Olux-E 0.05% Foam 100gm
It is used to treat skin rashes and other skin irritation.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
C
FDA Approved
May 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
Olux-E foam contains a strong medicine called clobetasol, which is a corticosteroid. It's used on the skin to reduce redness, itching, and swelling caused by skin conditions like psoriasis and seborrheic dermatitis. It works by calming down the immune response in the skin.
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. Use this medication only on your skin, as directed. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Continue using this medication as instructed, even if your symptoms improve. Before and after applying the medication, wash your hands thoroughly. However, if you're applying the medication to your hand, do not wash that hand after use.
Prepare the affected area by cleaning it before application, and make sure it's completely dry. Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Application Guidelines
Do not apply this medication to your face, underarms, or groin area unless your doctor specifically instructs you to do so.
Avoid using bandages, dressings, or makeup on the treated area unless your doctor advises you to do so.
Before use, shake the container well. To apply the foam, turn the can upside down. Note that some foams may melt if placed in your hand; consult your pharmacist for guidance on using the foam correctly.
Apply the foam to the affected area and gently rub it in.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration or freezing. Be aware of the expiration date or the duration for which you can store this medication before disposing of it. Protect the container from heat or open flames, and do not puncture or burn it, even if it appears empty.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember. If it's 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. Use this medication only on your skin, as directed. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Continue using this medication as instructed, even if your symptoms improve. Before and after applying the medication, wash your hands thoroughly. However, if you're applying the medication to your hand, do not wash that hand after use.
Prepare the affected area by cleaning it before application, and make sure it's completely dry. Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Application Guidelines
Do not apply this medication to your face, underarms, or groin area unless your doctor specifically instructs you to do so.
Avoid using bandages, dressings, or makeup on the treated area unless your doctor advises you to do so.
Before use, shake the container well. To apply the foam, turn the can upside down. Note that some foams may melt if placed in your hand; consult your pharmacist for guidance on using the foam correctly.
Apply the foam to the affected area and gently rub it in.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration or freezing. Be aware of the expiration date or the duration for which you can store this medication before disposing of it. Protect the container from heat or open flames, and do not puncture or burn it, even if it appears empty.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember. If it's 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
- Apply a thin layer of foam to the affected skin areas twice a day, as directed by your doctor. Gently rub it in until it disappears.
- Wash your hands before and after applying the foam, unless your hands are the treated area.
- Do not use more than 50 grams (one 100g can used halfway) per week.
- Do not use for longer than 2 consecutive weeks unless specifically instructed by your doctor.
- Avoid applying the foam to your face, groin, armpits, or if skin atrophy is present, unless directed by your doctor.
- Do not use with occlusive dressings (e.g., bandages, plastic wrap) unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not use on broken, infected, or irritated skin unless directed by your doctor.
- Keep the foam away from open flames or heat, as it is flammable.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected skin areas twice daily.
Condition-Specific Dosing:
Plaque Psoriasis:
Apply twice daily for up to 2 weeks. Do not exceed 50g per week.
Seborrheic Dermatitis:
Apply twice daily for up to 2 weeks. Do not exceed 50g per week.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in pediatric patients under 12 years of age). Use in children 12 years and older should be limited to the least amount compatible with an effective therapeutic regimen, due to increased risk of systemic absorption and HPA axis suppression.
Adolescent:
Apply a thin layer to affected skin areas twice daily for up to 2 weeks. Do not exceed 50g per week. Use with caution and for the shortest duration possible.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required for topical use.
Moderate:
No specific adjustment required for topical use.
Severe:
No specific adjustment required for topical use.
Dialysis:
No specific adjustment required for topical use.
Hepatic Impairment:
Mild:
No specific adjustment required for topical use.
Moderate:
No specific adjustment required for topical use.
Severe:
No specific adjustment required for topical use.
Pharmacology
Mechanism of Action
Clobetasol propionate is a high-potency synthetic 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, 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 (systemic absorption can occur, especially with prolonged use, large surface areas, occlusive dressings, or compromised skin barrier)
Tmax:
Not well-defined for topical application; systemic absorption is generally low but can lead to detectable plasma levels.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not well-defined for topical application; systemically absorbed corticosteroids are widely distributed.
ProteinBinding:
Approximately 97% (for systemically absorbed clobetasol)
CnssPenetration:
Limited (for topical application, systemic levels are generally too low to achieve significant CNS penetration)
Elimination:
HalfLife:
Not well-defined for topical application; systemically absorbed clobetasol has a short half-life (approx. 3-5 hours).
