Clobex 0.05% Lotion 118ml
It is used to treat skin rashes and other skin irritation.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?
Clobex Lotion is a very strong steroid medicine applied to the skin to reduce redness, itching, and swelling caused by certain skin conditions like psoriasis and eczema. It works by calming down the immune response in the skin. It's important to use it exactly as prescribed and for a short time because it's very potent.
How to Use This Medicine
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely.
Applying the Medication
Do not take this medication by mouth. It is for use on your skin only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Use the medication as directed, even if your symptoms improve.
Wash your hands before and after applying the medication, unless your hand is the treated area. If your hand is being treated, do 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.
Important Application Instructions
Do not apply the medication to your face, underarms, or groin area unless your doctor instructs you to do so.
Avoid using bandages, dressings, or makeup on the treated area unless your doctor advises you to do so.
Storing and Disposing of Your Medication
Store the medication at room temperature. Do not refrigerate or freeze it.
Be aware of the medication's expiration date and discard it if it is past that date.
Keep all medications in a safe place, out of the reach of children and pets.
Missing a 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 continue with 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 safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely.
Applying the Medication
Do not take this medication by mouth. It is for use on your skin only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Use the medication as directed, even if your symptoms improve.
Wash your hands before and after applying the medication, unless your hand is the treated area. If your hand is being treated, do 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.
Important Application Instructions
Do not apply the medication to your face, underarms, or groin area unless your doctor instructs you to do so.
Avoid using bandages, dressings, or makeup on the treated area unless your doctor advises you to do so.
Storing and Disposing of Your Medication
Store the medication at room temperature. Do not refrigerate or freeze it.
Be aware of the medication's expiration date and discard it if it is past that date.
Keep all medications in a safe place, out of the reach of children and pets.
Missing a 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 continue with 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 lotion.
- Apply a very thin layer only to the affected skin areas.
- Do not use more than the prescribed amount or for longer than 2 consecutive weeks unless directed by your doctor.
- Do not use on the face, groin, or armpits unless specifically instructed by your doctor, as these areas are more sensitive to side effects.
- 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. If contact occurs, rinse thoroughly with water.
- Keep out of reach of children.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin layer to the affected skin areas once daily. Treatment should be limited to 2 consecutive weeks, and the total dosage should not exceed 50 g per week.
Condition-Specific Dosing:
psoriasis:
Apply once daily for up to 2 consecutive weeks.
eczema:
Apply once daily for up to 2 consecutive weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 12 years of age due to increased risk of systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome). If used, extreme caution and limited duration are advised under strict medical supervision.
Adolescent:
Not recommended for children under 12 years of age. For adolescents 12 years and older, use with caution and limit duration to 2 consecutive weeks, not exceeding 50 g per week.
Dose Adjustments
Renal Impairment:
Mild:
No specific dosage adjustment recommended for topical use, but monitor for systemic effects if extensive application.
Moderate:
No specific dosage adjustment recommended for topical use, but monitor for systemic effects if extensive application.
Severe:
No specific dosage adjustment recommended for topical use, but monitor for systemic effects if extensive application.
Dialysis:
Considerations: Systemic absorption is possible; monitor for systemic effects.
Hepatic Impairment:
Mild:
No specific dosage adjustment recommended for topical use, but monitor for systemic effects if extensive application.
Moderate:
No specific dosage adjustment recommended for topical use, but monitor for systemic effects if extensive application.
Severe:
No specific dosage adjustment recommended for topical use, but monitor for systemic effects if extensive application.
Pharmacology
Mechanism of Action
Clobetasol propionate is a highly potent synthetic corticosteroid. It exerts its anti-inflammatory, antipruritic, and vasoconstrictive actions by inducing 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, from membrane phospholipids.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (depends on vehicle, skin integrity, site of application, occlusion). Significant systemic absorption can occur, especially with prolonged use, large surface areas, or occlusive dressings.
Tmax:
Not precisely defined for topical application due to variable absorption; systemic levels peak hours after application.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not precisely quantified for topical application; systemically absorbed drug distributes widely.
