Lidex 0.05% Soln 60ml
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 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 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 skin. Do not take it by mouth. 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 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
Store the medication at room temperature, keeping the lid tightly closed. Protect it from heat and keep it out of reach of children and pets. Make sure to store all medications in a safe and secure location.
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 continue with your regular schedule. Do not apply two doses at the same time or use extra doses to make up for a missed one.
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 skin. Do not take it by mouth. 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 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
Store the medication at room temperature, keeping the lid tightly closed. Protect it from heat and keep it out of reach of children and pets. Make sure to store all medications in a safe and secure location.
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 continue with 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 hands before and after applying the medication.
- Apply a thin layer to the affected skin area(s) as directed by your doctor, usually two to four times a day.
- Gently rub it in completely.
- Do not use more than the prescribed amount or for longer than directed.
- Do not bandage, cover, or wrap the treated skin area unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid contact with eyes, nose, 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 diaper rash.
- 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.
eczema:
Apply a thin film to the affected skin areas two to four times daily.
Pediatric Dosing
Neonatal:
Not established (increased risk of systemic absorption)
Infant:
Not established (increased risk of systemic absorption)
Child:
Apply a thin film to the affected skin areas two to four times daily. Use the least amount compatible with a therapeutic regimen. Avoid use on large surface areas or under occlusive dressings due to increased risk of systemic absorption.
Adolescent:
Apply a thin film to the affected skin areas two to four times daily.
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, 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 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:
Minimal systemic absorption (typically <1-5%), but can increase significantly with damaged skin, inflammation, occlusion, or large surface area application.
Tmax:
Not well-defined for topical application due to minimal systemic absorption.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not well-quantified for topical use; primarily distributed locally in the skin. If systemically absorbed, it distributes widely.
ProteinBinding:
High (>90%) if systemically absorbed.
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Not well-defined for topical use; systemic half-life of corticosteroids varies but is generally short (hours).
Clearance:
Not well-quantified for topical use.
ExcretionRoute:
Primarily renal excretion of inactive metabolites if systemically absorbed.
Unchanged:
<1% (if systemically absorbed)
Pharmacodynamics
OnsetOfAction:
Within hours to days for local anti-inflammatory effects.
PeakEffect:
Days to weeks of consistent application.
DurationOfAction:
Local effects persist for several hours after application.
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:
- Worsening of your skin condition or no improvement after 2 weeks.
- Signs of skin infection (e.g., increased redness, swelling, pus, fever).
- Severe burning, itching, irritation, or dryness of the treated skin.
- Thinning of the skin, easy bruising, or stretch marks.
- Unusual hair growth.
- Changes in skin color.
- Blurred vision or other eye problems.
- Unexplained weight gain, swelling in the face, or unusual fatigue (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 symptoms you experienced.
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.
* Any existing health problems, as this medication may interact with other medical conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dosage 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.
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.
* Any existing health problems, as this medication may interact with other medical conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust 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.
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 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, 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 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 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, 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 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 absorption, resulting in symptoms of hypercorticism (Cushing's syndrome), including: moon face, buffalo hump, central obesity, thinning skin, easy bruising, muscle weakness, hyperglycemia, glucosuria, and adrenal suppression.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify any signs of infection or contraindications.
Timing: Prior to initiation of therapy.
Routine Monitoring
Local skin reactions (e.g., atrophy, striae, telangiectasias, burning, itching, irritation)
Frequency: Regularly during treatment, especially with prolonged use or use on sensitive areas.
Target: Absence or minimal severity of reactions.
Action Threshold: If severe or persistent reactions occur, discontinue use and reassess.
Signs of systemic corticosteroid effects (e.g., Cushing's syndrome, hyperglycemia, adrenal suppression)
Frequency: Periodically, especially in pediatric patients, with prolonged use, large surface area application, or occlusive dressings.
Target: Absence of systemic effects.
Action Threshold: If suspected, perform appropriate diagnostic tests (e.g., plasma cortisol, ACTH stimulation test) and gradually withdraw the drug.
Signs of infection (e.g., worsening redness, pus, fever)
Frequency: Regularly during treatment.
Target: Absence of infection.
Action Threshold: If infection develops, discontinue fluocinonide and initiate appropriate antimicrobial therapy.
Symptom Monitoring
- Worsening of skin condition
- Increased redness, swelling, or pain at application site
- Pus or discharge from skin lesions
- Fever
- Unusual fatigue or weakness
- Weight gain, moon face, buffalo hump (signs of Cushing's)
- Increased thirst or urination (signs of hyperglycemia)
- Blurred vision (cataracts/glaucoma)
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 is minimal with topical use.
Second Trimester:
Minimal risk with appropriate topical use.
Third Trimester:
Minimal risk 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. Advise breastfeeding mothers not to apply fluocinonide to the breast or nipple area to avoid direct infant exposure.
Infant Risk:
Low risk with proper application, but potential for systemic effects if significant absorption occurs in mother.
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 amount compatible with a therapeutic regimen. Avoid use on large surface areas, under occlusive dressings, or for prolonged periods.
Geriatric Use
No specific dosage adjustments are typically required. However, geriatric patients may have thinner skin, which could potentially increase the risk of local side effects like skin atrophy. Use with caution and monitor for adverse effects.
Clinical Information
Clinical Pearls
- Fluocinonide is a high-potency topical corticosteroid; use it judiciously and for the shortest duration possible to achieve therapeutic effect.
- Educate patients on proper application technique: thin layer, gentle rub, and avoiding occlusive dressings unless specifically instructed.
- Warn patients about potential local side effects (skin atrophy, striae) and signs of systemic absorption, especially with prolonged use or on large body areas.
- Avoid use on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more prone to atrophy and other side effects.
- Do not use for rosacea or perioral dermatitis, as corticosteroids can exacerbate these conditions.
- If no improvement is seen after 2 weeks, reassess the diagnosis and treatment plan.
Alternative Therapies
- Other topical corticosteroids (e.g., clobetasol, betamethasone, triamcinolone, 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 dry skin conditions
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe dermatoses
Cost & Coverage
Average Cost:
Varies widely, typically $50 - $300+ per 60ml solution
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic), Tier 3 or higher (brand)
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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.