Clobetasol 0.05% Spray 59ml
It is used to treat plaque psoriasis.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Oct 2008
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. 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. 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 the 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 expiration date or the length of time you can store the medication before it needs to be discarded.
Protect the medication from heat and open flames.
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 the 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 expiration date or the length of time you can store the medication before it needs to be discarded.
Protect the medication from heat and open flames.
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
- Use exactly as prescribed by your doctor. Do not use more often or for longer than directed.
- Shake the spray well before each use.
- Hold the nozzle about 3-4 inches from the affected skin area and spray directly onto the lesion. Gently rub in if directed by your doctor, but often it's just sprayed on.
- Do not spray on your face, groin, or armpits unless specifically told to by your doctor, as these areas are more sensitive to side effects.
- Avoid spraying near your eyes, nose, or mouth. If it gets into your eyes, rinse thoroughly with water.
- Do not cover the treated area with bandages or other dressings unless your doctor tells you to, as this can increase absorption and side effects.
- Wash your hands thoroughly after applying the spray, unless your hands are the treated area.
- Do not use this medicine for any other condition than what it was prescribed for.
- 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
Condition-Specific Dosing:
psoriasis:
Apply to affected skin areas twice daily for up to 2 weeks. Do not exceed 50g (or 59ml) per week. Treatment beyond 2 weeks is not recommended, and total dosage should not exceed 50g (or 59ml) 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, similar to adult dosing, but with increased monitoring for systemic effects.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically required due to minimal systemic absorption.
Moderate:
No specific adjustment typically required due to minimal systemic absorption.
Severe:
No specific adjustment typically required due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment typically required due to minimal systemic absorption.
Moderate:
No specific adjustment typically required due to minimal systemic absorption.
Severe:
No specific adjustment typically required 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:
Variable; systemic absorption depends on the vehicle, integrity of the epidermal barrier, and use of occlusive dressings. Can range from <1% to >5% depending on application site and condition.
Tmax:
Not precisely quantified for topical application due to minimal systemic absorption.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not precisely quantified for topical application due to minimal systemic absorption.
ProteinBinding:
Highly protein-bound (e.g., >90%) once absorbed systemically.
CnssPenetration:
Limited
Elimination:
HalfLife:
Systemic half-life of absorbed clobetasol is not well-defined for topical application, but generally short for corticosteroids.
Clearance:
Not precisely quantified for topical application due to minimal systemic absorption.
ExcretionRoute:
Metabolites are primarily excreted by the kidneys, with some excretion in the bile.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Within days of initiation of therapy.
PeakEffect:
Within 1-2 weeks of continuous therapy.
DurationOfAction:
Effects persist as long as the drug is applied; residual effects may last for days 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. 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. 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:
- Worsening of your skin condition or no improvement after 2 weeks.
- Signs of skin infection (increased redness, swelling, pain, pus).
- Severe burning, itching, or irritation at the application site.
- Thinning of the skin, easy bruising, or stretch marks where the medicine is applied.
- Unusual fatigue, weakness, nausea, vomiting, dizziness, or lightheadedness (signs of systemic absorption and adrenal suppression).
- Increased thirst or urination (possible signs of high blood sugar).
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 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 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:
- Keep this medication away from open flames or sparks, as it may be flammable. Do not use it near an open flame or while smoking.
- This medication is not intended for treating diaper rash.
- It should not be used to treat acne, rosacea, or rashes around the mouth.
- When applying this medication to a large skin area 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 avoid potential interactions.
- Avoid applying this medication to cuts, scrapes, or damaged skin.
- Use this medication only for the duration prescribed by your doctor. Do not exceed the recommended treatment period.
Important safety considerations:
- If this medication is ingested, it can cause harm. In case of accidental ingestion, immediately contact a doctor or a poison control center.
- Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.
- The safety and efficacy of this medication in children of all ages have not been established. Consult your doctor before administering this medication to a child.
- When used in children, this medication requires careful monitoring due to a higher risk of certain side effects.
- In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Consult your doctor to discuss this potential effect.
- If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area.
Pregnancy and breastfeeding considerations:
- If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of using this medication during these periods to ensure the best outcome for both you and your baby.
To ensure safe use, follow these precautions:
- Keep this medication away from open flames or sparks, as it may be flammable. Do not use it near an open flame or while smoking.
- This medication is not intended for treating diaper rash.
- It should not be used to treat acne, rosacea, or rashes around the mouth.
- When applying this medication to a large skin area 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 avoid potential interactions.
- Avoid applying this medication to cuts, scrapes, or damaged skin.
- Use this medication only for the duration prescribed by your doctor. Do not exceed the recommended treatment period.
