning skin, easy bruising, muscle weakness, fatigue, hyperglycemia, and adrenal suppression.

What to Do:

Discontinue use 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 signs of infection or contraindications.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus)

Frequency: Daily to weekly, depending on severity

Target: Improvement in symptoms

Action Threshold: Lack of improvement or worsening of condition after 1-2 weeks may require re-evaluation.

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

Frequency: Daily to weekly

Target: Absence of new or worsening skin changes

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

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

Frequency: Periodically, especially with prolonged use, large surface area application, or occlusive dressings.

Target: Absence of systemic symptoms

Action Threshold: Any signs of systemic effects warrant immediate discontinuation and medical evaluation.

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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
  • Weight gain (rare, systemic)
  • Moon face (rare, systemic)
  • Fatigue (rare, systemic)

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though systemic absorption is minimal.
Second Trimester: Potential for fetal growth restriction or adrenal suppression with extensive use.
Third Trimester: Potential for fetal growth restriction or adrenal suppression with extensive use.
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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 appropriate use, but monitor for potential adverse effects if significant systemic absorption occurs in mother.
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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 achieves the desired therapeutic effect. Limit duration of treatment and avoid occlusive dressings.

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Geriatric Use

No specific dosage adjustments are recommended. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects like atrophy or purpura. Monitor for skin integrity.

Clinical Information

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Clinical Pearls

  • Fluocinonide is a high-potency topical corticosteroid; use it sparingly and for short durations, especially on sensitive areas like the face, groin, or axillae.
  • Avoid abrupt discontinuation after prolonged use on large areas, as this can lead to rebound flare-ups of the skin condition.
  • Educate patients on proper application technique: apply a thin film and rub in gently. Emphasize 'less is more' with potent steroids.
  • Occlusive dressings significantly increase systemic absorption and local side effects; advise against their use unless specifically instructed by a physician.
  • Monitor for signs of skin atrophy (thinning, shiny skin, visible blood vessels) or striae, which are common long-term side effects of potent topical steroids.
  • If no improvement is seen after 1-2 weeks, re-evaluate the diagnosis and treatment plan.
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Alternative Therapies

  • Other topical corticosteroids (e.g., clobetasol, betamethasone, triamcinolone, hydrocortisone) varying in potency.
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema.
  • Vitamin D analogs (e.g., calcipotriene) for psoriasis.
  • Topical retinoids (e.g., tazarotene) for psoriasis.
  • Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe cases.
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Cost & Coverage

Average Cost: $50 - $200 per 30gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 (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 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.