Clobetasol 0.05% Emollntfoam 50gm
It is used to treat skin rashes and other skin irritation.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
Category C
FDA Approved
Jun 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobetasol is a very strong medicine applied to the skin to reduce redness, swelling, and itching caused by certain skin conditions like psoriasis or eczema. It's a type of steroid, but it works on the skin, not like the steroids athletes use. It comes as a foam that you apply directly to the affected areas.
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 dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Do not apply the 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 dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Do not apply the 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 into the cap or 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 use more than directed or for longer than prescribed (typically 2 weeks).
- Do not use on the face, groin, or armpits unless specifically instructed by your doctor.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not bandage or cover the treated area unless directed by your doctor, as this can increase absorption.
- Keep away from open flames or heat, as the foam is flammable.
- Do not puncture or incinerate the can.
Available Forms & Alternatives
Available Strengths:
- Clobetasol Prop 0.05% Cream 60gm
- Clobetasol Prop 0.05% Oint 60gm
- Clobetasol Prop 0.05% Sol 50ml
- Clobetasol Prop 0.05% Cream 45gm
- Clobetasol Prop 0.05% Oint 30gm
- Clobetasol Prop 0.05% Oint 45gm
- Clobetasol Prop 0.05% Oint 15gm
- Clobetasol Prop 0.05% Cream 30gm
- Clobetasol Prop 0.05% Cream 15gm
- Clobetasol Prop 0.05% Sol 25ml
- Clobetasol Prop 0.05% Gel 30gm
- Clobetasol Prop 0.05% Gel 15gm
- Clobetasol Prop 0.05% Gel 60gm
- Clobetasol Prop 0.05% Gel 60gm
- Clobetasol 0.05% Emollient Crm 15gm
- Clobetasol 0.05% Emollient Crm 30gm
- Clobetasol 0.05% Emollient Crm 60gm
- Clobetasol Prop 0.05% Gel 15gm
- Clobetasol Prop 0.05% Gel 30gm
- Clobetasol Prop 0.05% Lotion 59ml
- Clobetasol Prop 0.05% Lotion 118ml
- Clobetasol 0.05% Shampoo 118ml
- Clobetasol 0.05% Emollntfoam 50gm
- Clobetasol 0.05% Emollnt Foam 100gm
- Clobetasol 0.05% Spray 59ml
- Clobetasol 0.05% Spray 125ml
- Clobetasol 0.05% Foam 50gm
- Clobetasol 0.05% Foam 100gm
- Clobetasol 0.05% Spray 59ml
- Clobetasol 0.05% Spray 125ml
- Clobetasol 0.05% Emollnt Foam 50gm
- Clobetasol 0.05% Shampoo 118ml
- Clobetasol Prop 0.05% Sol50ml
- Clobetasol Prop 0.05% Sol25ml
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to affected skin areas once daily.
Condition-Specific Dosing:
Plaque Psoriasis:
Apply to affected areas once daily for up to 2 weeks. Do not exceed 50g per week.
Atopic Dermatitis:
Apply to affected areas once daily for up to 2 weeks. Do not exceed 50g per week.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 12 years due to increased risk of systemic absorption and HPA axis suppression. If used, limit duration and monitor closely.
Adolescent:
For adolescents 12 years and older, use as per adult dosing, but limit duration and monitor for systemic effects.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended for topical use.
Moderate:
No specific adjustment recommended for topical use.
Severe:
No specific adjustment recommended for topical use.
Dialysis:
No specific adjustment recommended for topical use, as systemic absorption is minimal.
Hepatic Impairment:
Mild:
No specific adjustment recommended for topical use.
Moderate:
No specific adjustment recommended for topical use.
Severe:
No specific adjustment recommended for topical use.
Pharmacology
Mechanism of Action
Clobetasol propionate is a high-potency topical corticosteroid. It exerts its anti-inflammatory, antipruritic, and vasoconstrictive actions 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:
Varies; systemic absorption can occur, especially with prolonged use, large surface areas, occlusive dressings, or compromised skin barrier. Up to 5% reported in some studies.
Tmax:
Not precisely defined for topical application due to variable absorption; systemic levels peak hours after application.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not precisely quantified for topical use; distributes widely if absorbed systemically.
ProteinBinding:
Approximately 90% (for corticosteroids generally) when absorbed systemically.
CnssPenetration:
Limited, but can occur with significant systemic absorption.
Elimination:
HalfLife:
Systemic half-life is approximately 3-4 hours, but topical effects persist longer.
Clearance:
Not precisely quantified for topical use.
ExcretionRoute:
Primarily renal excretion of metabolites, with some biliary excretion.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Within hours to days for anti-inflammatory effects.
PeakEffect:
Within 1-2 weeks of consistent application.
DurationOfAction:
Effects persist for several hours after application; typically applied once daily.
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 symptoms, contact your doctor or seek medical help right away:
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. Many people may not experience any side effects or may only have 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 a comprehensive list of all 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 symptoms, contact your doctor or seek medical help right away:
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. Many people may not experience any side effects or may only have 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 a comprehensive list of all 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 allergy or infection).
- Signs of skin thinning: easy bruising, shiny skin, stretch marks (striae), spider veins (telangiectasias).
- Signs of skin infection: pus, worsening pain, fever.
- Signs of systemic absorption (rare but serious): unexplained weight gain, swelling in face/neck (moon face), muscle weakness, fatigue, vision changes (blurred vision, glaucoma, cataracts).
- Worsening of skin condition after stopping the medication (rebound effect).
