Clobetasol Prop 0.05% Lotion 118ml
It is used to treat skin rashes and other skin irritation.It is used to treat plaque psoriasis.
Drug Class
Corticosteroid, Topical
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
Category C
FDA Approved
Aug 1985
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobetasol propionate lotion is a strong medicine applied to the skin to reduce redness, itching, and swelling caused by skin conditions like psoriasis and eczema. It's a type of steroid, so it's important to use it exactly as prescribed and not for longer than recommended 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 to your skin only, avoiding the mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area, in which case you should not wash it after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Avoid applying the medication to 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 or freezing.
Be aware of the medication's expiration date and discard it when it is no longer usable.
Keep all medications in a safe location, out of the reach of children and pets.
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 to your skin only, avoiding the mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area, in which case you should not wash it after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Avoid applying the medication to 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 or freezing.
Be aware of the medication's expiration date and discard it when it is no longer usable.
Keep all medications in a safe location, out of the reach of children and pets.
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 lotion.
- Apply a thin layer only to the affected skin areas.
- Do not use more than the prescribed amount or for longer than 2 weeks unless directed by your doctor.
- Do not cover the treated area with bandages or other dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid contact with eyes, mouth, and other mucous membranes.
- Do not use on the face, groin, or armpits unless specifically directed by your doctor.
- Keep out of reach of children.
- Inform your doctor if your condition worsens or does not improve after 2 weeks.
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 a thin layer to the affected skin areas twice 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 a thin layer to affected areas twice daily for up to 2 consecutive weeks. Re-evaluate if no improvement.
eczema:
Apply a thin layer to affected areas twice daily for up to 2 consecutive weeks. Re-evaluate if no improvement.
Pediatric Dosing
Neonatal:
Not established (generally not recommended due to increased risk of systemic absorption and HPA axis suppression)
Infant:
Not established (generally not recommended due to increased risk of systemic absorption and HPA axis suppression)
Child:
Not recommended for children under 12 years of age. If used, limit to the smallest amount for the shortest duration possible, and monitor closely for systemic effects (e.g., HPA axis suppression).
Adolescent:
For adolescents 12 years and older, use with caution and limit to 2 consecutive weeks, not exceeding 50g/week, similar to adult dosing, but with close monitoring for systemic effects.
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 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. 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 can occur, especially with inflamed skin, occlusive dressings, or large surface areas. Percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Tmax:
Not well-defined for topical application due to variable systemic absorption.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not well-defined for topical application.
ProteinBinding:
Approximately 90% (for systemically absorbed corticosteroids)
CnssPenetration:
Limited for topical application; systemic absorption can lead to some CNS exposure.
Elimination:
HalfLife:
Not well-defined for topical application; systemically absorbed corticosteroids have variable half-lives (e.g., 3-4 hours for cortisol).
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Metabolites are primarily excreted in the urine and feces.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Within hours to days for anti-inflammatory and antipruritic effects.
PeakEffect:
Within days to a week of consistent application.
DurationOfAction:
Effects persist as long as applied; systemic effects can linger after discontinuation depending on extent of absorption.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek medical attention:
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
Most people do not experience serious side effects, and some may not have any side effects at all. However, if you notice any of the following side effects, contact your doctor if they bother you or do not go away:
Burning or stinging
Dry skin
* Redness
This is not a comprehensive list of all 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.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek medical attention:
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
Most people do not experience serious side effects, and some may not have any side effects at all. However, if you notice any of the following side effects, contact your doctor if they bother you or do not go away:
Burning or stinging
Dry skin
* Redness
This is not a comprehensive list of all 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:
- Severe burning, itching, or irritation of the treated skin
- New skin infections (redness, swelling, pus)
- Thinning of the skin, easy bruising, or stretch marks
- Acne or increased hair growth in treated areas
- Changes in skin color
- Unexplained fatigue, weakness, nausea, vomiting, or dizziness (signs of systemic absorption)
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, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other medications and health issues.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting 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, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other medications and health issues.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor.
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, acne, rosacea, or rashes around the mouth. When applying it to a large area of skin 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 ensure safe use. 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, seek immediate medical attention by calling a doctor or poison control center. Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult your doctor about this potential risk.
The safety and efficacy of this medication in children of all ages have not been established. If your child is prescribed this medication, use it with caution, as the risk of certain side effects may be higher in children. In some cases, this medication may affect growth in children and teenagers, necessitating regular growth checks; consult your doctor about this potential risk.
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 to discuss the potential benefits and risks to you and your baby.
