Clobetasol Prop 0.05% Sol 50ml
It is used to treat skin rashes and other skin irritation.
Drug Class
Corticosteroid, Topical
Pharmacologic Class
Glucocorticoid Receptor Agonist, Anti-inflammatory Agent
Pregnancy Category
Category C
FDA Approved
May 2003
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobetasol propionate solution is a very strong medicine applied to the skin, usually the scalp, to reduce redness, itching, and swelling caused by certain skin conditions like psoriasis or eczema. It's a type of steroid that works by calming down your body's immune response in the skin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Use this medication only as directed, and continue to use it even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area, in which case you should not wash it after application.
Clean the affected area before applying the medication, and make sure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Avoid applying the medication to your face, underarms, or groin area unless your doctor instructs you to do so.
Do not cover the treated area with bandages, dressings, or makeup unless your doctor advises you to do so.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration and freezing.
Be aware of the medication's expiration date and discard it when it is no longer usable.
Protect the medication from heat and open flames.
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 make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Use this medication only as directed, and continue to use it even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area, in which case you should not wash it after application.
Clean the affected area before applying the medication, and make sure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Avoid applying the medication to your face, underarms, or groin area unless your doctor instructs you to do so.
Do not cover the treated area with bandages, dressings, or makeup unless your doctor advises you to do so.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration and freezing.
Be aware of the medication's expiration date and discard it when it is no longer usable.
Protect the medication from heat and open flames.
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 make up for a missed dose.
Lifestyle & Tips
- Apply only to the affected areas of the scalp as directed by your doctor. Do not use on your face, groin, or armpits unless specifically instructed.
- Wash your hands thoroughly before and after applying the solution.
- Do not bandage, cover, or wrap the treated area unless directed by your doctor, as this can increase absorption and side effects.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use for longer than 2 consecutive weeks, and do not use more than 50 mL (one bottle) per week, unless specifically advised by your doctor.
- Inform your doctor if your condition does not improve after 2 weeks of treatment or if it worsens.
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 scalp areas twice daily, once in the morning and once at night.
Condition-Specific Dosing:
duration:
Treatment should be limited to 2 consecutive weeks. Total dosage should not exceed 50 mL (50 grams) per week.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established. Use in children under 12 years is not recommended due to increased risk of systemic absorption and HPA axis suppression.
Adolescent:
Not established. Use with caution and for limited duration if prescribed, due to increased risk of systemic absorption and HPA axis suppression compared to adults.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Clobetasol propionate is a highly potent synthetic corticosteroid. It acts by binding to glucocorticoid receptors in the cytoplasm, forming a complex that translocates to the nucleus. This complex then modulates gene expression, leading to the synthesis of anti-inflammatory proteins (e.g., lipocortins) and inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes) by inhibiting phospholipase A2. It exhibits anti-inflammatory, antipruritic, and vasoconstrictive properties.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <1%) through intact skin; however, absorption can increase significantly with inflammation, skin barrier disruption, occlusive dressings, or application to large surface areas.
Tmax:
Not precisely defined for topical application due to variable absorption; systemic levels are generally very low.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not precisely defined for topical application; systemically absorbed clobetasol distributes widely.
ProteinBinding:
Approximately 97% (systemically absorbed portion) to plasma proteins.
CnssPenetration:
Limited (systemically absorbed portion).
Elimination:
HalfLife:
Systemic half-life is approximately 3-5 hours (for absorbed drug).
Clearance:
Not precisely defined for topical application.
ExcretionRoute:
Primarily excreted by the kidneys, with some biliary excretion.
Unchanged:
Very little unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief.
PeakEffect:
Within 1-2 weeks 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
While rare, some people may experience severe and potentially life-threatening side effects when 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 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
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.
While rare, some people may experience severe and potentially life-threatening side effects when 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 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
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:
- Severe burning, itching, or irritation at the application site.
- Signs of skin thinning (e.g., easy bruising, shiny skin, stretch marks).
- New or worsening skin infection (e.g., pus, redness, warmth).
- Unusual hair growth or acne-like breakouts.
- Signs of systemic side effects: unusual tiredness, weight gain (especially in the face/trunk), muscle weakness, increased thirst or urination (rare, but possible with extensive 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 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.
To minimize risks, be aware that this drug is flammable and should not be used near an open flame or while smoking. Additionally, it is not intended for treating diaper rash, 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. It is also crucial to discuss with your doctor before using any other skin products, including soaps, to avoid potential interactions.
Avoid applying this drug to cuts, scrapes, or damaged skin. Furthermore, do not use this medication for a longer duration than prescribed by your doctor.
In case of accidental ingestion, this drug can be harmful, and you should immediately contact a doctor or a poison control center.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma, so it is vital to discuss this with your doctor.
