Clobetasol Prop 0.05% Gel 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
Corticosteroid, Potent
Pregnancy Category
Category C
FDA Approved
May 1983
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobetasol propionate gel is a very strong steroid medicine applied to the skin to reduce redness, swelling, and itching caused by certain skin conditions like eczema or psoriasis. It works by calming down the immune response in the skin. It's important to use it exactly as prescribed, usually for a short time, because using too much or for too long can cause side effects.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after 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 dry it thoroughly.
Gently rub a thin layer of the medication onto the affected skin.
Avoid applying the medication to your face, underarms, or groin area unless your doctor instructs you to do so.
Do not cover the treated area with bandages, dressings, or makeup unless your doctor advises you to do so.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration or freezing.
Be aware of the medication's expiration date or the length of time you can store it before disposing of it.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or use extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after 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 dry it thoroughly.
Gently rub a thin layer of the medication onto the affected skin.
Avoid applying the medication to your face, underarms, or groin area unless your doctor instructs you to do so.
Do not cover the treated area with bandages, dressings, or makeup unless your doctor advises you to do so.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration or freezing.
Be aware of the medication's expiration date or the length of time you can store it before disposing of it.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Apply a thin layer to the affected skin areas only. Do not use more than prescribed.
- Wash hands before and after applying the gel.
- Do not cover the treated area with bandages or other dressings unless directed by your doctor, as this can increase absorption and side effects.
- Avoid applying to the face, groin, or armpits unless specifically instructed by your doctor, as these areas are more prone to side effects.
- Do not use for longer than 2 consecutive weeks, and do not use more than 50 grams per week, unless directed by your doctor.
- Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
- Do not use on broken or infected skin without consulting your doctor.
- 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
Condition-Specific Dosing:
psoriasis:
Apply a thin layer to the affected skin areas twice daily for up to 2 weeks. Do not exceed 50 g per week.
eczema:
Apply a thin layer to the affected skin areas twice daily for up to 2 weeks. Do not exceed 50 g per week.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (use generally not recommended due to increased systemic absorption risk)
Child:
Not established (use generally not recommended due to increased systemic absorption risk; if used, limit to shortest duration and smallest amount)
Adolescent:
Apply a thin layer to the affected skin areas twice daily for up to 2 weeks. Do not exceed 50 g per week. Use with caution and under strict medical supervision due to increased risk of systemic effects.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Clobetasol propionate is a highly potent synthetic corticosteroid. It exerts its therapeutic effects primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions. Corticosteroids are thought to act by inducing phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (depends on skin integrity, vehicle, site, duration, and use of occlusive dressings); minimal systemic absorption under normal conditions, but can be significant with extensive use or compromised skin.
Tmax:
Not applicable for topical application to achieve systemic Tmax; local concentration is immediate.
FoodEffect:
Not applicable
Distribution:
Vd:
Not available (primarily local action)
ProteinBinding:
Variable, if systemically absorbed, binds to plasma proteins (e.g., transcortin, albumin).
CnssPenetration:
Limited (if systemically absorbed)
Elimination:
HalfLife:
Not precisely determined for topical application; systemic half-life of absorbed drug is variable.
Clearance:
Not precisely determined for topical application.
ExcretionRoute:
Renal (if systemically absorbed)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within hours to days for anti-inflammatory effects.
PeakEffect:
Within days to 1-2 weeks of consistent application.
DurationOfAction:
Effects persist for a period after discontinuation, but recurrence of symptoms is common if underlying condition is not resolved.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Irritation where the medication was applied
Thinning of the skin
Changes in eyesight, eye pain, or severe eye irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
Burning or stinging
Dry skin
* Redness
This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Irritation where the medication was applied
Thinning of the skin
Changes in eyesight, eye pain, or severe eye irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
Burning or stinging
Dry skin
* Redness
This is not an exhaustive list of all 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 skin condition or new skin problems (e.g., severe burning, itching, redness, dryness, thinning of skin, stretch marks, acne, hair growth)
- Signs of skin infection (e.g., pus, spreading redness, fever)
- Signs of systemic absorption (e.g., unusual weight gain, swelling in face/ankles, muscle weakness, fatigue, vision problems, increased thirst/urination)
- Allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
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 any new medication
Stopping any medication
Changing the dose of any medication
This will help you avoid potential interactions and ensure that it is safe to take this medication with your other drugs 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, as they may interact with this medication.
To ensure your safety, always check with your doctor before:
Starting any new medication
Stopping any medication
Changing the dose of any medication
This will help you avoid potential interactions and ensure that it is safe to take this medication with your other drugs 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, acne, rosacea, or rashes around the mouth. When applying it 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 accidentally swallowed, seek immediate medical attention by calling a doctor or poison control center. Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult with your doctor.
