Clobex 0.05% Shampoo 118ml
It is used to treat scalp psoriasis.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Category C
FDA Approved
May 2004
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clobex Shampoo is a strong (high-potency) steroid medicine used on the scalp to treat moderate to severe psoriasis. It helps reduce redness, itching, and scaling by calming down inflammation in the skin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. 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 any contact with your mouth, nose, ears, and eyes, as it may cause irritation or burning.
Do not apply this medication to your face, underarms, or groin area, and avoid using it on skin that is thinning.
Before and after application, wash your hands thoroughly.
To apply to the scalp, part your hair and apply a thin layer to the affected skin on a dry scalp. Gently rub in the medication and leave it on the scalp for 15 minutes.
Unless instructed 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 thoroughly. Be careful not to get the medication on unaffected skin. If the medication comes into contact with any other part of your body, rinse the area well with water.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration or freezing.
Be aware of the medication's expiration date and discard it accordingly.
Keep all medications in a safe and secure location, 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 scheduled dose, skip the missed dose and resume your regular application 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 accompanying information carefully. 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 any contact with your mouth, nose, ears, and eyes, as it may cause irritation or burning.
Do not apply this medication to your face, underarms, or groin area, and avoid using it on skin that is thinning.
Before and after application, wash your hands thoroughly.
To apply to the scalp, part your hair and apply a thin layer to the affected skin on a dry scalp. Gently rub in the medication and leave it on the scalp for 15 minutes.
Unless instructed 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 thoroughly. Be careful not to get the medication on unaffected skin. If the medication comes into contact with any other part of your body, rinse the area well with water.
Storage and Disposal
Store this medication at room temperature, avoiding refrigeration or freezing.
Be aware of the medication's expiration date and discard it accordingly.
Keep all medications in a safe and secure location, 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 scheduled dose, skip the missed dose and resume your regular application schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Use only on the scalp as directed by your doctor. Do not use on your face, groin, or armpits, or for diaper rash.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use for longer than 4 consecutive weeks unless specifically instructed by your doctor.
- Do not use more than 50 mL (1.75 fl oz) per week.
- Do not cover the treated area with a bandage or shower cap unless directed by your doctor, as this can increase absorption and side effects.
- Wash hands thoroughly after applying the shampoo.
- Inform your doctor if your condition worsens or does not improve after 4 weeks of treatment.
- Avoid using other topical products on the treated scalp area unless approved by your doctor.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film to the affected areas of the scalp once daily for up to 4 consecutive weeks. Total dosage should not exceed 50 g (50 mL or 1.75 fl oz) per week.
Condition-Specific Dosing:
scalp_psoriasis:
Apply once daily for up to 4 consecutive weeks. Discontinue when control is achieved. Re-evaluate if no improvement after 4 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and effectiveness in pediatric patients under 12 years of age have not been established. Use in children is generally not recommended due to increased risk of systemic absorption and HPA axis suppression.)
Adolescent:
Not established (Safety and effectiveness in pediatric patients under 12 years of age have not been established. For adolescents 12 years and older, use with caution and under strict medical supervision, similar to adult dosing but for shorter durations if possible.)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Clobetasol propionate is a high-potency topical 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, 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:
Minimal systemic absorption (typically <1% to 5% depending on skin integrity, vehicle, and duration of use). Absorption is increased by occlusive dressings, inflammation, and use on thin skin areas.
Tmax:
Not well-defined for topical application due to minimal systemic absorption. Peak plasma concentrations, if detectable, are typically very low (e.g., <0.1 ng/mL).
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not well-defined for topical application due to minimal systemic absorption.
ProteinBinding:
Approximately 97% (for systemically absorbed drug, primarily to albumin).
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Approximately 3-5 hours (for systemically absorbed drug).
Clearance:
Not well-defined for topical application.
ExcretionRoute:
Primarily renal excretion (for systemically absorbed drug), with some biliary excretion.
Unchanged:
Minimal (for systemically absorbed drug).
Pharmacodynamics
OnsetOfAction:
Within days to a week for symptomatic relief and reduction of inflammation.
PeakEffect:
Within 1-2 weeks of consistent application.
DurationOfAction:
Effects persist as long as treatment continues; rapid relapse upon discontinuation if underlying condition is not controlled.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 or seek medical attention 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. Many people may not experience any side effects or may only have mild 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
Hair loss
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 while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention 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. Many people may not experience any side effects or may only have mild 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
Hair loss
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 redness, burning, stinging, or itching on the scalp.
- Signs of skin infection (e.g., pus, spreading redness, fever).
- Thinning of the skin, easy bruising, or stretch marks on the scalp.
- Hair loss or changes in hair texture.
- Signs of systemic steroid absorption (rare but serious): unexplained weight gain, swelling in ankles/feet, increased thirst/urination, muscle weakness, fatigue, mood changes, vision problems. Seek immediate medical attention if these occur.
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.
Remember, before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so in conjunction with your other medications 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 to ensure safe use of this medication.
Remember, before starting, stopping, or changing the dose of any medication, including this one, you must consult with your doctor to confirm it is safe to do so in conjunction with your other medications 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. Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use.
To use this medication safely, avoid applying it to cuts, scrapes, or damaged skin. Additionally, do not use this medication for a longer period than prescribed by your doctor.
If you accidentally swallow this medication, seek immediate medical attention by calling a doctor or poison control center. This medication may increase the risk of developing cataracts or glaucoma, so it is crucial to discuss this potential risk with your doctor.
When using this medication in children, it is vital to exercise caution, as the risk of certain side effects may be higher in this population. This medication is not approved for use in children; however, your doctor may determine that the benefits of using this medication outweigh the risks. If your child has been prescribed this medication, consult with your doctor to understand the benefits and risks associated with its use.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of using this medication with you to ensure the best possible outcome for you and your baby.
