Clobetasol Prop 0.05% Cream 45gm
It is used to treat skin rashes and other skin irritation.It is used to treat plaque psoriasis.
Drug Class
Corticosteroid, Topical
Pharmacologic Class
Adrenocorticoid
Pregnancy Category
Category C
FDA Approved
Aug 1980
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobetasol propionate is a very strong steroid cream used on the skin to treat severe itching, redness, and swelling caused by certain skin conditions like eczema or psoriasis. It works by reducing inflammation. It's important to use it exactly as prescribed 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's essential to use this medication as directed, 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 application, unless your hand is the treated area, in which case you should not wash it after use.
Clean the affected area before applying the medication and dry it thoroughly.
Gently rub a thin layer of the medication onto the affected skin.
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 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's 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. It's essential to use this medication as directed, 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 application, unless your hand is the treated area, in which case you should not wash it after use.
Clean the affected area before applying the medication and dry it thoroughly.
Gently rub a thin layer of the medication onto the affected skin.
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 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's 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 cream.
- Apply a very thin layer only to the affected skin areas.
- Do not use more than the prescribed amount or for longer than prescribed (usually no more than 2 weeks continuously).
- Do not use on the face, groin, or armpits unless specifically directed by a doctor.
- Avoid contact with eyes.
- Do not cover the treated area with bandages or occlusive dressings unless instructed by your doctor, as this can increase absorption.
- 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 twice daily for up to 2 consecutive weeks. Total dosage should not exceed 50 g per week.
Condition-Specific Dosing:
Psoriasis:
Apply a thin layer to affected areas twice daily for up to 2 consecutive weeks. Limit treatment to 50 g/week. If no response after 2 weeks, re-evaluate diagnosis.
Eczema:
Apply a thin layer to affected areas twice daily for up to 2 consecutive weeks. Limit treatment to 50 g/week. If no response after 2 weeks, re-evaluate diagnosis.
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.
Adolescent:
For adolescents 12 years and older, use with caution and for the shortest duration possible, similar to adult dosing but with strict monitoring for systemic effects.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical use, as systemic absorption is minimal.
Moderate:
No specific adjustment needed for topical use, as systemic absorption is minimal.
Severe:
No specific adjustment needed for topical use, as systemic absorption is minimal.
Dialysis:
No specific adjustment needed for topical use, as systemic absorption is minimal.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical use, as systemic absorption is minimal.
Moderate:
No specific adjustment needed for topical use, as systemic absorption is minimal.
Severe:
No specific adjustment needed for topical use, as systemic absorption is minimal.
Pharmacology
Mechanism of Action
Clobetasol propionate is a highly potent synthetic corticosteroid. It exerts its anti-inflammatory, antipruritic, and vasoconstrictive actions 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; systemic absorption can occur, especially with prolonged use, large surface areas, occlusive dressings, or impaired skin barrier. Percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Tmax:
Not precisely defined for topical application due to variable absorption; systemic effects can manifest over days to weeks of continuous use.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not precisely quantified for topical application; once absorbed, corticosteroids are bound to plasma proteins in varying degrees.
ProteinBinding:
Varies, generally high for corticosteroids.
CnssPenetration:
Limited, but systemic absorption can lead to CNS effects in rare cases of significant HPA axis suppression.
Elimination:
HalfLife:
Not precisely defined for topical application due to variable absorption and metabolism; systemic half-life of absorbed corticosteroids varies.
Clearance:
Not precisely quantified for topical application.
ExcretionRoute:
Primarily excreted by the kidneys, with some biliary excretion.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Within hours to days for anti-inflammatory and antipruritic effects.
PeakEffect:
Within days to 2 weeks of consistent application.
DurationOfAction:
Effects persist as long as applied; systemic effects (e.g., HPA axis suppression) can take weeks to months to resolve after discontinuation.
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 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 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 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 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 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:
- Increased redness, swelling, or pus at the application site (signs of infection)
- Severe burning, itching, or irritation where the cream is applied
- Skin thinning, easy bruising, or stretch marks developing
- Unusual weight gain, especially in the face or upper back (signs of Cushing's syndrome)
- Increased thirst or urination (signs of high blood sugar)
- Blurred vision or other eye problems (e.g., cataracts, glaucoma)
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, before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so.
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, before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so.
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, acne, rosacea, or rashes around the mouth. When applying it to a large area of skin or near open wounds, exercise caution and consult your doctor.
Before using any 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. Do not use this medication for a longer period than prescribed by your doctor.
If this medication is accidentally swallowed, seek immediate medical attention by calling a doctor or poison control center. Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult your doctor about potential risks.
This medication may not be suitable for children of all ages, so it is crucial to consult your doctor before administering it to a child. When using this medication in children, exercise caution, as they may be more susceptible to certain side effects. In some cases, this medication may affect growth in children and teenagers, requiring regular growth checks; discuss this with your doctor.
