Clobex 0.05% Spray 59ml
It is used to treat plaque psoriasis.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Synthetic Glucocorticoid; Anti-inflammatory Agent
Pregnancy Category
Category C
FDA Approved
Oct 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobex Spray is a strong medicine applied to the skin to reduce redness, itching, and swelling caused by certain skin conditions like psoriasis. It's a type of steroid that works on the skin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Keep the medication away from your 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 this case, do not wash your hand 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 is no longer usable.
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. It is essential to use this medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Keep the medication away from your 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 this case, do not wash your hand 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 is no longer usable.
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
- Apply a thin layer of the spray to the affected skin area once daily. Do not spray directly onto the face, groin, or armpits.
- Gently rub it in if needed, but the spray is designed to spread easily.
- Wash your hands thoroughly after applying the medication.
- Do not cover the treated area with bandages or other dressings unless directed by your doctor, as this can increase absorption and side effects.
- Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not use for longer than 2 consecutive weeks unless specifically instructed by your doctor.
- Do not use more than 50 grams (one 59mL bottle) per week.
- Do not use on children under 18 years of age.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected areas once daily for up to 2 consecutive weeks. Do not exceed 50g (approximately 59mL) per week.
Condition-Specific Dosing:
Plaque Psoriasis:
Apply to affected areas once daily for up to 2 consecutive weeks. Treatment beyond 2 weeks is not recommended. Total dosage should not exceed 50g per week.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and effectiveness in pediatric patients under 18 years of age have not been established. Not recommended for use in pediatric patients.)
Adolescent:
Not established (Safety and effectiveness in pediatric patients under 18 years of age have not been established. Not recommended for use in pediatric patients.)
Dose Adjustments
Renal Impairment:
Mild:
Not typically required for topical use due to minimal systemic absorption.
Moderate:
Not typically required for topical use due to minimal systemic absorption.
Severe:
Not typically required for topical use due to minimal systemic absorption.
Dialysis:
Not applicable for topical use.
Hepatic Impairment:
Mild:
Not typically required for topical use due to minimal systemic absorption.
Moderate:
Not typically required for topical use due to minimal systemic absorption.
Severe:
Not typically required for topical use due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Clobetasol propionate is a high-potency synthetic corticosteroid. It exerts its therapeutic effects primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions. Corticosteroids are thought to act by inducing phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid.
Pharmacokinetics
Absorption:
Bioavailability:
Varies; systemic absorption of topical corticosteroids can occur, with the extent dependent on the vehicle, integrity of the epidermal barrier, and use of occlusive dressings. Up to 5% systemic absorption has been reported for clobetasol propionate cream/ointment.
Tmax:
Not well-defined for topical application; systemic levels are generally low.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not precisely quantified for topical application; systemically absorbed corticosteroids are widely distributed throughout the body.
ProteinBinding:
Approximately 97% (for systemic corticosteroids)
CnssPenetration:
Limited (for topical application, unless significant systemic absorption occurs)
Elimination:
HalfLife:
Systemic half-life of absorbed clobetasol is approximately 3-5 hours.
Clearance:
Not precisely quantified for topical application.
ExcretionRoute:
Primarily renal excretion of metabolites, with some biliary excretion.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Within days for anti-inflammatory and antipruritic effects.
PeakEffect:
Within 1-2 weeks of consistent application.
DurationOfAction:
Effects persist as long as treatment continues; local effects dissipate upon 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:
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:
Burning or stinging
Dry skin
* Redness
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Increased redness, itching, or irritation at the application site.
- Skin thinning, easy bruising, or stretch marks (striae).
- Changes in skin color (lightening or darkening).
- Acne-like breakouts or increased hair growth in the treated area.
- Signs of infection (pus, fever, worsening pain).
- Unusual tiredness, weakness, nausea, vomiting, or dizziness (signs of systemic absorption and adrenal suppression).
- Blurred vision or other vision problems (rare, but possible with long-term or extensive use).
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.
Do not start, stop, 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 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.
Do not start, stop, 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.
To minimize risks, 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 ensure safe use.
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.
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 using this medication in children, be aware that the risk of certain side effects may be higher. Additionally, this medication may affect growth in children and teens, and regular growth checks may be necessary. Consult your doctor to discuss these potential risks.
* If you are breast-feeding, avoid applying this medication directly to the nipple or surrounding area.
