Clobetasol 0.05% Spray 125ml
It is used to treat plaque psoriasis.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
Category C
FDA Approved
May 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobetasol is a very strong (high-potency) steroid medicine that you spray on your skin. It helps reduce redness, itching, and swelling caused by certain skin conditions like psoriasis or eczema. It works by calming down your body's natural response that causes these symptoms.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area, in which case you should not wash it after application.
Clean the affected area before applying the medication and dry it thoroughly.
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 and freezing.
Be aware of the medication's expiration date and discard it when it expires.
Protect the medication from heat and open flames.
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 make up for a missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area, in which case you should not wash it after application.
Clean the affected area before applying the medication and dry it thoroughly.
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 and freezing.
Be aware of the medication's expiration date and discard it when it expires.
Protect the medication from heat and open flames.
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 make up for a missed one.
Lifestyle & Tips
- Use exactly as prescribed by your doctor. Do not use more often or for longer than directed (usually no more than 2 weeks).
- Do not use on your face, groin, or armpits unless specifically directed by your doctor.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not cover the treated area with bandages or other dressings unless instructed by your doctor, as this can increase absorption and side effects.
- Wash your hands before and after applying the spray.
- Do not use on broken or infected skin without consulting your doctor.
- Keep out of reach of children.
Available Forms & Alternatives
Available Strengths:
- Clobetasol Prop 0.05% Cream 60gm
- Clobetasol Prop 0.05% Oint 60gm
- Clobetasol Prop 0.05% Sol 50ml
- Clobetasol Prop 0.05% Cream 45gm
- Clobetasol Prop 0.05% Oint 30gm
- Clobetasol Prop 0.05% Oint 45gm
- Clobetasol Prop 0.05% Oint 15gm
- Clobetasol Prop 0.05% Cream 30gm
- Clobetasol Prop 0.05% Cream 15gm
- Clobetasol Prop 0.05% Sol 25ml
- Clobetasol Prop 0.05% Gel 30gm
- Clobetasol Prop 0.05% Gel 15gm
- Clobetasol Prop 0.05% Gel 60gm
- Clobetasol Prop 0.05% Gel 60gm
- Clobetasol 0.05% Emollient Crm 15gm
- Clobetasol 0.05% Emollient Crm 30gm
- Clobetasol 0.05% Emollient Crm 60gm
- Clobetasol Prop 0.05% Gel 15gm
- Clobetasol Prop 0.05% Gel 30gm
- Clobetasol Prop 0.05% Lotion 59ml
- Clobetasol Prop 0.05% Lotion 118ml
- Clobetasol 0.05% Shampoo 118ml
- Clobetasol 0.05% Emollntfoam 50gm
- Clobetasol 0.05% Emollnt Foam 100gm
- Clobetasol 0.05% Spray 59ml
- Clobetasol 0.05% Spray 125ml
- Clobetasol 0.05% Foam 50gm
- Clobetasol 0.05% Foam 100gm
- Clobetasol 0.05% Spray 59ml
- Clobetasol 0.05% Spray 125ml
- Clobetasol 0.05% Emollnt Foam 50gm
- Clobetasol 0.05% Shampoo 118ml
- Clobetasol Prop 0.05% Sol50ml
- Clobetasol Prop 0.05% Sol25ml
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected skin areas twice daily for up to 2 consecutive weeks. Do not exceed 50 g (59 mL) per week.
Condition-Specific Dosing:
psoriasis:
Apply to affected areas twice daily for up to 2 consecutive weeks. Limit treatment to 50 g (59 mL) per week.
eczema:
Apply to affected areas twice daily for up to 2 consecutive weeks. Limit treatment to 50 g (59 mL) per week.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 12 years of age due to increased risk of systemic absorption and HPA axis suppression.
Adolescent:
For adolescents 12 years and older, use with caution and for limited duration (e.g., up to 2 weeks), similar to adult dosing, but monitor closely for systemic effects.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment typically required for topical administration.
Moderate:
No specific dose adjustment typically required for topical administration.
Severe:
No specific dose adjustment typically required for topical administration. Use with caution if extensive application leads to significant systemic absorption.
