Clobetasol Prop 0.05% Gel 30gm
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, synthetic; Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Sep 1983
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobetasol propionate gel is a very strong medicine used on the skin to reduce redness, swelling, and itching caused by certain skin conditions like eczema or psoriasis. It's a type of steroid that works by calming down the immune response in your 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'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 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.
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 disposal.
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 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.
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 disposal.
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, as directed by your doctor. Do not use more than prescribed or for longer than 2 weeks.
- Wash your hands before and after applying the gel.
- 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 contact with eyes, nose, mouth, and genital areas. If contact occurs, rinse thoroughly with water.
- Do not use on the face, groin, or armpits unless directed by your doctor.
- Do not use for diaper rash.
- 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.
Condition-Specific Dosing:
Psoriasis:
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.
Eczema:
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.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Use with caution; not recommended for children under 12 years of age. If used, limit treatment to 5 days and avoid occlusive dressings. Increased risk of systemic absorption and HPA axis suppression.
Adolescent:
Use with caution; not recommended for children under 12 years of age. If used, limit treatment to 5 days and avoid occlusive dressings. Increased risk of systemic absorption and HPA axis suppression.
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 diffuse across cell membranes and bind to specific cytoplasmic receptors. These complexes then enter the nucleus, bind to DNA (chromatin), and stimulate the transcription of messenger RNA (mRNA) and subsequent protein synthesis of various enzymes, which are ultimately responsible for the anti-inflammatory effects. This includes the induction of 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.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (minimal systemic absorption, typically <1% in intact skin; increased with inflammation, skin barrier disruption, or occlusive dressings)
Tmax:
Not well-defined for topical application; systemic levels are generally low and transient.
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not well-defined for topical application; systemically absorbed corticosteroids are widely distributed.
ProteinBinding:
Approximately 97% (for systemically absorbed portion)
CnssPenetration:
Limited (for topical application)
Elimination:
HalfLife:
Not well-defined for topical application; systemically absorbed corticosteroids have a half-life of approximately 3-4 hours.
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Renal (primarily as metabolites), some biliary.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Hours to days (for anti-inflammatory and antipruritic effects)
PeakEffect:
Days to 2 weeks (for maximal therapeutic effect)
DurationOfAction:
Variable, depending on application frequency and skin condition.
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. While many people may not experience any side effects or only have minor ones, it's essential to contact your doctor or seek medical help if you notice any of the following:
Burning or stinging
Dry skin
* Redness
These are not all the possible side effects that may occur. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical 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. While many people may not experience any side effects or only have minor ones, it's essential to contact your doctor or seek medical help if you notice any of the following:
Burning or stinging
Dry skin
* Redness
These are not all the possible side effects that may occur. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Increased redness, swelling, or pus at the application site (signs of infection)
- Thinning of the skin, easy bruising, or stretch marks (striae)
- Changes in skin color (lightening or darkening)
- Acne-like breakouts
- Excessive hair growth in treated areas
- Blurred vision or other vision problems (rare, but can indicate cataracts or glaucoma)
- Unusual weight gain, rounding of the face, or increased fatigue (signs of systemic absorption and HPA axis suppression)
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 drugs and health issues. Never start, stop, or adjust the dosage 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 drugs and health issues. Never start, stop, or adjust the dosage 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.
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 ingestion, immediately contact a doctor or a poison control center. 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. Before administering this medication to a child, consult with your doctor. When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Discuss this with your doctor.
If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area. If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication to 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 ingestion, immediately contact a doctor or a poison control center. 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. Before administering this medication to a child, consult with your doctor. When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Discuss this with your doctor.
If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area. If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic effects of corticosteroid excess, including Cushing's syndrome (e.g., moon face, central obesity, striae, hypertension, hyperglycemia, muscle weakness), adrenal suppression (fatigue, weakness, nausea, vomiting, low blood pressure), and growth retardation in children.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention.
Drug Interactions
Moderate Interactions
- Drugs that inhibit CYP3A4 (e.g., ritonavir, itraconazole): May increase systemic exposure to clobetasol, potentially leading to HPA axis suppression. Use with caution.
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify areas for treatment.
Timing: Prior to initiation of therapy
Adrenal function (HPA axis suppression)
Rationale: Consider if large areas are treated, prolonged use, or occlusive dressings are applied, especially in children. Can be assessed via ACTH stimulation test or morning plasma cortisol.
Timing: Prior to initiation if high risk, or after 2 weeks of treatment if concerns arise.
Routine Monitoring
Efficacy of treatment
Frequency: Weekly or bi-weekly
Target: Reduction in inflammation, pruritus, and lesion size.
Action Threshold: If no improvement or worsening, re-evaluate diagnosis and treatment plan.
Local adverse reactions (e.g., skin atrophy, striae, telangiectasias, folliculitis)
Frequency: At each follow-up visit
Target: Absence of new or worsening skin changes.
Action Threshold: If present, reduce frequency, discontinue, or switch to a less potent corticosteroid.
Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, HPA axis suppression)
Frequency: Periodically, especially with prolonged or extensive use
Target: Normal blood glucose, absence of Cushingoid features.
Action Threshold: If suspected, perform appropriate laboratory tests (e.g., morning cortisol, ACTH stimulation test) and discontinue or taper therapy.
Symptom Monitoring
- Burning
- Stinging
- Itching
- Dryness
- Folliculitis
- Hypertrichosis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Maceration of the skin
- Secondary infection
- Skin atrophy
- Striae
- Miliaria
- Weight gain (systemic)
- Moon face (systemic)
- Fatigue (systemic)
- Muscle weakness (systemic)
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. Systemic absorption is minimal, but prolonged or extensive use should be avoided.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity observed in animal studies with high doses of corticosteroids. Human data are limited.
Second Trimester:
Risk of fetal growth restriction or other systemic effects with prolonged or high-dose use.
Third Trimester:
Risk of fetal growth restriction or other systemic effects with prolonged or high-dose use. Neonatal adrenal insufficiency is a theoretical risk if significant systemic absorption occurs.
Lactation
Use with caution. It is not known whether topical clobetasol is excreted in human milk. Systemic absorption is minimal, but caution is advised. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with limited, short-term use on small areas. Potential for adverse effects if significant systemic absorption occurs in the mother and is transferred to the infant.
Pediatric Use
Not recommended for children under 12 years of age. Children are more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, growth retardation) due to a larger skin surface area to body weight ratio and immature skin barrier. If used, limit treatment to 5 days and avoid occlusive dressings.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may have thinner skin and be more prone to local adverse effects like skin atrophy.
Clinical Information
Clinical Pearls
- Clobetasol propionate 0.05% gel is a super high-potency topical corticosteroid; use it sparingly and for short durations (typically no more than 2 consecutive weeks).
- Total dosage should not exceed 50 grams per week to minimize the risk of systemic absorption and HPA axis suppression.
- Avoid using on the face, groin, or axillae unless specifically directed by a dermatologist, due to increased risk of skin atrophy, telangiectasias, and other local side effects.
- Patients should be advised to report any signs of local irritation, infection, or systemic side effects.
- Consider tapering therapy or switching to a lower potency corticosteroid for maintenance or if prolonged treatment is needed.
Alternative Therapies
- Other topical corticosteroids (e.g., fluocinonide, triamcinolone, hydrocortisone, betamethasone)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
- Vitamin D analogs (e.g., calcipotriene) for psoriasis
- Topical retinoids (e.g., tazarotene) for psoriasis
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe cases
Cost & Coverage
Average Cost:
$20 - $100 per 30gm 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 is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.