Clobetasol Prop 0.05% Oint 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
Glucocorticoid
Pregnancy Category
Category C
FDA Approved
May 1983
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobetasol propionate ointment is a very strong medicine used on the skin to treat severe itching, redness, and swelling caused by certain skin conditions like eczema or psoriasis. It works by reducing inflammation. It's important to use it exactly as prescribed, usually for a short time, because it's very potent.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Use this medication only as directed, and continue to use it even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area, in which case you should not wash it after application.
Clean the affected area before applying the medication, and make sure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Avoid applying the medication to your face, underarms, or groin area unless your doctor instructs you to do so.
Do not cover the treated area with bandages, dressings, or makeup unless your doctor advises you to do so.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration or freezing.
Be aware of the expiration date or the length of time you can store this medication before it needs to be discarded.
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 use extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Use this medication only as directed, and continue to use it even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area, in which case you should not wash it after application.
Clean the affected area before applying the medication, and make sure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Avoid applying the medication to your face, underarms, or groin area unless your doctor instructs you to do so.
Do not cover the treated area with bandages, dressings, or makeup unless your doctor advises you to do so.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration or freezing.
Be aware of the expiration date or the length of time you can store this medication before it needs to be discarded.
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 use extra doses.
Lifestyle & Tips
- Wash hands before and after applying the ointment.
- Apply a very thin layer only to the affected skin areas.
- Do not use more than the prescribed amount or for longer than 2 weeks unless directed by your doctor.
- Do not cover the treated area with bandages or plastic wrap unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid applying to 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 use on broken, infected, or irritated skin without medical advice.
- 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 once or twice daily. Treatment should be limited to 2 consecutive weeks, and the total dosage should not exceed 50 g per week.
Condition-Specific Dosing:
psoriasis:
Apply twice daily for up to 2 weeks. If no response, re-evaluate diagnosis.
eczema:
Apply once or twice daily for up to 2 weeks.
Pediatric Dosing
Neonatal:
Not established (contraindicated in infants under 1 year of age).
Infant:
Not established (contraindicated in infants under 1 year of age). Use in children <12 years is generally not recommended due to increased risk of systemic effects.
Child:
Dosing or Not established. Use in children <12 years is generally not recommended due to increased risk of systemic effects. If used, limit to shortest duration and smallest amount possible.
Adolescent:
Similar to adult dosing, but with caution and limited duration due to potential for 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 super-high potency corticosteroid. It acts by inducing phospholipase A2 inhibitory proteins, collectively called 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. Thus, clobetasol propionate exerts anti-inflammatory, antipruritic, and vasoconstrictive actions.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption; however, percutaneous absorption can occur, especially with prolonged use, large surface areas, or occlusive dressings. Absorption is higher in areas with thin skin (e.g., face, genitals) or damaged skin.
Tmax:
Not precisely quantifiable for topical application due to minimal systemic absorption. Systemic effects, if they occur, are delayed.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not precisely quantifiable due to minimal systemic absorption.
ProteinBinding:
Approximately 90% (for systemically absorbed corticosteroids).
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Not precisely quantifiable for topical application; systemic half-life of corticosteroids varies but is generally a few hours.
Clearance:
Not precisely quantifiable for topical application.
ExcretionRoute:
Metabolites are primarily excreted by the kidneys, with some biliary excretion.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Within hours to days for anti-inflammatory and antipruritic effects.
PeakEffect:
Within days to a week of consistent application.
DurationOfAction:
Effects persist for several hours after application; however, continuous application is needed for sustained therapeutic effect.
Confidence:
Medium
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
Reporting Side Effects
This is not an exhaustive list of possible side effects. 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.
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
Reporting Side Effects
This is not an exhaustive list of possible side effects. 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, itching, or irritation at the application site
- Skin thinning, easy bruising, or stretch marks (striae)
- Acne-like breakouts or increased hair growth in treated areas
- Signs of infection (pus, fever, worsening pain)
- Unusual tiredness, weight gain, swelling in ankles/feet, or muscle weakness (signs of systemic absorption/Cushing's syndrome)
- Blurred vision or eye pain (if used near eyes)
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 infection present 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.
Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm it is safe to do so in conjunction with this medication.
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 infection present 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.
Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm it is safe to do so in conjunction with this medication.
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 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 longer than the duration prescribed by your doctor.
If this medication is accidentally swallowed, it can be harmful, so immediately contact a doctor or a poison control center. Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult your doctor.
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 using this medication in children, exercise caution, as they may be at a higher risk of experiencing certain side effects. In some cases, this medication can affect growth in children and teenagers, making regular growth checks 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 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 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 longer than the duration prescribed by your doctor.