To use this medication safely, avoid applying it to cuts, scrapes, or damaged skin. Additionally, do not use this medication for a longer period than prescribed by your doctor.
If you accidentally swallow this medication, seek immediate medical attention by calling a doctor or poison control center. This medication may increase the risk of developing cataracts or glaucoma, so it is crucial to discuss this potential risk with your doctor.
When using this medication in children, it is vital to exercise caution, as the risk of certain side effects may be higher in this population. This medication is not approved for use in children; however, your doctor may determine that the benefits of using this medication outweigh the risks. If your child has been prescribed this medication, consult with your doctor to understand the benefits and risks associated with its use.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of using this medication with you to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including: moon face, central obesity, striae, hypertension, hyperglycemia, muscle weakness, fatigue, and adrenal suppression (HPA axis suppression).
- Acute overdose is unlikely with topical application.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. HPA axis function may need to be assessed (e.g., ACTH stimulation test). Call a poison control center (1-800-222-1222) or seek emergency medical attention if severe symptoms occur.
Drug Interactions
Monitoring
Baseline Monitoring
Assessment of scalp condition
Rationale: To establish baseline severity of psoriasis (e.g., erythema, scaling, thickness) and identify areas for treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response (reduction in psoriasis symptoms)
Frequency: Weekly or bi-weekly during treatment period.
Target: Improvement in erythema, scaling, and thickness.
Action Threshold: If no significant improvement after 4 weeks, re-evaluate diagnosis and treatment plan. Discontinue once control is achieved.
Local skin reactions (e.g., atrophy, striae, telangiectasias, folliculitis, burning, itching)
Frequency: At each follow-up visit.
Target: Absence or minimal local side effects.
Action Threshold: If severe or persistent local reactions occur, discontinue use and consider alternative therapy.
Signs/symptoms of HPA axis suppression (e.g., fatigue, weakness, nausea, vomiting, hypotension, weight loss)
Frequency: Periodically, especially with prolonged use, large surface area application, or occlusive dressings.
Target: Absence of symptoms.
Action Threshold: If suspected, perform HPA axis suppression tests (e.g., ACTH stimulation test). Discontinue or reduce frequency/potency if suppression is confirmed.
Signs of infection (e.g., pus, increased redness, warmth)
Frequency: At each follow-up visit.
Target: Absence of infection.
Action Threshold: If infection develops, discontinue clobetasol and initiate appropriate antimicrobial therapy.
Symptom Monitoring
- Burning or stinging sensation at application site
- Itching
- Dryness
- Folliculitis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Skin atrophy (thinning, easy bruising)
- Striae (stretch marks)
- Telangiectasias (spider veins)
- Signs of systemic absorption (e.g., weight gain, moon face, fatigue, muscle weakness, mood changes, increased thirst/urination - rare but possible with extensive use)
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 is minimal, but caution is advised.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenic effects observed in animal studies with systemic corticosteroids. Minimal systemic absorption with topical use reduces this risk, but caution is still warranted.
Second Trimester:
Similar considerations as first trimester. Risk of HPA axis suppression in the fetus is theoretical but low with appropriate topical use.
Third Trimester:
Similar considerations as first and second trimesters. Neonates born to mothers who have 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 areas that may come into direct contact with the infant's mouth or skin during breastfeeding.
Infant Risk:
Low risk of adverse effects to the infant due to minimal systemic absorption, but potential for growth suppression or other adverse effects cannot be entirely excluded if significant amounts are absorbed by the mother and transferred to milk. Avoid application to the breast area.
Pediatric Use
Safety and effectiveness in pediatric patients under 12 years of age have not been established. Children are more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio and immature skin barrier. Use in children should be limited to the least potent effective steroid for the shortest duration possible, and only under strict medical supervision.
Geriatric Use
No specific dosage adjustments are required. However, elderly patients may have thinner skin and be more prone to skin atrophy or other local side effects. Monitor for skin integrity and adverse reactions.
Clinical Information
Clinical Pearls
- Clobex Shampoo is a high-potency topical steroid; emphasize the importance of using it only on the scalp and for the prescribed duration (max 4 weeks).
- Educate patients on the proper application technique: apply to dry scalp, leave on for 15 minutes, then lather and rinse. This ensures adequate contact time.
- Warn patients about the risk of HPA axis suppression, especially with prolonged use, large surface areas, or occlusive dressings, although rare with proper use of the shampoo.
- Advise patients that rebound flares can occur if the medication is stopped abruptly after prolonged use.
- Stress the importance of not using this product on the face, groin, or axillae due to increased risk of side effects (e.g., skin thinning, perioral dermatitis, striae).
- Consider a 'drug holiday' or step-down to a lower potency steroid or non-steroidal agent for maintenance therapy after the initial 4-week treatment period.
Alternative Therapies
- Other topical corticosteroids (e.g., fluocinonide, betamethasone valerate, desoximetasone for scalp psoriasis)
- Topical vitamin D analogues (e.g., calcipotriene, calcitriol)
- Topical retinoids (e.g., tazarotene)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus - off-label for psoriasis)
- Coal tar preparations
- Salicylic acid (keratolytic)
- Phototherapy (UVB, PUVA)
- Systemic therapies for severe psoriasis (e.g., methotrexate, cyclosporine, biologics, oral retinoids)
Cost & Coverage
Average Cost:
Varies widely, typically $50 - $200+ per 118ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (for brand name); Tier 1 or 2 (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, including the amount taken and the time it happened, to facilitate prompt and appropriate care.