Clobetasol Prop 0.05% Sol25ml
It is used to treat skin rashes and other skin irritation.
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 propionate is a very strong (high-potency) steroid medicine applied to the skin. It works by reducing swelling, redness, and itching caused by certain skin conditions like eczema and psoriasis. It should only be used for short periods and exactly as prescribed by your doctor.
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 this case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
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 advised to do so by your doctor.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration and freezing.
Be aware of the medication's expiration date and discard it when necessary.
Protect the medication from heat and open flames.
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 dose, skip the missed dose and resume your regular 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. 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 this case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
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 advised to do so by your doctor.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration and freezing.
Be aware of the medication's expiration date and discard it when necessary.
Protect the medication from heat and open flames.
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 dose, skip the missed dose and resume your regular schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Wash your hands before and after applying the medication.
- Apply a very thin layer to the affected skin area only. Do not use more than prescribed.
- Do not cover the treated area with bandages or other dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid applying to the face, groin, or armpits unless directed by your doctor, as these areas are more susceptible to side effects.
- Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not use for longer than 2 consecutive weeks, or more than 50 grams per week, unless specifically advised by your doctor.
- Do not use on children under 12 years of age without specific medical advice.
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 twice daily for up to 2 consecutive weeks. If no response, re-evaluate diagnosis. Limit to 50g/week.
eczema:
Apply twice daily for up to 2 consecutive weeks. Limit to 50g/week.
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 in children over 12, limit duration and amount.
Adolescent:
For adolescents 12 years and older, use with caution and for limited duration (e.g., up to 2 weeks), similar to adult dosing but with close monitoring 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, as systemic absorption is minimal.
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 high-potency synthetic 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. Clobetasol also has vasoconstrictive, antipruritic, and anti-inflammatory properties.
Pharmacokinetics
Absorption:
Bioavailability:
Varies significantly; systemic absorption depends on the vehicle, integrity of the epidermal barrier, duration of exposure, and use of occlusive dressings. Absorption is higher on inflamed or damaged skin.
Tmax:
Not well-defined for topical application; systemic levels are generally low.
FoodEffect:
Not applicable
Distribution:
Vd:
Not specifically quantified for topical application; systemically absorbed corticosteroids are widely distributed.
ProteinBinding:
Approximately 90% (for systemically absorbed corticosteroids)
CnssPenetration:
Limited
Elimination:
HalfLife:
Not specifically quantified for topical application; systemically absorbed corticosteroids have variable half-lives (e.g., 4-6 hours for cortisol).
Clearance:
Not specifically quantified for topical application.
ExcretionRoute:
Primarily renal (metabolites), some biliary excretion.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within hours to days for anti-inflammatory effects.
PeakEffect:
Within days to a week of consistent application.
DurationOfAction:
Effects persist as long as applied; local effects may last for 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 symptoms, contact your doctor or seek immediate medical attention:
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 fainting
+ 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 site of application
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 immediate medical attention:
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 fainting
+ 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 site of application
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 your skin condition or no improvement after 2 weeks.
- Signs of skin infection (e.g., increased redness, swelling, pus, fever).
- Skin thinning, easy bruising, stretch marks, or changes in skin color at the application site.
- Acne-like breakouts or increased hair growth where applied.
- Unusual tiredness, weakness, nausea, dizziness, or weight gain (signs of too much steroid absorbed into the body).
- Blurred vision or other vision problems (rare, but possible with long-term 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.
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 symptoms you experienced.
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.
To minimize risks, follow these precautions:
- Keep this medication away from open flames or sparks, as it is flammable. Do not use it near an open flame or while smoking.
- This medication is not intended for treating diaper rash.
- It should not be used to treat acne, rosacea, or rashes around the mouth.
- When applying this medication to a large skin area or near open wounds, exercise caution and consult your doctor.
- Before using any other skin products or drugs, including soaps, discuss them with your doctor to avoid potential interactions.
- Avoid applying this medication to cuts, scrapes, or damaged skin.
- Do not use this medication for a longer duration than prescribed by your doctor.
In case of accidental ingestion, seek immediate medical attention or contact a poison control center, as this medication can be harmful if swallowed.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult your doctor about these potential risks.
This medication may not be suitable for all ages, especially children. Before administering it to a child, consult your doctor to discuss the potential benefits and risks.
When using this medication in children, be aware that the risk of certain side effects may be higher. Additionally, it may affect growth in children and teenagers, necessitating regular growth checks. Consult your doctor about these potential effects.
If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of using this medication during these conditions to ensure the best outcome for both you and your baby.
To minimize risks, follow these precautions:
- Keep this medication away from open flames or sparks, as it is flammable. Do not use it near an open flame or while smoking.
- This medication is not intended for treating diaper rash.
- It should not be used to treat acne, rosacea, or rashes around the mouth.
