Lidex 0.05% Gel 15gm
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
C
FDA Approved
Mar 1993
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 certain skin conditions like eczema or psoriasis. It works by calming down the skin's immune response.
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
This medication is for topical use only, meaning it should be applied directly to the affected area of skin. Do not ingest it or apply it to 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 that hand after application. Clean the affected skin area before applying the medication and make sure it is completely dry. Then, apply a thin layer of the medication to the affected area and gently rub it in.
Unless your doctor advises you to do so, do not cover the treated area with bandages or dressings.
Storage and Disposal
To maintain the medication's effectiveness, store it at room temperature with the lid tightly closed. Protect it from heat sources. Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose Instructions
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 resume your regular application schedule. Do not apply two doses at once or use extra doses to make up for a missed dose.
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
This medication is for topical use only, meaning it should be applied directly to the affected area of skin. Do not ingest it or apply it to 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 that hand after application. Clean the affected skin area before applying the medication and make sure it is completely dry. Then, apply a thin layer of the medication to the affected area and gently rub it in.
Unless your doctor advises you to do so, do not cover the treated area with bandages or dressings.
Storage and Disposal
To maintain the medication's effectiveness, store it at room temperature with the lid tightly closed. Protect it from heat sources. Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose Instructions
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 resume 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 hands before and after applying the medication.
- Apply a thin layer to the affected skin area and rub in gently. Do not use more than directed.
- Do not cover the treated area with bandages or other dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid applying to the face, groin, or armpits unless directed by your doctor.
- Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
- Do not use for longer than prescribed, especially on children, as it can lead to serious side effects.
- Inform your doctor if your condition does not improve after 2 weeks of treatment or if it worsens.
Available Forms & Alternatives
Dosing & Administration
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 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.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established, use with extreme caution due to increased systemic absorption risk.
Child:
Apply a thin film to the affected skin areas two to four times daily. Limit duration of treatment and amount applied. Avoid occlusive dressings. Monitor for signs of systemic toxicity (e.g., HPA axis suppression).
Adolescent:
Apply a thin film to the affected skin areas two to four times daily. Limit duration of treatment and amount applied. Avoid occlusive dressings.
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
Mechanism of Action
Fluocinonide is a high-potency corticosteroid. It exerts its therapeutic effects primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions. Corticosteroids are thought to act 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:
Variable (depends on vehicle, skin integrity, area of application, duration, and occlusion)
Tmax:
Not applicable for topical application (systemic absorption is minimal and variable)
FoodEffect:
Not applicable
Distribution:
Vd:
Not well-defined for topical application (systemic absorption is minimal)
ProteinBinding:
High (approximately 90% or more, if systemically absorbed)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not well-defined for topical application (systemic absorption is minimal and variable)
Clearance:
Not well-defined for topical application
ExcretionRoute:
Renal (primarily as inactive metabolites, if systemically absorbed)
Unchanged:
Minimal (if systemically absorbed)
Pharmacodynamics
OnsetOfAction:
Within hours to days (local anti-inflammatory effect)
PeakEffect:
Within days to weeks (local anti-inflammatory effect)
DurationOfAction:
Varies with application frequency and individual response
Safety & Warnings
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. Many people experience no side effects or only mild ones. If you experience any of the following side effects or any other symptoms that concern you or do not go away, contact your doctor:
Burning or stinging sensation
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.
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. Many people experience no side effects or only mild ones. If you experience any of the following side effects or any other symptoms that concern you or do not go away, contact your doctor:
Burning or stinging sensation
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:
- Severe burning, itching, or irritation at the application site
- Signs of skin infection (e.g., increased redness, swelling, pus, fever)
- Skin thinning, easy bruising, or stretch marks (striae)
- Acne or increased hair growth where applied
- Unusual fatigue, weakness, or weight gain (signs of systemic absorption)
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 allergic reaction you experienced, including any symptoms that occurred.
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 identify potential interactions between this medication and other substances you are taking.
* Any health problems you have, 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 other medications and health conditions. Do not start, stop, or change 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 allergic reaction you experienced, including any symptoms that occurred.
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 identify potential interactions between this medication and other substances you are taking.
* Any health problems you have, 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 other medications and health conditions. Do not start, stop, or change 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.
