Lidex 0.05% Gel 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; Anti-inflammatory agent
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 certain skin conditions like eczema or psoriasis. It works by calming down the skin's immune response.
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. 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 that hand after applying the medication.
Before applying the medication, make sure the affected area is clean and dry. Gently rub a thin layer of the medication onto the affected skin. Unless instructed to do so by your doctor, do not cover the treated area with bandages or dressings.
Storing and Disposing of Your Medication
To maintain the effectiveness 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 secure location, out of the reach of children and pets.
Missing 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 resume your regular application schedule. Do not apply two doses at the same time 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. 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 that hand after applying the medication.
Before applying the medication, make sure the affected area is clean and dry. Gently rub a thin layer of the medication onto the affected skin. Unless instructed to do so by your doctor, do not cover the treated area with bandages or dressings.
Storing and Disposing of Your Medication
To maintain the effectiveness 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 secure location, out of the reach of children and pets.
Missing 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 resume your regular application 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 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.
- 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 getting the gel in your eyes, nose, or mouth. If it gets into your eyes, rinse thoroughly with water.
- Do not use this medication for longer than prescribed, typically no more than 2-4 weeks for continuous use, to avoid skin thinning and other side effects.
- Keep out of reach of children.
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. Occlusive dressings may be used for recalcitrant lesions, but only under physician supervision and for limited periods.
Eczema:
Apply a thin film to the affected skin areas two to four times daily.
Pediatric Dosing
Neonatal:
Not established (use with extreme caution due to increased systemic absorption risk)
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. Use the least amount for the shortest duration possible. Avoid use on large surface areas or under occlusive dressings due to increased risk of systemic absorption and HPA axis suppression.
Adolescent:
Apply a thin film to the affected skin areas two to four times daily.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical use, as systemic absorption is generally minimal.
Moderate:
No specific adjustment needed for topical use, as systemic absorption is generally minimal.
Severe:
No specific adjustment needed for topical use, as systemic absorption is generally minimal.
Dialysis:
No specific adjustment needed for topical use, as systemic absorption is generally minimal.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical use, as systemic absorption is generally minimal.
Moderate:
No specific adjustment needed for topical use, as systemic absorption is generally minimal.
Severe:
No specific adjustment needed for topical use, as systemic absorption is generally minimal.
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; systemic absorption depends on the vehicle, integrity of the epidermal barrier, duration of exposure, and use of occlusive dressings. Absorption is increased on denuded skin, with inflammation, and in intertriginous areas.
Tmax:
Not well-defined for topical application; systemic levels are generally low.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not well-defined for topical application.
ProteinBinding:
Systemically absorbed corticosteroids are bound to plasma proteins to varying degrees.
CnssPenetration:
Limited, unless significant systemic absorption occurs.
Elimination:
HalfLife:
Not well-defined for topical application; systemic half-life of corticosteroids varies.
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Metabolites are primarily excreted by the kidneys, with some excretion in the bile.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief.
PeakEffect:
Within days to weeks of consistent application.
DurationOfAction:
Varies; effects persist as long as applied, but prolonged use can lead to tachyphylaxis or adverse effects.
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: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, drowsiness, excessive 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. 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 unusual symptoms that bother you or persist, contact your doctor for guidance:
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.
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: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, drowsiness, excessive 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. 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 unusual symptoms that bother you or persist, contact your doctor for guidance:
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.
Seek Immediate Medical Attention If You Experience:
- Skin irritation, burning, itching, or redness that worsens or does not improve.
- Development of new skin problems like acne, folliculitis (hair follicle inflammation), or skin infections.
- Signs of skin thinning, such as easy bruising, stretch marks (striae), or shiny skin.
- Changes in skin color (lightening or darkening).
- Increased hair growth in the treated area.
