Lidex-E 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.
đŸˇī¸
Drug Class
Anti-inflammatory agents
đŸ§Ŧ
Pharmacologic Class
Topical corticosteroids, Glucocorticoids
🤰
Pregnancy Category
Category C
✅
FDA Approved
Mar 1990
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Lidex-E 0.05% Cream is a strong medicine applied to the skin to reduce redness, swelling, and itching caused by certain skin conditions like eczema or psoriasis. It belongs to a class of medicines called corticosteroids.
📋

How to Use This Medicine

Using Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you 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, meaning it should be applied directly to the affected area of skin. Do not take it by mouth. Avoid getting the medication in your mouth, nose, or eyes, as it may cause 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 directed to do so by your doctor, do not cover the treated area with bandages or dressings.

Storing and Disposing of Your Medication

Store the medication at room temperature, keeping the lid tightly closed. Protect it from heat sources. Keep all medications in a safe place, out of the reach of children and pets.

Missing a Dose

If you miss a dose, apply it as soon as you remember. However, 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 to make up for a missed one.
💡

Lifestyle & Tips

  • Wash your hands thoroughly before and after applying the cream.
  • Apply a very thin layer of cream only to the affected skin areas.
  • Rub the cream in gently until it disappears.
  • Do not cover the treated area with bandages, plastic wrap, or other occlusive dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
  • Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Do not use on the face, groin, or armpits unless specifically directed by your doctor.
  • Do not use for longer than prescribed, typically no more than 2 weeks for adults.

Dosing & Administration

đŸ‘¨â€âš•ī¸

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. Rub in gently and completely. Do not use occlusive dressings unless directed by physician.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (Increased risk of systemic toxicity due to larger skin surface area to body weight ratio)
Adolescent: Similar to adult dosing, but with caution and for shortest duration possible.
âš•ī¸

Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

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

Pharmacology

đŸ”Ŧ

Mechanism of Action

Fluocinonide is a high-potency topical corticosteroid. 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. It also possesses vasoconstrictive and antiproliferative actions.
📊

Pharmacokinetics

Absorption:

Bioavailability: Not quantifiable (varies significantly)
Tmax: Not well-defined for topical application
FoodEffect: Not applicable for topical administration

Distribution:

Vd: Not available
ProteinBinding: Not available (minimal systemic absorption)
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Not available (systemic half-life of corticosteroids varies)
Clearance: Not available
ExcretionRoute: Renal
Unchanged: Not available
âąī¸

Pharmacodynamics

OnsetOfAction: Hours to days for symptomatic relief
PeakEffect: Not well-defined for topical application
DurationOfAction: Varies with frequency of application and individual response

Safety & Warnings

âš ī¸

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, 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:

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.
🚨

Seek Immediate Medical Attention If You Experience:

  • Worsening of your skin condition or no improvement after the prescribed treatment period.
  • Signs of a skin infection (e.g., pus, fever, increased pain, redness, or swelling).
  • Severe burning, stinging, itching, or irritation at the application site.
  • Changes in skin appearance such as thinning, easy bruising, stretch marks (striae), or unusual hair growth.
  • Any signs of systemic side effects like unusual weight gain, swelling in your face or neck, or feeling unusually tired.
📋

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 dose of any medication without first consulting your doctor.
âš ī¸

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. Discuss this with your doctor.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.
🆘

Overdose Information

Overdose Symptoms:

  • Symptoms of excessive systemic absorption may include: Cushing's syndrome (e.g., moon face, central obesity, buffalo hump), hyperglycemia (high blood sugar), glucosuria (sugar in urine), and suppression of the hypothalamic-pituitary-adrenal (HPA) axis (fatigue, weakness, nausea, vomiting).

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 (Poison Control).

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • Not available
🔴

Major Interactions

  • Not available
🟡

Moderate Interactions

  • Not available
đŸŸĸ

Minor Interactions

  • Not available

Monitoring

đŸ”Ŧ

Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify any pre-existing skin integrity issues.

