Clobetasol Prop 0.05% Cream 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 Receptor Agonist
Pregnancy Category
C
FDA Approved
Dec 1989
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobetasol is a very strong corticosteroid cream used on the skin to reduce severe redness, itching, and swelling caused by 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 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 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 use extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Use this medication only as directed, and continue to use it even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area, in which case you should not wash it after application.
Clean the affected area before applying the medication, and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
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 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 use extra doses.
Lifestyle & Tips
- Apply a very thin layer only to the affected skin areas as directed by your doctor.
- Do not use more than the prescribed amount or for longer than recommended (usually no more than 2 weeks at a time).
- Do not use on the face, groin, or armpits unless specifically instructed by your doctor, as these areas are more sensitive to side effects.
- Do not cover the treated area with bandages or plastic wrap unless your doctor tells you to, as this can increase absorption and side effects.
- Wash your hands thoroughly before and after applying the cream.
- Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
- 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 affected skin areas twice daily.
Condition-Specific Dosing:
maxWeeklyDose:
Not to exceed 50 grams per week
duration:
Limit treatment to 2 consecutive weeks; for resistant lesions, up to 4 weeks may be considered under strict medical supervision.
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 to smallest amount and shortest duration.
Adolescent:
Not recommended for children under 12 years. For adolescents 12 years and older, use with caution and for limited duration, similar to adult dosing but with increased monitoring for systemic effects.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for typical topical use.
Moderate:
No specific adjustment needed for typical topical use.
Severe:
No specific adjustment needed for typical topical use. Use with caution if extensive skin involvement or impaired skin barrier, as systemic absorption may increase.
Hepatic Impairment:
Mild:
No specific adjustment needed for typical topical use.
Moderate:
No specific adjustment needed for typical topical use.
Severe:
No specific adjustment needed for typical topical use. Use with caution if extensive skin involvement or impaired skin barrier, as systemic absorption may increase.
Pharmacology
Mechanism of Action
Clobetasol propionate is a super-high potency topical corticosteroid. It acts 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. Clobetasol also exhibits anti-inflammatory, antipruritic, and vasoconstrictive properties.
Pharmacokinetics
Absorption:
Bioavailability:
Varies; systemic absorption is generally low but can increase with prolonged use, extensive surface area, occlusion, or impaired skin barrier. Up to 5% of applied dose can be absorbed.
Tmax:
Not well-defined for topical systemic absorption; systemic levels are typically very low.
FoodEffect:
Not applicable
Distribution:
Vd:
Not well-defined for topical administration.
ProteinBinding:
Highly protein-bound (to plasma proteins) once absorbed systemically.
CnssPenetration:
Limited/No significant
Elimination:
HalfLife:
Systemic half-life is approximately 3-5 hours (for absorbed drug).
Clearance:
Not well-defined for topical administration.
ExcretionRoute:
Primarily renal excretion of metabolites, some biliary excretion.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Clinical effects (reduction in inflammation, pruritus) typically observed within hours to days.
PeakEffect:
Peak therapeutic effect usually seen within days to 1-2 weeks of consistent application.
DurationOfAction:
Effects may persist for some time after discontinuation, but duration varies based on condition and individual response.
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 contact your doctor or seek medical help if you notice any of the following:
Burning or stinging
Dry skin
* Redness
These are not all the possible side effects that may occur. 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. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you notice any of the following:
Burning or stinging
Dry skin
* Redness
These are not all the possible side effects that may occur. 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:
- Worsening of your skin condition or development of new skin problems (e.g., new rashes, infections).
- Signs of skin thinning: easy bruising, stretch marks (striae), spider veins (telangiectasias), or changes in skin color.
- Signs of infection: pus, increased redness, warmth, or pain.
- Signs of systemic absorption (rare but serious): unusual weight gain, swelling in your face (moon face), increased thirst or urination, fatigue, weakness, or changes in mood.
- Severe burning, itching, or irritation at the application site.
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, as they may interact with this medication.
To ensure your safety, always check with your doctor before starting, stopping, or changing the dose of any medication. Do not make any changes to your medication regimen without consulting your doctor first.
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, as they may interact with this medication.
To ensure your safety, always check with your doctor before starting, stopping, or changing the dose of any medication. Do not make any changes to your medication regimen without consulting your doctor first.
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 other skincare 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 an extended period beyond the duration prescribed by your doctor. If ingested, this medication 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 your doctor about potential risks. The suitability of this medication for children of all ages has not been established; consult your doctor before administering it 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 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 to discuss the potential benefits and risks to both 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 other skincare 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 an extended period beyond the duration prescribed by your doctor. If ingested, this medication 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 your doctor about potential risks. The suitability of this medication for children of all ages has not been established; consult your doctor before administering it 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 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 to discuss the potential benefits and risks to both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic effects of corticosteroid excess, including Cushing's syndrome (e.g., moon face, central obesity, thin skin, easy bruising), hyperglycemia, glucosuria, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis (leading to adrenal insufficiency upon withdrawal).
