Lidex 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
Pregnancy Category
Category C
FDA Approved
Jun 1971
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluocinonide is a strong corticosteroid medicine applied to the skin to reduce redness, swelling, and itching caused by various 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 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. Wash your hands before and after applying the medication, unless your hand is the area being treated, in which case you should not wash your hand after application.
Before applying the medication, clean the affected area and dry it thoroughly. Apply a thin layer of the medication to the affected skin and gently rub it in. Unless instructed to do so by your doctor, do not cover the treated area with bandages or dressings.
Storing and Disposing of Your Medication
Store your medication at room temperature, with the lid tightly closed, and protect it from heat. Keep all medications in a safe place, 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 dose, skip the missed dose and resume 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 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. Wash your hands before and after applying the medication, unless your hand is the area being treated, in which case you should not wash your hand after application.
Before applying the medication, clean the affected area and dry it thoroughly. Apply a thin layer of the medication to the affected skin and gently rub it in. Unless instructed to do so by your doctor, do not cover the treated area with bandages or dressings.
Storing and Disposing of Your Medication
Store your medication at room temperature, with the lid tightly closed, and protect it from heat. Keep all medications in a safe place, 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 dose, skip the missed dose and resume 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 cream.
- Apply a thin layer to the affected skin area and rub in gently. Do not use more than prescribed.
- Do not cover the treated area with bandages or dressings unless directed by your doctor, as this can increase absorption and side effects.
- Avoid applying to the face, groin, or armpits unless specifically instructed by your doctor.
- Avoid contact with eyes, nose, mouth, or other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not use for longer than prescribed, especially on children, as prolonged use can lead to skin thinning or other side effects.
- Inform your doctor if your condition does not improve or worsens after a few days of treatment.
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 formulation and severity.
Dose Range:
2 - 4 mg
Condition-Specific Dosing:
cream_gel_solution:
Apply a thin film to the affected skin areas two to four times daily.
ointment:
Apply a thin film to the affected skin areas two to three 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 use on face, groin, or axillae, or under occlusive dressings. Monitor for HPA axis suppression.
Adolescent:
Apply a thin film to the affected skin areas two to four times daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (minimal systemic absorption).
Dialysis:
No specific considerations for topical use.
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (minimal systemic absorption).
Pharmacology
Mechanism of Action
Fluocinonide is a high-potency corticosteroid. It exerts its anti-inflammatory, antipruritic, and vasoconstrictive actions through induction of 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; generally low systemic absorption. Absorption is increased by occlusive dressings, inflammation, and in areas with thin skin (e.g., face, scrotum) or in pediatric patients. Approximately 1-5% of applied dose may be absorbed systemically.
Tmax:
Not precisely defined for topical application due to variable absorption; systemic effects are generally not seen unless extensive application or occlusion.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not precisely quantified for topical use; systemically absorbed corticosteroids are widely distributed throughout the body.
ProteinBinding:
Systemically absorbed corticosteroids are extensively bound to plasma proteins, primarily corticosteroid-binding globulin and albumin.
CnssPenetration:
Limited (systemic absorption is minimal).
Elimination:
HalfLife:
Not precisely defined for topical application; systemically absorbed corticosteroids have variable half-lives.
Clearance:
Not precisely defined for topical application.
ExcretionRoute:
Metabolites are primarily excreted by the kidneys.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief.
PeakEffect:
Days to weeks of consistent application for maximal therapeutic effect.
DurationOfAction:
Varies with frequency of application and individual response.
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:
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:
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 redness, swelling, or irritation at the application site.
- Signs of skin infection (e.g., pus, fever).
- Thinning of the skin, easy bruising, or stretch marks (striae).
- Acne-like breakouts or increased hair growth in the treated area.
- Any signs of systemic side effects, such as unusual tiredness, weight gain, swelling in ankles/feet, or vision problems (rare with proper topical 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.
Potential interactions with other medications or health conditions. This medication may interact with other prescription or over-the-counter (OTC) drugs, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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.
Potential interactions with other medications or health conditions. This medication may interact with other prescription or over-the-counter (OTC) drugs, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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 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 can affect growth in children and teenagers, making regular growth checks necessary. Consult with your doctor to discuss the potential risks and benefits.
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 area of skin 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 can affect growth in children and teenagers, making regular growth checks necessary. Consult with your doctor to discuss the potential risks and benefits.
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:
- Chronic overdose or misuse can lead to systemic effects of hypercorticism (Cushing's syndrome), including moon face, central obesity, hypertension, hyperglycemia, and HPA axis suppression.
- Local symptoms may include severe skin atrophy, striae, and telangiectasias.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control) for advice.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify any contraindications (e.g., skin infections).
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response and local adverse effects (e.g., skin atrophy, striae, telangiectasias, folliculitis)
Frequency: Regularly during treatment, especially if prolonged or extensive use.
Target: Improvement in dermatosis symptoms without significant local adverse effects.
Action Threshold: If no improvement or worsening of condition, or significant adverse effects, re-evaluate diagnosis and treatment.
Signs of HPA axis suppression (e.g., fatigue, weakness, weight loss, hypotension)
Frequency: Periodically, especially with prolonged use, extensive body surface area application, or use under occlusion.
Target: Absence of signs/symptoms of HPA axis suppression.
Action Threshold: If suspected, perform appropriate laboratory tests (e.g., ACTH stimulation test) and consider gradual withdrawal or alternative therapy.
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., Cushing's syndrome, hyperglycemia, glucosuria, growth retardation in children)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Category C. Avoid large amounts or prolonged use.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity with high doses of systemic corticosteroids; topical absorption is minimal but caution advised.
Second Trimester:
Similar considerations as first trimester; minimal systemic absorption reduces risk.
Third Trimester:
Similar considerations; potential for HPA axis suppression in the neonate with extensive maternal use near term (rare with topical).
Lactation
Use with caution. It is not known whether topical fluocinonide is excreted in human milk. Systemically administered corticosteroids appear in human milk. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with proper topical use due to minimal systemic absorption, but monitor infant for any unusual effects.
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. Use the least potent corticosteroid for the shortest duration possible. Avoid occlusive dressings. Monitor growth and development.
Geriatric Use
No specific dosage adjustments are typically needed. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects such as skin atrophy, purpura, and striae.
Clinical Information
Clinical Pearls
- Fluocinonide is a high-potency topical corticosteroid; use it judiciously and for the shortest effective duration to minimize local and systemic side effects.
- Educate patients on proper application technique: a thin layer, gently rubbed in, and avoiding excessive amounts or prolonged use.
- Warn patients against using fluocinonide on the face, groin, or axillae unless specifically instructed by a physician, due to increased risk of skin atrophy and other side effects in these sensitive areas.
- Consider step-down therapy to a lower potency corticosteroid or non-steroidal agent once the acute inflammation is controlled.
- Always rule out fungal or bacterial infections before initiating corticosteroid therapy, as corticosteroids can worsen these conditions.
Alternative Therapies
- Other topical corticosteroids (e.g., clobetasol, betamethasone, triamcinolone, hydrocortisone) varying in potency.
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema.
- Topical 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, oral immunosuppressants) for severe, widespread dermatoses.
Cost & Coverage
Average Cost:
Varies widely by formulation and pharmacy (e.g., $30 - $200+ for 60gm) per 60gm tube
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.