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Clobetasol Prop 0.05% Cream 30gm

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
Sep 1983
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clobetasol propionate is a very strong (super-high potency) corticosteroid medicine that you put on your skin. It helps reduce redness, swelling, and itching caused by certain skin conditions like eczema and 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's essential to use this medication as directed, 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 application, unless your hand is the treated area, in which case you should not wash it after use.
Clean the affected area before applying the medication and dry it thoroughly.
 Gently rub a thin layer of the medication onto the affected skin.
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.

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's 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.
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Lifestyle & Tips

  • Wash your hands before and after applying the cream.
  • Apply a very thin layer of cream only to the affected skin areas, as directed by your doctor.
  • Do not use more than the prescribed amount or for longer than 2 weeks, unless specifically instructed by your doctor.
  • Do not use more than 50 grams (one 30gm tube and part of another) per week.
  • Avoid applying the cream to your face, groin, armpits, or diaper area unless specifically told to by your doctor, as these areas are more sensitive to side effects.
  • 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 getting the cream in your eyes, nose, or mouth. If it gets into your eyes, rinse thoroughly with water.
  • Do not use this cream for acne, rosacea, or fungal/bacterial infections without specific medical advice, as it can worsen these conditions.
  • 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 50 grams 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 (generally not recommended for children under 12 years due to increased risk of systemic effects)
Child: Not established (generally not recommended for children under 12 years due to increased risk of systemic effects). For children 12 years and older, use with caution and for shortest duration possible, not exceeding 2 weeks.
Adolescent: Apply a thin layer to the affected skin areas twice daily for up to 2 consecutive weeks. Do not exceed 50 grams per week. Use with caution and for shortest duration possible.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed for topical use due to minimal systemic absorption.
Moderate: No specific adjustment needed for topical use due to minimal systemic absorption.
Severe: No specific adjustment needed for topical use due to minimal systemic absorption. However, monitor for signs of systemic absorption if used extensively or for prolonged periods.
Dialysis: Considerations: No specific adjustment. Monitor for systemic effects if used extensively.

Hepatic Impairment:

Mild: No specific adjustment needed for topical use due to minimal systemic absorption.
Moderate: No specific adjustment needed for topical use due to minimal systemic absorption.
Severe: No specific adjustment needed for topical use due to minimal systemic absorption. However, monitor for signs of systemic absorption if used extensively or for prolonged periods.

Pharmacology

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Mechanism of Action

Clobetasol propionate is a highly potent synthetic 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, lipocortins, which 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; systemic absorption is minimal but can occur, especially with prolonged use, large surface area application, or occlusive dressings. Absorption is increased in areas with thin skin (e.g., face, genitals) and in children.
Tmax: Not well-defined for topical application; systemic levels are generally low.
FoodEffect: Not applicable

Distribution:

Vd: Not well-defined for topical application due to minimal systemic absorption.
ProteinBinding: Approximately 90% (for systemically absorbed drug)
CnssPenetration: Limited

Elimination:

HalfLife: Not well-defined for topical application; systemic half-life of absorbed drug is approximately 3-5 hours.
Clearance: Not well-defined for topical application.
ExcretionRoute: Primarily renal excretion of metabolites, with some biliary excretion.
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Within hours to days for anti-inflammatory effects.
PeakEffect: Within days of consistent application.
DurationOfAction: Effects persist as long as applied; local effects may last for 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 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 minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:

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, 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.
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Seek Immediate Medical Attention If You Experience:

  • Increased redness, swelling, or pus at the application site (signs of infection)
  • Severe burning, itching, or irritation that worsens after applying the cream
  • Thinning of the skin, easy bruising, or stretch marks appearing in the treated area
  • Changes in skin color (lightening or darkening)
  • Acne-like breakouts or small bumps around the mouth (perioral dermatitis)
  • Blurred vision or other eye problems
  • Unexplained weight gain, swelling in the face, or unusual fatigue (signs of systemic absorption/Cushing's syndrome)
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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.

This medication is not intended to treat diaper rash, acne, rosacea, or rashes around the mouth. When applying it to a large area of skin or near open wounds, exercise caution and consult your doctor.

Before using other skincare products or medications, including soaps, discuss them with your doctor to ensure safe use. Avoid applying this medication to cuts, scrapes, or damaged skin.

Do not use this medication for an extended period beyond the duration prescribed by your doctor. If ingested, this medication 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; therefore, consult your doctor about potential risks. The suitability of this medication for children of all ages has not been established; consult your doctor before administering it to a child.