Important safety considerations:
- If this medication is ingested, it can cause harm. In case of accidental ingestion, immediately contact a doctor or a poison control center.
- Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.
- The safety and efficacy of this medication in children of all ages have not been established. Consult your doctor before administering this medication to a child.
- When used in children, this medication requires careful monitoring due to a higher risk of certain side effects.
- In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Consult your doctor to discuss this potential effect.
- If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area.
Pregnancy and breastfeeding considerations:
- If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of using this medication during these periods to ensure the best outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Acute overdose with topical clobetasol is unlikely due to minimal systemic absorption.
- Chronic overuse or use on large surface areas, broken skin, or under occlusion can lead to systemic effects such as Cushing's syndrome (e.g., moon face, buffalo hump, central obesity), hyperglycemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis (leading to adrenal insufficiency upon withdrawal).
What to Do:
If you suspect chronic overuse or systemic effects, contact your doctor immediately. For acute accidental ingestion, call a poison control center (1-800-222-1222) or seek emergency medical attention. Management is supportive.
Drug Interactions
Monitoring
Baseline Monitoring
Assessment of skin condition (type, severity, extent of lesion)
Rationale: To establish baseline for efficacy and safety monitoring.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical efficacy (reduction in inflammation, pruritus, scaling)
Frequency: Weekly or as clinically indicated during treatment period.
Target: Improvement in symptoms.
Action Threshold: Lack of improvement or worsening of condition may indicate need for re-evaluation or alternative therapy.
Local adverse reactions (e.g., atrophy, striae, telangiectasias, burning, itching, irritation, folliculitis)
Frequency: At each follow-up visit.
Target: Absence or minimal local reactions.
Action Threshold: Presence of significant local reactions may warrant discontinuation or change in therapy.
Signs of HPA axis suppression (e.g., fatigue, weakness, nausea, vomiting, hypotension, hypoglycemia)
Frequency: Periodically, especially with extensive or prolonged use, or in pediatric patients.
Target: Normal adrenal function.
Action Threshold: If suspected, perform ACTH stimulation test or morning plasma cortisol levels. Discontinue or gradually withdraw if HPA axis suppression is confirmed.
Signs of infection (e.g., redness, warmth, pus, fever)
Frequency: At each follow-up visit.
Target: Absence of infection.
Action Threshold: If infection develops, discontinue clobetasol and initiate appropriate antimicrobial therapy.
Symptom Monitoring
- Worsening of skin condition
- Increased redness, swelling, or pain at application site
- Pus or discharge from lesions
- Fever or chills
- Unusual fatigue or weakness
- Nausea or vomiting
- Dizziness or lightheadedness
- Increased thirst or urination (signs of hyperglycemia)
Special Patient Groups
Pregnancy
Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Clobetasol is a potent corticosteroid, and systemic absorption can occur. Animal studies have shown teratogenic effects.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenic effects, though human data are limited. Avoid if possible.
Second Trimester:
Risk of fetal growth restriction or other systemic effects if significant absorption occurs. Use with caution.
Third Trimester:
Risk of fetal growth restriction or other systemic effects if significant absorption occurs. Use with caution.
Lactation
It is not known whether topical clobetasol is excreted in human 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 is administered to a nursing woman. If used, avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with limited, short-term use on small areas; higher risk with extensive, prolonged use due to potential for systemic absorption and excretion into breast milk, leading to potential adverse effects on the infant (e.g., growth suppression, adrenal suppression).
Pediatric Use
Not recommended for children under 12 years of age. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature adults due to a larger skin surface area to body weight ratio. Prolonged use should be avoided. If use is necessary, it should be for the shortest duration and least potent effective dose.
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 systemic absorption. Use with caution and monitor for adverse effects.
Clinical Information
Clinical Pearls
- Clobetasol is a very potent topical corticosteroid; use should be limited to short courses (typically 2 weeks) to minimize the risk of local and systemic side effects.
- Avoid use on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more prone to atrophy and other side effects.
- HPA axis suppression is a significant concern, especially with prolonged use, large surface areas, occlusive dressings, or in pediatric patients. Monitor for signs and symptoms.
- Patients should be educated on the correct application technique and the importance of not exceeding the recommended dose or duration.
- If no improvement is seen after 2 weeks, the diagnosis should be re-evaluated.
Alternative Therapies
- Other topical corticosteroids (e.g., fluocinonide, triamcinolone, betamethasone, hydrocortisone - varying potencies)
- Vitamin D analogs (e.g., calcipotriene for psoriasis)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus for eczema)
- Topical retinoids (e.g., tazarotene for psoriasis)
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine for severe cases)
Cost & Coverage
Average Cost:
$100 - $400 per 59ml spray
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand) / Tier 1 (Generic)
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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.