Clobex 0.05% Spray 125ml
It is used to treat plaque psoriasis.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Category C
FDA Approved
May 2008
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobex Spray contains a very strong steroid medicine used on the skin to reduce redness, itching, and swelling caused by certain skin conditions. It's important to use it exactly as prescribed and for a short time to avoid side effects.
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 area being treated.
Clean the affected area before applying the medication, and make sure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Avoid applying the medication to your face, underarms, or groin area unless your doctor instructs you to do so.
Do not cover the treated area with bandages, dressings, or makeup unless your doctor advises you to do so.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration 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 Instructions
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 make up for a missed dose.
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 area being treated.
Clean the affected area before applying the medication, and make sure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Avoid applying the medication to your face, underarms, or groin area unless your doctor instructs you to do so.
Do not cover the treated area with bandages, dressings, or makeup unless your doctor advises you to do so.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration 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 Instructions
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 make up for a missed dose.
Lifestyle & Tips
- Wash hands before and after applying the spray.
- Spray directly onto the affected skin area and gently rub in, if necessary.
- Do not spray on the face, groin, or armpits unless specifically directed by your doctor.
- Do not use on broken or infected skin.
- Avoid contact with eyes, nose, and mouth.
- Do not bandage, cover, or wrap the treated skin area unless directed by your doctor, as this can increase absorption and side effects.
- Do not use for longer than 2 consecutive weeks without consulting your doctor.
- Do not exceed the recommended amount (e.g., 50g or 60mL per week).
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected areas twice daily
Condition-Specific Dosing:
duration:
Limit treatment to 2 consecutive weeks. Total dosage should not exceed 50 g (60 mL) per week.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Not recommended for patients under 18 years of age due to potential for HPA axis suppression)
Adolescent:
Not established (Not recommended for patients under 18 years of age due to potential for HPA axis suppression)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical use
Moderate:
No specific adjustment needed for topical use
Severe:
No specific adjustment needed for topical use
Dialysis:
No specific considerations for topical use
Hepatic Impairment:
Mild:
No specific adjustment needed for topical use
Moderate:
No specific adjustment needed for topical use
Severe:
No specific adjustment needed for topical use
Pharmacology
Mechanism of Action
Clobetasol propionate is a super-high potency corticosteroid. It induces phospholipase A2 inhibitory proteins, collectively called lipocortins. These proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Pharmacokinetics
Absorption:
Bioavailability:
Not quantifiable for topical application; varies based on vehicle, skin integrity, site of application, and occlusion. Systemic absorption can occur.
Tmax:
Not well-defined for topical application.
FoodEffect:
Not applicable for topical application.
Distribution:
Vd:
Not quantifiable for topical application; widely distributed after systemic absorption.
ProteinBinding:
Highly protein-bound (to albumin and transcortin) after systemic absorption.
CnssPenetration:
Limited for topical application; can occur with significant systemic absorption.
Elimination:
HalfLife:
Not well-defined for topical application; varies based on systemic absorption.
Clearance:
Not quantifiable for topical application.
ExcretionRoute:
Metabolites 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:
Not precisely defined for topical application; clinical improvement typically seen within 2 weeks.
DurationOfAction:
Varies; effects persist as long as applied, with residual anti-inflammatory effects after cessation.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent 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 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 may cause side effects. Many people experience no side effects or only minor 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, 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 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 may cause side effects. Many people experience no side effects or only minor 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, 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 thirst or urination (may indicate high blood sugar)
- Unusual weight gain, especially in the face or trunk
- Swelling in ankles or feet
- Muscle weakness or fatigue
- Changes in vision (blurred vision, halos around lights)
- Skin thinning, easy bruising, stretch marks, or changes in skin color
- Increased hair growth on the body or face
- Acne or rash around the mouth
- Signs of skin infection (redness, pus, worsening pain)
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 adjust 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 adjust 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, be aware of the following precautions:
- This medication is flammable, so avoid using it near open flames or while smoking.
- Do not apply this medication to treat diaper rash.
- It is not intended for treating acne, rosacea, or rashes around the mouth.
- Exercise caution when applying this medication to large areas of skin or near open wounds; consult your doctor for guidance.
- Before using any other skin products or medications, including soaps, discuss them with 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; 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 risk with your doctor.