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Renal (primarily as metabolites), also some biliary excretion.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within days of initiation (for anti-inflammatory/antipruritic effects)
PeakEffect:
Within 1-2 weeks of continuous use
DurationOfAction:
Effects persist as long as applied; systemic effects resolve upon discontinuation.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following signs or symptoms, contact your doctor or seek medical help right away:
Allergic reaction symptoms, 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
High blood sugar symptoms, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Cushing's syndrome symptoms, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Weak adrenal gland symptoms, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Irritation at the application site
Thinning of the skin
Changes in eyesight, eye pain, or severe eye irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or do not go away:
Burning or stinging
Dry skin
* Redness
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 signs or symptoms, contact your doctor or seek medical help right away:
Allergic reaction symptoms, 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
High blood sugar symptoms, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Cushing's syndrome symptoms, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Weak adrenal gland symptoms, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Irritation at the application site
Thinning of the skin
Changes in eyesight, eye pain, or severe eye irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or do not go away:
Burning or stinging
Dry skin
* Redness
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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, itching, or irritation at the application site (may indicate an allergic reaction or worsening condition)
- Signs of skin thinning, such as easy bruising, shiny skin, or stretch marks (striae)
- Development of new skin infections (e.g., pus, increased pain, fever)
- Acne-like breakouts or increased hair growth in treated areas
- Unusual fatigue, weakness, nausea, vomiting, dizziness, or weight gain (signs of possible systemic absorption and adrenal suppression)
- Blurred vision or other vision problems (rare, but possible with long-term use or high 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.
If you have thinning skin at the site where you will be applying this medication.
* If there is an active infection at the site where this medication will be used.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change 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 allergic reaction you experienced, including any symptoms that occurred.
If you have thinning skin at the site where you will be applying this medication.
* If there is an active infection at the site where this medication will be used.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change 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.
To ensure safe use, follow these precautions:
- Keep this medication away from open flames or sparks, as it may be flammable. Do not use it near an open flame or while smoking.
- Do not apply this medication to treat diaper rash.
- Avoid using this medication to treat acne, rosacea, or rashes around the mouth.
- When applying this medication to a large area of skin or near open wounds, exercise caution and consult your doctor.
- Before using other skin products or medications, including soaps, consult your doctor to avoid potential interactions.
- Do not apply this medication to cuts, scrapes, or damaged skin.
- Use this medication only for the duration prescribed by your doctor. Do not exceed the recommended treatment period.
Important safety considerations:
- If this medication is ingested, it may cause harm. In case of accidental ingestion, immediately contact a doctor or a poison control center.
- Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.
- The safety and efficacy of this medication in children of all ages have not been established. Consult your doctor before administering this medication to a child.
- When using this medication in children, be aware that the risk of certain side effects may be higher. Additionally, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so discuss this with your doctor.
- If you are breast-feeding, avoid applying this medication directly to the nipple or the surrounding area.
Before starting treatment, inform your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Your doctor will help you weigh the benefits and risks of using this medication during these situations.
To ensure safe use, follow these precautions:
- Keep this medication away from open flames or sparks, as it may be flammable. Do not use it near an open flame or while smoking.
- Do not apply this medication to treat diaper rash.
- Avoid using this medication to treat acne, rosacea, or rashes around the mouth.
- When applying this medication to a large area of skin or near open wounds, exercise caution and consult your doctor.
- Before using other skin products or medications, including soaps, consult your doctor to avoid potential interactions.
- Do not apply this medication to cuts, scrapes, or damaged skin.
- Use this medication only for the duration prescribed by your doctor. Do not exceed the recommended treatment period.
Important safety considerations:
- If this medication is ingested, it may cause harm. In case of accidental ingestion, immediately contact a doctor or a poison control center.
- Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.
- The safety and efficacy of this medication in children of all ages have not been established. Consult your doctor before administering this medication to a child.
- When using this medication in children, be aware that the risk of certain side effects may be higher. Additionally, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so discuss this with your doctor.
- If you are breast-feeding, avoid applying this medication directly to the nipple or the surrounding area.