Dialysis:
No specific considerations for topical administration, as systemic absorption is generally minimal.
Hepatic Impairment:
Mild:
No specific dose adjustment typically required for topical administration.
Moderate:
No specific dose adjustment typically required for topical administration.
Severe:
No specific dose adjustment typically required for topical administration. Use with caution if extensive application leads to significant systemic absorption.
Pharmacology
Mechanism of Action
Clobetasol propionate is a high-potency corticosteroid that exerts its therapeutic effects by binding to glucocorticoid receptors in the cytoplasm. This complex then translocates to the nucleus, where it modulates gene expression, leading to the synthesis of anti-inflammatory proteins (e.g., lipocortins) and inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes). This results in anti-inflammatory, antipruritic, and vasoconstrictive actions.
Pharmacokinetics
Absorption:
Bioavailability:
Varies significantly based on skin integrity, vehicle, application site, and use of occlusive dressings. Systemic absorption is generally low but can increase with inflamed skin, prolonged use, or large surface areas.
Tmax:
Not well-quantified for topical administration due to variable systemic absorption.
FoodEffect:
Not applicable (topical administration).
Distribution:
Vd:
Not well-quantified for topical administration.
ProteinBinding:
Approximately 90% (for systemically absorbed drug).
CnssPenetration:
Limited
Elimination:
HalfLife:
Not well-quantified for topical administration; systemic half-life of absorbed drug is approximately 3-5 hours.
Clearance:
Not well-quantified for topical administration.
ExcretionRoute:
Primarily renal excretion of metabolites, with some biliary excretion.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Within hours to days for anti-inflammatory effects.
PeakEffect:
Within days to a week of consistent application.
DurationOfAction:
Effects persist as long as applied; local effects can last for hours after application.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 help right away:
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 help right away:
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 irritation, burning, stinging, or redness at the application site.
- Thinning of the skin, easy bruising, or development of stretch marks (striae).
- Acne-like breakouts or increased hair growth where the spray is applied.
- Signs of infection (pus, fever, worsening pain).
- Unusual tiredness, weakness, weight gain, swelling in your face or neck (signs of too much steroid absorption).
- Blurred vision or other eye problems (rare, but report immediately).
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 modify the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication in combination 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 modify the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication in combination 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.
To ensure safe use, follow these precautions:
This medication is flammable, so avoid using it near open flames or while smoking.
Do not apply this medication to treat diaper rash.
This medication is not intended 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 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.
Important safety considerations:
If this medication is ingested, it can cause harm. In case of accidental ingestion, immediately contact a doctor or poison control center.
Long-term use of this medication may increase the risk of cataracts or glaucoma. Discuss this potential risk 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, exercise caution, as the risk of certain side effects may be higher. Additionally, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Discuss these potential risks with your doctor.
Special considerations for breastfeeding and pregnancy:
If you are breastfeeding, avoid applying this medication directly to the nipple or surrounding area.
* If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of using this medication to ensure the best outcome for you and your baby.
To ensure safe use, follow these precautions:
This medication is flammable, so avoid using it near open flames or while smoking.
Do not apply this medication to treat diaper rash.
This medication is not intended 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 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.
Important safety considerations:
If this medication is ingested, it can cause harm. In case of accidental ingestion, immediately contact a doctor or poison control center.
Long-term use of this medication may increase the risk of cataracts or glaucoma. Discuss this potential risk 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, exercise caution, as the risk of certain side effects may be higher. Additionally, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Discuss these potential risks with your doctor.
Special considerations for breastfeeding and pregnancy:
If you are breastfeeding, avoid applying this medication directly to the nipple or surrounding area.
* If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of using this medication to ensure the best outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Signs of Cushing's syndrome (e.g., moon face, buffalo hump, central obesity, skin thinning, easy bruising)
- Hyperglycemia (high blood sugar)
- Glucosuria (sugar in urine)
- Adrenal insufficiency (fatigue, weakness, nausea, vomiting, low blood pressure) upon abrupt withdrawal after prolonged, extensive use.
