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Clobetasol Prop 0.05% Lotion 59ml

Manufacturer ACTAVIS Active Ingredient Clobetasol Lotion(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 2001
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Clobetasol propionate lotion is a very strong (high-potency) steroid medicine applied to the skin. It helps reduce redness, itching, and swelling caused by certain skin conditions like eczema and psoriasis. It should only be used for a short time and exactly as prescribed by your doctor.
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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.
 Keep the medication away from your 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 this 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.
 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 and discard it when it is no longer usable.
 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 to make up for a missed dose.
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Lifestyle & Tips

  • Apply a thin layer only to the affected skin areas. Do not use more than prescribed.
  • Wash your hands thoroughly before and after applying the lotion.
  • Do not cover the treated area with bandages or other dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
  • Avoid applying to the face, groin, or armpits unless directed by your doctor, as these areas are more susceptible to side effects.
  • Do not use for longer than 2 consecutive weeks, or exceed 50 grams per week, to minimize the risk of side effects.
  • Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Do not use on children under 12 years of age without specific doctor's instructions and close monitoring.
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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 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 a thin layer to the 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.
eczema: Apply a thin layer to the 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.
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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). If used, limit to the smallest amount for the shortest duration.
Adolescent: For adolescents 12 years and older, use with caution and limit to 2 consecutive weeks, not exceeding 50 g per week, similar to adult dosing, but with close monitoring for systemic effects.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required for topical use.
Moderate: No specific dose adjustment required for topical use.
Severe: No specific dose adjustment required for topical use, but systemic absorption may be a concern with extensive use in patients with severe renal impairment.
Dialysis: No specific recommendations. Monitor for systemic effects if extensive use is necessary.

Hepatic Impairment:

Mild: No specific dose adjustment required for topical use.
Moderate: No specific dose adjustment required for topical use.
Severe: No specific dose adjustment required for topical use, but systemic absorption may be a concern with extensive use in patients with severe hepatic impairment due to reduced metabolism.

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, collectively called lipocortins. These proteins are thought to 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; systemic absorption occurs, with the extent depending on the vehicle, integrity of the epidermal barrier, site of application, duration of exposure, and use of occlusive dressings. Higher absorption occurs on areas with thin skin (e.g., face, scrotum) or damaged skin.
Tmax: Not precisely quantified for topical application; systemic levels are generally low but can accumulate with extensive or prolonged use.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: Not available for topical application; after systemic absorption, corticosteroids are widely distributed throughout the body.
ProteinBinding: Approximately 90% bound to plasma proteins (primarily transcortin and albumin) after systemic absorption.
CnssPenetration: Limited for topical application; however, systemic absorption can lead to some CNS penetration.

Elimination:

HalfLife: Not precisely determined for topical application; systemic corticosteroids have varying half-lives (e.g., hydrocortisone has a plasma half-life of 8-12 hours).
Clearance: Not available for topical application.
ExcretionRoute: Metabolites are primarily excreted by the kidneys, with some excretion in the bile.
Unchanged: Very little unchanged drug is excreted.
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Pharmacodynamics

OnsetOfAction: Rapid, typically within hours to days of initial application.
PeakEffect: Within several days to a week of consistent application.
DurationOfAction: Depends on the frequency of application and the severity of the condition; effects persist as long as the drug is applied, but treatment duration is limited to prevent adverse effects.
Confidence: Medium

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
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
 Signs of high blood sugar, including:
+ Confusion
+ Drowsiness
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or abdomen
+ Moon face
+ Severe headache
+ Slow wound healing
 Signs of a weak adrenal gland, including:
+ Severe nausea or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Extreme fatigue
+ Mood changes
+ Decreased appetite
+ Weight loss
Skin changes, such as:
+ Acne
+ Stretch marks
+ Slow wound healing
+ Excessive hair growth
 Irritation at the application site
Thinning of the skin
 Changes in vision, 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 unusual symptoms, contact your doctor for advice:

Burning or stinging sensations
 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:

  • Increased redness, swelling, or pus at the application site (signs of infection)
  • Skin thinning, stretch marks (striae), or spider veins (telangiectasias) in the treated area
  • Acne-like breakouts or increased hair growth where applied
  • Blurred vision or eye pain
  • Unusual weight gain, swelling in the face or body, or muscle weakness (signs of systemic steroid absorption)
  • Increased thirst or urination (signs of high blood sugar)
  • Slowed growth in children
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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

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 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 an extended period beyond what your doctor has prescribed.

If this medication is ingested, it can be harmful. In the event 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. Consult your doctor to discuss this potential risk.

This medication may not be suitable for children of all ages. Before administering it to a child, consult your doctor to determine the appropriate course of treatment. When using this medication in children, exercise caution, as they may be at a higher risk of experiencing certain side effects.

