Olux-E 0.05% Foam 50gm
It is used to treat skin rashes and other skin irritation.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Synthetic Adrenocortical Steroid; Anti-inflammatory Agent
Pregnancy Category
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 works by reducing redness, swelling, and itching caused by certain skin conditions like psoriasis and eczema. It's important to use it exactly as prescribed, usually for a short time, to avoid side effects.
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 as directed and continue to use it even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area, in which case you should not wash it after application.
Clean the affected area before applying the medication and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Do not apply this medication to your face, underarms, or groin area unless your doctor instructs you to do so.
Avoid using bandages, dressings, or makeup on the treated area unless your doctor advises you to do so.
Special Instructions for Foam
Shake the can well before use.
To use the foam, turn the can upside down. Note that some foams may melt if placed in your hand, so consult your pharmacist for guidance on how to use 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 length of time you can store this medication before it needs to be discarded.
Protect the medication from heat or open flames, and do not puncture or burn the can, even if it appears to be empty.
Missed Dose
If you miss a dose, apply it as soon as you remember.
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 use this medication correctly, follow your doctor's instructions and read all the information provided. Use this medication only as directed and continue to use it even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area, in which case you should not wash it after application.
Clean the affected area before applying the medication and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Do not apply this medication to your face, underarms, or groin area unless your doctor instructs you to do so.
Avoid using bandages, dressings, or makeup on the treated area unless your doctor advises you to do so.
Special Instructions for Foam
Shake the can well before use.
To use the foam, turn the can upside down. Note that some foams may melt if placed in your hand, so consult your pharmacist for guidance on how to use 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 length of time you can store this medication before it needs to be discarded.
Protect the medication from heat or open flames, and do not puncture or burn the can, even if it appears to be empty.
Missed Dose
If you miss a dose, apply it as soon as you remember.
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.
Lifestyle & Tips
- Wash hands before and after applying the foam.
- Shake the can well before use.
- Invert the can and dispense a small amount of foam onto a cool surface (not directly onto hands, as it will melt).
- Gently massage the foam into the affected skin area until it disappears.
- Do not apply to the face, groin, or armpits unless specifically directed by a doctor.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use with occlusive dressings (e.g., bandages, plastic wrap) unless directed by your doctor, as this can increase absorption and side effects.
- Do not use for longer than 2 consecutive weeks without consulting your doctor.
- Do not exceed 50 grams per week.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer of foam to the affected skin areas twice daily for up to 2 consecutive weeks. Total dosage should not exceed 50 grams per week.
Condition-Specific Dosing:
Plaque Psoriasis:
Apply twice daily for up to 2 weeks. If no improvement, reassess diagnosis. Do not use for more than 2 weeks without re-evaluation.
Atopic Dermatitis:
Apply twice daily for up to 2 weeks. If no improvement, reassess diagnosis. Do not use for more than 2 weeks without re-evaluation.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
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 a larger skin surface area to body mass ratio, children are at greater risk of systemic toxicity (e.g., HPA axis suppression) than adults.
Adolescent:
Safety and efficacy not established in pediatric patients under 12 years of age. For adolescents 12 years and older, use with caution and limit duration of treatment.
Dose Adjustments
Renal Impairment:
Mild:
No specific dosage adjustment recommended due to minimal systemic absorption.
Moderate:
No specific dosage adjustment recommended due to minimal systemic absorption.
Severe:
No specific dosage adjustment recommended due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific dosage adjustment recommended due to minimal systemic absorption.
Moderate:
No specific dosage adjustment recommended due to minimal systemic absorption.
Severe:
No specific dosage adjustment recommended due to minimal systemic absorption.
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, 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 (less than 1%) through intact skin. Absorption increases with inflammation, skin barrier disruption, occlusive dressings, and application to large surface areas.
Tmax:
Not typically reported for topical application due to variable and minimal systemic absorption.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not clinically relevant for topical application due to minimal systemic absorption.
ProteinBinding:
Approximately 90% (if absorbed systemically, similar to other corticosteroids).
CnssPenetration:
Limited (not clinically significant for topical use).
