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Clobetasol Prop 0.05% Sol50ml

Manufacturer MICRO LABORATORIES Active Ingredient Clobetasol Solution(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
Synthetic 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 solution is a very strong steroid medicine applied to the skin. It helps reduce redness, swelling, and itching caused by certain skin conditions like psoriasis and eczema.
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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 make sure it is completely 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.

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.

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 to make up for a missed dose.
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Lifestyle & Tips

  • Apply a very thin layer only to the affected skin areas as directed by your doctor.
  • Wash your hands thoroughly before and after applying the medication.
  • Do not use more than the prescribed amount or for longer than 2 weeks, unless specifically instructed by your doctor.
  • Do not cover the treated area with bandages or dressings unless your doctor tells you to, as this can increase absorption and side effects.
  • Avoid applying the solution to your face, groin, or armpits unless specifically directed by your doctor, as these areas are more susceptible to side effects.
  • Avoid getting the solution in your eyes, nose, or mouth. If it gets into your eyes, rinse thoroughly with water.
  • Do not use this medication for diaper rash.
  • Inform your doctor if your condition does not improve after 2 weeks of treatment or if it worsens.
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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 mL 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 adverse effects (e.g., HPA axis suppression, Cushing's syndrome, growth retardation). If used, limit to 5 days and small areas.
Adolescent: For adolescents 12 years and older, use as per adult dosing, but with caution and limited duration due to higher surface area to body weight ratio.
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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: No specific adjustment needed for topical use.

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 high-potency synthetic 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. Thus, clobetasol propionate exerts anti-inflammatory, antipruritic, and vasoconstrictive actions.
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Pharmacokinetics

Absorption:

Bioavailability: Varies significantly; systemic absorption can occur, especially with prolonged use, extensive surface area application, occlusion, or compromised skin barrier. Percutaneous absorption is approximately 0.1% to 5% depending on vehicle, site, and integrity of skin.
Tmax: Not precisely quantified for topical application due to variable absorption.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: Not well characterized for topical administration.
ProteinBinding: Systemically absorbed corticosteroids are extensively bound to plasma proteins, primarily transcortin and albumin.
CnssPenetration: Limited systemic penetration from topical application; CNS effects are rare unless significant systemic absorption occurs.

Elimination:

HalfLife: Systemic half-life of absorbed clobetasol is approximately 3-5 hours.
Clearance: Not precisely quantified for topical administration.
ExcretionRoute: Renal (metabolites) and biliary.
Unchanged: Minimal unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Within hours to days for symptomatic relief (e.g., reduction in itching, redness).
PeakEffect: Within days of consistent application.
DurationOfAction: Effects persist as long as applied; local effects may last for several hours after application.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention 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 help 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. While many people may not experience any side effects or only have 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 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:

  • Severe burning, itching, or irritation at the application site
  • New or worsening skin thinning, stretch marks, or spider veins
  • Changes in skin color
  • Acne or hair growth in treated areas
  • Signs of infection (e.g., pus, spreading redness)
  • Unexplained fatigue, weakness, dizziness
  • Swelling in your face or ankles
  • Unusual weight gain
  • Blurred vision or other eye 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.

Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm it is safe to do so in conjunction with this medication.
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Precautions & Cautions

Important Warnings and Cautions

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

Fire Hazard
This medication is flammable and may catch fire. To minimize risk, avoid using it near open flames or while smoking.

Contraindications
Do not use this medication to treat diaper rash, acne, rosacea, or rashes around the mouth.

Precautions for Application
When applying this medication to a large area of skin or near open wounds, exercise caution and consult your doctor.

Interactions with Other Skin Products
Before using other medications or products on your skin, including soaps, consult your doctor to ensure safe use.

Skin Application Precautions
Avoid applying this medication to cuts, scrapes, or damaged skin.

Duration of Use
Do not use this medication for longer than prescribed by your doctor.

Ingestion Warning
If this medication is swallowed, it may cause harm. In the event of ingestion, immediately contact a doctor or poison control center.

Ocular Risks
This medication may increase the risk of cataracts or glaucoma. Discuss this potential risk with your doctor.

Pediatric Use
This medication may not be suitable for children of all ages. 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 some cases, this medication may affect growth in children and teens, and regular growth checks may be necessary.