Before starting treatment, inform your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Your doctor will help you weigh the benefits and risks of using this medication during these situations.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use of topical corticosteroids can lead to systemic effects, including Cushing's syndrome (characterized by moon face, buffalo hump, central obesity, thin skin, easy bruising, muscle weakness), hyperglycemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis (leading to adrenal insufficiency upon abrupt withdrawal).
- Local symptoms may include severe skin atrophy, striae, and telangiectasias.
What to Do:
If overdose is suspected, contact a poison control center or emergency medical services immediately. For the U.S., call 1-800-222-1222. Treatment is supportive and symptomatic. Gradual withdrawal of the corticosteroid may be necessary to prevent adrenal insufficiency.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis (e.g., plaque psoriasis, seborrheic dermatitis) and identify areas for treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response (reduction in inflammation, pruritus, scaling)
Frequency: Weekly or as clinically indicated during treatment period.
Target: Improvement in symptoms.
Action Threshold: If no improvement after 2 weeks, reassess diagnosis and treatment plan. If improvement, consider tapering or discontinuing.
Local skin reactions (e.g., atrophy, striae, telangiectasias, burning, itching, irritation, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, miliaria)
Frequency: At each follow-up visit.
Target: Absence or minimal reactions.
Action Threshold: If severe or persistent reactions occur, discontinue use and manage appropriately.
Signs of HPA axis suppression (e.g., fatigue, weakness, nausea, vomiting, hypotension, hypoglycemia)
Frequency: Periodically, especially with prolonged use, large surface areas, or occlusive dressings.
Target: Absence of symptoms.
Action Threshold: If suspected, perform HPA axis suppression tests (e.g., ACTH stimulation test) and discontinue or gradually withdraw the drug.
Symptom Monitoring
- Burning or stinging at application site
- Itching or irritation
- Skin thinning or atrophy
- Stretch marks (striae)
- Spider veins (telangiectasias)
- Acne-like eruptions
- Increased hair growth (hypertrichosis)
- Changes in skin color (hypopigmentation)
- Signs of infection (redness, swelling, pus)
- Unusual fatigue or weakness
- Weight gain (especially in face/trunk)
- Increased thirst or urination
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. Systemic absorption of topical corticosteroids can occur.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though systemic absorption from topical use is generally low.
Second Trimester:
Risk of fetal growth restriction or other adverse effects with high systemic exposure.
Third Trimester:
Risk of fetal growth restriction or other adverse effects with high systemic exposure; potential for HPA axis suppression in the neonate if used extensively near term.
Lactation
Clobetasol is excreted in breast milk following systemic administration. It is not known whether topical administration 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 direct infant exposure.
Infant Risk:
Low risk with limited, short-term topical use. Potential for adverse effects (e.g., growth suppression, HPA axis suppression) if significant systemic absorption occurs in the mother and drug is transferred to the infant via milk.
Pediatric Use
Pediatric patients are more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio and immature skin barrier function. HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Use in children under 12 years is not recommended. For children 12 years and older, use the smallest amount for the shortest duration necessary.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may have thinner skin and be more prone to skin atrophy, requiring careful monitoring.
Clinical Information
Clinical Pearls
- Olux-E is a super-high potency topical corticosteroid. It should be used for short durations (typically up to 2 weeks) to minimize the risk of local and systemic side effects, particularly HPA axis suppression.
- Patients should be instructed on the correct application technique, including applying a thin layer and gently rubbing it in until it disappears.
- Emphasize the importance of not exceeding the recommended weekly limit (50g) and duration of treatment.
- Warn patients about applying the foam to sensitive areas like the face, groin, or axillae, or under occlusive dressings, unless specifically instructed by a healthcare provider.
- Monitor for signs of HPA axis suppression, especially in patients using large amounts, for prolonged periods, or in pediatric patients.
- The foam formulation may be preferred by some patients due to its ease of application on hairy areas and its emollient properties.
Alternative Therapies
- Other topical corticosteroids (e.g., betamethasone, fluocinonide, triamcinolone, hydrocortisone, desonide) of varying potencies.
- Vitamin D analogs (e.g., calcipotriene) for psoriasis.
- Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for inflammatory skin conditions.
- Topical retinoids (e.g., tazarotene) for psoriasis.
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe psoriasis.
- Phototherapy (UVB, PUVA) for psoriasis.
- Antifungal agents (e.g., ketoconazole, ciclopirox) for seborrheic dermatitis.
Cost & Coverage
Average Cost:
$100 - $500+ per 100gm foam
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.