Clobetasol 0.05% Foam 50gm
It is used to treat skin rashes and other skin irritation.It is used to treat scalp psoriasis.It is used to treat plaque psoriasis.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Corticosteroid
Pregnancy Category
Category C
FDA Approved
Mar 2004
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobetasol foam is a very strong steroid medicine used on the skin to treat severe itching, redness, and swelling caused by certain skin conditions like psoriasis or eczema. It works by reducing inflammation.
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 on your skin, as directed. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Continue using the medication as instructed, even if your symptoms improve. Before and after applying the medication, wash your hands thoroughly. However, if you're treating a skin condition on your hand, do not wash your hand after applying the medication.
Prepare the affected area by cleaning it before use and drying it well. Apply a thin layer of the medication to the affected skin and gently rub it in. Unless your doctor advises otherwise, do not apply the medication to your face, underarms, or groin area.
Do not cover the treated area with bandages, dressings, or makeup unless your doctor instructs you to do so. If you're using a foam formulation, check with your pharmacist to see if it needs to be shaken before use. To use the foam, turn the can upside down and apply it directly to the affected area, gently rubbing it in. Note that some foams may melt if placed in your hand.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration or freezing. Be aware of the storage duration and discard the medication when it expires. Protect the medication from heat and open flames, and do not puncture or burn the container, even if it appears empty.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule. Do not apply two doses at the same time or use extra doses to make up for a missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Use this medication only on your skin, as directed. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Continue using the medication as instructed, even if your symptoms improve. Before and after applying the medication, wash your hands thoroughly. However, if you're treating a skin condition on your hand, do not wash your hand after applying the medication.
Prepare the affected area by cleaning it before use and drying it well. Apply a thin layer of the medication to the affected skin and gently rub it in. Unless your doctor advises otherwise, do not apply the medication to your face, underarms, or groin area.
Do not cover the treated area with bandages, dressings, or makeup unless your doctor instructs you to do so. If you're using a foam formulation, check with your pharmacist to see if it needs to be shaken before use. To use the foam, turn the can upside down and apply it directly to the affected area, gently rubbing it in. Note that some foams may melt if placed in your hand.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration or freezing. Be aware of the storage duration and discard the medication when it expires. Protect the medication from heat and open flames, and do not puncture or burn the container, even if it appears empty.
Missed Dose
If you miss a dose, apply it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule. Do not apply two doses at the same time or use extra doses to make up for a missed one.
Lifestyle & Tips
- Apply a thin layer of foam to the affected skin area only, as directed by your doctor. Do not use more than prescribed.
- Wash your hands before and after applying the foam.
- 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 other dressings unless instructed by your doctor, as this can increase absorption and side effects.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use for longer than 2 weeks continuously, unless specifically advised by 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 of foam 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 a thin layer of foam to the affected skin areas once or twice daily for up to 2 consecutive weeks. Re-evaluate if no improvement.
eczema:
Apply a thin layer of foam to the affected skin areas once or twice daily for up to 2 consecutive weeks. Re-evaluate if no improvement.
Pediatric Dosing
Neonatal:
Not established. Use is generally not recommended due to increased risk of systemic absorption and HPA axis suppression.
Infant:
Not established. Use is generally not recommended due to increased risk of systemic absorption and HPA axis suppression.
Child:
Not recommended for children under 12 years of age. For children 12 years and older, use with extreme caution and for the shortest duration possible, typically not exceeding 2 weeks. Monitor closely for signs of HPA axis suppression and growth retardation.
Adolescent:
For adolescents 12 years and older, apply a thin layer of foam to the affected skin areas once or twice daily for up to 2 consecutive weeks. Total dosage should not exceed 50 g per week. Monitor closely for signs of HPA axis suppression.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Clobetasol propionate is a highly potent synthetic corticosteroid. It exerts its therapeutic effects primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions. Corticosteroids diffuse across cell membranes and bind with high affinity to specific cytoplasmic receptors. This binding leads to a complex series of events, including translocation of the receptor-steroid complex into the nucleus, where it binds to specific DNA sequences (glucocorticoid response elements). This interaction modulates gene expression, leading to the synthesis of certain proteins (e.g., lipocortins) that inhibit phospholipase A2, thereby controlling the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes. They also suppress the immune response by inhibiting the migration of macrophages and leukocytes to the site of inflammation, and by reversing capillary permeability.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <1%) through intact skin. Absorption can be increased by occlusive dressings, inflammation, skin barrier disruption, and application to large surface areas or intertriginous areas.