Timing: Prior to initiation of therapy

📊

Routine Monitoring

Therapeutic efficacy (reduction in inflammation, pruritus)

Frequency: Regularly during treatment

Target: Improvement in symptoms

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, hypopigmentation)

Frequency: Regularly during treatment, especially with prolonged use

Target: Absence of new or worsening skin changes

Action Threshold: Development of significant local adverse effects may require discontinuation or change in therapy.

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

Frequency: Periodically, especially with prolonged use, large surface areas, or occlusive dressings

Target: Normal adrenal function, blood glucose levels

Action Threshold: Symptoms or lab abnormalities (e.g., low morning cortisol, elevated blood glucose) warrant investigation and potential discontinuation.

đŸ‘ī¸

Symptom Monitoring

  • Worsening of skin condition
  • Signs of secondary infection (pus, fever, increased pain)
  • Severe burning, stinging, or irritation at application site
  • Skin thinning, easy bruising, stretch marks (striae)
  • Increased hair growth in treated areas
  • Acne-like eruptions
  • Unusual weight gain, swelling in face/neck (signs of systemic absorption)

Special Patient Groups

🤰

Pregnancy

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

Trimester-Specific Risks:

First Trimester: Potential for teratogenic effects, though systemic absorption from topical use is generally low.
Second Trimester: Use with caution; monitor for fetal growth.
Third Trimester: Use with caution; monitor for fetal growth and adrenal suppression in neonate if significant systemic absorption occurs.
🤱

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. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Avoid applying to breast area to prevent direct infant ingestion.

Infant Risk: Low risk to infant due to minimal systemic absorption, but caution advised.
đŸ‘ļ

Pediatric Use

Pediatric patients may be more susceptible to systemic toxicity (e.g., HPA axis suppression, Cushing's syndrome, intracranial hypertension) due to a larger skin surface area to body weight ratio. Not recommended for children under 12 years of age without specific medical advice and close monitoring. Use the least potent effective corticosteroid for the shortest duration possible.

👴

Geriatric Use

No specific dosage adjustments are generally needed. However, geriatric patients may have thinner, more fragile skin, increasing the risk of local adverse effects like skin atrophy and purpura. Monitor closely for skin integrity and adverse reactions.

Clinical Information

💎

Clinical Pearls

  • Fluocinonide 0.05% is classified as a high-potency topical corticosteroid. Its potency can vary slightly depending on the vehicle (cream, gel, ointment, solution), with ointments generally being more potent than creams.
  • Due to its high potency, fluocinonide should generally be used for short durations (e.g., typically no more than 2 weeks for adults) to minimize the risk of local and systemic side effects.
  • Avoid prolonged use on sensitive areas such as the face, groin, axillae, or under occlusive dressings, as these practices significantly increase the risk of adverse effects like skin atrophy, telangiectasias, and HPA axis suppression.
  • Patients should be instructed on the proper application technique: apply a thin film and rub in gently. Over-application does not increase efficacy but increases the risk of side effects.
  • If no improvement is seen after the recommended treatment period, the diagnosis should be re-evaluated.
🔄

Alternative Therapies

  • Other topical corticosteroids of varying potencies (e.g., clobetasol propionate, betamethasone dipropionate, triamcinolone acetonide, hydrocortisone)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for certain inflammatory dermatoses, especially on sensitive areas.
  • Emollients and moisturizers for barrier repair and symptomatic relief.
  • Systemic therapies (e.g., oral corticosteroids, immunosuppressants, biologics) for severe or widespread conditions.
  • Phototherapy (e.g., UVB, PUVA) for conditions like psoriasis.
💰

Cost & Coverage

Average Cost: $300 - $500 per 30gm tube of Lidex-E 0.05% Cream
Generic Available: Yes
Insurance Coverage: Often Tier 2 or 3 for brand, Tier 1 for generic
📚

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 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 overdose, including the medication taken, the amount, and the time it occurred.