This drug may not be suitable for children of all ages, and its use in children requires careful consideration. If your child is using this medication, be aware that the risk of certain side effects may be higher, and it may affect their growth. Regular growth checks may be necessary, and you should discuss this with your doctor.
When breast-feeding, avoid applying this drug directly on the nipple or the surrounding area.
If you are pregnant, planning to become pregnant, or are breast-feeding, it is crucial to consult with your doctor to weigh the benefits and risks of using this medication to you and your baby.
To minimize risks, be aware that this drug is flammable and should not be used near an open flame or while smoking. Additionally, it is not intended for treating diaper rash, 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. It is also crucial to discuss with your doctor before using any other skin products, including soaps, to avoid potential interactions.
Avoid applying this drug to cuts, scrapes, or damaged skin. Furthermore, do not use this medication for a longer duration than prescribed by your doctor.
In case of accidental ingestion, this drug can be harmful, and you should immediately contact a doctor or a poison control center.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma, so it is vital to discuss this with your doctor.
This drug may not be suitable for children of all ages, and its use in children requires careful consideration. If your child is using this medication, be aware that the risk of certain side effects may be higher, and it may affect their growth. Regular growth checks may be necessary, and you should discuss this with your doctor.
When breast-feeding, avoid applying this drug directly on the nipple or the surrounding area.
If you are pregnant, planning to become pregnant, or are breast-feeding, it is crucial to consult with your doctor to weigh the benefits and risks of using this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic absorption, potentially causing symptoms of Cushing's syndrome (e.g., moon face, central obesity, thin skin, easy bruising, muscle weakness), hyperglycemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
What to Do:
If you suspect an overdose or significant systemic absorption, contact your doctor or a poison control center immediately (e.g., 1-800-222-1222). Management is supportive and may involve gradual withdrawal of the medication.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition and extent of dermatosis
Rationale: To establish baseline severity and guide treatment duration.
Timing: Prior to initiation of therapy.
Routine Monitoring
Signs of local adverse reactions (e.g., atrophy, striae, telangiectasias, irritation, infection)
Frequency: At each follow-up visit, or as symptoms arise.
Target: Absence of new or worsening adverse reactions.
Action Threshold: If present, consider reducing frequency, discontinuing, or changing therapy.
Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, HPA axis suppression)
Frequency: Periodically, especially with prolonged use, large surface area application, or occlusive dressings.
Target: Normal clinical parameters; normal cortisol levels if tested.
Action Threshold: If suspected, perform ACTH stimulation test, plasma cortisol, or urinary free cortisol. Discontinue or gradually withdraw if HPA axis suppression is confirmed.
Symptom Monitoring
- Burning, itching, irritation, dryness at application site
- Folliculitis, hypertrichosis, acneiform eruptions
- Hypopigmentation, perioral dermatitis, allergic contact dermatitis
- Maceration of the skin, secondary infection
- Skin atrophy, striae, telangiectasias
- Unusual fatigue, weight gain, moon face (signs of Cushing's syndrome)
- Increased thirst, increased 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. Animal studies have shown teratogenic effects with corticosteroids.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though systemic absorption from topical use is generally low.
Second Trimester:
Risk generally considered low with limited topical use.
Third Trimester:
Risk generally considered low with limited topical use; however, potential for 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 into human milk. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for clobetasol and any potential adverse effects on the breastfed infant.
Infant Risk:
Low risk with limited topical use. Avoid applying to the breast or nipple area to prevent direct infant exposure.
Pediatric Use
Children are more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio and immature skin barrier. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported. Prolonged use should be avoided, and use in children under 12 years is generally not recommended.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may have thinner skin, which could potentially increase systemic absorption, though this is generally not clinically significant with appropriate use.
Clinical Information
Clinical Pearls
- Clobetasol propionate 0.05% solution is a super-high potency topical corticosteroid; use it sparingly and for short durations (typically 2 weeks maximum).
- It is particularly useful for scalp conditions due to its liquid formulation.
- Educate patients thoroughly on proper application technique, avoiding overuse, and the importance of not using occlusive dressings.
- Monitor for signs of local skin atrophy (thinning, striae) and systemic absorption, especially in children or with extensive/prolonged use.
- If no improvement is seen after 2 weeks, re-evaluate the diagnosis and treatment plan.
Alternative Therapies
- Other topical corticosteroids of varying potencies (e.g., fluocinonide, betamethasone, triamcinolone, hydrocortisone)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing effects
- Vitamin D analogs (e.g., calcipotriene) for psoriasis
- Coal tar preparations
- Salicylic acid preparations
- Phototherapy (UVB, PUVA)
- Systemic agents (e.g., methotrexate, biologics) for severe, widespread disease not responsive to topical therapy
Cost & Coverage
Average Cost:
$50 - $200 per 50mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand) depending on insurance plan.
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.