Lidex-E 0.05% Cream 60gm
It is used to treat skin rashes and other skin irritation.It is used to treat psoriasis.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
Category C
FDA Approved
Jun 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluocinonide is a strong steroid cream used on the skin to reduce redness, swelling, itching, and discomfort caused by various skin conditions like eczema and psoriasis. It works by calming down the immune response in the skin.
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 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, 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 by your doctor, do not cover the treated area with bandages or dressings.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature with the lid tightly closed. Protect the medication from heat sources. Keep all medications in a safe and secure location, 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 scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not apply two doses at the same time or use extra doses to make up for a missed dose.
To use this medication safely and effectively, 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, 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 by your doctor, do not cover the treated area with bandages or dressings.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature with the lid tightly closed. Protect the medication from heat sources. Keep all medications in a safe and secure location, 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 scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Wash your hands before and after applying the cream.
- Apply a thin layer of cream to the affected skin area, gently rubbing it in until it disappears.
- Do not cover the treated area with bandages or plastic wrap unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid applying the cream to your eyes, mouth, or inside your nose. If it gets into these areas, rinse thoroughly with water.
- Do not use this cream for longer than prescribed or on large areas of your body without consulting your doctor.
- Do not use on the face, groin, or armpits unless directed by a doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film to the affected area 2 to 4 times daily, depending on the severity of the condition.
Dose Range:
2 - 4 mg
Condition-Specific Dosing:
eczema:
Apply a thin film to the affected area 2 to 4 times daily.
psoriasis:
Apply a thin film to the affected area 2 to 4 times daily.
Pediatric Dosing
Neonatal:
Not established (increased risk of systemic absorption and HPA axis suppression).
Infant:
Not established (increased risk of systemic absorption and HPA axis suppression).
Child:
Use with caution and under strict medical supervision. Limit to the smallest amount compatible with an effective therapeutic regimen. Not recommended for children under 12 years of age without physician supervision due to higher risk of systemic effects.
Adolescent:
Apply a thin film to the affected area 2 to 4 times daily, with caution regarding total dose and duration.
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, as systemic absorption is minimal.
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
Mechanism of Action
Fluocinonide is a high-potency topical 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.
Pharmacokinetics
Absorption:
Bioavailability:
Varies (dependent on vehicle, skin integrity, site of application, and use of occlusive dressings). Systemic absorption is generally low but can increase with prolonged use, large surface areas, or compromised skin barrier.
Tmax:
Not applicable for topical application (systemic levels are usually negligible).
FoodEffect:
Not applicable for topical application.
Distribution:
Vd:
Not applicable for topical application (minimal systemic distribution).
ProteinBinding:
Not applicable for topical application (minimal systemic protein binding).
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Not precisely determined for topical application due to minimal systemic absorption.
Clearance:
Not precisely determined for topical application.
ExcretionRoute:
Renal (for systemically absorbed drug).
Unchanged:
Not precisely determined for topical application.
Pharmacodynamics
OnsetOfAction:
Hours to days (for anti-inflammatory and antipruritic effects).
PeakEffect:
Days to weeks of consistent application.
DurationOfAction:
Varies with frequency of application and individual response.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 medical help right away:
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 experience no 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 or seek medical help:
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.
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 medical help right away:
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 experience no 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 or seek medical help:
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 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.
- Unusual hair growth or acne-like breakouts.
- Any signs of systemic side effects like unexplained weight gain, swelling in the face, or unusual fatigue (especially with prolonged or extensive use).
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.
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.
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.
To minimize potential risks, avoid applying this medication to cuts, scrapes, or damaged skin. When applying it to a large area of skin or near open wounds, exercise caution and discuss the application with your doctor.
Adhere to your doctor's instructions regarding the duration of treatment, and do not use this medication for an extended period beyond the recommended timeframe.
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, exercise caution, as they 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 possible outcome for you and your baby.
To minimize potential risks, avoid applying this medication to cuts, scrapes, or damaged skin. When applying it to a large area of skin or near open wounds, exercise caution and discuss the application with your doctor.