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 an extended period beyond what your doctor has prescribed. Additionally, if you are treating an 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, so regular growth checks may be necessary. Consult with your doctor to discuss this further.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to weigh the benefits and risks of this medication for both you and your baby.
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 an extended period beyond what your doctor has prescribed. Additionally, if you are treating an 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, so regular growth checks may be necessary. Consult with your doctor to discuss this further.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to weigh the benefits and risks of 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 Cushing's syndrome (e.g., moon face, buffalo hump, central obesity), hyperglycemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis (fatigue, weakness, nausea, vomiting, low blood pressure).
- Local skin atrophy, striae, telangiectasias.
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, area of affected skin)
Rationale: To establish baseline for treatment efficacy and identify potential contraindications or precautions.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical response (reduction in inflammation, pruritus, erythema)
Frequency: Regularly, at follow-up visits (e.g., weekly to bi-weekly initially)
Target: Improvement in symptoms
Action Threshold: Lack of improvement or worsening of condition after 2 weeks may warrant re-evaluation of diagnosis or treatment.
Local adverse reactions (e.g., atrophy, striae, telangiectasias, folliculitis, burning, itching, irritation)
Frequency: At each follow-up visit and patient self-monitoring
Target: Absence or minimal reactions
Action Threshold: Significant or persistent adverse reactions warrant discontinuation or change in therapy.
Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, glucosuria, HPA axis suppression)
Frequency: Periodically, especially with prolonged use, large surface area application, or occlusion. Consider plasma cortisol levels or ACTH stimulation test if suspicion is high.
Target: Normal physiological function
Action Threshold: Any signs of systemic effects require immediate medical evaluation and potential discontinuation.
Symptom Monitoring
- Worsening of skin condition
- Severe burning, itching, or irritation at application site
- Signs of skin infection (redness, warmth, pus)
- Skin thinning, easy bruising, striae (stretch marks)
- Increased hair growth at application site
- Acne-like eruptions
- Changes in vision (e.g., blurred vision, glaucoma, cataracts)
- Unusual fatigue or weakness
- Weight gain, especially in the face and trunk
Special Patient Groups
Pregnancy
Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid large areas, prolonged use, or occlusive dressings.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though data for topical corticosteroids are limited. Use with caution.
Second Trimester:
Risk of systemic absorption and potential fetal effects. Use with caution.
Third Trimester:
Risk of systemic absorption and potential fetal effects, including HPA axis suppression. Use with caution.
Lactation
L3 (Moderately Safe). 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 of adverse effects if used appropriately. Monitor infant for any signs of systemic corticosteroid effects (e.g., growth suppression).
Pediatric Use
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects, including HPA axis suppression and Cushing's syndrome. Prolonged use should be avoided. Use the least potent corticosteroid that is effective. Avoid occlusive dressings.
Geriatric Use
No specific dosage adjustments are typically required. However, elderly patients may have thinner skin and be more prone to local adverse effects such as skin atrophy or purpura. Monitor for skin integrity and adverse reactions.
Clinical Information
Clinical Pearls
- Fluocinonide 0.05% gel is a high-potency topical corticosteroid; use should be limited to short-term treatment (typically 2 weeks) for severe inflammatory dermatoses.
- Avoid use on the face, groin, or axillae due to increased risk of skin atrophy, telangiectasias, and striae in these sensitive areas.
- Occlusive dressings significantly increase systemic absorption and should be avoided unless specifically directed by a physician for recalcitrant conditions.
- Patients should be educated on the proper application technique (thin film, gentle rub) and the importance of not exceeding the prescribed duration or frequency.
- Monitor pediatric patients closely for signs of HPA axis suppression, as they are more susceptible due to a larger skin surface area to body weight ratio.
Alternative Therapies
- Other topical corticosteroids (e.g., Clobetasol propionate for higher potency, Triamcinolone acetonide for medium potency, Hydrocortisone for low potency)
- Topical calcineurin inhibitors (e.g., Tacrolimus, Pimecrolimus) for eczema, especially on sensitive areas
- Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., Crisaborole) for eczema
- Systemic therapies (e.g., oral corticosteroids, biologics, immunosuppressants) for severe, widespread, or refractory conditions
- Emollients and moisturizers for barrier repair and symptom management
Cost & Coverage
Average Cost:
Check current market data per 15gm 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'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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.