Breast-Feeding Precautions
If you are breast-feeding, avoid applying this medication directly to the nipple or surrounding area.

Pregnancy and Breast-Feeding Considerations
If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor. You will need to discuss the potential benefits and risks of using this medication to 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, central obesity, buffalo hump, skin thinning, easy bruising, muscle weakness, fatigue, hypertension, hyperglycemia, and adrenal suppression (HPA axis suppression).

What to Do:

If overdose is suspected due to extensive or prolonged use, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Management involves gradual withdrawal of the steroid and supportive care to manage symptoms of adrenal insufficiency if HPA axis suppression occurs.

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

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

Frequency: Regularly during treatment, especially after 2 weeks of use.

Target: Absence of new or worsening reactions.

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

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

Frequency: Periodically, especially with prolonged use, extensive body surface area application, or occlusion.

Target: Normal adrenal function.

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

Intraocular pressure (if applied near eyes)

Frequency: Periodically, if applied to eyelids or periorbital area.

Target: Normal IOP.

Action Threshold: Elevated IOP may indicate glaucoma; discontinue use and consult ophthalmologist.

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Symptom Monitoring

  • Increased redness or irritation at application site
  • Burning or stinging sensation
  • Itching that worsens or does not improve
  • Skin thinning or fragility
  • Appearance of stretch marks (striae)
  • Spider veins (telangiectasias)
  • Acne-like eruptions or folliculitis
  • Excessive hair growth (hypertrichosis)
  • Changes in skin pigmentation
  • Signs of systemic absorption: unexplained fatigue, weakness, weight gain, swelling in face/neck (moon face), easy bruising, delayed wound healing.

Special Patient Groups

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Pregnancy

Clobetasol propionate is classified as 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 teratogenic effects observed in animal studies with systemic corticosteroids. Use with caution and only if clearly needed.
Second Trimester: Risk of fetal growth restriction or other adverse effects with prolonged or high-dose systemic corticosteroid exposure. Topical absorption is generally low, but caution is advised.
Third Trimester: Risk of fetal growth restriction or other adverse effects with prolonged or high-dose systemic corticosteroid exposure. Topical absorption is generally low, but caution is advised.
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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. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for clobetasol and any potential adverse effects on the breastfed infant from clobetasol or from the underlying maternal condition.

Infant Risk: Low risk with limited, short-term use on small areas, avoiding application to the breast or nipple area to prevent direct infant exposure.
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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. Clobetasol solution is not recommended for children under 12 years of age. If used in older children, limit duration and monitor closely.

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Geriatric Use

No specific dose adjustments are required. However, elderly patients may have thinner skin and be more prone to local adverse effects such as skin atrophy, purpura, and telangiectasias. Monitor for these effects.

Clinical Information

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Clinical Pearls

  • Clobetasol propionate 0.05% solution is a super high-potency topical corticosteroid. It should be used with extreme caution and for limited durations.
  • The maximum recommended duration of treatment is 2 consecutive weeks, and the total dosage should not exceed 50 mL per week.
  • Avoid use on the face, groin, or axillae, or for diaper dermatitis, due to increased risk of local and systemic side effects.
  • Patients should be advised to wash their hands after applying the medication.
  • HPA axis suppression is a significant concern, especially with prolonged use, extensive body surface area application, or occlusion. Patients should be monitored for signs of systemic absorption.
  • Rebound flares can occur upon abrupt discontinuation after prolonged use; gradual tapering may be considered for some patients.
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Alternative Therapies

  • Other high-potency topical corticosteroids (e.g., fluocinonide, betamethasone dipropionate)
  • Medium-potency topical corticosteroids (e.g., triamcinolone acetonide, mometasone furoate)
  • Low-potency topical corticosteroids (e.g., hydrocortisone)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing therapy, especially on sensitive areas.
  • Emollients and moisturizers for barrier repair and symptom relief.
  • Systemic therapies (e.g., biologics, oral immunosuppressants) for severe, widespread, or refractory dermatoses.
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Cost & Coverage

Average Cost: Varies widely, typically $50 - $200+ per 50 mL bottle
Generic Available: Yes
Insurance Coverage: Tier 1-3 depending on insurance plan and formulary.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 guidance. 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 medication taken, the amount, and the time it occurred.