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Clobetasol 0.05% Emollnt Foam 100gm

Manufacturer PERRIGO 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
Aug 2004
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clobetasol 0.05% Emollient Foam is a very strong steroid medicine applied to the skin. It helps reduce redness, itching, and swelling caused by skin conditions like eczema and psoriasis. It comes as a foam, which can be easier to apply to hairy areas.
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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.
Clean the affected area before applying the medication, and make sure it is dry.
 Apply a thin layer of the medication to the affected skin and gently rub it in.
Avoid applying the medication to your 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. If you have questions about using the foam, consult your pharmacist.
Apply the foam to the affected area and gently rub it in.

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 it needs to be discarded.
 Protect the medication from heat or open flames, and do not puncture or burn the can, even if it seems 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 schedule.
* Do not apply two doses at the same time or use extra doses.
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Lifestyle & Tips

  • Apply a thin layer of foam only to the affected skin areas as directed by your doctor.
  • Do not use more than the prescribed amount or for longer than 2 consecutive weeks, unless specifically instructed by your doctor, to avoid serious side effects.
  • Wash your hands thoroughly before and after applying the foam.
  • Do not cover the treated area with bandages, plastic wrap, or other occlusive dressings unless your doctor tells you to, as this can increase absorption and side effects.
  • Avoid applying the foam to the face, groin, or armpits unless specifically directed by your doctor, as these areas are more sensitive to steroid side effects.
  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
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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. Treatment should be limited to 2 consecutive weeks, and the total dosage should not exceed 50 g per week.

Condition-Specific Dosing:

psoriasis: Apply to affected areas once or twice daily for up to 2 consecutive weeks. Re-evaluate if no improvement after 2 weeks.
eczema: Apply to affected areas once or twice daily for up to 2 consecutive weeks. Re-evaluate if no improvement after 2 weeks.
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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, extreme caution and limited duration under strict medical supervision.
Adolescent: For adolescents 12 years and older, use with caution and limit duration to 2 consecutive weeks, similar to adult dosing, but monitor closely for systemic effects.
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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 adjustment needed 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

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Mechanism of Action

Clobetasol propionate is a super-high potency corticosteroid. It induces 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. Clobetasol also exhibits vasoconstrictive and antiproliferative actions.
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Pharmacokinetics

Absorption:

Bioavailability: Varies; generally low systemic absorption (<1%) through intact skin, but can increase significantly with inflammation, skin barrier disruption, occlusion, or application to large surface areas.
Tmax: Not precisely defined for topical application due to variable absorption; systemic levels are typically very low.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: Not precisely quantified for topical use; systemically absorbed corticosteroids are extensively bound to plasma proteins (primarily albumin and corticosteroid-binding globulin).
ProteinBinding: Approximately 90% (for systemically absorbed portion).
CnssPenetration: Limited

Elimination:

HalfLife: Not precisely defined for topical application; systemically absorbed clobetasol has a half-life of approximately 3-5 hours.
Clearance: Not precisely quantified for topical use.
ExcretionRoute: Primarily renal excretion of metabolites, with some biliary excretion.
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Within hours (for anti-inflammatory and vasoconstrictive effects).
PeakEffect: Within 12-24 hours of application.
DurationOfAction: Effects can persist for several hours after application.

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 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 fainting
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
 Irritation at the application site
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 help if they bother you or do not go away:

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 your skin condition or new skin problems (e.g., severe burning, itching, redness, dryness).
  • Signs of skin infection (e.g., pus, increased pain, fever, spreading redness).
  • Skin thinning, easy bruising, stretch marks (striae), or spider veins (telangiectasias) in the treated area.
  • Unusual hair growth.
  • Acne-like breakouts.
  • Signs of systemic absorption, especially with prolonged or extensive use: unusual tiredness, weakness, weight gain (especially in the face and trunk), swelling in ankles/feet, increased thirst or urination, vision problems.
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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 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.

To guarantee your safety, do not start, stop, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other medications and health conditions.
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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.

To minimize risks, be aware of the following precautions:
- This medication is flammable, so avoid using it near open flames or while smoking.
- Do not apply this medication to treat diaper rash.
- It is not intended for treating acne, rosacea, or rashes around the mouth.
- Exercise caution when applying this medication to large skin areas or near open wounds; consult your doctor for guidance.
- Before using 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.
- Use this medication only for the duration prescribed by your doctor.

