Clobetasol 0.05% Emollient Crm 15gm
It is used to treat skin rashes and other skin irritation.It is used to treat plaque psoriasis.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Aug 1985
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobetasol is a very strong steroid cream used on the skin to reduce severe redness, itching, and swelling caused by certain skin conditions like eczema or psoriasis. 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 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 completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Avoid applying the medication to your face, underarms, or groin area unless your doctor instructs you to do so.
Do not cover the treated area with bandages, dressings, or makeup unless your doctor advises you to do so.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration or freezing.
Be aware of the medication's expiration date and discard it when it is no longer usable.
Keep all medications in a safe and secure location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
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 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 completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Avoid applying the medication to your face, underarms, or groin area unless your doctor instructs you to do so.
Do not cover the treated area with bandages, dressings, or makeup unless your doctor advises you to do so.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration or freezing.
Be aware of the medication's expiration date and discard it when it is no longer usable.
Keep all medications in a safe and secure location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
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
- Apply a very thin layer of the cream only to the affected skin areas, as directed by your doctor.
- Wash your hands before and after applying the cream.
- Do not use more cream than prescribed, or for longer than 2 consecutive weeks, unless specifically instructed by your doctor, to avoid serious side effects.
- Do not use on the face, groin, or armpits unless your doctor specifically tells you to, as these areas are more sensitive to side effects.
- Do not cover the treated area with bandages, plastic wrap, or tight clothing unless your doctor tells you to, as this can increase absorption and side effects.
- 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
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 twice daily for up to 2 consecutive weeks. Total dosage should not exceed 50 g per week.
Condition-Specific Dosing:
psoriasis:
Apply twice daily for up to 2 consecutive weeks. Max 50g/week.
eczema:
Apply twice daily for up to 2 consecutive weeks. Max 50g/week.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 12 years for prolonged use (more than 5 days) due to increased risk of systemic absorption and HPA axis suppression. If used, limit to shortest duration possible.
Adolescent:
For adolescents 12 years and older, use similar to adult dosing but with extreme caution and limited duration due to higher surface area to body weight ratio.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical use, but monitor for systemic effects with extensive or prolonged use.
Moderate:
No specific adjustment needed for topical use, but monitor for systemic effects with extensive or prolonged use.
Severe:
No specific adjustment needed for topical use, but monitor for systemic effects with extensive or prolonged use.
Dialysis:
Considerations: Minimal systemic absorption typically, so dialysis is not a primary consideration for topical use. Monitor for systemic effects if extensive use.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical use, but monitor for systemic effects with extensive or prolonged use.
Moderate:
No specific adjustment needed for topical use, but monitor for systemic effects with extensive or prolonged use.
Severe:
No specific adjustment needed for topical use, but monitor for systemic effects with extensive or prolonged use.
Pharmacology
Mechanism of Action
Clobetasol propionate is a super-high potency corticosteroid. It induces 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. Thus, clobetasol exerts anti-inflammatory, antipruritic, and vasoconstrictive actions.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (depends on skin integrity, vehicle, site, occlusive dressings)
Tmax:
Not precisely defined for topical absorption, systemic levels peak variably.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not precisely quantified for topical absorption, but if absorbed, distributed throughout the body.
ProteinBinding:
Not precisely quantified for topical absorption, but generally high for corticosteroids.
CnssPenetration:
Limited (systemic absorption is generally low for topical use)
Elimination:
HalfLife:
Not precisely defined for topical absorption, but generally short for systemic corticosteroids (hours).
Clearance:
Not precisely defined for topical absorption.
ExcretionRoute:
Renal (metabolites), Biliary (minor)
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within hours for anti-inflammatory and antipruritic effects.
PeakEffect:
Within days of consistent application.
DurationOfAction:
Effects persist for several hours after application.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following signs or symptoms, contact your doctor or seek medical attention immediately:
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
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 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. While many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
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 signs or symptoms, contact your doctor or seek medical attention immediately:
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
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 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. While many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
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:
- Increased redness, swelling, or pus at the application site (signs of infection)
- Severe burning, stinging, or irritation where the cream is applied
- Skin thinning, easy bruising, or stretch marks (striae) developing on the treated skin
- Acne or increased hair growth in the treated area
- Any signs of systemic steroid absorption, such as unexplained weight gain, swelling in the face or body, increased thirst or urination, fatigue, or mood changes (these are rare but serious)
- Worsening of your skin condition or no improvement after 1-2 weeks of use
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
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 in conjunction with your other treatments and health issues.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
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 in conjunction with your other treatments and health issues.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
This medication is not intended to treat diaper rash. Additionally, it should not be used 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 with your doctor.
Before using any other medications or products on your skin, including soaps, discuss them with your doctor. Avoid applying this medication to cuts, scrapes, or damaged skin. Do not use this medication for an extended period beyond what your doctor has prescribed.
If this medication is accidentally swallowed, it can be harmful. In such cases, immediately contact a doctor or a poison control center. Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult with your doctor.
This medication may not be suitable for children of all ages. Before administering it to a child, consult with your doctor. When using this medication in children, exercise caution, as the risk of certain side effects may be higher. In some cases, this medication can affect growth in children and teenagers, necessitating regular growth checks; discuss this with your doctor.
If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area. If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication to you and your baby.
This medication is not intended to treat diaper rash. Additionally, it should not be used 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 with your doctor.
Before using any other medications or products on your skin, including soaps, discuss them with your doctor. Avoid applying this medication to cuts, scrapes, or damaged skin. Do not use this medication for an extended period beyond what your doctor has prescribed.