What to Do:
If you suspect an overdose or significant systemic absorption, discontinue use and contact your doctor immediately. For acute overdose, call 1-800-222-1222 (Poison Control) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- None significant for typical topical use.
Major Interactions
- None significant for typical topical use.
Moderate Interactions
- None significant for typical topical use. (Theoretical risk of systemic corticosteroid interactions if significant absorption occurs, e.g., with strong CYP3A4 inhibitors like ritonavir, itraconazole, but highly unlikely with proper topical use).
Minor Interactions
- None significant for typical topical use.
Monitoring
Baseline Monitoring
Skin condition (type, extent, severity of lesions)
Rationale: To establish baseline for assessing treatment efficacy and adverse effects.
Timing: Prior to initiation of therapy.
Patient history (age, comorbidities, previous corticosteroid use)
Rationale: To identify risk factors for adverse effects (e.g., HPA axis suppression, skin atrophy).
Timing: Prior to initiation of therapy.
Routine Monitoring
Skin condition (improvement, signs of atrophy, striae, telangiectasias, folliculitis, secondary infection)
Frequency: Weekly during initial treatment, then as clinically indicated.
Target: Reduction in inflammation, pruritus, and lesion size without significant local adverse effects.
Action Threshold: Worsening of condition, development of new skin lesions, signs of infection, or local adverse effects (e.g., significant skin thinning, burning, irritation).
Signs/symptoms of HPA axis suppression (e.g., fatigue, weakness, weight loss, nausea, vomiting, hypotension)
Frequency: Periodically, especially with extensive use, prolonged use, or use under occlusion.
Target: Absence of symptoms.
Action Threshold: Presence of symptoms; consider laboratory testing (e.g., morning cortisol, ACTH stimulation test).
Symptom Monitoring
- Local skin reactions: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria, telangiectasias.
- Systemic effects (rare with proper use): Cushing's syndrome, hyperglycemia, glucosuria, HPA axis suppression (adrenal insufficiency), growth retardation in children, cataracts, glaucoma.
Special Patient Groups
Pregnancy
Pregnancy Category C. Use clobetasol propionate during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with corticosteroids.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity (e.g., cleft palate, skeletal abnormalities) observed in animal studies with high doses of potent corticosteroids. Human data are limited, but systemic absorption is generally low with topical use.
Second Trimester:
Similar considerations as the first trimester. Risk of fetal harm is generally considered low with limited topical use.
Third Trimester:
Potential for HPA axis suppression in the neonate if used extensively or for prolonged periods, particularly near term. Neonates of mothers who have received substantial doses of corticosteroids during pregnancy should be observed for signs of hypoadrenalism.
Lactation
Use with caution. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. However, systemically administered corticosteroids are secreted into breast milk. Avoid applying to the breast area to prevent direct infant exposure.
Infant Risk:
Low risk with proper use due to minimal systemic absorption. Monitor infant for any unusual effects.
Pediatric Use
Not recommended for children under 12 years of age. Pediatric patients may be more susceptible to systemic toxicity from topical corticosteroids due to their larger skin surface area to body weight ratio and immature skin barrier. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Growth retardation may also occur.
Geriatric Use
No specific dose adjustments are required. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects such as skin atrophy, purpura, and telangiectasias. Use with caution and monitor closely.
Clinical Information
Clinical Pearls
- Clobetasol propionate 0.05% is a super-high potency topical corticosteroid; it should be used sparingly and for short durations (typically no more than 2 consecutive weeks, and total weekly dose not exceeding 50g) to minimize the risk of local and systemic side effects.
- Avoid use on the face, groin, axillae, or under occlusion unless specifically directed by a dermatologist, due to the increased risk of skin atrophy, striae, telangiectasias, and systemic absorption in these sensitive areas.
- Patients should be educated on the proper application technique and the importance of not exceeding the prescribed duration or amount.
- Monitor patients, especially children and those with extensive skin involvement or impaired skin barrier, for signs of HPA axis suppression.
- Not indicated for the treatment of rosacea or perioral dermatitis, as it can exacerbate these conditions.
Alternative Therapies
- Other topical corticosteroids (e.g., fluocinonide, betamethasone, triamcinolone for lower potency needs)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus for sensitive areas or long-term use)
- Vitamin D analogs (e.g., calcipotriene for psoriasis)
- Coal tar preparations
- Salicylic acid
- Phototherapy (for psoriasis, severe eczema)
- Systemic agents (e.g., biologics, methotrexate, cyclosporine for severe, widespread disease)
Cost & Coverage
Average Cost:
$20 - $100+ per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 for generic formulations; higher tiers for brand names.
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.