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Clobetasol 0.05% Emollient Crm 60gm

Manufacturer TARO Active Ingredient Clobetasol Cream, Gel, and Ointment(kloe BAY ta sol) Pronunciation kloe BAY ta sol
It is used to treat skin rashes and other skin irritation.It is used to treat plaque psoriasis.
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Drug Class
Topical Corticosteroid
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Pharmacologic Class
Glucocorticoid
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Pregnancy Category
Category C
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FDA Approved
Aug 1983
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clobetasol is a very strong steroid medicine that you put on your skin. It helps reduce redness, swelling, and itching caused by skin conditions like eczema or psoriasis. It works by calming down your 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. It is essential to use this medication as directed, even if your symptoms improve.

Application Instructions

Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
 Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, do not wash your hand 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.
 Unless instructed by your doctor, do not apply the medication to your face, underarms, or groin area.
Do not use bandages, dressings, or makeup on the treated area unless advised by your doctor.

Storage and Disposal

 Store this medication at room temperature, avoiding refrigeration or freezing.
Be aware of the medication's expiration date or the length of time you can store it before disposal.
 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 use extra doses.
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Lifestyle & Tips

  • Apply a very thin layer only to the affected skin areas.
  • Wash your hands before and after applying the cream.
  • Do not use more than directed by your doctor, and do not use for longer than 2 weeks unless specifically told to.
  • Do not cover the treated area with bandages or plastic wrap unless your doctor tells you to, as this can increase absorption.
  • Avoid applying to the face, groin, or armpits unless specifically instructed by your doctor, as these areas are more sensitive.
  • Do not use on broken or infected skin without consulting your doctor.
  • Keep out of reach of children.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin layer to the affected skin areas twice daily for up to 2 consecutive weeks. Do not exceed 50g per week.

Condition-Specific Dosing:

psoriasis: Apply twice daily for up to 2 consecutive weeks. Re-evaluate if no improvement.
eczema: Apply twice daily for up to 2 consecutive weeks. Re-evaluate if no improvement.
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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, limit to shortest duration and smallest amount.
Adolescent: For adolescents 12 years and older, use as for adults, but limit treatment to 2 weeks and re-evaluate.
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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: Considerations: Systemic absorption is minimal; however, if extensive use leads to systemic effects, monitor for fluid retention and electrolyte imbalances.

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

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Mechanism of Action

Clobetasol propionate is a highly potent synthetic 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: Varies significantly; systemic absorption can occur, especially with prolonged use, large surface areas, occlusive dressings, or compromised skin barrier. Up to 5% of applied dose can be absorbed.
Tmax: Not precisely defined for topical application due to variable absorption; systemic effects can manifest over days to weeks with chronic use.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: Not precisely quantified for topical use; systemically absorbed corticosteroids are widely distributed.
ProteinBinding: Approximately 90% (for systemically absorbed corticosteroids), primarily to albumin and transcortin.
CnssPenetration: Limited (for systemically absorbed corticosteroids), but can occur.

Elimination:

HalfLife: Approximately 3-5 hours (for systemically absorbed corticosteroids).
Clearance: Not precisely quantified for topical use.
ExcretionRoute: Primarily renal excretion of metabolites, with some biliary excretion.
Unchanged: Minimal unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Within hours to days for local 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.

Safety & Warnings

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Side Effects

Urgent 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 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 at the site of application
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. While many people may not experience any 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 other symptoms that bother you or do not go away, contact your doctor:

Burning or stinging
 Dry skin
* Redness

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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:

  • Skin thinning, easy bruising, or stretch marks appearing where you apply the cream.
  • Worsening of your skin condition or new skin problems like acne, increased hair growth, or skin discoloration.
  • Signs of infection (pus, fever, worsening pain, spreading redness).
  • Feeling unusually tired, weak, dizzy, or experiencing unexplained weight gain, especially in your face or stomach. These could be signs of too much medicine being absorbed into your body.
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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 symptoms you experienced.
 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 dose 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.

This medication is not intended to treat diaper rash. Additionally, it should not be used to treat acne, rosacea, or rashes around the mouth.

When applying this medication to a large area of skin or near open wounds, exercise caution and consult with your doctor. Before using any other medications or products on your skin, including soaps, discuss them with your doctor.

Avoid applying this medication to cuts, scrapes, or damaged skin. Do not use this medication for a longer period than prescribed by your doctor.

If this medication is accidentally swallowed, it can be harmful. In such cases, immediately contact a doctor or a poison control center.

Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Consult with your doctor to discuss this potential risk.

This medication may not be suitable for children of all ages. Before administering this medication to a child, consult with your doctor. 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. Discuss this potential risk with your doctor.

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. It is crucial to discuss the benefits and risks of using this medication to ensure the well-being of both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Cushing's syndrome (moon face, buffalo hump, central obesity, skin thinning, easy bruising)
  • Hyperglycemia (high blood sugar)
  • Glucosuria (sugar in urine)
  • Adrenal insufficiency (fatigue, weakness, nausea, vomiting, low blood pressure) upon abrupt withdrawal after prolonged, extensive use.

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

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Moderate Interactions

  • Other systemic corticosteroids (increased risk of HPA axis suppression)
  • Drugs that inhibit CYP3A4 (e.g., ritonavir, itraconazole) - theoretical risk of increased systemic exposure if significant absorption occurs.

Monitoring

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Baseline Monitoring

Skin condition assessment (type, severity, location of dermatosis)

Rationale: To establish baseline for efficacy and guide treatment duration.

Timing: Prior to initiation of therapy.

Area of body surface affected

Rationale: To assess risk of systemic absorption; larger areas increase risk.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Clinical signs of efficacy (e.g., reduction in erythema, scaling, pruritus)

Frequency: Weekly or as clinically indicated.

Target: Improvement in dermatological symptoms.

Action Threshold: Lack of improvement after 2 weeks warrants re-evaluation of diagnosis and treatment.

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

Frequency: Weekly or as clinically indicated.

Target: Absence or minimal local irritation.

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

Signs of HPA axis suppression (e.g., fatigue, weakness, weight loss, hypotension)

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

Target: Normal adrenal function.

Action Threshold: If suspected, perform ACTH stimulation test or plasma cortisol levels. Discontinue or gradually withdraw if suppression is confirmed.

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Symptom Monitoring

  • Increased redness or irritation at application site
  • Burning or stinging sensation
  • Itching that worsens
  • Thinning of skin (atrophy)
  • Stretch marks (striae)
  • Spider veins (telangiectasias)
  • Acne-like eruptions
  • Increased hair growth at application site
  • Signs of secondary infection (pus, fever, worsening pain)
  • Unexplained fatigue or weakness
  • Weight gain, especially in the face or trunk (Cushingoid features)

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. Animal studies have shown teratogenic effects. Systemic absorption can occur.

Trimester-Specific Risks:

First Trimester: Potential for teratogenic effects observed in animal studies with high doses of potent corticosteroids. Avoid if possible.
Second Trimester: Use with caution; systemic absorption can occur. Monitor for fetal growth restriction.
Third Trimester: Use with caution; systemic absorption can occur. Monitor for fetal growth restriction and potential for HPA axis suppression in the neonate if used extensively.
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Lactation

L3 (Moderately safe). It is not known whether topical clobetasol is excreted in human milk. Systemically administered corticosteroids appear in human milk. Use with caution. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with limited topical use. Potential for systemic effects in infant if significant maternal absorption occurs or if applied to breast and ingested.
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Pediatric Use

Children are more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, growth retardation) 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 and shortest duration possible, and avoid occlusive dressings.

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Geriatric Use

No specific dose adjustments are generally needed. However, elderly patients may have thinner skin, increasing susceptibility to local adverse effects like skin atrophy and purpura. Monitor closely for skin integrity and systemic effects.

Clinical Information

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Clinical Pearls

  • Clobetasol is a super-high potency topical corticosteroid; use it sparingly and for short durations (typically no more than 2 consecutive weeks).
  • Educate patients on the 'less is more' principle: a thin layer is sufficient. Using more does not improve efficacy but increases the risk of side effects.
  • Avoid use on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more prone to atrophy and other side effects.
  • Do not use occlusive dressings unless specifically instructed by a physician, as this significantly increases systemic absorption.
  • Monitor for signs of HPA axis suppression, especially in children or with extensive/prolonged use.
  • Consider pulse dosing or intermittent therapy for chronic conditions to minimize side effects.
  • Re-evaluate the diagnosis if no improvement is seen after 2 weeks of treatment.
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Alternative Therapies

  • Other topical corticosteroids (e.g., triamcinolone, fluocinonide, betamethasone, hydrocortisone - varying potencies)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema, 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, widespread conditions.
  • Emollients and moisturizers for barrier repair and symptom relief.
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Cost & Coverage

Average Cost: $30 - $100 per 60gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your 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 your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification. 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 name of the medication taken, the amount, and the time it occurred.