Before starting this medication, inform your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Your doctor will help you weigh the benefits and risks of using this medication during these situations.
To minimize risks, 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 ensure safe use.
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.
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 using this medication in children, be aware that the risk of certain side effects may be higher. Additionally, this medication may affect growth in children and teens, and regular growth checks may be necessary. Consult your doctor to discuss these potential risks.
* If you are breast-feeding, avoid applying this medication directly to the nipple or surrounding area.
Before starting this medication, inform your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Your doctor will help you weigh the benefits and risks of using this medication during these situations.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic effects due to increased absorption, including suppression of the hypothalamic-pituitary-adrenal (HPA) axis, Cushing's syndrome, hyperglycemia, and glycosuria.
- Symptoms of HPA axis suppression may include fatigue, weakness, nausea, vomiting, low blood pressure, and dizziness.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment should be initiated. In case of acute overdose, call a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention.
Drug Interactions
Moderate Interactions
- Drugs that inhibit CYP3A4 (e.g., ritonavir, itraconazole): May increase systemic exposure to clobetasol, potentially leading to HPA axis suppression.
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of the dermatosis and identify areas for treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response and adverse skin reactions (e.g., atrophy, striae, telangiectasias, folliculitis)
Frequency: Regularly during treatment, especially at follow-up visits.
Target: Improvement in dermatosis with minimal or no adverse effects.
Action Threshold: If no improvement after 2 weeks, or if adverse reactions occur, reassess diagnosis and treatment. Discontinue if significant skin atrophy or other severe local reactions develop.
Signs and symptoms of HPA axis suppression (e.g., fatigue, weakness, nausea, vomiting, hypotension)
Frequency: Periodically, especially with extensive use, prolonged duration, or use under occlusion.
Target: Absence of symptoms.
Action Threshold: If symptoms occur, consider HPA axis evaluation (e.g., ACTH stimulation test, plasma cortisol, urinary free cortisol). If suppression is confirmed, gradually withdraw the drug or substitute with a less potent corticosteroid.
Symptom Monitoring
- Burning
- Stinging
- Itching
- Dryness
- Folliculitis
- Hypertrichosis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Maceration of the skin
- Secondary infection
- Skin atrophy
- Striae
- Miliaria
- Signs of Cushing's syndrome (e.g., moon face, buffalo hump, central obesity)
- Hyperglycemia
- Glycosuria
Special Patient Groups
Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant women. Clobetasol propionate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity observed in animal studies with high doses of corticosteroids. Use with caution.
Second Trimester:
Use with caution; systemic absorption is possible.
Third Trimester:
Use with caution; potential for HPA axis suppression in the newborn if used extensively or for prolonged periods near term.
Lactation
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Use with caution. If used, avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with limited, short-term use. Monitor infant for potential adverse effects such as growth retardation or adrenal suppression, though unlikely with typical topical use.
Pediatric Use
Safety and effectiveness in pediatric patients under 18 years of age have not been established. Pediatric patients may be more susceptible to systemic toxicity from topical corticosteroids due to their larger skin surface area to body weight ratio. Not recommended for use in pediatric patients.
Geriatric Use
Clinical studies of Clobex Spray did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Elderly patients may have thinner skin and be more susceptible to local adverse effects like atrophy.
Clinical Information
Clinical Pearls
- Clobex Spray is a super high-potency topical corticosteroid; use it sparingly and for short durations (max 2 weeks) to minimize systemic absorption and local side effects.
- Do not use on the face, groin, or axillae, or for diaper dermatitis, as these areas are more susceptible to corticosteroid side effects.
- Educate patients on the proper application technique: spray a thin layer, do not rub excessively, and wash hands after use.
- Monitor for signs of HPA axis suppression, especially in patients using large amounts, on large surface areas, or under occlusion.
- If no improvement is seen after 2 weeks, reassess the diagnosis and treatment plan.
Alternative Therapies
- Other topical corticosteroids of varying potencies (e.g., fluocinonide, triamcinolone, hydrocortisone)
- Vitamin D analogs (e.g., calcipotriene) for psoriasis
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for inflammatory skin conditions
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe psoriasis
- Phototherapy
Cost & Coverage
Average Cost:
Varies widely, typically $100 - $500+ per 59mL spray
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3, depending on insurance plan and formulary. Generic versions are often Tier 1 or 2.
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. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.