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Clobetasol 0.05% Emollnt Foam 50gm

Manufacturer MYLAN Active Ingredient Clobetasol Emollient Foam(kloe BAY ta sol) Pronunciation kloe BAY ta sol
It is used to treat skin rashes and other skin irritation.
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Drug Class
Topical Corticosteroid
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Pharmacologic Class
Glucocorticoid Receptor Agonist
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Pregnancy Category
Category C
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FDA Approved
May 2006
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clobetasol 0.05% Emollient Foam is a strong steroid medicine applied to the skin to reduce redness, swelling, and itching caused by certain skin conditions like psoriasis or eczema. It works by calming down the body's immune response in the skin.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Use this medication only as directed, and continue to use it even if your symptoms improve.

Application Instructions

Apply this medication only to your skin, avoiding the mouth, nose, and eyes, as it may cause burning.
 Wash your hands before and after applying the medication, unless your hand is the 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.

Special Instructions for Foam

Shake the can well before use.
 To use the foam, turn the can upside down. Note that some foams may melt if placed in your hand, so consult your pharmacist for guidance on how to use the foam correctly.
Apply the foam to the affected area and gently rub it in.

Storage and Disposal

 Store this medication at room temperature, avoiding refrigeration and freezing.
Be aware of the expiration date or the length of time you can store this medication before it needs to be discarded.
 Protect the medication from heat and open flames, and do not puncture or burn the can even if it appears empty.

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 application schedule.
* Do not apply two doses at the same time or use extra doses.
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Lifestyle & Tips

  • Wash hands before and after applying the foam.
  • Shake the can well before use.
  • Invert the can and dispense a small amount of foam into the cap or onto a cool surface (not directly onto hands as it will melt).
  • Gently massage the foam into the affected skin area until it disappears.
  • Apply a thin layer only to the affected areas, not to healthy skin.
  • 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, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Do not use for longer than 2 consecutive weeks unless specifically instructed by your doctor.
  • Do not use more than 50 grams (one can) per week.
  • Keep the foam away from open flames or heat, as it is flammable.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin layer to affected skin areas once or twice daily.

Condition-Specific Dosing:

psoriasis: Apply a thin layer to affected skin areas once or twice daily for up to 2 consecutive weeks. Do not exceed 50 grams per week.
dermatitis: Apply a thin layer to affected skin areas once or twice daily for up to 2 consecutive weeks. Do not exceed 50 grams per week.
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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. If used, apply a thin layer once daily for the shortest duration possible, not exceeding 2 weeks.
Adolescent: For adolescents 12 years and older, apply a thin layer to affected skin areas once or twice daily for up to 2 consecutive weeks. Do not exceed 50 grams per week.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed for topical application due to minimal systemic absorption.
Moderate: No specific adjustment needed for topical application due to minimal systemic absorption.
Severe: No specific adjustment needed for topical application due to minimal systemic absorption.
Dialysis: No specific adjustment needed for topical application due to minimal systemic absorption.

Hepatic Impairment:

Mild: No specific adjustment needed for topical application due to minimal systemic absorption.
Moderate: No specific adjustment needed for topical application due to minimal systemic absorption.
Severe: No specific adjustment needed for topical application due to minimal systemic absorption.
Confidence: Medium

Pharmacology

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Mechanism of Action

Clobetasol propionate is a high-potency corticosteroid. It exerts its anti-inflammatory, antipruritic, and vasoconstrictive actions 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.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption; varies with skin integrity, vehicle, and use of occlusive dressings. Approximately 0.1% to 5% can be absorbed systemically.
Tmax: Not precisely defined for topical application due to minimal systemic absorption; local effects are rapid.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: Not precisely quantified for topical application; systemically absorbed clobetasol distributes widely.
ProteinBinding: Systemically absorbed corticosteroids are bound to plasma proteins to varying degrees, primarily to albumin and corticosteroid-binding globulin.
CnssPenetration: Limited (systemic absorption is minimal, so CNS penetration is negligible for topical use).

Elimination:

HalfLife: Systemic half-life of absorbed clobetasol is approximately 3-5 hours.
Clearance: Not precisely quantified for topical application.
ExcretionRoute: Renal (primarily as metabolites), also some biliary excretion.
Unchanged: Minimal unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Within hours to days for anti-inflammatory effects.
PeakEffect: Within days to 1-2 weeks of consistent application.
DurationOfAction: Effects persist as long as applied; local effects can last for hours after application.
Confidence: Medium

Safety & Warnings

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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 medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
 Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
 Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
 Irritation where the medication was applied
Thinning of the skin
 Changes in eyesight, eye pain, or severe eye irritation

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

Burning or stinging
 Dry skin
* Redness

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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.
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Seek Immediate Medical Attention If You Experience:

  • Worsening of skin condition or no improvement after 2 weeks.
  • Signs of skin infection (e.g., pus, spreading redness, fever).
  • Severe burning, itching, or irritation at the application site.
  • Skin thinning, easy bruising, stretch marks, or changes in skin color.
  • Unusual hair growth.
  • Acne-like rash.
  • Blurred vision or eye pain.
  • Symptoms of high blood sugar (e.g., increased thirst, increased urination).
  • Symptoms of Cushing's syndrome (e.g., weight gain, rounded face, fatigue, muscle weakness).
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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 and its symptoms.
 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 with your other medications and health conditions.

Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When using this medication, exercise caution to avoid exposure to open flames or sparks, as it may be flammable. Do not use this medication near an open flame or while smoking.

This medication is not intended to treat diaper rash, acne, rosacea, or rashes around the mouth. If you have any of these conditions, consult your doctor for alternative treatments.

When applying this medication to a large area of skin or near open wounds, use caution and consult your doctor. Additionally, before using other skin products or medications, including soaps, discuss them with your doctor to avoid potential interactions.

Avoid applying this medication to cuts, scrapes, or damaged skin, as it may cause further irritation. Do not use this medication for an extended period beyond the duration prescribed by your doctor.

If this medication is accidentally ingested, it may cause harm. In such cases, immediately contact a doctor or poison control center for assistance.

Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Regular monitoring and discussions with your doctor are crucial to minimize these risks.

This medication may not be suitable for children of all ages. Before administering it to a child, consult your doctor to discuss the potential benefits and risks. When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population.

In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary to monitor any potential effects. Consult your doctor to determine the best course of action.

If you are breast-feeding, avoid applying this medication directly to the nipple or the surrounding area to prevent potential harm to your baby.

If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor. It is essential to discuss the benefits and risks of using this medication during these periods to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including: moon face, buffalo hump, central obesity, thinning skin, easy bruising, muscle weakness, fatigue, hyperglycemia, hypertension, and adrenal suppression.

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call a poison control center immediately (1-800-222-1222) or seek emergency medical attention.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify areas for application.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus, scaling)

Frequency: Weekly or as clinically indicated during treatment period.

Target: Improvement in symptoms.

Action Threshold: Lack of improvement or worsening symptoms may require re-evaluation of diagnosis or treatment.

Local skin adverse effects (e.g., atrophy, striae, telangiectasias, folliculitis, perioral dermatitis)

Frequency: Weekly or as clinically indicated.

Target: Absence of new or worsening adverse effects.

Action Threshold: Development of significant local adverse effects may require discontinuation or reduction in frequency/potency.

Signs of HPA axis suppression (e.g., fatigue, weakness, nausea, vomiting, hypotension)

Frequency: Periodically, especially with prolonged use, large surface area application, or occlusive dressings.

Target: Absence of symptoms.

Action Threshold: Presence of symptoms warrants immediate medical evaluation and potential HPA axis testing (e.g., ACTH stimulation test).

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Symptom Monitoring

  • Burning
  • Itching
  • Irritation
  • Dryness
  • Folliculitis
  • Hypertrichosis
  • Acneiform eruptions
  • Hypopigmentation
  • Perioral dermatitis
  • Allergic contact dermatitis
  • Maceration of the skin
  • Secondary infection
  • Skin atrophy
  • Striae
  • Miliaria
  • Signs of Cushing's syndrome (e.g., moon face, buffalo hump, central obesity)
  • Signs of hyperglycemia (e.g., increased thirst, urination)
  • Blurred vision (due to cataracts or glaucoma)

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. High-potency topical corticosteroids should be used sparingly, for the shortest duration, and on the smallest area possible.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though data for topical steroids are limited and generally reassuring for appropriate use.
Second Trimester: Risk of systemic absorption and potential fetal effects (e.g., low birth weight) with extensive or prolonged use.
Third Trimester: Risk of systemic absorption and potential fetal effects (e.g., low birth weight) with extensive or prolonged use. Adrenal suppression in the neonate is a theoretical risk with high-dose maternal use.
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Lactation

Use with caution. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with appropriate, limited use. Potential for growth suppression or other adverse effects if significant systemic absorption occurs in the mother and transfers to the infant via breast milk.
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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 and immature skin barrier. Not recommended for children under 12 years of age. If used in adolescents, apply for the shortest duration possible and monitor closely.

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Geriatric Use

No specific dose adjustments are typically needed. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects (e.g., skin atrophy, purpura) and potentially systemic absorption. Use with caution and monitor skin integrity.

Clinical Information

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Clinical Pearls

  • Clobetasol propionate is a super high-potency topical corticosteroid; use should be limited to short-term treatment (typically 2 weeks) to minimize the risk of local and systemic side effects.
  • The foam formulation is often preferred for hairy areas or large surface areas due to ease of application and rapid absorption.
  • Patients should be educated on the correct application technique (thin layer, gentle massage) and the importance of not exceeding the recommended duration or amount (50g/week).
  • Avoid use on the face, groin, or axillae unless specifically directed by a physician, as these areas are more prone to atrophy and other side effects.
  • Rebound flares can occur upon abrupt discontinuation after prolonged use; gradual tapering may be considered for some patients under medical supervision.
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Alternative Therapies

  • Other topical corticosteroids of varying potencies (e.g., betamethasone, fluocinonide, triamcinolone, hydrocortisone)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing effects, especially on sensitive areas.
  • Vitamin D analogs (e.g., calcipotriene) for psoriasis.
  • Topical retinoids (e.g., tazarotene) for psoriasis.
  • Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe or widespread dermatoses.
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Cost & Coverage

Average Cost: $150 - $400 per 50gm foam
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (may require prior authorization depending on plan)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.