Clobetasol 0.05% Emollient Crm 30gm
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 1983
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobetasol is a very strong steroid cream used to treat severe skin conditions like eczema and psoriasis. It works by reducing redness, swelling, and itching. It's important to use it exactly as prescribed, usually for a short time, because it's very potent.
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. It is essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, do not wash your hand 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.
Unless instructed by your doctor, do not apply the medication to your face, underarms, or groin area.
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 or the length of time you can store it before disposal.
Keep all medications in a safe place, out of the reach of children and pets.
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 take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, do not wash your hand 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.
Unless instructed by your doctor, do not apply the medication to your face, underarms, or groin area.
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 or the length of time you can store it before disposal.
Keep all medications in a safe place, out of the reach of children and pets.
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 take extra doses.
Lifestyle & Tips
- Wash your hands before and after applying the cream.
- Apply a very thin layer only to the affected skin areas. Do not use more than prescribed.
- Do not apply to the face, groin, or armpits unless specifically directed by your doctor, as these areas are more susceptible to side effects.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not cover the treated area with bandages or occlusive dressings unless instructed 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 use more than 50 grams per week.
- Keep out of reach of children.
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 the affected skin areas once or twice daily. Treatment should be limited to 2 consecutive weeks, and the total dosage should not exceed 50 g per week.
Condition-Specific Dosing:
psoriasis:
Apply a thin layer to the affected skin areas once or twice daily for up to 2 consecutive weeks. Re-evaluate if no improvement.
eczema:
Apply a thin layer to the affected skin areas once or twice daily for up to 2 consecutive weeks. Re-evaluate if no improvement.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 12 years of age due to increased risk of systemic absorption and HPA axis suppression. If used, limit to shortest duration and smallest amount possible.
Adolescent:
For adolescents 12 years and older, use with caution and limit treatment to 2 consecutive weeks, similar to adult dosing, but monitor closely for systemic effects.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical use.
Moderate:
No specific adjustment needed for topical use.
Severe:
No specific adjustment needed for topical use.
Dialysis:
No specific considerations for topical use.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical use.
Moderate:
No specific adjustment needed for topical use.
Severe:
No specific adjustment needed for topical use.
Pharmacology
Mechanism of Action
Clobetasol propionate is a highly potent 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, which 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 significantly; systemic absorption can occur, especially with prolonged use, large surface areas, occlusive dressings, or compromised skin barrier. Up to 5% of applied dose can be absorbed.
Tmax:
Not well-defined for topical application; systemic effects can manifest over days to weeks.
FoodEffect:
Not applicable
Distribution:
Vd:
Not typically quantified for topical application; if absorbed systemically, distributes widely.
ProteinBinding:
High (approximately 90%) if absorbed systemically.
CnssPenetration:
Limited, but possible with significant systemic absorption.
Elimination:
HalfLife:
Not well-defined for topical application; systemic half-life of absorbed clobetasol is approximately 3-5 hours.
Clearance:
Not typically quantified for topical application.
ExcretionRoute:
Renal (primarily as metabolites), some biliary.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief (e.g., reduction in pruritus, erythema).
PeakEffect:
Days to 1-2 weeks of continuous application.
DurationOfAction:
Effects persist for a period after discontinuation, but rebound flare can occur.
Safety & Warnings
Side Effects
Urgent 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. 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 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. 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:
- Worsening of skin condition or new skin irritation (e.g., burning, stinging, redness)
- Signs of skin infection (pus, fever, increased pain or swelling)
- Skin thinning, easy bruising, or stretch marks appearing on the treated area
- Unusual hair growth on the treated area
- Acne-like breakouts
- Signs of systemic absorption, especially in children: unusual weight gain, swelling in the face, fatigue, weakness, increased thirst or urination.
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 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, 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 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.
Important Usage Precautions:
- This medication is not intended to treat diaper rash.
- Do not use 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 with your doctor.
Before Using Other Skin Products:
- Consult with your doctor before using any other drugs or products on your skin, including soaps.
Application Guidelines:
- Avoid applying this medication to cuts, scrapes, or damaged skin.
- Do not use this medication for a longer duration than prescribed by your doctor.
Safety Precautions:
- If this medication is swallowed, it may cause harm. In such cases, immediately contact a doctor or a poison control center.
- This medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.
Pediatric Use:
- This medication may not be suitable for children of all ages. Consult with your doctor before administering this medication to a child.
- When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population.
- In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Discuss this potential risk with your doctor.
Breast-Feeding Precautions:
- If you are breast-feeding, avoid applying this medication directly to the nipple or the surrounding area.
Pregnancy and Breast-Feeding Considerations:
- If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor. It is crucial to discuss the benefits and risks of using this medication to ensure the best possible outcome for you and your baby.
Important Usage Precautions:
- This medication is not intended to treat diaper rash.
- Do not use 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 with your doctor.
Before Using Other Skin Products:
- Consult with your doctor before using any other drugs or products on your skin, including soaps.
Application Guidelines:
- Avoid applying this medication to cuts, scrapes, or damaged skin.
- Do not use this medication for a longer duration than prescribed by your doctor.
