Clobetasol Prop 0.05% Oint 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
Glucocorticoid; Anti-inflammatory agent
Pregnancy Category
Category C
FDA Approved
Aug 1983
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobetasol is a very strong (high-potency) steroid medicine that you put on your skin. It helps reduce redness, swelling, and itching caused by skin conditions like eczema and psoriasis. It 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. 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 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 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 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 take extra doses.
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 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 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 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 take extra doses.
Lifestyle & Tips
- Apply a very thin layer only to the affected skin areas.
- Wash your hands before and after applying the ointment.
- Do not use more than prescribed or for longer than 2 weeks unless directed by your doctor.
- Do not use on your face, groin, or armpits unless specifically told to by your doctor.
- Do not cover the treated area with bandages or tight dressings unless instructed by your doctor, as this can increase absorption.
- Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
- 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 film 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 twice daily for up to 2 weeks. Re-evaluate if no improvement.
Eczema:
Apply twice daily for up to 2 weeks. Re-evaluate if no improvement.
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 for children under 12 years due to increased systemic absorption risk and HPA axis suppression)
Adolescent:
For adolescents 12 years and older, apply a thin film to affected areas twice daily for up to 2 consecutive weeks. Do not exceed 50 g per week.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical use due to minimal systemic absorption.
Moderate:
No specific adjustment needed for topical use due to minimal systemic absorption.
Severe:
No specific adjustment needed for topical use due to minimal systemic absorption.
Dialysis:
No specific adjustment needed for topical use due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical use due to minimal systemic absorption.
Moderate:
No specific adjustment needed for topical use due to minimal systemic absorption.
Severe:
No specific adjustment needed for topical use due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Clobetasol propionate is a high-potency synthetic 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; minimal systemic absorption (typically <1%) but can increase with inflamed skin, occlusion, or large surface areas.
Tmax:
Not well-defined for topical application; systemic levels are generally undetectable.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not well-defined for topical application; systemically absorbed corticosteroids are extensively bound to plasma proteins.
ProteinBinding:
Approximately 97% (for systemically absorbed corticosteroids)
CnssPenetration:
Limited (for systemically absorbed corticosteroids)
Elimination:
HalfLife:
Not well-defined for topical application; systemically absorbed corticosteroids have variable half-lives.
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Renal and biliary (for systemically absorbed portion).
Unchanged:
Minimal (for systemically absorbed portion).
Pharmacodynamics
OnsetOfAction:
Within hours to days for anti-inflammatory effects.
PeakEffect:
Within days of consistent application.
DurationOfAction:
Effects persist as long as applied; residual effects may last for a short period after discontinuation.
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 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. However, 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 attention if they bother you or do not go away:
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 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. However, 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 attention if they bother you or do not go away:
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:
- Increased redness, burning, itching, or irritation where you applied the medicine.
- Thinning of the skin, easy bruising, or stretch marks (striae) in the treated area.
- Acne-like breakouts or increased hair growth in the treated area.
- Signs of infection (pus, worsening pain, fever) in the treated area.
- If used extensively or for too long, watch for signs of systemic absorption like unusual weight gain, swelling in the face (moon face), or feeling very tired.
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 dosage 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 dosage 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, acne, rosacea, or rashes around the mouth. When applying it to a large area of skin or near open wounds, exercise caution and consult your doctor.
Before using any other skin products or medications, including soaps, discuss them with your doctor to ensure safe use. Avoid applying this medication to cuts, scrapes, or damaged skin. Do not use this medication for an extended period beyond the duration prescribed by your doctor.
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 your doctor about this potential risk.
This medication may not be suitable for children of all ages, so it is crucial to consult your doctor before administering it to a child. When used in children, this medication requires careful monitoring due to a higher risk of certain side effects. In some cases, it may affect growth in children and teenagers, necessitating regular growth checks; 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 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 your doctor.
Before using any other skin products or medications, including soaps, discuss them with your doctor to ensure safe use. Avoid applying this medication to cuts, scrapes, or damaged skin. Do not use this medication for an extended period beyond the duration prescribed by your doctor.
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 your doctor about this potential risk.
This medication may not be suitable for children of all ages, so it is crucial to consult your doctor before administering it to a child. When used in children, this medication requires careful monitoring due to a higher risk of certain side effects. In some cases, it may affect growth in children and teenagers, necessitating regular growth checks; 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 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 corticosteroids, including suppression of the hypothalamic-pituitary-adrenal (HPA) axis, Cushing's syndrome, hyperglycemia, and glucosuria.
- Symptoms may include weight gain, moon face, central obesity, thinning skin, easy bruising, muscle weakness, fatigue, and high blood sugar.
What to Do:
If overdose is suspected, contact a poison control center (e.g., 1-800-222-1222) or seek immediate medical attention. Treatment involves gradual withdrawal of the drug and supportive care for any systemic effects.
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.
Area of body surface affected
Rationale: To estimate total dose and risk of systemic absorption.
Timing: Prior to initiation of therapy.
Routine Monitoring
Efficacy (reduction in inflammation, pruritus)
Frequency: Weekly or as clinically indicated.
Target: Improvement in symptoms.
Action Threshold: If no improvement after 2 weeks, re-evaluate diagnosis and treatment.
Local adverse reactions (skin atrophy, striae, telangiectasias, folliculitis, burning, itching)
Frequency: At each follow-up visit.
Target: Absence or minimal signs.
Action Threshold: If severe or persistent, discontinue use.
Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, HPA axis suppression)
Frequency: Periodically, especially with prolonged use, large surface areas, or occlusion.
Target: Absence of signs/symptoms.
Action Threshold: If suspected, perform appropriate tests (e.g., ACTH stimulation test, plasma cortisol) and discontinue gradually.
Symptom Monitoring
- Burning
- Itching
- Irritation
- Dryness
- Folliculitis
- Hypertrichosis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Maceration of the skin
- Secondary infection
- Skin atrophy
- Striae
- Miliaria
- Weight gain (especially in children)
- Moon face (especially in children)
- Growth retardation (especially in children)
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 teratogenic effects, though systemic absorption from topical use is minimal.
Second Trimester:
Risk generally considered low with appropriate topical use.
Third Trimester:
Risk generally considered low with appropriate topical use.
Lactation
Use with caution. It is not known whether topical clobetasol is excreted in human milk. Systemically administered corticosteroids appear in human milk. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with proper application, but monitor for potential adverse effects if significant systemic absorption occurs in the mother.
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. Not recommended for children under 12 years of age. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported. Growth retardation may occur.
Geriatric Use
No specific dosage adjustments are necessary. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects like skin atrophy and purpura. Monitor for skin integrity.
Clinical Information
Clinical Pearls
- Clobetasol propionate is one of the most potent topical corticosteroids; use sparingly and for short durations (typically max 2 weeks).
- Avoid use on the face, groin, or axillae unless specifically directed by a dermatologist due to increased risk of skin atrophy, telangiectasias, and perioral dermatitis.
- Occlusive dressings significantly increase systemic absorption and local adverse effects; avoid unless specifically instructed by a physician.
- Patients should be advised to report any signs of local irritation, skin thinning, or systemic effects.
- Abrupt discontinuation after prolonged use on large areas may lead to rebound flare of the underlying dermatosis.
Alternative Therapies
- Other topical corticosteroids (e.g., fluocinonide, triamcinolone, hydrocortisone, betamethasone)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for conditions like eczema, especially on sensitive areas.
- Vitamin D analogs (e.g., calcipotriene) for psoriasis.
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread conditions.
Cost & Coverage
Average Cost:
$20 - $100+ per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 for generic; higher tiers for brand names.
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 your 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.