Clobetasol Prop 0.05% Gel 60gm
It is used to treat skin rashes and other skin irritation.It is used to treat plaque psoriasis.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Corticosteroid
Pregnancy Category
Category C
FDA Approved
May 1993
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobetasol propionate is a very strong (super-high potency) corticosteroid medicine applied to the skin. It helps reduce redness, itching, and swelling caused by certain skin conditions like eczema and psoriasis. It works by calming down the body's inflammatory 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. It is 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 application.
Clean the affected area before applying the medication and dry it thoroughly.
Gently rub a thin layer of the medication onto the affected skin.
Unless instructed by your doctor, do not apply this medication to your face, underarms, or groin area.
Avoid using bandages, dressings, or makeup on the treated area unless advised by your doctor.
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 it can be stored before disposal.
Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If the missed dose is close to the time for your next scheduled dose, skip the missed dose and resume your regular application 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, 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 application.
Clean the affected area before applying the medication and dry it thoroughly.
Gently rub a thin layer of the medication onto the affected skin.
Unless instructed by your doctor, do not apply this medication to your face, underarms, or groin area.
Avoid using bandages, dressings, or makeup on the treated area unless advised by your doctor.
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 it can be stored before disposal.
Keep all medications in a safe location, out of the reach of children and pets.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If the missed dose is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Apply a very thin layer only to the affected skin areas as directed by your doctor.
- Wash your hands before and after applying the gel.
- Do not use more than the prescribed amount or for longer than 2 consecutive weeks, unless specifically instructed by your doctor.
- Do not use on the face, groin, or armpits unless specifically directed by your doctor, as these areas are more prone to side effects.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not cover the treated area with bandages or other occlusive dressings unless instructed by your doctor, as this can increase absorption and side effects.
- 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. Do not exceed 50 g per week.
Condition-Specific Dosing:
psoriasis:
Apply a thin layer to the affected skin areas twice daily for up to 2 consecutive weeks. Do not exceed 50 g per week.
eczema:
Apply a thin layer to the affected skin areas twice daily for up to 2 consecutive weeks. Do not exceed 50 g per 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.
Adolescent:
For adolescents 12 years and older, use with caution and for limited duration, similar to adult dosing but with close monitoring for systemic effects.
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 adjustment needed 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 topical corticosteroid. It exerts its anti-inflammatory, antipruritic, and vasoconstrictive actions 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.
Pharmacokinetics
Absorption:
Bioavailability:
Varies; systemic absorption is generally low (<1%) but can be increased by factors such as 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 due to variable absorption.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not well-quantified for topical application; systemically absorbed corticosteroids are bound to plasma proteins.
ProteinBinding:
Systemically absorbed corticosteroids are extensively bound to plasma proteins, primarily transcortin and albumin.
CnssPenetration:
Limited systemic penetration from topical application; CNS effects are rare unless significant systemic absorption occurs.
Elimination:
HalfLife:
Not well-defined for topical application; systemically absorbed corticosteroids have variable half-lives (e.g., cortisol 60-90 minutes).
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Systemically absorbed corticosteroids and their metabolites are primarily excreted by the kidneys.
Unchanged:
Minimal unchanged drug excreted following topical application.
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief (e.g., reduction in itching, redness).
PeakEffect:
Within 1-2 weeks of consistent application.
DurationOfAction:
Effects persist as long as treatment continues; typically applied twice daily.
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 immediately or seek emergency 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 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 unusual symptoms, contact your doctor for advice:
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 immediately or seek emergency 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 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 unusual symptoms, contact your doctor for advice:
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., pus, spreading redness, fever).
- Severe burning, itching, or irritation at the application site.
- Thinning of the skin, easy bruising, or stretch marks (striae) in the treated area.
- Changes in skin color (lightening or darkening).
- Unusual hair growth.
- Symptoms of systemic absorption, especially with prolonged or extensive use: unusual tiredness, weight loss, headache, swelling in ankles/feet, vision problems, increased thirst/urination (signs of high blood sugar).
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.
To guarantee your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
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.
To guarantee your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
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. Additionally, it should not be used to treat acne, rosacea, or rashes around the mouth. When applying this medication to a large area of skin or near open wounds, exercise caution and consult with your doctor.
Before using any other medications or products on your skin, including soaps, discuss them with your doctor. Avoid applying this medication to cuts, scrapes, or damaged skin. Do not use this medication for an extended period beyond what your doctor has prescribed.
If this medication is ingested, it can be harmful. In the event of accidental ingestion, immediately contact a doctor or a poison control center.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Consult with your doctor to discuss this potential risk.
This medication may not be suitable for children of all ages. Before administering this medication to a child, consult with your doctor to determine the appropriate course of treatment. When using this medication in children, exercise caution, as they may be at a higher risk for certain side effects.
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Discuss this potential risk with your doctor.
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. It is crucial to discuss the benefits and risks of using this medication to ensure the best possible outcome for both you and your baby.
This medication is not intended to treat diaper rash. Additionally, it should not be used to treat acne, rosacea, or rashes around the mouth. When applying this medication to a large area of skin or near open wounds, exercise caution and consult with your doctor.
