Lidex 0.05% Gel 30gm
It is used to treat skin rashes and other skin irritation.It is used to treat psoriasis.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Jun 1971
DEA Schedule
Not Controlled
Overview
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 immune response in the skin.
How to Use This Medicine
Using Your Medication Correctly
To get the most benefit from your medication, use it exactly as directed by your doctor. Carefully read all the information provided with your medication and follow the instructions closely. Continue using the medication as instructed, 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 your 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 that hand after application. Clean the affected area before applying the medication and make sure it is completely dry. Then, apply a thin layer of the medication to the affected skin and gently rub it in.
Unless your doctor advises you to do so, do not cover the treated area with bandages or dressings.
Storing and Disposing of Your Medication
Store your 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 forget to apply a dose, do so 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 application schedule. Do not apply two doses at once or use extra doses to make up for a missed dose.
To get the most benefit from your medication, use it exactly as directed by your doctor. Carefully read all the information provided with your medication and follow the instructions closely. Continue using the medication as instructed, 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 your 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 that hand after application. Clean the affected area before applying the medication and make sure it is completely dry. Then, apply a thin layer of the medication to the affected skin and gently rub it in.
Unless your doctor advises you to do so, do not cover the treated area with bandages or dressings.
Storing and Disposing of Your Medication
Store your 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 forget to apply a dose, do so 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 application schedule. Do not apply two doses at once or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Wash your hands before and after applying the gel.
- Apply a thin layer of the gel to the affected skin area, gently rubbing it in until it disappears.
- Do not use more than directed or for longer than prescribed, as this can increase side effects.
- Avoid applying the gel to your face, groin, or armpits unless specifically instructed by your doctor, as these areas are more sensitive.
- Do not cover the treated area with bandages or other dressings 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.
- Keep out of reach of children.
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:
psoriasis:
Apply 2 to 4 times daily.
eczema:
Apply 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). Use with extreme caution and for shortest duration possible if medically necessary.
Child:
Apply a thin film to the affected area 2 to 4 times daily. Limit treatment to the smallest area and shortest duration possible (e.g., 2 weeks) due to increased risk of systemic absorption and HPA axis suppression.
Adolescent:
Apply a thin film to the affected area 2 to 4 times daily.
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
Mechanism of Action
Fluocinonide is a high-potency topical corticosteroid. It acts by inducing phospholipase A2 inhibitory proteins, 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. Fluocinonide also exhibits anti-inflammatory, antipruritic, and vasoconstrictive properties.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (depends on vehicle, skin integrity, area of application, duration of exposure, and use of occlusive dressings). Systemic absorption can occur.
Tmax:
Not well-defined for topical application due to variable absorption.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not well-defined for topical application.
ProteinBinding:
Not well-defined for topical application; systemically absorbed corticosteroids are highly protein bound.
CnssPenetration:
Limited (systemic absorption is generally low).
Elimination:
HalfLife:
Not well-defined for topical application.
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Primarily renal (metabolites and some unchanged drug).
Unchanged:
Not well-defined for topical application.
Pharmacodynamics
OnsetOfAction:
Within hours for symptomatic relief (e.g., reduced itching, redness).
PeakEffect:
Within days of consistent application.
DurationOfAction:
Varies; effects persist as long as applied, but prolonged use can lead to tachyphylaxis.
Safety & Warnings
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 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 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 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 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:
- Increased burning, itching, or irritation where the gel is applied.
- Skin thinning, easy bruising, or stretch marks appearing on the treated skin.
- Acne-like breakouts or hair bumps (folliculitis).
- Signs of skin infection (e.g., pus, worsening redness, warmth, pain).
- Unusual weight gain, swelling in the face, or feeling very tired (signs of too much medicine absorbed into the body, especially with long-term 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 is crucial to avoid potential interactions between this medication and other substances.
Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to:
Discuss all your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Avoid starting, stopping, or changing the dosage of any medication without first consulting your doctor. This precaution will help prevent potential adverse interactions and ensure the optimal effectiveness of your treatment regimen.
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 is crucial to avoid potential interactions between this medication and other substances.
Any existing health problems, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to:
Discuss all your medications and health problems with your doctor and pharmacist to verify that it is safe to take this medication in conjunction with your other treatments.
