Clobetasol 0.05% Shampoo 118ml
It is used to treat scalp psoriasis.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Synthetic Glucocorticoid; Anti-inflammatory Agent
Pregnancy Category
Category C
FDA Approved
May 2004
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobetasol 0.05% shampoo is a very strong steroid medicine used on the scalp to treat severe itching, redness, and scaling caused by psoriasis. It helps reduce inflammation and discomfort. It should only be used for a short time, usually up to 4 weeks, and exactly as prescribed by your doctor.
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 scalp and hair, avoiding the mouth, nose, ears, and eyes, as it may cause burning.
Do not apply to the face, underarms, or groin area, and avoid using on skin that is thinning.
Wash your hands before and after applying the medication.
To apply to the scalp, part your hair and put a thin layer on the affected skin. Make sure the scalp is dry before applying. Gently rub in the medication and leave it on the scalp for 15 minutes.
Unless directed by your doctor, do not cover your head with a shower cap, bathing cap, or towel while the medication is on your hair.
After 15 minutes, wet your hair with water, lather, and rinse well. Be careful not to get the medication on unaffected skin. If it does come into contact with other areas, rinse well with water.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration or freezing.
Be aware of the expiration date or the length of time you can store this medication before disposing of it.
Keep all medications in a safe place, out of the reach of children and pets.
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 take 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 scalp and hair, avoiding the mouth, nose, ears, and eyes, as it may cause burning.
Do not apply to the face, underarms, or groin area, and avoid using on skin that is thinning.
Wash your hands before and after applying the medication.
To apply to the scalp, part your hair and put a thin layer on the affected skin. Make sure the scalp is dry before applying. Gently rub in the medication and leave it on the scalp for 15 minutes.
Unless directed by your doctor, do not cover your head with a shower cap, bathing cap, or towel while the medication is on your hair.
After 15 minutes, wet your hair with water, lather, and rinse well. Be careful not to get the medication on unaffected skin. If it does come into contact with other areas, rinse well with water.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration or freezing.
Be aware of the expiration date or the length of time you can store this medication before disposing of it.
Keep all medications in a safe place, out of the reach of children and pets.
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 take extra doses.
Lifestyle & Tips
- Use only on the scalp as directed; do not use on the face, groin, or armpits unless specifically instructed by a doctor.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use more than the prescribed amount or for longer than 4 consecutive weeks.
- Do not cover the treated area with a bandage or shower cap unless directed by your doctor, as this can increase absorption.
- Wash hands thoroughly after applying the shampoo.
- Keep out of reach of children.
Available Forms & Alternatives
Available Strengths:
- Clobetasol Prop 0.05% Cream 60gm
- Clobetasol Prop 0.05% Oint 60gm
- Clobetasol Prop 0.05% Sol 50ml
- Clobetasol Prop 0.05% Cream 45gm
- Clobetasol Prop 0.05% Oint 30gm
- Clobetasol Prop 0.05% Oint 45gm
- Clobetasol Prop 0.05% Oint 15gm
- Clobetasol Prop 0.05% Cream 30gm
- Clobetasol Prop 0.05% Cream 15gm
- Clobetasol Prop 0.05% Sol 25ml
- Clobetasol Prop 0.05% Gel 30gm
- Clobetasol Prop 0.05% Gel 15gm
- Clobetasol Prop 0.05% Gel 60gm
- Clobetasol Prop 0.05% Gel 60gm
- Clobetasol 0.05% Emollient Crm 15gm
- Clobetasol 0.05% Emollient Crm 30gm
- Clobetasol 0.05% Emollient Crm 60gm
- Clobetasol Prop 0.05% Gel 15gm
- Clobetasol Prop 0.05% Gel 30gm
- Clobetasol Prop 0.05% Lotion 59ml
- Clobetasol Prop 0.05% Lotion 118ml
- Clobetasol 0.05% Shampoo 118ml
- Clobetasol 0.05% Emollntfoam 50gm
- Clobetasol 0.05% Emollnt Foam 100gm
- Clobetasol 0.05% Spray 59ml
- Clobetasol 0.05% Spray 125ml
- Clobetasol 0.05% Foam 50gm
- Clobetasol 0.05% Foam 100gm
- Clobetasol 0.05% Spray 59ml
- Clobetasol 0.05% Spray 125ml
- Clobetasol 0.05% Emollnt Foam 50gm
- Clobetasol 0.05% Shampoo 118ml
- Clobetasol Prop 0.05% Sol50ml
- Clobetasol Prop 0.05% Sol25ml
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected scalp areas once daily for up to 4 consecutive weeks. Total dosage should not exceed 50g (50mL or 1.75 fl oz) per week.
