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Clobetasol Prop 0.05% Sol 25ml

Manufacturer TARO 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 receptor agonist; Anti-inflammatory agent
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Pregnancy Category
Category C
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FDA Approved
Aug 1985
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clobetasol propionate is a very strong (high-potency) corticosteroid medicine applied to the skin or scalp to reduce inflammation, redness, and itching caused by certain skin conditions like psoriasis or eczema. It works by calming down the 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.

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.
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Lifestyle & Tips

  • Apply a thin layer only to the affected skin or scalp area as directed by your doctor.
  • Do not use more than the prescribed amount or for longer than the prescribed duration (usually no more than 2 consecutive weeks).
  • Do not use on the face, groin, or armpits unless specifically instructed by your doctor.
  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Wash your hands thoroughly after applying the medication.
  • Do not cover the treated area with bandages or dressings unless directed by your doctor, as this can increase absorption and side effects.
  • Inform your doctor if your condition does not improve after 2 weeks of treatment.
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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 area of the scalp or skin twice daily

Condition-Specific Dosing:

psoriasis: Apply to affected areas twice daily for up to 2 consecutive weeks. Total dosage should not exceed 50 g per week.
eczema: Apply to affected areas twice daily for up to 2 consecutive weeks. Total dosage should not exceed 50 g per week.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (use generally not recommended due to increased risk of systemic absorption and HPA axis suppression)
Child: Not established (use generally not recommended due to increased risk of systemic absorption and HPA axis suppression). If used, limit to shortest duration and smallest amount possible, typically not exceeding 5 days.
Adolescent: Similar to adult dosing, but with caution and limited duration due to potential for HPA axis suppression.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)
Dialysis: No specific considerations (minimal systemic absorption)

Hepatic Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)

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: Variable; generally low systemic absorption (less than 1%) through intact skin, but can increase significantly with inflammation, skin barrier disruption, occlusive dressings, or application to large surface areas.
Tmax: Not typically relevant for topical application; systemic levels are usually undetectable or very low.
FoodEffect: Not applicable (topical administration)

Distribution:

Vd: Not well-quantified for topical application due to minimal systemic absorption. Systemically absorbed corticosteroids are extensively distributed to all body tissues.
ProteinBinding: Approximately 90% (for systemically absorbed corticosteroids)
CnssPenetration: Limited (for topically absorbed amounts)

Elimination:

HalfLife: Not well-defined for topical application due to variable absorption; systemic half-life of corticosteroids is typically 2-4 hours.
Clearance: Not well-quantified for topical application.
ExcretionRoute: Renal excretion of metabolites; small amounts of unchanged drug may be excreted in bile.
Unchanged: Minimal (for systemically absorbed amounts)
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Pharmacodynamics

OnsetOfAction: Within hours for symptomatic relief (e.g., reduction in itching, redness)
PeakEffect: Within days of consistent application for maximal anti-inflammatory effect.
DurationOfAction: Localized effect persists for several 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 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 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 a comprehensive list of all 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
  • Signs of skin infection (e.g., pus, spreading redness, fever)
  • Skin thinning, easy bruising, or stretch marks (striae) in the treated area
  • Changes in skin color (lightening or darkening)
  • Acne-like breakouts or increased hair growth in the treated area
  • Unusual fatigue, weight loss, dizziness, nausea, or swelling (rare, but can indicate systemic absorption and adrenal suppression)
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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. Never start, stop, or adjust 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.

To ensure safe use, follow these precautions:
- Keep this medication away from open flames or sparks, and do not smoke while using it, as it may be flammable.
- Do not use this medication to treat diaper rash, acne, rosacea, or rashes around the mouth.

When applying this medication:
- Exercise caution when covering large areas of skin or applying it to areas with open wounds. Consult your doctor for guidance.
- Before using any other skin products, including soaps, consult your doctor to avoid potential interactions.
- Avoid applying this medication to cuts, scrapes, or damaged skin.
- Use this medication only for the duration prescribed by your doctor. Do not exceed the recommended treatment period.

Important safety considerations:
- If this medication is ingested, it may cause harm. In case of accidental ingestion, immediately contact a doctor or a poison control center.
- Long-term use of this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.

Special considerations for children and adolescents:
- This medication may not be suitable for all ages. Consult your doctor before administering it to a child.
- When used in children, this medication requires careful monitoring due to a higher risk of certain side effects.
- In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary. Discuss this potential effect with your doctor.

For breastfeeding mothers:
- Avoid applying this medication directly to the nipple or the surrounding area to prevent potential harm to the infant.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the benefits and risks of using this medication to ensure the best outcome for both 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 use gradually under medical supervision. Symptomatic and supportive treatment. Call a poison control center (e.g., 1-800-222-1222) or seek immediate medical attention.

Drug Interactions

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Contraindicated Interactions

  • None (due to minimal systemic absorption)
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Major Interactions

  • None (due to minimal systemic absorption)
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Moderate Interactions

  • None (due to minimal systemic absorption)
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Minor Interactions

  • None (due to minimal systemic absorption)

Monitoring

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Baseline Monitoring

Skin condition (type, severity, extent of lesion)

Rationale: To establish baseline for efficacy assessment and identify contraindications.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in redness, scaling, itching)

Frequency: Weekly or as clinically indicated

Target: Improvement of symptoms

Action Threshold: Lack of improvement after 2 weeks, consider re-evaluation of diagnosis or treatment.

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

Frequency: At each follow-up visit

Target: Absence of or minimal adverse effects

Action Threshold: Presence of significant or worsening adverse effects; discontinue or reduce frequency.

Signs of HPA axis suppression (e.g., fatigue, weight loss, dizziness, nausea)

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

Target: Normal HPA axis function

Action Threshold: Symptoms suggestive of suppression; consider ACTH stimulation test or plasma cortisol levels.

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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 (rare, with extensive/prolonged use)

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 with caution, for the shortest duration, and on the smallest body surface area possible.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity with high doses of corticosteroids in animal studies; human data are limited.
Second Trimester: Risk of fetal growth restriction or other adverse effects with prolonged or extensive use of potent corticosteroids.
Third Trimester: Risk of adrenal suppression in the neonate if used extensively or for prolonged periods near term.
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Lactation

Use with caution. It is not known whether topical clobetasol is excreted in human milk. Systemic corticosteroids are excreted in breast milk. 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.

Infant Risk: Low risk with limited, short-term topical use. Avoid applying 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) due to a larger skin surface area to body weight ratio and immature skin barrier. Use should be limited to the smallest amount compatible with an effective therapeutic regimen and for the shortest possible duration, typically not exceeding 5 days. Not recommended for children under 12 years of age.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Clobetasol propionate is one of the most potent topical corticosteroids; use should be limited to short-term treatment (typically 2 weeks) to minimize risk of local and systemic side effects.
  • Avoid prolonged use on the face, groin, or axillae, as these areas are more susceptible to atrophy and other side effects.
  • HPA axis suppression is a significant concern, especially with extensive application, occlusive dressings, or in pediatric patients. Monitor for signs and symptoms.
  • Patients should be instructed on proper application technique: apply a thin film to the affected area and rub in gently.
  • If no improvement is seen after 2 weeks, the diagnosis should be re-evaluated.
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Alternative Therapies

  • Other topical corticosteroids of lower potency (e.g., triamcinolone, fluocinonide, betamethasone)
  • Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
  • Vitamin D analogs (e.g., calcipotriene) for psoriasis
  • Retinoids (e.g., tazarotene) for psoriasis
  • Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread conditions
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Cost & Coverage

Average Cost: $50 - $200 per 25ml bottle
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. 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 emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.