Tmax:
Not well-defined for topical application due to minimal systemic absorption. Peak local effect is within hours.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not clinically significant for topical application due to minimal systemic absorption.
ProteinBinding:
Approximately 97% (for systemically absorbed portion, primarily to albumin and alpha-1 acid glycoprotein).
CnssPenetration:
Limited (not clinically relevant for topical application).
Elimination:
HalfLife:
Not well-defined for topical application due to minimal systemic absorption. Systemically absorbed corticosteroids are primarily eliminated renally.
Clearance:
Not clinically significant for topical application.
ExcretionRoute:
Primarily renal (for systemically absorbed portion).
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Local anti-inflammatory and antipruritic effects can be observed within hours of application.
PeakEffect:
Full therapeutic effect typically observed within days to a week of consistent application.
DurationOfAction:
Effects persist as long as applied, but treatment duration is limited to 2 weeks.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although 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 immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Irritation 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 help:
Burning or stinging
Dry skin
* Redness
This is not a complete 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.
Although 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 immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Irritation 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 help:
Burning or stinging
Dry skin
* Redness
This is not a complete 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 burning at the application site
- Skin thinning, easy bruising, or stretch marks (striae) where the medicine is applied
- New or worsening acne-like bumps
- Signs of skin infection (pus, warmth, spreading redness)
- Unusual fatigue, weakness, nausea, vomiting, or dizziness (signs of systemic absorption)
- Blurred vision or other eye problems (if applied 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 you have an 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 medications and health conditions.
Remember, do not start, stop, or change the dose 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 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 you have an 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 medications and health conditions.
Remember, do not start, stop, or change the dose 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.
To ensure safe use, please note the following precautions:
This medication is flammable, so avoid using it near open flames or while smoking.
Do not use this medication to treat diaper rash, 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 your doctor.
Before using other skin products or medications, including soaps, consult your doctor to avoid potential interactions.
Avoid applying this medication to cuts, scrapes, or damaged skin.
Use this medication only for the duration prescribed by your doctor.
In case of accidental ingestion, seek immediate medical attention by calling a doctor or poison control center.
Additionally, be aware of the following potential risks:
Long-term use of this medication may increase the risk of cataracts or glaucoma; discuss this with your doctor.
This medication may not be suitable for children of all ages; consult your doctor before administering it to a child.
When using this medication in children, be cautious, as the risk of certain side effects may be higher.
In some cases, this medication may affect growth in children and teenagers, requiring regular growth checks; discuss this with your doctor.
If you are breast-feeding, avoid applying this medication directly to the nipple or surrounding area.
Before taking this medication, inform your doctor if you are pregnant, plan to become pregnant, or are breast-feeding, as you will need to discuss the potential benefits and risks to you and your baby.
To ensure safe use, please note the following precautions:
This medication is flammable, so avoid using it near open flames or while smoking.
Do not use this medication to treat diaper rash, 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 your doctor.
Before using other skin products or medications, including soaps, consult your doctor to avoid potential interactions.
Avoid applying this medication to cuts, scrapes, or damaged skin.
Use this medication only for the duration prescribed by your doctor.
In case of accidental ingestion, seek immediate medical attention by calling a doctor or poison control center.
Additionally, be aware of the following potential risks:
Long-term use of this medication may increase the risk of cataracts or glaucoma; discuss this with your doctor.
This medication may not be suitable for children of all ages; consult your doctor before administering it to a child.
When using this medication in children, be cautious, as the risk of certain side effects may be higher.
In some cases, this medication may affect growth in children and teenagers, requiring regular growth checks; discuss this with your doctor.
If you are breast-feeding, avoid applying this medication directly to the nipple or surrounding area.
Before taking this medication, inform your doctor if you are pregnant, plan to become pregnant, or are breast-feeding, as you will need to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Signs of Cushing's syndrome (e.g., moon face, central obesity, thin skin, easy bruising)
- Hyperglycemia (high blood sugar)
- Glucosuria (sugar in urine)
- HPA axis suppression (fatigue, weakness, nausea, vomiting, low blood pressure)
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Contraindicated Interactions
- None known due to minimal systemic absorption.