The safety and efficacy of this medication in children of all ages have not been established. If your child is prescribed this medication, use it with caution, as the risk of certain side effects may be higher in children. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Discuss this with your doctor.
If you are breast-feeding, avoid applying this medication directly to the nipple or the surrounding area. If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
This medication is not intended to treat diaper rash, acne, rosacea, or rashes around the mouth. When applying it to a large area of skin or near open wounds, exercise caution and consult 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 accidentally swallowed, seek immediate medical attention by calling a doctor or poison control center. Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult with your doctor.
The safety and efficacy of this medication in children of all ages have not been established. If your child is prescribed this medication, use it with caution, as the risk of certain side effects may be higher in children. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Discuss this with your doctor.
If you are breast-feeding, avoid applying this medication directly to the nipple or the surrounding area. If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic effects of hypercorticism (Cushing's syndrome), including: moon face, central obesity, striae, hypertension, hyperglycemia, adrenal suppression, growth retardation in children, and cataracts/glaucoma.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call a poison control center immediately (1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify areas for application.
Timing: Prior to initiation of therapy
Routine Monitoring
Local skin reactions (e.g., atrophy, striae, telangiectasias, burning, itching)
Frequency: At each follow-up visit (e.g., 2-4 weeks)
Target: Absence of severe reactions
Action Threshold: If severe reactions occur, discontinue or reduce frequency/potency.
Signs of HPA axis suppression (e.g., fatigue, weakness, weight loss, hypotension)
Frequency: Periodically, especially with prolonged or extensive use, or in pediatric patients.
Target: Normal adrenal function
Action Threshold: If suspected, perform ACTH stimulation test or plasma cortisol levels. Discontinue or taper if confirmed.
Signs of infection (e.g., worsening redness, pus, fever)
Frequency: At each follow-up visit
Target: Absence of infection
Action Threshold: If infection develops, initiate appropriate antimicrobial therapy; discontinue clobetasol if infection worsens.
Symptom Monitoring
- Burning or stinging sensation at application site
- Itching
- Skin atrophy (thinning, easy bruising)
- Striae (stretch marks)
- Telangiectasias (spider veins)
- Folliculitis
- Acneiform eruptions
- Perioral dermatitis
- Allergic contact dermatitis
- Secondary infection
- Signs of systemic absorption (e.g., weight gain, moon face, fatigue, weakness, delayed wound healing, hyperglycemia, blurred vision)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with corticosteroids. Systemic absorption is minimal with topical use, but prolonged or extensive use should be avoided.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenic effects observed in animal studies with systemic corticosteroids; risk with topical clobetasol is low due to minimal absorption but caution advised.
Second Trimester:
Risk of fetal growth retardation or other systemic effects if significant absorption occurs; generally low risk with appropriate topical use.
Third Trimester:
Risk of adrenal suppression in the neonate if significant maternal absorption occurs, especially with prolonged use 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. If used, avoid applying to the breast area to prevent direct infant exposure.
Infant Risk:
Low risk with appropriate use due to minimal systemic absorption, but monitor infant for any signs of systemic corticosteroid effects (e.g., growth suppression).
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. Use in children under 12 years is generally not recommended. If used, limit to the smallest amount for the shortest duration necessary, and monitor closely for signs of HPA axis suppression, Cushing's syndrome, and growth retardation.
Geriatric Use
No specific dosage adjustments are required. However, elderly patients may have thinner skin and be more prone to local side effects such as skin atrophy, purpura, and telangiectasias. Monitor for these effects.
Clinical Information
Clinical Pearls
- Clobetasol propionate is a super-high potency topical corticosteroid; it should be used for short-term treatment (typically no more than 2 consecutive weeks) to minimize the risk of local and systemic side effects.
- Total weekly dosage should not exceed 50 grams.
- Avoid use on the face, groin, or axillae due to increased risk of skin atrophy, telangiectasias, and striae in these sensitive areas.
- Occlusive dressings significantly increase systemic absorption and should generally be avoided unless specifically directed by a physician.
- Patients should be advised to report any signs of local irritation, skin thinning, or systemic effects (e.g., unusual weight gain, fatigue).
- Abrupt discontinuation after prolonged or extensive use may lead to rebound flare of the underlying skin condition or adrenal insufficiency.
Alternative Therapies
- Other topical corticosteroids (e.g., betamethasone, fluocinonide, triamcinolone, hydrocortisone, depending on potency needed)
- 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.
Cost & Coverage
Average Cost:
$20 - $100 per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.