In some cases, this medication can affect growth in children and teenagers. Regular growth checks may be necessary. Consult your doctor to discuss this potential risk.

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. You and your doctor will need to discuss the potential 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:

  • Signs of Cushing's syndrome (e.g., moon face, buffalo hump, central obesity, skin thinning, easy bruising)
  • Adrenal insufficiency (e.g., fatigue, weakness, nausea, vomiting, low blood pressure) upon abrupt withdrawal after prolonged high-dose use
  • Hyperglycemia (high blood sugar)

What to Do:

If overdose is suspected, contact a poison control center immediately (1-800-222-1222 in the US) or seek emergency medical attention. Management is supportive and symptomatic. Gradual withdrawal of the corticosteroid may be necessary if HPA axis suppression is present.

Drug Interactions

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Major Interactions

  • Ritonavir (due to strong CYP3A4 inhibition, can significantly increase systemic exposure to clobetasol, leading to Cushing's syndrome and adrenal suppression)
  • Itraconazole (due to strong CYP3A4 inhibition, can significantly increase systemic exposure to clobetasol, leading to Cushing's syndrome and adrenal suppression)

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.

Adrenal function (e.g., plasma cortisol, ACTH stimulation test)

Rationale: Consider for patients at high risk of HPA axis suppression (e.g., extensive body surface area treatment, prolonged use, use under occlusion, pediatric patients).

Timing: Prior to initiation of therapy, especially if prolonged or extensive use is anticipated.

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Routine Monitoring

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

Frequency: Regularly during treatment, at each follow-up visit.

Target: Absence or minimal signs of adverse reactions.

Action Threshold: If severe or persistent reactions occur, discontinue use or reduce frequency/potency.

Signs of systemic absorption (e.g., Cushingoid features, hyperglycemia, growth retardation in children)

Frequency: Regularly during treatment, especially with prolonged or extensive use.

Target: Absence of systemic signs.

Action Threshold: If signs of systemic absorption appear, evaluate for HPA axis suppression and consider discontinuation or alternative therapy.

Adrenal function (e.g., plasma cortisol, ACTH stimulation test)

Frequency: Periodically during prolonged or extensive therapy, especially in pediatric patients.

Target: Normal adrenal function.

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

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Symptom Monitoring

  • Worsening of skin condition or lack of improvement after 2 weeks
  • Signs of skin infection (redness, pus, increased pain)
  • Excessive thirst or urination (possible hyperglycemia)
  • Unusual weight gain, moon face, buffalo hump (Cushingoid features)
  • Blurred vision or eye pain (possible glaucoma/cataracts)
  • Growth retardation in children

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. Systemic absorption can occur, and high-potency topical corticosteroids used extensively or for prolonged periods may increase the risk of low birth weight.

Trimester-Specific Risks:

First Trimester: Potential for teratogenic effects, though data from human topical use are limited. Avoid extensive use.
Second Trimester: Risk of fetal growth restriction with extensive or prolonged use of high-potency topical corticosteroids.
Third Trimester: Risk of fetal growth restriction and potential for HPA axis suppression in the neonate if used extensively near term.
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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. Caution should be exercised when clobetasol propionate lotion is administered to a nursing woman. Avoid applying to the breast area to prevent direct infant exposure.

Infant Risk: Low risk with limited, short-term use on small areas. Potential for systemic effects in the infant if significant maternal systemic absorption occurs or if applied directly to the breast and ingested by the infant.
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Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Use in children under 12 years is generally not recommended. If used, limit to the smallest amount for the shortest duration possible, and monitor closely for systemic effects and growth retardation.

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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, requiring careful monitoring.

Clinical Information

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Clinical Pearls

  • Clobetasol propionate 0.05% lotion is a super high-potency topical corticosteroid; use it sparingly and for short durations (typically 2 weeks maximum) to minimize systemic absorption and local side effects.
  • Educate patients thoroughly on proper application technique, emphasizing thin layers and avoiding occlusion unless specifically instructed.
  • Warn patients about the risk of HPA axis suppression, especially with extensive use, prolonged therapy, or in pediatric patients.
  • Avoid use on the face, groin, or axillae due to increased risk of skin atrophy, telangiectasias, and striae in these sensitive areas.
  • If no improvement is seen after 2 weeks, re-evaluate the diagnosis and treatment plan; prolonged use is rarely justified.
  • Consider tapering off if used for more than 2 weeks to prevent rebound flares of the dermatosis.
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Alternative Therapies

  • Other topical corticosteroids (e.g., medium to high potency for less severe conditions or maintenance)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for sensitive areas or long-term management
  • 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 59ml bottle
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (preferred or non-preferred brand/generic), varies by insurance 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 occurred.