Adhere to your doctor's instructions regarding the duration of treatment, and do not use this medication for an extended period beyond the recommended timeframe.
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, exercise caution, as they 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 possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Symptoms of Cushing's syndrome (e.g., moon face, central obesity, buffalo hump)
- Hyperglycemia (high blood sugar)
- Glycosuria (sugar in urine)
- Adrenal insufficiency (fatigue, weakness, nausea, vomiting) upon abrupt withdrawal after prolonged use
- 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
Baseline Monitoring
Skin condition assessment (type, severity, extent of lesion)
Rationale: To establish baseline for efficacy and adverse effect monitoring.
Timing: Prior to initiation of therapy.
Area of application
Rationale: To assess risk of systemic absorption.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (reduction in inflammation, pruritus, erythema)
Frequency: Weekly or as clinically indicated.
Target: Improvement in symptoms.
Action Threshold: Lack of improvement or worsening symptoms may indicate need for re-evaluation or alternative therapy.
Local adverse effects (skin atrophy, striae, telangiectasias, folliculitis, burning, itching, irritation)
Frequency: At each follow-up visit.
Target: Absence or minimal adverse effects.
Action Threshold: Presence of significant adverse effects requires dose reduction, discontinuation, or change in therapy.
Signs of secondary infection
Frequency: At each follow-up visit.
Target: Absence of infection.
Action Threshold: Presence of infection requires appropriate antimicrobial therapy and possible discontinuation of fluocinonide.
Hypothalamic-Pituitary-Adrenal (HPA) axis suppression (e.g., plasma cortisol levels, ACTH stimulation test)
Frequency: Consider for prolonged use, large surface areas, or occlusive dressings, especially in children.
Target: Normal HPA axis function.
Action Threshold: Evidence of suppression requires gradual withdrawal or reduction in potency/frequency.
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., weight gain, moon face, fatigue, hyperglycemia, hypertension)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption of topical corticosteroids can occur, and animal studies have shown teratogenic effects.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenic effects observed in animal studies with systemic corticosteroids.
Second Trimester:
Use with caution; minimal systemic absorption is expected with proper topical use.
Third Trimester:
Use with caution; minimal systemic absorption is expected with proper topical use.
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 proper use, but monitor infant for potential adverse effects if significant maternal systemic absorption occurs.
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. Risk of HPA axis suppression, Cushing's syndrome, and growth retardation is higher. Use the least potent corticosteroid for the shortest duration possible. Not recommended for children under 12 years without physician supervision.
Geriatric Use
No specific dosage adjustments are generally needed. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects like skin atrophy, purpura, and telangiectasias. Monitor closely for these effects.
Clinical Information
Clinical Pearls
- Fluocinonide is a high-potency (Class II) topical corticosteroid. It should be used for short durations (typically no more than 2-4 weeks) to minimize the risk of local and systemic side effects.
- Avoid prolonged use on the face, groin, or axillae, as these areas are more prone to skin atrophy, striae, and telangiectasias.
- Occlusive dressings significantly increase systemic absorption and should only be used under strict medical supervision.
- Patients should be educated on the proper application technique: apply a very thin layer and rub in gently.
- Discontinuation after prolonged use, especially on large areas, should be gradual to prevent rebound flares of the skin condition or adrenal insufficiency.
Alternative Therapies
- Other high-potency topical corticosteroids (e.g., Clobetasol propionate, Halobetasol propionate)
- Medium-potency topical corticosteroids (e.g., Triamcinolone acetonide, Mometasone furoate)
- Low-potency topical corticosteroids (e.g., Hydrocortisone)
- Topical calcineurin inhibitors (e.g., Tacrolimus, Pimecrolimus) for steroid-sparing therapy
- Emollients and moisturizers for barrier repair
- Systemic therapies (e.g., oral corticosteroids, biologics) for severe, widespread conditions
Cost & Coverage
Average Cost:
$20 - $100 per 60gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
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's a good idea 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.