Condition-Specific Dosing:
scalpPsoriasis:
Apply a thin film to the affected areas of the scalp once daily. Leave on for 15 minutes, then rinse thoroughly. Treatment should be limited to 4 consecutive weeks. Discontinue use when control is achieved. If no improvement is seen after 4 weeks, reassessment of diagnosis may be necessary.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 12 years of age due to increased risk of systemic absorption and HPA axis suppression.
Adolescent:
For adolescents 12 years and older, use with caution and limit treatment to 4 consecutive weeks, similar to adult dosing, but with close monitoring for systemic effects.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended for topical use.
Moderate:
No specific adjustment recommended for topical use.
Severe:
No specific adjustment recommended for topical use.
Dialysis:
Considerations: Systemic absorption is minimal; therefore, dialysis is not expected to significantly impact drug levels. No specific adjustment needed.
Hepatic Impairment:
Mild:
No specific adjustment recommended for topical use.
Moderate:
No specific adjustment recommended for topical use.
Severe:
No specific adjustment recommended for topical use.
Pharmacology
Mechanism of Action
Clobetasol propionate is a highly potent synthetic corticosteroid. It exerts its therapeutic effects primarily through anti-inflammatory, antipruritic, and vasoconstrictive actions. It binds to glucocorticoid receptors in the cytoplasm, forming a complex that translocates to the nucleus, where it modulates gene expression. This leads to the synthesis of lipocortins, which inhibit phospholipase A2, thereby controlling the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.
Pharmacokinetics
Absorption:
Bioavailability:
Variable; systemic absorption can occur, especially with prolonged use, large surface areas, occlusive dressings, or compromised skin barrier. Bioavailability is generally low but increases with skin inflammation.
Tmax:
Not precisely defined for topical application due to variable systemic absorption.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not precisely quantified for topical application; widely distributed in tissues after systemic absorption.
ProteinBinding:
Approximately 90% bound to plasma proteins (e.g., albumin, transcortin) after systemic absorption.
CnssPenetration:
Limited for topical application; significant penetration only with high systemic absorption.
Elimination:
HalfLife:
Approximately 3-5 hours (for systemically absorbed drug, highly variable for topical).
Clearance:
Not precisely quantified for topical application.
ExcretionRoute:
Metabolites are primarily excreted in the urine and, to a lesser extent, in the feces.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Within days of initiation for anti-inflammatory and antipruritic effects.
PeakEffect:
Within 1-2 weeks of consistent use.
DurationOfAction:
Effects persist as long as treatment continues; local effects may last for several days after discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate 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
As with any medication, you may experience side effects. While many people have no side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any others that bother you or do not go away, contact your doctor:
Burning or stinging
Dry skin
Redness
Hair loss
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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.
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 immediate 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
As with any medication, you may experience side effects. While many people have no side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any others that bother you or do not go away, contact your doctor:
Burning or stinging
Dry skin
Redness
Hair loss
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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 redness, itching, or irritation on the scalp
- Signs of skin infection (pus, spreading redness, fever)
- Thinning of the skin, stretch marks, or easy bruising on the scalp
- Hair loss or changes in hair growth
- Blurred vision or other eye problems (e.g., cataracts, glaucoma)
- Signs of too much steroid in the body (e.g., unusual weight gain, swelling in the face, muscle weakness, fatigue, new or worsening high blood sugar)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have thinning skin at the site where you will be applying this medication.
* If there is an active infection at the site where this medication will be used.
This list is not exhaustive, and it is crucial to discuss all your medications (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 treatments and health issues. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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 (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 treatments and health issues. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before using any other medications or products on your skin, including soaps, consult with your doctor.
To ensure safe use, avoid applying this medication to cuts, scrapes, or damaged skin. Additionally, do not use this medication for a longer period than prescribed by your doctor.
If this medication is accidentally swallowed, it may cause harm, so it is crucial to call a doctor or poison control center immediately.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma; therefore, discuss this potential risk with your doctor.
When using this medication in children, it is crucial to exercise caution, as the risk of certain side effects may be higher in this age group.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of using this medication to you and your baby.
Note that this medication is not approved for use in children; however, your doctor may decide that the benefits of using this medication outweigh the risks. If your child has been prescribed this medication, ask your doctor about the benefits and risks, and discuss any questions or concerns you may have about giving this medication to your child.
To ensure safe use, avoid applying this medication to cuts, scrapes, or damaged skin. Additionally, do not use this medication for a longer period than prescribed by your doctor.
If this medication is accidentally swallowed, it may cause harm, so it is crucial to call a doctor or poison control center immediately.