If you are breast-feeding, avoid applying this medication directly to the nipple or the surrounding area. If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
This medication is not intended to treat diaper rash, acne, rosacea, or rashes around the mouth. When applying it to a large area of skin or near open wounds, exercise caution and consult your doctor.
Before using any 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. Do not use this medication for a longer period than prescribed by your doctor.
If this medication is accidentally swallowed, seek immediate medical attention by calling a doctor or poison control center. Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult your doctor about potential risks.
This medication may not be suitable for children of all ages, so it is crucial to consult your doctor before administering it to a child. When using this medication in children, exercise caution, as they may be more susceptible to certain side effects. In some cases, this medication may affect growth in children and teenagers, requiring regular growth checks; discuss this with your doctor.
If you are breast-feeding, avoid applying this medication directly to the nipple or the surrounding area. If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Symptoms of Cushing's syndrome (e.g., moon face, central obesity, striae)
- Hyperglycemia (high blood sugar)
- Glucosuria (sugar in urine)
- Suppression of the hypothalamic-pituitary-adrenal (HPA) axis
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment should be initiated. 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 areas for application.
Timing: Prior to initiation of therapy.
Adrenal function (e.g., plasma cortisol, ACTH stimulation test)
Rationale: To assess for baseline HPA axis suppression, especially in patients at higher risk (e.g., extensive use, prolonged use, occlusive dressings, pediatric patients).
Timing: Consider before initiating prolonged or extensive therapy.
Routine Monitoring
Skin condition assessment
Frequency: Weekly or as clinically indicated
Target: Improvement in inflammation, pruritus, and lesion appearance.
Action Threshold: If no improvement after 2 weeks, re-evaluate diagnosis and treatment. If worsening, discontinue.
Signs of local adverse reactions (e.g., atrophy, striae, telangiectasias, folliculitis)
Frequency: At each follow-up visit
Target: Absence of new or worsening local side effects.
Action Threshold: If present, reduce frequency, discontinue, or switch to lower potency steroid.
Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, HPA axis suppression)
Frequency: Periodically, especially with prolonged or extensive use
Target: Absence of systemic signs/symptoms.
Action Threshold: If suspected, perform appropriate laboratory tests (e.g., plasma cortisol, glucose) and gradually withdraw medication.
Symptom Monitoring
- Worsening of skin condition
- New or worsening skin thinning (atrophy)
- Stretch marks (striae)
- Spider veins (telangiectasias)
- Acne-like eruptions
- Folliculitis
- Skin discoloration
- Increased hair growth at application site
- Signs of infection (redness, pus, fever)
- Unusual fatigue or weakness
- Weight gain (especially around the face/trunk)
- Increased thirst or urination (signs of hyperglycemia)
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 can occur.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though data for topical corticosteroids are limited. Avoid if possible.
Second Trimester:
Use with caution; monitor for systemic effects.
Third Trimester:
Use with caution; monitor for systemic effects. High doses or prolonged use may affect fetal growth.
Lactation
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Use with caution. If used, avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with limited, short-term use on small areas. Potential for systemic effects in infant if significant absorption occurs in mother or if applied directly to breast.
Pediatric Use
Not recommended for children under 12 years of age due to a higher ratio of skin surface area to body weight, increasing the risk of systemic absorption and HPA axis suppression. If use is unavoidable in older children, limit to the smallest effective amount for the shortest duration possible, and monitor closely for signs of systemic toxicity.
Geriatric Use
No specific dosage adjustments are typically needed. However, elderly patients may have thinner skin, which could increase the risk of local and systemic side effects. Use with caution and monitor for adverse reactions.
Clinical Information
Clinical Pearls
- Clobetasol propionate is one of the most potent topical corticosteroids; reserve its use for severe, recalcitrant dermatoses.
- Limit treatment duration to 2 consecutive weeks for most conditions, and total weekly dosage to 50 grams, to minimize risk of HPA axis suppression and local skin atrophy.
- Avoid use on the face, groin, or axillae, and in children under 12 years, due to increased risk of adverse effects.
- Patients should be advised on the proper application technique: a very thin layer, gently rubbed in.
- Tapering may be necessary after prolonged use to prevent rebound flares of the dermatosis.
Alternative Therapies
- Other topical corticosteroids of varying potencies (e.g., betamethasone, fluocinonide, triamcinolone, hydrocortisone)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing effects, especially on sensitive areas.
- Systemic therapies (e.g., methotrexate, biologics) for severe, widespread, or refractory conditions.
Cost & Coverage
Average Cost:
$30 - $100+ per 45g tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or 4 (brand)
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, including the amount taken and the time it happened, to ensure you receive the best possible care.