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
Monitoring
Baseline Monitoring
Skin condition assessment (type, severity, extent of lesion)
Rationale: To establish baseline for efficacy and adverse effect monitoring.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical signs of efficacy (e.g., reduction in erythema, scaling, pruritus)
Frequency: Regularly during treatment (e.g., weekly)
Target: Improvement in symptoms
Action Threshold: Lack of improvement or worsening symptoms may indicate need for re-evaluation or alternative therapy.
Local adverse reactions (e.g., skin atrophy, striae, telangiectasias, folliculitis, burning, stinging)
Frequency: Regularly during treatment
Target: Absence or minimal
Action Threshold: Presence of significant local adverse effects warrants discontinuation or change in therapy.
Signs/symptoms of HPA axis suppression (e.g., fatigue, weakness, weight loss, hypotension, nausea, vomiting)
Frequency: If used extensively, for prolonged periods, or in high-risk patients (children, large surface area, occlusive dressings)
Target: Absence
Action Threshold: Presence of symptoms warrants immediate medical evaluation and potential HPA axis testing (e.g., ACTH stimulation test).
Blood glucose (especially in diabetic patients)
Frequency: If significant systemic absorption is suspected or in diabetic patients
Target: Within normal limits
Action Threshold: Elevated blood glucose may indicate systemic absorption and require dose adjustment of antidiabetic medications or discontinuation of clobetasol.
Symptom Monitoring
- Increased redness or irritation at application site
- Skin thinning or bruising
- Development of stretch marks (striae)
- Acne-like eruptions
- Increased hair growth at application site
- Signs of infection (pus, fever)
- Unusual fatigue or weakness
- Weight gain or swelling (especially in face/neck)
- Blurred vision (rare, with prolonged systemic exposure)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. High-potency topical corticosteroids should be used with caution, for limited duration, and on small areas.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though data for topical steroids are limited and generally reassuring for limited use.
Second Trimester:
Risk of systemic absorption and potential fetal effects (e.g., growth restriction) if used extensively.
Third Trimester:
Risk of systemic absorption and potential fetal effects (e.g., HPA axis suppression) if used extensively.
Lactation
Clobetasol is excreted in breast milk following systemic administration. While systemic absorption from topical application is generally low, caution should be exercised. Use the lowest effective dose for the shortest duration. Avoid applying to the breast area to prevent direct infant exposure.
Infant Risk:
Low risk with limited, short-term use on small areas. Potential for adverse effects (e.g., growth suppression, HPA axis suppression) with extensive or prolonged maternal use due to systemic absorption.
Pediatric Use
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. Not recommended for children under 12 years of age. If used in adolescents, monitor closely and limit duration and amount.
Geriatric Use
Generally safe for use in the elderly. However, geriatric patients may have thinner skin, which could increase the risk of local adverse effects (e.g., atrophy, purpura) and potentially systemic absorption. Use with caution and monitor skin integrity.
Clinical Information
Clinical Pearls
- Clobetasol propionate 0.05% spray is a super high-potency topical corticosteroid; use it judiciously and for short durations (typically up to 2 weeks).
- Emphasize the 'less is more' approach: a thin layer is sufficient. Do not apply excessively.
- Educate patients on the signs of skin atrophy (thinning, bruising, shiny appearance) and systemic absorption (e.g., fatigue, weight gain).
- This spray formulation is often preferred for hairy areas or large surface areas due to ease of application and rapid drying.
- Avoid using on the face, groin, or axillae unless specifically directed by a dermatologist, due to increased risk of local side effects in these sensitive areas.
- Re-evaluate the patient if no improvement is seen after 2 weeks of treatment.
Alternative Therapies
- Other topical corticosteroids of varying potencies (e.g., triamcinolone, fluocinonide, betamethasone, hydrocortisone)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema, especially on sensitive areas.
- Vitamin D analogs (e.g., calcipotriene) for psoriasis.
- Topical retinoids (e.g., tazarotene) for psoriasis.
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread conditions.
- Phototherapy (UVB, PUVA).
Cost & Coverage
Average Cost:
$100 - $300+ per 125ml spray
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (may require prior authorization for brand)
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 have additional patient information leaflets, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, we encourage you 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 reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.