If this medication is accidentally swallowed, it can be harmful, so immediately contact a doctor or a poison control center. Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult your doctor.
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 using this medication in children, exercise caution, as they may be at a higher risk of experiencing certain side effects. In some cases, this medication can affect growth in children and teenagers, making regular growth checks 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 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 Cushing's syndrome (e.g., moon face, central obesity, thin skin, easy bruising), hyperglycemia, glucosuria, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
- Acute overdose is unlikely with topical application due to minimal absorption.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call a poison control center immediately (1-800-222-1222 in the US) 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.
HPA axis suppression assessment (e.g., plasma cortisol levels, ACTH stimulation test)
Rationale: Consider if large body surface area is treated, prolonged use, or occlusive dressings are used, especially in children, due to risk of systemic absorption.
Timing: Prior to initiation if high risk, or if symptoms of systemic absorption develop.
Routine Monitoring
Local skin reactions (e.g., atrophy, striae, telangiectasias, burning, itching, irritation)
Frequency: Regularly during treatment (e.g., weekly or at follow-up visits).
Target: Absence of new or worsening reactions.
Action Threshold: If severe or persistent reactions occur, discontinue use and re-evaluate.
Signs of systemic corticosteroid effects (e.g., Cushing's syndrome, hyperglycemia, growth retardation in children)
Frequency: Periodically, especially with prolonged or extensive use.
Target: Absence of systemic signs.
Action Threshold: If signs develop, discontinue use gradually and consult endocrinologist.
Intraocular pressure (if applied near eyes)
Frequency: Periodically, especially with prolonged use near eyes.
Target: Normal intraocular pressure.
Action Threshold: If elevated, discontinue use and refer to ophthalmologist.
Symptom Monitoring
- Worsening of skin condition
- New skin irritation, burning, itching, redness
- Thinning of skin, easy bruising
- Development of stretch marks (striae)
- Increased hair growth in treated areas
- Acne-like eruptions
- Changes in vision (if applied near eyes)
- Unusual fatigue, weakness, dizziness (signs of HPA axis suppression)
- Increased thirst or urination (signs of hyperglycemia)
Special Patient Groups
Pregnancy
Clobetasol propionate is Pregnancy Category C. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. High potency topical corticosteroids should be used with caution, for the shortest duration, and on the smallest body surface area possible.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity with high doses of systemic corticosteroids; topical absorption is minimal but caution advised.
Second Trimester:
Risk of fetal growth restriction or HPA axis suppression with extensive or prolonged use.
Third Trimester:
Risk of fetal growth restriction or HPA axis suppression with extensive or prolonged use.
Lactation
Clobetasol propionate is rated L3 (moderately safe) for lactation. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised. If used, avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk of adverse effects to the infant with limited, short-term use. Monitor for signs of systemic effects in the infant if used extensively by the mother.
Pediatric Use
Children are more susceptible to systemic toxicity from topical corticosteroids due to their larger skin surface area to body weight ratio. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported. Growth retardation may occur. Use in children under 12 years is generally not recommended. If used, limit to the smallest amount and shortest duration possible, and monitor closely for systemic effects.
Geriatric Use
No specific dosage adjustments are generally needed. However, elderly patients may have thinner skin, which could potentially increase systemic absorption and susceptibility to local side effects (e.g., skin atrophy, purpura). Use with caution and monitor for adverse effects.
Clinical Information
Clinical Pearls
- Clobetasol propionate is one of the most potent topical corticosteroids; reserve its use for severe, recalcitrant dermatoses.
- Emphasize the 'thin layer' application and strict adherence to the 2-week maximum treatment duration to minimize systemic absorption and local side effects.
- Educate patients on the signs of skin atrophy (thinning, shiny skin, visible blood vessels) and HPA axis suppression.
- Avoid use on the face, groin, or axillae unless specifically directed by a dermatologist, due to increased risk of side effects in these sensitive areas.
- Consider tapering the frequency of application (e.g., every other day) or switching to a lower potency corticosteroid for maintenance therapy if prolonged treatment is needed.
- Always assess for underlying infection before initiating corticosteroid therapy, as it can worsen fungal or bacterial infections.
Alternative Therapies
- Other high-potency topical corticosteroids (e.g., Halobetasol propionate, Betamethasone dipropionate augmented)
- Medium-potency topical corticosteroids (e.g., Triamcinolone acetonide, Mometasone furoate)
- Low-potency topical corticosteroids (e.g., Hydrocortisone)
- Topical calcineurin inhibitors (e.g., Tacrolimus, Pimecrolimus) for sensitive areas or long-term use
- 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 60g tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.