Major Interactions
- None known due to minimal systemic absorption.
Moderate Interactions
- None known due to minimal systemic absorption.
Minor Interactions
- None known due to minimal systemic absorption.
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity, extent, and type of dermatosis.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical response of dermatosis
Frequency: Weekly or as clinically indicated
Target: Improvement in redness, scaling, itching
Action Threshold: Lack of improvement after 2 weeks, or worsening of condition, requires re-evaluation of diagnosis and treatment.
Local skin adverse reactions (e.g., atrophy, striae, telangiectasias, burning, itching, irritation)
Frequency: At each follow-up visit
Target: Absence of new or worsening local reactions
Action Threshold: Presence of significant local adverse reactions warrants discontinuation or change in therapy.
Signs of HPA axis suppression (e.g., fatigue, weakness, nausea, vomiting, hypotension, weight loss)
Frequency: Periodically, especially with prolonged use, large surface area application, or in pediatric patients.
Target: Absence of symptoms
Action Threshold: If suspected, perform ACTH stimulation test. Discontinue drug gradually if suppression confirmed.
Growth monitoring (in pediatric patients)
Frequency: Regularly (e.g., every 3-6 months)
Target: Normal growth velocity
Action Threshold: Growth retardation warrants discontinuation or reduction in therapy.
Symptom Monitoring
- Skin thinning or atrophy
- Stretch marks (striae)
- Easy bruising
- Increased hair growth (hypertrichosis)
- Acne-like eruptions
- Perioral dermatitis
- Burning, itching, irritation at application site
- Signs of secondary infection (pus, increased redness, warmth)
- Unusual fatigue or weakness
- Weight gain (especially central obesity)
- Moon face
- Delayed wound healing
Special Patient Groups
Pregnancy
Clobetasol is classified as Pregnancy Category C. Animal studies have shown teratogenic effects. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid large areas, prolonged use, or occlusive dressings.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenic effects observed in animal studies. Use with caution and only if clearly needed.
Second Trimester:
Potential for fetal growth restriction or other adverse effects with high doses or prolonged use. Use with caution.
Third Trimester:
Potential for fetal growth restriction or other adverse effects with high doses or prolonged use. Use with caution.
Lactation
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when Clobetasol foam is administered to a nursing woman. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with limited, short-term use on small areas, but potential for growth suppression or other adverse effects with extensive or prolonged use.
Pediatric Use
Children are more susceptible to systemic adverse effects (HPA axis suppression, Cushing's syndrome, growth retardation) from topical corticosteroids due to a larger skin surface area to body weight ratio. Use in children under 12 years is generally not recommended. If used in adolescents (12 years and older), limit treatment to the shortest duration possible (e.g., 2 weeks) and monitor closely for systemic effects.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may have thinner skin, which could potentially increase the risk of local adverse effects like skin atrophy. Use with caution and monitor for skin integrity.
Clinical Information
Clinical Pearls
- Clobetasol is a super-high potency topical corticosteroid; use it judiciously and for short durations (typically 2 weeks).
- Educate patients on proper application technique: a thin layer, only to affected areas, and avoiding healthy skin.
- Warn patients about the risk of skin atrophy, striae, and telangiectasias with prolonged use, especially on the face or intertriginous areas.
- Be vigilant for signs of HPA axis suppression, particularly in children or with extensive use, though rare with proper topical application.
- Foam formulations can be particularly useful for hairy areas or large surface areas due to ease of application and spreadability.
Alternative Therapies
- Medium to high potency topical corticosteroids (e.g., Triamcinolone, Fluocinonide, Mometasone) for less severe conditions or maintenance.
- Topical calcineurin inhibitors (e.g., Tacrolimus, Pimecrolimus) for steroid-sparing therapy, especially on sensitive areas.
- Vitamin D analogs (e.g., Calcipotriene) for psoriasis.
- Systemic therapies (e.g., biologics, oral immunosuppressants) for severe, widespread, or refractory dermatoses.
Cost & Coverage
Average Cost:
$100 - $300 per 50gm can
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 for more information. 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 details about the overdose, including the medication taken, the amount, and the time it occurred.