Safety Precautions:
- If this medication is swallowed, it may cause harm. In such cases, immediately contact a doctor or a poison control center.
- This medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.
Pediatric Use:
- This medication may not be suitable for children of all ages. Consult with your doctor before administering this medication to a child.
- When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population.
- In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Discuss this potential risk with your doctor.
Breast-Feeding Precautions:
- If you are breast-feeding, avoid applying this medication directly to the nipple or the surrounding area.
Pregnancy and Breast-Feeding Considerations:
- If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor. It is crucial to discuss the benefits and risks of using this medication to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic effects due to absorption, including: Adrenal suppression (fatigue, weakness, nausea, vomiting, low blood pressure), Cushing's syndrome (moon face, central obesity, thin skin, striae, hypertension, hyperglycemia), growth retardation in children.
What to Do:
Discontinue use gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention if severe symptoms occur.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis (e.g., erythema, scaling, lichenification) and identify any pre-existing skin atrophy or infection.
Timing: Prior to initiation of therapy.
Extent of body surface area (BSA) involved
Rationale: To guide appropriate amount of medication and assess risk of systemic absorption.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (reduction in symptoms/lesions)
Frequency: Weekly during treatment period (up to 2 weeks).
Target: Significant improvement in erythema, pruritus, and lesion morphology.
Action Threshold: If no improvement after 2 weeks, re-evaluate diagnosis and treatment plan; discontinue if condition resolves.
Local skin adverse effects (e.g., atrophy, striae, telangiectasias, burning, itching, folliculitis, infection)
Frequency: Weekly during treatment period and at follow-up.
Target: Absence of new or worsening local adverse effects.
Action Threshold: If severe local reactions occur, discontinue use. If signs of infection, treat appropriately.
Signs of HPA axis suppression (e.g., fatigue, weakness, weight loss, hypotension)
Frequency: Consider if large areas, prolonged use, or occlusive dressings are employed, especially in children.
Target: Normal adrenal function.
Action Threshold: If suspected, perform ACTH stimulation test or morning cortisol levels. Discontinue or taper if suppression confirmed.
Signs of Cushing's syndrome (e.g., moon face, central obesity, striae, hypertension, hyperglycemia)
Frequency: Consider if large areas, prolonged use, or occlusive dressings are employed, especially in children.
Target: Absence of signs.
Action Threshold: If suspected, discontinue or taper.
Symptom Monitoring
- Increased skin redness or irritation at application site
- Burning or stinging sensation
- Skin thinning or bruising (atrophy)
- Appearance of stretch marks (striae)
- Visible small blood vessels (telangiectasias)
- Acne-like eruptions or folliculitis
- Signs of skin infection (pus, worsening pain, fever)
- Unusual fatigue or weakness
- Weight gain or swelling (especially in face/trunk)
- Increased thirst or urination (signs of hyperglycemia)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid large areas, prolonged use, or occlusive dressings.
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:
Similar considerations as first trimester; monitor for fetal growth restriction with extensive use.
Third Trimester:
Similar considerations; risk of HPA axis suppression in the neonate with extensive maternal use near term.
Lactation
Use with caution. It is not known whether topical clobetasol is excreted in human milk. Systemic corticosteroids are excreted in human milk. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with limited, short-term use on small areas. Potential for infant exposure and adverse effects (e.g., growth suppression, HPA axis suppression) with extensive maternal use.
Pediatric Use
Not recommended for children under 12 years of age. Children are more susceptible to systemic adverse effects (HPA axis suppression, Cushing's syndrome, growth retardation) due to a larger skin surface area to body weight ratio and immature skin barrier. If use is unavoidable, limit to the smallest amount and shortest duration possible, and monitor closely.
Geriatric Use
No specific dosage adjustments are required. However, elderly patients may have thinner skin and be more prone to local adverse effects (e.g., atrophy, purpura). Monitor closely for skin integrity and systemic effects.
Clinical Information
Clinical Pearls
- Clobetasol is one of the most potent topical corticosteroids (Class I). It should be reserved for severe, recalcitrant dermatoses.
- Due to its high potency, treatment duration should generally not exceed 2 consecutive weeks to minimize the risk of local and systemic side effects, especially HPA axis suppression.
- Avoid use on the face, groin, axillae, or under occlusion unless specifically directed by a dermatologist, as these areas are more prone to atrophy, striae, and systemic absorption.
- Patients should be educated on the 'less is more' principle: apply a very thin layer, just enough to cover the affected area.
- Rebound flares of the underlying skin condition can occur upon abrupt discontinuation, especially after prolonged use. Tapering may be considered for long-term users under medical supervision.
- Emollient cream formulation is generally preferred for dry, scaly lesions, while gel or foam may be better for hairy areas or weeping lesions.
Alternative Therapies
- Other topical corticosteroids (e.g., betamethasone dipropionate, fluocinonide for high potency; triamcinolone acetonide for medium potency; hydrocortisone for low potency)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for sensitive areas or long-term maintenance, especially in 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, widespread disease not responsive to topical agents.
Cost & Coverage
Average Cost:
$20 - $80 per 30gm tube of generic clobetasol propionate 0.05% cream/ointment
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 for generic formulations; higher tiers for brand-name products.
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. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.