- Signs of systemic absorption, especially in children or with extensive use: unusual weight gain, swelling in the face or ankles, muscle weakness, fatigue, or slow wound healing.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about any allergies you have, including:
An allergy to this medication or any of its components
An allergy to other medications, foods, or substances
The specific symptoms you experienced as a result of the allergy
Additionally, this medication may interact with other medications or health conditions. To ensure safe use, please disclose the following information to your doctor and pharmacist:
All prescription and over-the-counter medications you are currently taking
Any natural products or vitamins you are using
Any existing health problems or conditions
It is crucial to verify that it is safe to take this medication in combination with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about any allergies you have, including:
An allergy to this medication or any of its components
An allergy to other medications, foods, or substances
The specific symptoms you experienced as a result of the allergy
Additionally, this medication may interact with other medications or health conditions. To ensure safe use, please disclose the following information to your doctor and pharmacist:
All prescription and over-the-counter medications you are currently taking
Any natural products or vitamins you are using
Any existing health problems or conditions
It is crucial to verify that it is safe to take this medication in combination with your other medications and health conditions. Do not initiate, discontinue, or modify the dosage 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. In addition, 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, 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 you will need to discuss the benefits and risks of using this medication to 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. In addition, 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, 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 you will need to discuss the benefits and risks of using this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or extensive use can lead to systemic absorption, potentially causing Cushing's syndrome (e.g., moon face, buffalo hump, central obesity), hyperglycemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
- Local symptoms may include severe skin atrophy, striae, or telangiectasias.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment should be initiated. Call a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- None known for topical application.
Major Interactions
- None known for topical application.
Moderate Interactions
- None known for topical application.
Minor Interactions
- None known for topical application.
Monitoring
Baseline Monitoring
Skin condition assessment (type, severity, extent of lesion)
Rationale: To establish baseline for efficacy and safety monitoring.
Timing: Prior to initiation of therapy.
Patient history (age, comorbidities, concurrent medications)
Rationale: To identify risk factors for adverse effects (e.g., pediatric patients, extensive use, pre-existing skin atrophy).
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response (reduction in inflammation, pruritus)
Frequency: Weekly to bi-weekly during initial treatment, then as needed.
Target: Improvement in symptoms and lesion appearance.
Action Threshold: Lack of improvement or worsening symptoms may indicate need for re-evaluation or alternative therapy.
Local skin adverse effects (atrophy, striae, telangiectasias, folliculitis, perioral dermatitis, hypertrichosis, hypopigmentation)
Frequency: At each follow-up visit.
Target: Absence of new or worsening skin changes.
Action Threshold: Development of significant local adverse effects requires discontinuation or reduction in potency/frequency.
Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, HPA axis suppression)
Frequency: Periodically, especially with extensive use, prolonged therapy, or in pediatric patients.
Target: Absence of systemic signs/symptoms.
Action Threshold: Presence of systemic signs/symptoms warrants immediate discontinuation and medical evaluation.
Symptom Monitoring
- Worsening of skin condition
- Increased redness, itching, or burning at application site
- Development of new skin lesions (e.g., acne, folliculitis)
- Thinning of skin, easy bruising, or stretch marks
- Changes in skin color (lightening or darkening)
- Increased hair growth in treated areas
- Signs of infection (pus, fever)
- Unusual fatigue, weight gain, or swelling (signs of systemic absorption)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with systemically administered corticosteroids. Topical absorption is generally low, but extensive use or use on large surface areas should be avoided.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though risk with topical use is low.
Second Trimester:
Generally considered safer than first trimester, but still use with caution.
Third Trimester:
No specific risks identified beyond general corticosteroid effects; avoid extensive use near term.
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. If used, avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with limited topical use; potential for adverse effects if significant systemic absorption occurs in mother and drug passes into milk.
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 for the shortest duration possible. Avoid occlusive dressings and use on large surface areas.
Geriatric Use
No specific dosage adjustments are required. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects like skin atrophy and purpura. Monitor closely for skin integrity.
Clinical Information
Clinical Pearls
- Fluocinonide is a high-potency topical corticosteroid; use it sparingly and for short durations (typically 2-4 weeks) to minimize the risk of local and systemic side effects.
- Avoid using fluocinonide on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more prone to adverse effects like skin atrophy and telangiectasias.
- Educate patients on the proper application technique: a thin film is sufficient. More is not better and increases the risk of side effects.
- Occlusive dressings significantly increase systemic absorption and should only be used under strict medical supervision for recalcitrant lesions.
- Monitor pediatric patients closely for signs of HPA axis suppression, as they are more susceptible due to their higher surface area to body weight ratio.
- If no improvement is seen after 2 weeks, re-evaluate the diagnosis and treatment plan.
Alternative Therapies
- Other topical corticosteroids (e.g., clobetasol propionate, betamethasone dipropionate, triamcinolone acetonide, hydrocortisone)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
- Vitamin D analogs (e.g., calcipotriene) for psoriasis
- Topical retinoids (e.g., tazarotene) for psoriasis
- Emollients and moisturizers for barrier repair
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread conditions
Cost & Coverage
Average Cost:
$20 - $100 per 60gm tube of generic gel
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (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 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.