* Avoid starting, stopping, or changing the dosage of any medication without first consulting your doctor. This precaution will help prevent potential adverse interactions and ensure the optimal effectiveness of your treatment regimen.
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, including 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 skin area or near open wounds, exercise caution and discuss the application with your doctor.
Adhere to your doctor's prescribed treatment duration and avoid using this medication for an extended period. If the treated area is in the diaper region, refrain from using tight-fitting diapers or plastic pants, as this may 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, making regular growth checks 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 for both you and your baby.
To minimize potential risks, avoid applying this medication to cuts, scrapes, or damaged skin. When applying it to a large skin area or near open wounds, exercise caution and discuss the application with your doctor.
Adhere to your doctor's prescribed treatment duration and avoid using this medication for an extended period. If the treated area is in the diaper region, refrain from using tight-fitting diapers or plastic pants, as this may 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, making regular growth checks 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 for both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic effects due to absorption, including suppression of the hypothalamic-pituitary-adrenal (HPA) axis, Cushing's syndrome, hyperglycemia, and glucosuria.
- Symptoms may include: moon face, central obesity, thinning skin, easy bruising, muscle weakness, fatigue, high blood sugar.
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. Treatment is supportive and may involve gradual withdrawal of the medication.
Drug Interactions
Monitoring
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
Efficacy (reduction in inflammation, pruritus)
Frequency: Regularly, at follow-up visits (e.g., weekly to bi-weekly initially).
Target: Significant improvement in symptoms.
Action Threshold: Lack of improvement or worsening symptoms may indicate need for re-evaluation or alternative therapy.
Local skin adverse reactions (e.g., atrophy, striae, telangiectasias, folliculitis, burning, itching, irritation)
Frequency: At each follow-up visit and patient self-monitoring.
Target: Absence of or minimal adverse effects.
Action Threshold: Presence of significant or worsening local adverse effects requires discontinuation or reduction in frequency/potency.
Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, HPA axis suppression)
Frequency: Periodically, especially with prolonged use, large surface area application, or occlusive dressings. More frequent in pediatric patients.
Target: Normal adrenal function and glucose levels.
Action Threshold: Symptoms or lab abnormalities (e.g., low morning cortisol, elevated glucose) require immediate re-evaluation and potential discontinuation.
Symptom Monitoring
- Increased redness or irritation at application site
- Skin thinning, bruising, or shiny appearance (atrophy)
- Stretch marks (striae)
- Visible small blood vessels (telangiectasias)
- Acne-like eruptions or folliculitis
- Signs of secondary infection (pus, increased pain, fever)
- Unusual fatigue, weight gain, moon face, or other signs of Cushing's syndrome (rare with appropriate topical use)
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 teratogenicity, though systemic absorption from topical use is generally low.
Second Trimester:
Risk generally considered low with appropriate topical use.
Third Trimester:
Risk generally considered low with appropriate topical use.
Lactation
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Use with caution in nursing mothers. If used, avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Risk is generally low with limited topical use, but potential for systemic effects in infant if significant absorption occurs or if applied to breast.
Pediatric Use
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature adults due to a larger skin surface area to body weight ratio. Use the least potent corticosteroid that is effective, for the shortest duration possible. Avoid occlusive dressings.
Geriatric Use
No specific dosage adjustments are required. However, elderly patients may have thinner skin, which could potentially increase systemic absorption or local adverse effects like skin atrophy. Monitor for skin fragility and other local adverse reactions.
Clinical Information
Clinical Pearls
- Fluocinonide is a high-potency topical corticosteroid; use it sparingly and for short durations to minimize the risk of local and systemic side effects.
- Avoid using on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more prone to atrophy and other side effects.
- Educate patients on the 'thin film' application technique to prevent overuse.
- Warn patients against using occlusive dressings unless explicitly prescribed, as this significantly increases absorption.
- Monitor pediatric patients closely for signs of HPA axis suppression due to their increased susceptibility.
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 steroid-sparing therapy
- Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole)
- Systemic therapies (e.g., biologics, oral immunosuppressants) for severe dermatoses
Cost & Coverage
Average Cost:
Varies widely, typically $20 - $100+ per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. 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. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.