This medication is not intended to treat diaper rash, acne, rosacea, or rashes around the mouth. When applying it to a large area of skin 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 ensure safe use. 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, seek immediate medical attention by calling a doctor or poison control center. Prolonged use of this medication may increase the risk of developing cataracts or glaucoma; therefore, consult your doctor about this potential risk.
The safety and efficacy of this medication in children of all ages have not been established. If your child is prescribed this medication, use it with caution, as the risk of certain side effects may be higher in children. In some cases, this medication may affect growth in children and teenagers, necessitating regular growth checks; consult your doctor about this potential risk.
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 to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Symptoms of Cushing's syndrome (e.g., moon face, central obesity, buffalo hump, thinning skin, easy bruising)
- Hyperglycemia (high blood sugar)
- Glucosuria (sugar in urine)
- Adrenal insufficiency upon withdrawal (fatigue, weakness, nausea, vomiting, hypotension)
What to Do:
If systemic absorption leading to overdose is suspected, contact a poison control center immediately (Call 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is supportive and symptomatic. Gradual withdrawal of the corticosteroid may be necessary to prevent adrenal insufficiency.
Drug Interactions
Moderate Interactions
- Drugs that inhibit CYP3A4 (e.g., ritonavir, itraconazole): May increase systemic exposure to clobetasol, potentially leading to increased systemic corticosteroid effects (e.g., HPA axis suppression).
Monitoring
Baseline Monitoring
Skin condition (e.g., severity of psoriasis/eczema, presence of infection)
Rationale: To assess initial disease state and guide treatment.
Timing: Prior to initiation of therapy.
Area of body surface affected
Rationale: To estimate potential for systemic absorption and guide total weekly dosage.
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: If no improvement after 2 weeks, re-evaluate diagnosis and treatment plan.
Local skin adverse effects (e.g., atrophy, striae, telangiectasias, folliculitis, infection)
Frequency: At each follow-up visit, or if patient reports new symptoms.
Target: Absence of new or worsening adverse effects.
Action Threshold: If significant local adverse effects develop, discontinue or reduce frequency/potency.
Signs/symptoms of HPA axis suppression (e.g., fatigue, weakness, nausea, vomiting, hypotension, weight loss)
Frequency: Periodically, especially with prolonged use, large surface areas, or occlusive dressings.
Target: Absence of symptoms.
Action Threshold: If suspected, perform ACTH stimulation test or plasma cortisol levels. Discontinue or taper therapy if confirmed.
Symptom Monitoring
- Skin thinning or atrophy
- Stretch marks (striae)
- Spider veins (telangiectasias)
- Acne-like eruptions (folliculitis)
- Increased hair growth (hypertrichosis)
- Changes in skin color (hypopigmentation)
- Burning, itching, irritation at application site
- Signs of infection (redness, pus, warmth)
- Unusual fatigue or weakness
- Weight gain (especially central obesity)
- Moon face
- Easy bruising
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 corticosteroids are limited. Avoid if possible.
Second Trimester:
Risk of systemic effects on fetus (e.g., growth retardation, HPA axis suppression) if significant maternal absorption occurs.
Third Trimester:
Risk of systemic effects on fetus (e.g., growth retardation, HPA axis suppression) if significant maternal absorption occurs. Neonates born to mothers who received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
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. 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 use, prolonged use, or application to areas where the infant could ingest the drug.
Pediatric Use
Children are more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, growth retardation) from topical corticosteroids due to a larger skin surface area to body weight ratio. Not recommended for children under 12 years of age. If used, limit to the smallest amount for the shortest duration possible, and monitor closely.
Geriatric Use
No specific dosage adjustments are generally needed. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects (e.g., atrophy, purpura) and potentially systemic absorption. Use with caution and monitor for adverse effects.
Clinical Information
Clinical Pearls
- Clobetasol propionate is a super-high potency topical corticosteroid; use it sparingly and for short durations (typically no more than 2 consecutive weeks).
- The total weekly dose should not exceed 50 grams to minimize the risk of systemic absorption and HPA axis suppression.
- Avoid using on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more prone to atrophy and other side effects.
- Occlusive dressings significantly increase systemic absorption and should generally be avoided unless specifically prescribed.
- Monitor for signs of HPA axis suppression, especially in patients using large amounts, for prolonged periods, or on large body surface areas.
- Patients should be advised to report any signs of local skin irritation, infection, or systemic symptoms.
Alternative Therapies
- Other topical corticosteroids (e.g., betamethasone, fluocinonide, triamcinolone, hydrocortisone - varying potencies)
- Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
- Vitamin D analogs (e.g., calcipotriene) for psoriasis
- Retinoids (e.g., tazarotene) for psoriasis
- Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread conditions
Cost & Coverage
Average Cost:
$50 - $200 per 118ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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'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.