Elimination:
HalfLife:
Not precisely determined for topical application due to minimal systemic absorption; systemic half-life of absorbed clobetasol is approximately 3-5 hours.
Clearance:
Not clinically relevant for topical application due to minimal systemic absorption.
ExcretionRoute:
Primarily renal excretion (if absorbed systemically), with some biliary excretion.
Unchanged:
Minimal unchanged drug excreted (if absorbed systemically).
Pharmacodynamics
OnsetOfAction:
Within days of initiation of therapy for local effects.
PeakEffect:
Within 1-2 weeks for maximal local anti-inflammatory effect.
DurationOfAction:
Effects persist as long as applied; HPA axis suppression can persist for days after discontinuation if significant absorption occurred.
Safety & Warnings
Side Effects
Serious 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 medical attention immediately:
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 Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of a weak adrenal gland, including:
+ 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 where the medication was applied
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. 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
* Redness
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 medical attention immediately:
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 Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of a weak adrenal gland, including:
+ 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 where the medication was applied
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. 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
* Redness
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:
- Severe burning, itching, or irritation at the application site.
- Signs of skin thinning (e.g., easy bruising, shiny skin, stretch marks).
- New or worsening skin infection (e.g., pus, spreading redness).
- Unusual hair growth.
- Acne-like rash.
- Signs of systemic side effects, especially if used extensively: unusual tiredness, weakness, nausea, vomiting, dizziness, swelling in ankles/feet, increased thirst or urination (signs of high blood sugar).
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 and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, share any health problems you have to ensure safe use of this medication.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so in conjunction with this medication.
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 and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, share any health problems you have to ensure safe use of this medication.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to confirm it is safe to do so in conjunction with this medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To minimize risks, be aware of the following precautions:
- This medication is flammable, so avoid using it near open flames or while smoking.
- Do not apply this medication to treat diaper rash.
- It is not intended for treating acne, rosacea, or rashes around the mouth.
- Exercise caution when applying this medication to large areas of skin or near open wounds; consult your doctor for guidance.
- Before using other skin products or medications, including soaps, discuss them with your doctor to ensure safe use.
- Avoid applying this medication to cuts, scrapes, or damaged skin.
- Use this medication only for the duration prescribed by your doctor.
In case of accidental ingestion, seek immediate medical attention by calling a doctor or poison control center, as this medication can be harmful if swallowed.
Additionally, be aware that this medication may increase the risk of developing cataracts or glaucoma; discuss this potential risk with your doctor.
This medication may not be suitable for children of all ages, so it is crucial to consult with your doctor before administering it to a child. When used in children, this medication requires careful monitoring due to a potentially higher risk of side effects. In some cases, it may affect growth in children and teenagers, necessitating regular growth checks; your doctor will advise on the necessary precautions.
If you are breastfeeding, avoid applying this medication directly on the nipple or the surrounding area.
It is also important to inform your doctor if you are pregnant, planning to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.
To minimize risks, be aware of the following precautions:
- This medication is flammable, so avoid using it near open flames or while smoking.
- Do not apply this medication to treat diaper rash.
- It is not intended for treating acne, rosacea, or rashes around the mouth.
- Exercise caution when applying this medication to large areas of skin or near open wounds; consult your doctor for guidance.
- Before using other skin products or medications, including soaps, discuss them with your doctor to ensure safe use.
- Avoid applying this medication to cuts, scrapes, or damaged skin.
- Use this medication only for the duration prescribed by your doctor.
In case of accidental ingestion, seek immediate medical attention by calling a doctor or poison control center, as this medication can be harmful if swallowed.
Additionally, be aware that this medication may increase the risk of developing cataracts or glaucoma; discuss this potential risk with your doctor.
This medication may not be suitable for children of all ages, so it is crucial to consult with your doctor before administering it to a child. When used in children, this medication requires careful monitoring due to a potentially higher risk of side effects. In some cases, it may affect growth in children and teenagers, necessitating regular growth checks; your doctor will advise on the necessary precautions.
If you are breastfeeding, avoid applying this medication directly on the nipple or the surrounding area.