Before using any other medications or products on your skin, including soaps, discuss them with your doctor. Avoid applying this medication to cuts, scrapes, or damaged skin. Do not use this medication for an extended period beyond what your doctor has prescribed.
If this medication is ingested, it can be harmful. In the event of accidental ingestion, immediately contact a doctor or a poison control center.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Consult with your doctor to discuss this potential risk.
This medication may not be suitable for children of all ages. Before administering this medication to a child, consult with your doctor to determine the appropriate course of treatment. When using this medication in children, exercise caution, as they may be at a higher risk for certain side effects.
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Discuss this potential risk with your doctor.
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. It is crucial to discuss the benefits and risks of using this medication to ensure the best possible outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or extensive use can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including: moon face, buffalo hump, central obesity, thinning skin, easy bruising, muscle weakness, high blood pressure, high blood sugar, and adrenal suppression.
What to Do:
If you suspect an overdose or significant systemic absorption, contact your doctor or poison control center immediately. Call 1-800-222-1222. Treatment is supportive and may involve gradual withdrawal of the corticosteroid.
Drug Interactions
Contraindicated Interactions
- Not available
Major Interactions
- Not available (due to minimal systemic absorption)
Moderate Interactions
- Not available (due to minimal systemic absorption)
Minor Interactions
- Not available (due to minimal systemic absorption)
Monitoring
Baseline Monitoring
Skin condition (e.g., redness, scaling, lichenification)
Rationale: To assess severity of dermatosis and establish a baseline for treatment efficacy.
Timing: Prior to initiation of therapy.
Area of body surface affected
Rationale: To estimate potential for systemic absorption and guide total amount of drug used.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (reduction in symptoms)
Frequency: Weekly during treatment period
Target: Significant improvement in signs and symptoms of dermatosis.
Action Threshold: Lack of improvement or worsening of condition after 2 weeks; consider alternative diagnosis or treatment.
Local adverse effects (e.g., skin atrophy, striae, telangiectasias, burning, itching, irritation)
Frequency: Weekly during treatment period
Target: Absence or minimal local adverse effects.
Action Threshold: Development of significant local adverse effects; discontinue or reduce frequency/potency.
Signs of HPA axis suppression (e.g., fatigue, weight loss, hypotension, hyperglycemia)
Frequency: Periodically, especially with extensive or prolonged use, or in pediatric patients.
Target: Normal cortisol levels (if tested).
Action Threshold: Clinical signs of HPA axis suppression or abnormal cortisol levels; discontinue or taper therapy, consider endocrinology consult.
Symptom Monitoring
- Burning
- Stinging
- Itching
- Irritation
- Dryness
- Folliculitis
- Hypertrichosis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Skin atrophy
- Striae
- Miliaria
- Secondary infection
- Signs of Cushing's syndrome (e.g., moon face, buffalo hump, central obesity)
- Hyperglycemia
- Glucosuria
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Clobetasol propionate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. High potency topical corticosteroids should generally be avoided or used with extreme caution during pregnancy.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though data from human studies with topical corticosteroids are limited. Use only if clearly needed.
Second Trimester:
Potential for fetal growth restriction or other systemic effects if significant absorption occurs. Use with caution.
Third Trimester:
Potential for fetal growth restriction or other systemic effects if significant absorption occurs. Use with caution.
Lactation
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Caution should be exercised when clobetasol propionate is administered to a nursing woman. Avoid applying to the breast area to prevent direct infant exposure.
Infant Risk:
Low risk with limited, short-term use, but monitor infant for any signs of adverse effects. Avoid application to areas where the infant may ingest the medication.
Pediatric Use
Not recommended for children under 12 years of age. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature adults due to a larger skin surface area to body weight ratio. Use in adolescents (12 years and older) should be limited to short durations and small areas, with close monitoring.
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 the risk of local adverse effects like skin atrophy. Use with caution and monitor for skin integrity.
Clinical Information
Clinical Pearls
- Clobetasol propionate is a super-high potency topical corticosteroid; use for short durations (typically 2 weeks) to minimize risk of local and systemic side effects.
- Avoid use on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more susceptible to atrophy and other side effects.
- HPA axis suppression is a significant risk, especially with prolonged use, large surface areas, or occlusive dressings. Consider periodic evaluation of HPA axis if extensive use is anticipated.
- Patients should be educated on proper application technique (thin layer, gentle rub) and the importance of not exceeding the prescribed duration or amount.
- Rebound flares can occur upon abrupt discontinuation after prolonged use; gradual tapering may be considered for some conditions.
Alternative Therapies
- Other topical corticosteroids of lower potency (e.g., triamcinolone, fluocinonide, betamethasone)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for certain inflammatory skin conditions, especially on sensitive areas like the face.
- Vitamin D analogs (e.g., calcipotriene) for psoriasis.
- Emollients and moisturizers for barrier repair and symptom relief.
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread dermatoses.
Cost & Coverage
Average Cost:
Varies widely by pharmacy and formulation (gel, cream, ointment); generic 60g tube typically $20-$100+ per 60g tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic formulations) on most commercial and Medicare Part D plans.
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 medication taken, the amount, and the time it happened.