If this medication is accidentally swallowed, it can be harmful. In such cases, immediately contact a doctor or a poison control center. Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult with your doctor.
This medication may not be suitable for children of all ages. Before administering it to a child, consult with your doctor. When using this medication in children, exercise caution, as the risk of certain side effects may be higher. In some cases, this medication can affect growth in children and teenagers, necessitating regular growth checks; discuss this with your doctor.
If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area. If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Systemic absorption leading to signs of hypercorticism (Cushing's syndrome), such as moon face, buffalo hump, central obesity, skin thinning, easy bruising, striae, muscle weakness, hypertension, hyperglycemia.
- Adrenal insufficiency (HPA axis suppression) upon withdrawal, leading to fatigue, weakness, nausea, vomiting, low blood pressure.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. If HPA axis suppression is severe, systemic corticosteroid replacement may be necessary. 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 any pre-existing skin infections or contraindications.
Timing: Prior to initiation of therapy.
HPA axis function (e.g., plasma cortisol, ACTH stimulation test)
Rationale: Consider for patients at high risk of systemic absorption (e.g., extensive body surface area treated, prolonged use, pediatric patients, occlusive dressings) to assess baseline adrenal function.
Timing: Prior to initiation of therapy if high risk.
Routine Monitoring
Efficacy (reduction in inflammation, pruritus, erythema)
Frequency: Daily to weekly
Target: Improvement in symptoms
Action Threshold: Lack of improvement or worsening symptoms after 1-2 weeks may indicate need for re-evaluation or alternative therapy.
Local skin adverse effects (e.g., atrophy, striae, telangiectasias, folliculitis, burning, stinging, irritation, signs of infection)
Frequency: Daily to weekly
Target: Absence of new or worsening adverse effects
Action Threshold: Presence of significant local adverse effects warrants discontinuation or reduction in frequency/potency.
Signs of systemic absorption (e.g., weight gain, moon face, fatigue, hyperglycemia, hypertension, growth retardation in children)
Frequency: Periodically, especially with prolonged or extensive use
Target: Absence of systemic symptoms
Action Threshold: Presence of systemic symptoms warrants immediate discontinuation and medical evaluation for HPA axis suppression or Cushing's syndrome.
HPA axis function (e.g., plasma cortisol, ACTH stimulation test)
Frequency: Periodically (e.g., after 2 weeks of continuous use, or if systemic symptoms appear) for high-risk patients.
Target: Normal adrenal function
Action Threshold: Evidence of HPA axis suppression requires gradual withdrawal of the drug and/or initiation of systemic corticosteroid replacement therapy.
Symptom Monitoring
- Worsening of skin condition
- Signs of skin infection (increased redness, warmth, swelling, pus, fever)
- Severe burning, stinging, or itching at application site
- Skin thinning, easy bruising, stretch marks (striae)
- Acne or increased hair growth (hirsutism)
- Changes in body fat distribution (e.g., moon face, buffalo hump)
- Unexplained weight gain or swelling
- Increased thirst or urination
- Fatigue, weakness, or mood changes
Special Patient Groups
Pregnancy
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. High potency topical corticosteroids should generally be avoided or used with extreme caution and for the shortest possible duration during pregnancy.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity with high doses of systemic corticosteroids; topical absorption is generally low but caution is advised.
Second Trimester:
Risk of fetal growth restriction or other adverse effects with prolonged or high-dose systemic exposure; topical absorption is generally low but caution is advised.
Third Trimester:
Risk of HPA axis suppression in the neonate if used extensively or for prolonged periods near term.
Lactation
L3 (Moderately Safe). Clobetasol is excreted in breast milk following systemic administration. It is unknown whether topical application results in sufficient systemic absorption to produce detectable quantities in breast milk. Use with caution. Avoid applying to the breast area to prevent direct infant exposure.
Infant Risk:
Low risk of adverse effects to the infant with appropriate topical use, but monitor for potential systemic effects in the infant if mother uses extensively.
Pediatric Use
Children are more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, growth retardation) from topical corticosteroids due to a larger skin surface area to body weight ratio. Not recommended for children under 12 years for prolonged use (more than 5 days). If used, limit to the smallest amount and shortest duration possible under strict medical supervision.
Geriatric Use
No specific dose adjustments are required. However, elderly patients may have thinner skin and be more prone to local adverse effects such as skin atrophy, purpura, and telangiectasias. Monitor closely for these effects.
Clinical Information
Clinical Pearls
- Clobetasol is a super-high potency topical corticosteroid; it should be used judiciously and for short durations.
- The maximum recommended duration of treatment is 2 consecutive weeks for adults, and the total dosage should not exceed 50 grams per week.
- Avoid use on the face, groin, or axillae unless specifically directed by a dermatologist, due to increased risk of skin atrophy, telangiectasias, and other adverse effects in these sensitive areas.
- Occlusive dressings significantly increase systemic absorption and should be avoided unless specifically instructed by a physician.
- Patients should be advised to report any signs of local irritation, infection, or systemic side effects immediately.
- Abrupt discontinuation after prolonged or extensive use can lead to rebound flares of the underlying skin condition or symptoms of adrenal insufficiency.
Alternative Therapies
- Medium to low potency topical corticosteroids (for less severe conditions or maintenance)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for sensitive areas or long-term use
- Vitamin D analogs (e.g., calcipotriene) for psoriasis
- Topical retinoids
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread, or refractory dermatoses
Cost & Coverage
Average Cost:
$20 - $100 per 15gm tube (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic formulations)
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 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.