Important safety considerations:
- If this medication is ingested, it can cause harm; immediately contact a doctor or poison control center if this occurs.
- Long-term use of this medication may increase the risk of developing cataracts or glaucoma; discuss this risk with your doctor.
- The safety and efficacy of this medication in children of all ages have not been established; consult your doctor before administering it to a child.
- When used in children, this medication requires careful monitoring due to a potentially higher risk of side effects.
- In some cases, this medication may affect growth in children and teenagers, necessitating regular growth assessments; discuss this with your doctor.
- If you are breastfeeding, avoid applying this medication directly to the nipple or the surrounding area.

Before starting this medication, it is crucial to discuss the following with your doctor:
- If you are pregnant, planning to become pregnant, or are breastfeeding, you and your doctor need to weigh the benefits and risks of using this medication to ensure the best outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use can lead to systemic absorption, potentially causing Cushing's syndrome (e.g., moon face, central obesity, striae, hypertension, hyperglycemia), adrenal insufficiency (HPA axis suppression) upon withdrawal, and growth retardation in children.

What to Do:

If you suspect an overdose or significant systemic absorption, contact your doctor or poison control center immediately. Call 1-800-222-1222. Management involves gradual withdrawal of the corticosteroid and symptomatic treatment.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify any pre-existing skin infections or atrophy.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Local skin reactions (e.g., atrophy, striae, telangiectasias, folliculitis, burning, itching)

Frequency: At each follow-up visit (e.g., weekly or bi-weekly during treatment).

Target: Absence of new or worsening reactions.

Action Threshold: If severe or persistent reactions occur, discontinue use and re-evaluate.

Signs of skin infection

Frequency: At each follow-up visit.

Target: Absence of redness, warmth, pus, or increased pain.

Action Threshold: If infection suspected, discontinue clobetasol and initiate appropriate antimicrobial therapy.

Hypothalamic-Pituitary-Adrenal (HPA) axis suppression (e.g., plasma cortisol levels, ACTH stimulation test)

Frequency: Consider if used extensively, for prolonged periods, under occlusion, on large surface areas, or in pediatric patients.

Target: Normal cortisol response.

Action Threshold: If suppression is detected, gradually withdraw the drug, reduce frequency, or substitute with a less potent corticosteroid.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness, swelling, or pain at application site (signs of infection)
  • Skin thinning, easy bruising, stretch marks (striae)
  • Unusual hair growth (hypertrichosis)
  • Acne-like eruptions
  • Fatigue, weakness, weight gain, moon face (signs of systemic absorption/Cushing's syndrome)

Special Patient Groups

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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 teratogenicity, though systemic absorption from topical use is low.
Second Trimester: Risk generally considered lower than first trimester, but still use with caution.
Third Trimester: Risk generally considered lower than first trimester, but still use with caution. Neonates born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
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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 in nursing mothers. Avoid applying to the breast area to prevent direct infant exposure.

Infant Risk: Low risk with limited, short-term use due to minimal systemic absorption, but monitor infant for any unusual effects. Avoid direct contact with infant's skin.
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Pediatric Use

Children are more susceptible to systemic toxicity from topical corticosteroids, including HPA axis suppression, Cushing's syndrome, and growth retardation, due to a larger skin surface area to body weight ratio. Clobetasol 0.05% Emollient Foam is not recommended for children under 12 years of age. If used in older children or adolescents, extreme caution, limited duration, and close monitoring for systemic effects are essential.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may have thinner skin and be more prone to skin atrophy or purpura, so monitor closely.

Clinical Information

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Clinical Pearls

  • Clobetasol is a super-high potency topical corticosteroid; use it sparingly and only for the prescribed duration (typically no more than 2 consecutive weeks).
  • The foam formulation is particularly useful for treating hairy areas of the body or large surface areas.
  • Always advise patients to wash their hands after applying the foam to avoid accidental transfer to sensitive areas like the eyes or mucous membranes.
  • Educate patients on the signs of local side effects (e.g., skin thinning, stretch marks) and systemic absorption (e.g., fatigue, weight gain) and when to contact their healthcare provider.
  • Avoid abrupt discontinuation after prolonged use on large areas, as this can lead to rebound flares of the underlying skin condition or adrenal insufficiency.
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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 eczema
  • Vitamin D analogues (e.g., calcipotriene) for psoriasis
  • Retinoids (e.g., tazarotene) for psoriasis
  • Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread disease
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Cost & Coverage

Average Cost: $100 - $500+ per 100gm foam
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (varies by 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.