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 existing health problems you have. Your doctor will help you determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dose 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 and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Additionally, share any existing health problems you have. Your doctor will help you determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dose 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 minimize risks, be aware that this drug is flammable and should not be used near an open flame or while smoking.
This medication is not intended to treat diaper rash, acne, rosacea, or rashes around the mouth. When applying it to a large skin area or near open wounds, exercise caution and consult your doctor.
Before using other skincare products or drugs, including soaps, discuss them with your doctor to ensure safe use. Avoid applying this medication to cuts, scrapes, or damaged skin.
Do not exceed the prescribed duration of use, as directed by your doctor. If this drug is accidentally swallowed, immediately contact a doctor or a poison control center, as it may cause harm.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult your doctor about potential risks.
This drug 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, as the risk of certain side effects may be higher. In some cases, it may affect growth in children and teenagers, necessitating regular growth checks; discuss this with your doctor.
If you are breastfeeding, avoid applying this drug directly on the nipple or the surrounding area.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
To minimize risks, be aware that this drug is flammable and should not be used near an open flame or while smoking.
This medication is not intended to treat diaper rash, acne, rosacea, or rashes around the mouth. When applying it to a large skin area or near open wounds, exercise caution and consult your doctor.
Before using other skincare products or drugs, including soaps, discuss them with your doctor to ensure safe use. Avoid applying this medication to cuts, scrapes, or damaged skin.
Do not exceed the prescribed duration of use, as directed by your doctor. If this drug is accidentally swallowed, immediately contact a doctor or a poison control center, as it may cause harm.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult your doctor about potential risks.
This drug 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, as the risk of certain side effects may be higher. In some cases, it may affect growth in children and teenagers, necessitating regular growth checks; discuss this with your doctor.
If you are breastfeeding, avoid applying this drug directly on the nipple or the surrounding area.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic corticosteroid effects, including Cushing's syndrome (moon face, buffalo hump, central obesity, skin thinning), hyperglycemia, glucosuria, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 for poison control advice.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition and extent of affected area
Rationale: To assess baseline severity and guide treatment duration.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (reduction in inflammation, pruritus)
Frequency: Weekly during treatment period, then as needed.
Target: Significant improvement in symptoms.
Action Threshold: If no improvement after 2 weeks, re-evaluate diagnosis and treatment.
Local adverse reactions (e.g., skin atrophy, striae, telangiectasias, folliculitis)
Frequency: Weekly during treatment period, then as needed.
Target: Absence of or minimal adverse effects.
Action Threshold: Discontinue if severe local reactions occur; consider lower potency or alternative therapy.
Signs of HPA axis suppression (e.g., fatigue, weakness, weight loss)
Frequency: Periodically, especially with prolonged use, large surface areas, or in children.
Target: Normal HPA axis function.
Action Threshold: If suspected, perform ACTH stimulation test or plasma cortisol levels. Taper drug if suppression confirmed.
Symptom Monitoring
- Burning, itching, irritation, dryness at application site
- Folliculitis, hypertrichosis, acneiform eruptions
- Hypopigmentation, perioral dermatitis, allergic contact dermatitis
- Skin atrophy, striae, miliaria, secondary infection
- Signs of systemic absorption: Cushing's syndrome, hyperglycemia, glucosuria (rare)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. High-potency topical corticosteroids should be used with caution, for the shortest duration, and on the smallest possible area.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though data for topical corticosteroids are limited and generally low risk.
Second Trimester:
Risk of HPA axis suppression in the mother and potential for fetal growth restriction with extensive use.
Third Trimester:
Risk of HPA axis suppression in the mother and potential for fetal growth restriction with extensive use; neonatal adrenal insufficiency possible if mother used extensively near term.
Lactation
L3 (Moderately Safe). Clobetasol is excreted in breast milk. Use with caution. Avoid applying to the breast area to prevent infant ingestion. Use the lowest effective dose for the shortest duration.
Infant Risk:
Low risk with limited topical use. Potential for systemic effects in infant if significant maternal absorption and excretion into milk occurs, or if applied to breast and ingested.
Pediatric Use
Children are more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio and immature skin barrier. Use in children under 12 years is generally not recommended. If used, limit to the smallest amount for the shortest duration, and monitor closely for HPA axis suppression and growth retardation.
Geriatric Use
No specific dose adjustments are necessary. However, elderly patients may have thinner skin and be more prone to local adverse effects like skin atrophy and purpura. Monitor closely for skin integrity and adverse reactions.
Clinical Information
Clinical Pearls
- Clobetasol propionate is a super high-potency topical corticosteroid; use it sparingly and for short durations (typically no more than 2 consecutive weeks).
- The foam formulation is often preferred for hairy areas or large surface areas due to its ease of application and rapid absorption.
- Patients should be educated on the proper application technique to avoid systemic absorption and local side effects.
- Avoid abrupt discontinuation after prolonged use on large areas, as this can lead to rebound flares of the underlying skin condition.
- Always consider the total weekly dose (e.g., 50g per week) to minimize the risk of HPA axis suppression.
Alternative Therapies
- Other topical corticosteroids (e.g., betamethasone, fluocinonide, triamcinolone, hydrocortisone - varying potencies)
- Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for atopic dermatitis
- Vitamin D analogs (e.g., calcipotriene) for psoriasis
- Retinoids (e.g., tazarotene) for psoriasis
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe cases
Cost & Coverage
Average Cost:
$150 - $400 per 50gm foam
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (may require prior authorization for brand, generic often preferred)
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.