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, necessitating regular growth checks; discuss this 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 to discuss the potential benefits and risks to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use of topical clobetasol can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including: moon face, central obesity, buffalo hump, skin thinning, easy bruising, muscle weakness, fatigue, hyperglycemia, hypertension, and adrenal suppression.
  • In children, chronic overdose can lead to growth retardation and delayed weight gain.

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment should be initiated. If acute adrenal insufficiency occurs, administer systemic corticosteroids. 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

Area of application and total body surface area involved

Rationale: To estimate potential for systemic absorption and guide dosing limits.

Timing: Prior to initiation of therapy

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Routine Monitoring

Clinical response and local adverse effects (e.g., skin atrophy, striae, telangiectasias, burning, itching)

Frequency: Regularly during treatment, especially at follow-up visits (e.g., after 2 weeks)

Target: Improvement in dermatosis without significant local side effects

Action Threshold: Worsening condition, signs of skin atrophy, or severe local irritation warrant discontinuation or re-evaluation.

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

Frequency: Periodically, especially with prolonged or extensive use, or in pediatric patients.

Target: Absence of symptoms

Action Threshold: Presence of symptoms warrants investigation (e.g., ACTH stimulation test) and potential discontinuation.

Signs of infection (e.g., redness, warmth, pus)

Frequency: Regularly during treatment

Target: Absence of infection

Action Threshold: Signs of infection warrant appropriate antimicrobial therapy and re-evaluation of clobetasol use.

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Symptom Monitoring

  • Skin thinning or atrophy
  • Stretch marks (striae)
  • Spider veins (telangiectasias)
  • Burning, itching, irritation, or stinging at application site
  • Folliculitis (inflammation of hair follicles)
  • Acneiform eruptions
  • Hypopigmentation (lightening of skin color)
  • Perioral dermatitis
  • Allergic contact dermatitis
  • Signs of systemic absorption: weight gain, moon face, fatigue, weakness, delayed wound healing (Cushing's syndrome symptoms)
  • Hyperglycemia (increased blood sugar)
  • Blurred vision or other visual disturbances (cataracts, 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. Animal studies have shown teratogenic effects with corticosteroids. Systemic absorption of topical clobetasol is minimal, but caution is advised.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though systemic absorption from topical use is low.
Second Trimester: Risk of fetal growth restriction or other adverse effects with high systemic exposure, but unlikely with appropriate topical use.
Third Trimester: Risk of fetal growth restriction or other adverse effects with high systemic exposure, but unlikely with appropriate topical use. Neonatal adrenal suppression is a theoretical risk if significant maternal systemic absorption occurs.
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Lactation

Use with caution. It is not known whether topical clobetasol is excreted in human milk. Systemic absorption is minimal, so infant exposure is likely low. Avoid applying to the breast area to prevent direct infant ingestion.

Infant Risk: Low risk with appropriate use, but monitor infant for any signs of adverse effects.
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Pediatric Use

Children are more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio. Not recommended for children under 12 years of age. If used in adolescents (12 years and older), use the smallest amount for the shortest duration possible, and monitor closely for signs of HPA axis suppression, Cushing's syndrome, and growth retardation.

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Geriatric Use

No specific dose adjustments are required. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects like skin atrophy and purpura. Monitor for these effects.

Clinical Information

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Clinical Pearls

  • Clobetasol propionate is a super-high potency topical corticosteroid; it should be used for short durations (typically no more than 2 consecutive weeks) to minimize the risk of local and systemic side effects.
  • Avoid use on the face, groin, or axillae unless specifically directed by a dermatologist, as these areas are more prone to atrophy, telangiectasias, and other side effects.
  • Do not use occlusive dressings unless specifically instructed by a physician, as occlusion significantly increases systemic absorption.
  • Patients should be advised to report any signs of local irritation, skin thinning, or systemic symptoms (e.g., fatigue, weight gain) to their healthcare provider.
  • Consider alternative, less potent corticosteroids for maintenance therapy or for less severe conditions once the acute flare is controlled.
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Alternative Therapies

  • Other topical corticosteroids (e.g., betamethasone dipropionate, fluocinonide, triamcinolone acetonide, hydrocortisone)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for conditions like atopic dermatitis, especially on sensitive areas where corticosteroids are less preferred.
  • Vitamin D analogs (e.g., calcipotriene) for psoriasis.
  • Retinoids (e.g., tazarotene) for psoriasis.
  • Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread dermatoses not controlled by topical agents.
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Cost & Coverage

Average Cost: $20 - $100+ per 30gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for 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 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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.