- The suitability of this medication for children of all ages has not been established; consult your doctor before administering it 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, necessitating regular growth checks; consult your doctor for more information.
- If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area.
Before starting this medication, it is crucial to discuss the following with your doctor:
- If you are pregnant, planning to become pregnant, or are breastfeeding, you and your doctor need to weigh the benefits and risks of using this medication to ensure the best outcome for you and your baby.
To minimize risks, be aware of the following precautions:
- This medication is flammable, so avoid using it near open flames or while smoking.
- Do not apply this medication to treat diaper rash.
- It is not intended for treating acne, rosacea, or rashes around the mouth.
- Exercise caution when applying this medication to large areas of skin or near open wounds; consult your doctor for guidance.
- Before using any other skin products or medications, including soaps, discuss them with 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; 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 risk with your doctor.
- The suitability of this medication for children of all ages has not been established; consult your doctor before administering it 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, necessitating regular growth checks; consult your doctor for more information.
- If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area.
Before starting this medication, it is crucial to discuss the following with your doctor:
- If you are pregnant, planning to become pregnant, or are breastfeeding, you and your doctor need to weigh the benefits and risks of using this medication to ensure the best outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic effects such as Cushing's syndrome (e.g., moon face, central obesity, striae), hyperglycemia, glucosuria, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of skin condition
Rationale: To establish baseline severity of dermatosis.
Timing: Prior to initiation of therapy.
Routine Monitoring
Signs of HPA axis suppression (e.g., fatigue, weight loss, hypotension)
Frequency: Periodically, especially with prolonged or extensive use.
Target: Normal adrenal function.
Action Threshold: If signs or symptoms occur, consider HPA axis evaluation (e.g., ACTH stimulation test) and discontinuation/reduction of therapy.
Signs of Cushing's syndrome (e.g., moon face, central obesity, striae)
Frequency: Periodically, especially with prolonged or extensive use.
Target: Absence of Cushingoid features.
Action Threshold: If signs or symptoms occur, consider HPA axis evaluation and discontinuation/reduction of therapy.
Local skin reactions (e.g., atrophy, striae, telangiectasias, burning, itching)
Frequency: At each follow-up visit.
Target: Minimal to no local adverse effects.
Action Threshold: If severe or persistent, discontinue therapy.
Symptom Monitoring
- Increased thirst or urination (signs of hyperglycemia)
- Blurred vision (cataracts, glaucoma)
- Fatigue, weakness, dizziness (adrenal suppression)
- Weight gain, swelling (fluid retention, Cushing's)
- Skin thinning, bruising, stretch marks
- Increased hair growth (hypertrichosis)
- Acneiform eruptions
- Perioral dermatitis
- Secondary infection
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with corticosteroids.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though human data for topical corticosteroids are limited.
Second Trimester:
Risk of fetal growth restriction or other adverse effects with high doses or prolonged use.
Third Trimester:
Risk of fetal growth restriction or other adverse effects with high doses or prolonged use.
Lactation
Caution should be exercised when clobetasol propionate is administered to a nursing woman. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with limited, short-term use; higher risk with extensive application, prolonged use, or application to breast area due to potential for systemic absorption and excretion into breast milk, leading to infant growth suppression or other adverse effects.
Pediatric Use
Not recommended for patients under 18 years of age. Pediatric patients may be more susceptible to systemic toxicity from topical corticosteroids due to their larger skin surface area to body weight ratio. HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids.
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.
Clinical Information
Clinical Pearls
- Clobex Spray is a super-high potency topical corticosteroid; use with extreme caution and only for short durations (max 2 weeks).
- Avoid use on the face, groin, or axillae due to increased risk of local and systemic side effects.
- Patients should be instructed not to use more than 60 mL (50 g) per week.
- Monitor for signs of HPA axis suppression, especially in pediatric patients or with extensive/prolonged use.
- Consider alternative therapies for long-term management of chronic skin conditions.
Alternative Therapies
- Medium to high potency topical corticosteroids (e.g., triamcinolone, fluocinonide, mometasone)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for long-term management or sensitive areas
- Phototherapy (UVB, PUVA)
- Systemic immunomodulators (e.g., methotrexate, cyclosporine, biologics) for severe, widespread disease
Cost & Coverage
Average Cost:
Varies widely, typically high for brand-name Clobex Spray per 125ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 for brand; Tier 1 for 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'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 medication taken, the amount, and the time it happened.