ProteinBinding:
Approximately 97% (for systemically absorbed corticosteroids)
CnssPenetration:
Limited (for systemically absorbed corticosteroids, but not primary route of action for topical use)
Elimination:
HalfLife:
Approximately 3-5 hours (for systemically absorbed clobetasol)
Clearance:
Not precisely quantified for topical application.
ExcretionRoute:
Primarily renal excretion of metabolites, some biliary excretion.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Within hours for symptomatic relief (e.g., reduced itching, redness); full anti-inflammatory effect may take days.
PeakEffect:
Within days of consistent application.
DurationOfAction:
Effects persist for several hours after application; typically applied once daily.
Confidence:
Medium
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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 experience any of the following:
Burning or stinging
Dry skin
* Redness
If you have any concerns about side effects or experience any other symptoms that bother you or do not go away, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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 experience any of the following:
Burning or stinging
Dry skin
* Redness
If you have any concerns about side effects or experience any other symptoms that bother you or do not go away, contact your doctor for medical advice. 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:
- Severe burning, stinging, or irritation at the application site
- New or worsening skin thinning, stretch marks, or changes in skin color
- Acne-like breakouts or increased hair growth in treated areas
- Signs of skin infection (e.g., pus, increased redness, warmth, pain)
- Unexplained weight gain, swelling in the face, increased thirst, or frequent urination (signs of systemic absorption)
- Blurred vision or other vision problems
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, as they may interact with this medication.
To ensure your safety, always check with your doctor before starting, stopping, or changing the dose of any medication, including this one. This will help prevent potential interactions and ensure that it is safe for you to take this medication with your other drugs 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, as they may interact with this medication.
To ensure your safety, always check with your doctor before starting, stopping, or changing the dose of any medication, including this one. This will help prevent potential interactions and ensure that it is safe for you to take this medication with your other drugs 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.
This medication is not intended to treat diaper rash. Additionally, it should not be used 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 with your doctor.
Before using other medications or products on your skin, including soaps, discuss them with your doctor. Avoid applying this medication to cuts, scrapes, or damaged skin. Do not use this medication for an extended period beyond what your doctor has prescribed.
If this medication is accidentally swallowed, it can be harmful. In such cases, immediately contact a doctor or a poison control center. Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult with your doctor.
This medication may not be suitable for children of all ages. Before administering it to a child, consult with your doctor. When using this medication in children, exercise caution, as the risk of certain side effects may be higher. In some cases, this medication can affect growth in children and teenagers, and they may require regular growth checks; discuss this with your doctor.
If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area. If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication to you and your baby.
This medication is not intended to treat diaper rash. Additionally, it should not be used 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 with your doctor.
Before using other medications or products on your skin, including soaps, discuss them with your doctor. Avoid applying this medication to cuts, scrapes, or damaged skin. Do not use this medication for an extended period beyond what your doctor has prescribed.
If this medication is accidentally swallowed, it can be harmful. In such cases, immediately contact a doctor or a poison control center. Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult with your doctor.
This medication may not be suitable for children of all ages. Before administering it to a child, consult with your doctor. When using this medication in children, exercise caution, as the risk of certain side effects may be higher. In some cases, this medication can affect growth in children and teenagers, and they may require regular growth checks; discuss this with your doctor.
If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area. If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication to you and your baby.
Overdose Information
Overdose Symptoms:
- Signs of Cushing's syndrome (e.g., moon face, central obesity, thinning skin, easy bruising, muscle weakness)
- Hyperglycemia (high blood sugar)
- Adrenal insufficiency (fatigue, weakness, nausea, vomiting, low blood pressure) upon abrupt withdrawal after prolonged, extensive use
What to Do:
If you suspect an overdose or significant systemic absorption, contact your doctor or poison control center immediately (e.g., call 1-800-222-1222 in the US). Treatment is supportive and may involve gradual withdrawal of the medication.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify areas for application.
Timing: Prior to initiation of therapy.