It is also important to inform your doctor if you are pregnant, planning to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic effects due to absorption, including suppression of the hypothalamic-pituitary-adrenal (HPA) axis, Cushing's syndrome, hyperglycemia, and glucosuria. Symptoms may include: fatigue, weakness, nausea, vomiting, low blood pressure, weight gain (especially in the face and trunk), muscle weakness, and increased blood sugar.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call a Poison Control Center (1-800-222-1222) or seek immediate medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition (affected area)
Rationale: To assess severity of dermatosis and establish a baseline for treatment efficacy and adverse effects.
Timing: Prior to initiation of therapy.
Routine Monitoring
Local skin reactions (e.g., atrophy, striae, telangiectasias, burning, itching, irritation)
Frequency: Regularly during treatment, especially if prolonged or occlusive.
Target: Absence or minimal severity of reactions.
Action Threshold: If severe or persistent reactions occur, discontinue use and reassess.
Signs of HPA axis suppression (e.g., fatigue, weakness, nausea, vomiting, hypotension)
Frequency: Consider if used extensively, on large surface areas, under occlusion, or in pediatric patients.
Target: Normal adrenal function.
Action Threshold: If suspected, perform ACTH stimulation test or plasma cortisol levels. Discontinue or gradually withdraw if suppression is confirmed.
Signs of infection (e.g., worsening redness, pus, fever)
Frequency: Regularly during treatment.
Target: Absence of infection.
Action Threshold: If infection develops, discontinue clobetasol and initiate appropriate antimicrobial therapy.
Symptom Monitoring
- Burning
- Stinging
- 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 Cushing's syndrome (e.g., moon face, buffalo hump, central obesity)
- Hyperglycemia
- Glucosuria
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 corticosteroids. Systemic absorption is minimal, but caution is advised.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity observed in animal studies with high systemic doses of corticosteroids. Risk with topical clobetasol is considered low due to minimal absorption.
Second Trimester:
Risk considered low due to minimal systemic absorption.
Third Trimester:
Risk considered low due to minimal systemic absorption. Avoid large areas or prolonged use near term.
Lactation
Use with caution. It is not known whether topical clobetasol is excreted in human milk. Systemic absorption is minimal, so infant exposure is expected to be low. Avoid applying to the breast area to prevent direct infant ingestion.
Infant Risk:
Low risk of adverse effects to breastfed infant due to minimal maternal systemic absorption and likely low excretion into breast milk. Monitor infant for any unusual effects.
Pediatric Use
Children are more susceptible to systemic toxicity (e.g., HPA axis suppression, Cushing's syndrome) from topical corticosteroids due to a larger skin surface area to body mass ratio and immature skin barrier. Use in children under 12 years is not recommended. If used in adolescents, limit duration and amount.
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 or purpura, requiring careful monitoring.
Clinical Information
Clinical Pearls
- Olux-E is a high-potency topical corticosteroid; limit treatment duration to 2 weeks to minimize risk of HPA axis suppression and local skin atrophy.
- The foam formulation is often preferred for hairy areas or large surface areas due to ease of application and rapid absorption.
- Instruct patients to apply the foam to a cool surface (e.g., a saucer) before applying to the skin, as it melts quickly on warm hands.
- Avoid use on the face, groin, or axillae unless specifically directed by a dermatologist, due to increased risk of local side effects (e.g., atrophy, telangiectasias, perioral dermatitis).
- Patients should be advised not to use more than 50 grams per week to prevent systemic absorption and side effects.
Alternative Therapies
- Other high-potency topical corticosteroids (e.g., betamethasone dipropionate, halobetasol propionate)
- Medium-potency topical corticosteroids (e.g., triamcinolone acetonide, fluocinolone acetonide)
- Low-potency topical corticosteroids (e.g., hydrocortisone)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for atopic dermatitis
- Vitamin D analogs (e.g., calcipotriene) for psoriasis
- Topical retinoids (e.g., tazarotene) for psoriasis
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe cases.
Cost & Coverage
Average Cost:
Varies widely, typically $200 - $800+ per 50gm foam
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 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 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.