Lidex 0.05% Cream 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
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 belongs to a group of medicines called corticosteroids.
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, do not wash your hand after applying the medication.
Before applying the medication, make sure to clean the affected area and dry it well. Then, 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
To maintain the effectiveness of your medication, store it at room temperature with the lid tightly closed. Protect the medication from heat sources. Keep all medications in a safe and 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, do not wash your hand after applying the medication.
Before applying the medication, make sure to clean the affected area and dry it well. Then, 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
To maintain the effectiveness of your medication, store it at room temperature with the lid tightly closed. Protect the medication from heat sources. Keep all medications in a safe and 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 cream.
- Apply a thin layer of cream to the affected skin area, gently rubbing it in until it disappears.
- 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 the cream to the face, groin, or armpits unless specifically instructed by your doctor, as these areas are more prone to side effects.
- Do not use the cream for longer than prescribed, typically no more than 2 weeks for adults, or on large areas of the body.
- Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
- Do not use for diaper rash in infants.
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 caution and for limited duration due to higher risk of systemic absorption and HPA axis suppression.
Child:
Apply a thin film to the affected skin areas two to four times daily. Use with caution and for limited duration due to higher risk of systemic absorption and HPA axis suppression. Avoid use on large surface areas or under occlusive dressings.
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 (minimal systemic absorption).
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 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:
Variable (depends on vehicle, skin integrity, area of application, duration of exposure, and use of occlusive dressings). Systemic absorption is generally low but can increase significantly under certain conditions.
Tmax:
Not applicable for topical application to achieve systemic peak; local effect is primary.
FoodEffect:
Not applicable (topical).
Distribution:
Vd:
Not applicable for topical application; systemically absorbed corticosteroids are widely distributed.
ProteinBinding:
Not applicable for topical application; systemically absorbed corticosteroids are highly protein bound.
CnssPenetration:
Limited (systemic absorption is low).
Elimination:
HalfLife:
Not precisely determined for topical application; systemically absorbed corticosteroids have variable half-lives.
Clearance:
Not precisely determined for topical application; systemically absorbed corticosteroids are cleared primarily via hepatic metabolism.
ExcretionRoute:
Metabolites are primarily excreted by the kidneys, with some biliary excretion.
Unchanged:
Very little unchanged drug is excreted systemically.
Pharmacodynamics
OnsetOfAction:
Hours to days (for anti-inflammatory and antipruritic effects).
PeakEffect:
Days to weeks of consistent application.
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, 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. Many people experience no side effects or only mild ones. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Burning or stinging sensations
Dry skin
Itching
This is not an exhaustive list of possible side effects. If you have 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, 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. Many people experience no side effects or only mild ones. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Burning or stinging sensations
Dry skin
Itching
This is not an exhaustive list of possible side effects. If you have 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.
- Burning or stinging sensation that does not go away.
- Thinning of the skin, easy bruising, or stretch marks (striae).
- Acne-like breakouts or increased hair growth in the treated area.
- Signs of infection (pus, fever).
- If used extensively or for prolonged periods, watch for signs of systemic absorption such as unusual tiredness, weight gain, swelling in ankles/feet, or changes in mood.
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, any of 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) medications, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, 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 current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of 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) medications, natural products, and vitamins. This information will help your doctor identify potential interactions between this medication and other substances.
* Any existing health problems, 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 current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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 any concerns with your doctor.
Adhere to your doctor's instructions regarding the duration of treatment, and do not use this medication for an extended period beyond the recommended timeframe. If the treated area is in the diaper region, avoid 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 to 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 any concerns with your doctor.
Adhere to your doctor's instructions regarding the duration of treatment, and do not use this medication for an extended period beyond the recommended timeframe. If the treated area is in the diaper region, avoid 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 to you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use of topical corticosteroids can lead to systemic effects, including suppression of the hypothalamic-pituitary-adrenal (HPA) axis, Cushing's syndrome, hyperglycemia, and glucosuria.
- Symptoms of HPA axis suppression may include fatigue, weakness, nausea, vomiting, and low blood pressure.
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
Rationale: To establish baseline severity of dermatosis and identify areas for application.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (reduction in inflammation, pruritus)
Frequency: Regularly during treatment, typically within 1-2 weeks.
Target: Improvement in symptoms.
Action Threshold: Lack of improvement or worsening symptoms may require re-evaluation or alternative therapy.
Local adverse reactions (e.g., skin atrophy, striae, telangiectasias, burning, itching)
Frequency: Regularly during treatment.
Target: Absence or minimal signs of adverse reactions.
Action Threshold: Presence of significant local adverse reactions may require discontinuation or reduction in frequency/potency.
Signs of HPA axis suppression (e.g., fatigue, weakness, weight loss, hypotension)
Frequency: Periodically, especially with prolonged use, large surface area application, or occlusive dressings.
Target: Normal HPA axis function.
Action Threshold: Suspicion of HPA axis suppression may warrant laboratory testing (e.g., ACTH stimulation test, plasma cortisol levels) and gradual withdrawal of the drug.
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 corticosteroid effects (e.g., Cushing's syndrome, hyperglycemia, glucosuria, HPA axis suppression)
Special Patient Groups
Pregnancy
Category C. Use 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 from topical use is generally low.
Second Trimester:
Risk of fetal growth restriction or other adverse effects with high-dose or prolonged use.
Third Trimester:
Risk of fetal growth restriction or other adverse effects with high-dose or prolonged use.
Lactation
L3 (Moderately Safe). 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 appropriate use, but potential for systemic effects in infant if significant amounts are absorbed by mother and transferred via milk.
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 and use on large surface areas.
Geriatric Use
No specific dose adjustments are required. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects like skin atrophy or purpura. Use with caution.
Clinical Information
Clinical Pearls
- Fluocinonide 0.05% is a high-potency topical corticosteroid; use should be limited to short-term treatment (typically 2 weeks for adults) to minimize the risk of local and systemic side effects.
- Avoid abrupt discontinuation after prolonged use, especially on the face, as this can lead to rebound dermatitis.
- Not for ophthalmic use. Avoid contact with eyes.
- Patients should be instructed on the proper application technique: apply a very thin layer and rub in gently.
- Occlusive dressings significantly increase systemic absorption and should generally be avoided unless specifically directed by a physician for resistant conditions.
- 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, betamethasone dipropionate, triamcinolone acetonide, hydrocortisone)
- Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for atopic dermatitis
- Vitamin D analogs (e.g., calcipotriene) for psoriasis
- Emollients and moisturizers for dry skin conditions
Cost & Coverage
Average Cost:
$20 - $60 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 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 for more information. 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. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to help healthcare professionals provide the best possible care.