Area of application and total body surface area (BSA) involved
Rationale: To estimate potential for systemic absorption and guide dosage limits.
Timing: Prior to initiation of therapy.
HPA axis assessment (e.g., plasma cortisol, ACTH stimulation test)
Rationale: Consider for patients at high risk of systemic absorption (e.g., extensive use, prolonged use, children, occlusive dressings).
Timing: Prior to initiation if indicated.
Routine Monitoring
Local skin reactions (e.g., atrophy, striae, telangiectasias, burning, stinging, folliculitis)
Frequency: At each follow-up visit (e.g., weekly or bi-weekly during treatment).
Target: Absence or minimal.
Action Threshold: If severe or persistent, discontinue use or reduce frequency.
Signs of systemic absorption (e.g., Cushingoid features, hyperglycemia, growth retardation in children)
Frequency: At each follow-up visit, especially with prolonged or extensive use.
Target: Absence.
Action Threshold: If present, discontinue use and evaluate HPA axis function.
HPA axis suppression (e.g., plasma cortisol, ACTH stimulation test)
Frequency: Periodically, especially if treatment exceeds 2 weeks, involves large areas, or in high-risk patients.
Target: Normal HPA axis function.
Action Threshold: If suppressed, gradually withdraw therapy and manage adrenal insufficiency.
Symptom Monitoring
- Worsening of skin condition
- Signs of skin infection (redness, pus, warmth, pain)
- Severe burning, stinging, or itching at application site
- Development of new skin lesions (e.g., acne, rosacea-like eruption)
- Systemic symptoms such as unexplained weight gain, moon face, fatigue, muscle weakness, increased thirst, frequent urination (signs of Cushing's syndrome or hyperglycemia)
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. Systemic absorption can occur.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though data for topical clobetasol is limited. Avoid if possible.
Second Trimester:
Use with caution; monitor for systemic effects.
Third Trimester:
Use with caution; monitor for systemic effects and potential for HPA axis suppression in the neonate if used extensively.
Lactation
It is not known whether topical clobetasol is excreted in human milk. Systemically administered corticosteroids appear in human milk. Caution should be exercised when Clobex Lotion is administered to a nursing woman. Avoid applying to the breast area to prevent infant ingestion.
Infant Risk:
Low risk with limited, short-term topical use, but potential for systemic effects in infant if significant maternal absorption occurs or if applied to breast.
Pediatric Use
Not recommended for children under 12 years of age due to a higher risk of systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, growth retardation) due to a larger skin surface area to body weight ratio. If used, extreme caution, limited duration, and close monitoring are essential.
Geriatric Use
No specific dosage adjustments are generally needed. However, elderly patients may have thinner skin and be more susceptible to local side effects (e.g., skin atrophy, purpura) and potentially systemic absorption. Monitor closely.
Clinical Information
Clinical Pearls
- Clobetasol propionate 0.05% is one of the most potent topical corticosteroids available. Its use should be limited to severe dermatoses and for short durations (typically 2 weeks).
- Emphasize to patients the importance of applying a very thin layer and not exceeding the recommended amount (e.g., 50g/week) or duration.
- Educate patients on the signs of local side effects (skin thinning, stretch marks) and systemic absorption (Cushingoid features, hyperglycemia) and when to contact their healthcare provider.
- Avoid use on the face, groin, axillae, or under occlusion unless specifically directed by a dermatologist due to increased risk of side effects in these sensitive areas.
- Consider HPA axis suppression testing (e.g., ACTH stimulation test) if used extensively, for prolonged periods, or in high-risk populations like children.
Alternative Therapies
- Less potent topical corticosteroids (e.g., triamcinolone, fluocinonide, mometasone) for less severe conditions or maintenance.
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing therapy, especially on sensitive areas.
- Vitamin D analogs (e.g., calcipotriene) for psoriasis.
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread, or refractory dermatoses.
Cost & Coverage
Average Cost:
Varies widely (e.g., $100 - $500+) per 118ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand name); Tier 1 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, 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 check with your pharmacist. If you have any questions or concerns about this medication, consult 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.