Long-term use of this medication may increase the risk of developing cataracts or glaucoma; therefore, discuss this potential risk with your doctor.
When using this medication in children, it is crucial to exercise caution, as the risk of certain side effects may be higher in this age group.
If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of using this medication to you and your baby.
Note that this medication is not approved for use in children; however, your doctor may decide that the benefits of using this medication outweigh the risks. If your child has been prescribed this medication, ask your doctor about the benefits and risks, and discuss any questions or concerns you may have about giving this medication to your child.
Overdose Information
Overdose Symptoms:
- Symptoms of Cushing's syndrome (moon face, central obesity, striae, hypertension, hyperglycemia)
- Adrenal insufficiency upon abrupt withdrawal after prolonged high-dose use
- Local skin atrophy
What to Do:
Discontinue use gradually under medical supervision. Symptomatic and supportive treatment. Call a poison control center (1-800-222-1222) or seek immediate medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Assessment of scalp condition (severity of psoriasis, extent of lesions)
Rationale: To establish baseline for efficacy monitoring and determine appropriate duration of treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response (reduction in scaling, erythema, pruritus)
Frequency: Weekly or as clinically indicated.
Target: Improvement in psoriatic lesions.
Action Threshold: If no improvement after 4 weeks, reassess diagnosis and treatment plan.
Local adverse reactions (e.g., atrophy, telangiectasias, folliculitis, burning, stinging)
Frequency: Regularly during treatment.
Target: Absence or minimal local irritation.
Action Threshold: If severe or persistent, discontinue use.
Signs of HPA axis suppression (e.g., fatigue, weakness, nausea, hypotension)
Frequency: Periodically, especially with prolonged use, large surface areas, or in pediatric patients.
Target: Normal HPA axis function.
Action Threshold: If suspected, perform ACTH stimulation test or morning cortisol levels. Discontinue or taper therapy if suppression is confirmed.
Symptom Monitoring
- Burning or stinging sensation at application site
- Itching
- Folliculitis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Secondary infection
- Skin atrophy (thinning, striae, telangiectasias)
- Signs of systemic absorption (e.g., weight gain, moon face, fatigue, weakness, hyperglycemia, hypertension, blurred vision)
Special Patient Groups
Pregnancy
Clobetasol is Pregnancy Category C. It should be used 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 teratogenic effects, though systemic absorption from topical use is generally low.
Second Trimester:
Risk of fetal growth restriction or other adverse effects, particularly with high doses or prolonged use.
Third Trimester:
Risk of fetal growth restriction or other adverse effects, particularly with high doses or prolonged use. Neonates born to mothers who received substantial doses of corticosteroids during pregnancy should be 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. Caution should be exercised when clobetasol propionate shampoo is administered to a nursing woman. Avoid applying to areas where the infant might ingest the medication.
Infant Risk:
Low risk with limited topical use, but potential for systemic effects in infant if significant maternal absorption occurs or if applied to areas where infant can ingest.
Pediatric Use
Not recommended for children under 12 years of age. Pediatric patients may be more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio and immature skin barrier. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Use in adolescents (12 years and older) should be limited to 4 weeks with close monitoring.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may have thinner skin, which could potentially increase systemic absorption or local adverse effects. Use with caution and monitor for adverse reactions.
Clinical Information
Clinical Pearls
- Clobetasol 0.05% shampoo is a super-high potency topical corticosteroid; limit treatment duration to 4 consecutive weeks to minimize risk of HPA axis suppression and local skin atrophy.
- Patients should be instructed to apply the shampoo to dry scalp, leave it on for 15 minutes, and then rinse thoroughly. This is crucial for proper efficacy and to minimize residue.
- Avoid using on the face, groin, or axillae due to increased risk of skin atrophy and other adverse effects in these sensitive areas.
- Educate patients on signs of HPA axis suppression (e.g., fatigue, weight gain, moon face) and local adverse effects (e.g., skin thinning, striae).
- If no improvement is seen after 4 weeks, the diagnosis should be re-evaluated, and alternative treatments considered.
Alternative Therapies
- Other topical corticosteroids (e.g., betamethasone valerate, fluocinonide, desoximetasone)
- Topical vitamin D analogs (e.g., calcipotriene)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus - off-label for psoriasis)
- Topical retinoids (e.g., tazarotene)
- Coal tar preparations
- Salicylic acid preparations
- Phototherapy (UVB, PUVA)
- Systemic therapies for severe psoriasis (e.g., methotrexate, cyclosporine, biologics)
Cost & Coverage
Average Cost:
$100 - $300 per 118ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (Preferred or Non-Preferred Brand/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'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.