- When applying this medication to a large skin area or near open wounds, exercise caution and consult your doctor.
- Before using any other skin products or drugs, including soaps, discuss them with your doctor to avoid potential interactions.
- Avoid applying this medication to cuts, scrapes, or damaged skin.
- Do not use this medication for a longer duration than prescribed by your doctor.
In case of accidental ingestion, seek immediate medical attention or contact a poison control center, as this medication can be harmful if swallowed.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult your doctor about these potential risks.
This medication may not be suitable for all ages, especially children. Before administering it to a child, consult your doctor to discuss the potential benefits and risks.
When using this medication in children, be aware that the risk of certain side effects may be higher. Additionally, it may affect growth in children and teenagers, necessitating regular growth checks. Consult your doctor about these potential effects.
If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of using this medication during these conditions to ensure the best outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Signs of Cushing's syndrome (e.g., moon face, central obesity, buffalo hump)
- Hyperglycemia (high blood sugar)
- Glycosuria (sugar in urine)
- Suppression of the hypothalamic-pituitary-adrenal (HPA) axis (e.g., fatigue, weakness, nausea, hypotension)
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call a poison control center immediately (e.g., 1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Moderate Interactions
- CYP3A4 inhibitors (e.g., ritonavir, itraconazole): May increase systemic exposure to clobetasol, potentially leading to HPA axis suppression. Clinical significance is low with appropriate topical use but increases with extensive or prolonged use.
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify any pre-existing skin damage or infection.
Timing: Prior to initiation of therapy.
HPA axis assessment (e.g., ACTH stimulation test, plasma cortisol)
Rationale: Consider for patients at high risk of systemic absorption (e.g., extensive body surface area, prolonged use, occlusive dressings, pediatric patients) to establish baseline function.
Timing: Prior to initiation of therapy in high-risk patients.
Routine Monitoring
Efficacy of treatment
Frequency: Weekly or bi-weekly during active treatment phase.
Target: Reduction in inflammation, pruritus, and lesion size.
Action Threshold: Lack of improvement or worsening of condition after 2 weeks; consider re-evaluation of diagnosis or treatment.
Local adverse reactions (e.g., skin atrophy, striae, telangiectasias, folliculitis, perioral dermatitis, secondary infection)
Frequency: At each follow-up visit (weekly/bi-weekly).
Target: Absence of new or worsening local adverse effects.
Action Threshold: Appearance of significant local adverse effects; consider reducing frequency, potency, or discontinuing use.
Signs of HPA axis suppression (e.g., fatigue, weakness, nausea, hypotension)
Frequency: Periodically, especially with prolonged or extensive use, or in pediatric patients.
Target: Normal HPA axis function.
Action Threshold: Clinical signs or laboratory evidence of HPA axis suppression; consider gradual withdrawal of therapy and/or systemic corticosteroid replacement.
Symptom Monitoring
- Worsening of skin condition
- Increased redness, swelling, or pain at application site (signs of infection)
- Thinning of skin, easy bruising, or stretch marks (signs of skin atrophy)
- Increased hair growth at application site
- Acne-like eruptions
- Fatigue, weakness, nausea, dizziness (potential signs of systemic absorption/HPA axis suppression)
Special Patient Groups
Pregnancy
Category C. Clobetasol propionate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with high doses of corticosteroids.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though systemic absorption from topical use is generally low.
Second Trimester:
Risk of fetal growth restriction with high systemic exposure.
Third Trimester:
Risk of HPA axis suppression in the newborn if used extensively or for prolonged periods near term.
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. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with limited, short-term use, but potential for systemic effects in the infant if significant absorption occurs in the mother.
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. If used in older children, limit duration and amount, 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 such as skin atrophy, purpura, and telangiectasias. Monitor closely for these effects.
Clinical Information
Clinical Pearls
- Clobetasol propionate is a super high-potency topical corticosteroid; use it judiciously and for short durations (typically no more than 2 weeks).
- Educate patients thoroughly on proper application technique: thin layer, only to affected areas, and avoid occlusion unless specifically instructed.
- Be vigilant for signs of HPA axis suppression, especially in children, or with extensive body surface area treatment, or prolonged use.
- Consider step-down therapy to a lower potency corticosteroid or non-steroidal agent once the acute flare is controlled.
- Warn patients about potential for rebound flares if discontinued abruptly after prolonged use.
- Not for use on the face, groin, or axillae unless under strict medical supervision due to increased risk of atrophy, telangiectasias, and perioral dermatitis.
Alternative Therapies
- Other topical corticosteroids (e.g., betamethasone, fluocinonide, triamcinolone, hydrocortisone - varying potencies)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema, especially on sensitive areas.
- 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 dermatoses not controlled by topical agents.
Cost & Coverage
Average Cost:
$50 - $200+ per 25ml bottle (0.05% solution)
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 this 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 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.